 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES March 27, 2002 MEMORANDUM SUBJECT: Occupational Exposure and Risk Assessment/ Characterization for the Proposed Use of Linuron on Rhubarb and Celeriac.

FROM: Shanna Recore, Industrial Hygienist Reregistration Branch II Health Effects Division (7509C)

TO: Carol Christensen, Risk Assessor Reregistration Branch II Health Effects Division (7509C)

THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C)

Please find the review of Linuron.

DP Barcode: D281845 Pesticide Chemical Codes: 035506 EPA Reg Numbers: 1812 245, 1812 320 PHED: Yes, Version 1.1 Summary 2 Interregional Research Project No. 4 (IR 4), on behalf of Griffin Corporation, is proposing two new uses, rhubarb and celeriac, for the herbicides Linex ® 50DF (dry flowable) and Linex ® 4L (liquid) which controls grasses and broadleaf weeds. Linuron may be applied either by ground sprayers or chemigation to rhubarb and celeriac. A maximum of one application of 1.5 lbs active ingredient (ai)/ acre per season is proposed.

Based on the proposed use patterns, short term dermal and inhalation exposures (1 30 days) are expected for private applicators (farmers treating their own crops) and commercial applicators. Since no chemical specific data are available to assess potential exposure to workers, the exposure and risk assessment presented in this document are based on the Pesticide Handler Exposure Database Version 1.1 (PHED, Surrogate Exposure Guide, August 1998). The maximum application rate listed on the label was used for all calculations. The standard values for acreage were taken from HED Exposure Science Advisory Committee (Expo SAC) Policy # 9.1, effective September 25, 2001. All calculated Margins of Exposure (MOEs) do not exceed HED's level of concern at the minimum personal protective equipment (PPE) level.

Workers having potential post application re entry exposure to linuron from the proposed use include scouts and workers re entering treated fields to perform irrigation and handweeding tasks. Since linuron will be applied at the early stages of crop growth, low potential for post application exposure is expected. In order to demonstrate that minimal exposure and risk are expected, a post application exposure assessment was done for scouting, handweeding and irrigating. The estimated MOE for these activities related to the proposed use of linuron on rhubarb and celeriac does not exceed HED's level of concern, on the day of application.

Use Patterns and Formulations IR 4, on behalf of Griffin LLC, has proposed the registration of two new uses, rhubarb and celeriac, for the previously registered herbicides Linex ® 50DF (EPA Reg. No. 1812 320) and Linex ® 4L (EPA Reg. No. 1812 245). Linex ® 50DF is a dry flowable containing 50% of the ai linuron. Linex ® 4L is a liquid containing 40.6% of the ai linuron. According to the labels, this product is applied as a non direct spray to control annual grasses and broadleaf weeds. A maximum of one to two application per season of 0.75 to 1.5 lbs ai/ acre, but no more than 2 lb ai/ acre/ year, may be applied by ground sprayers or by chemigation (Linex ® 4L only). For Linex ® 50DF, applications using irrigation equipment is prohibited. According to the proposed labels, linuron is applied to rhubarb, after harvest but before the regrowth of crop, and to celeriac, before a height of eight inches is reached and before annual grasses exceed two inches in height and before broadleaf weed exceed six inches in height. Table 1 summarizes the proposed linuron use on rhubarb and celeriac. Currently, there are no registered or proposed residential uses of linuron. 4,5 Table 1: Use Pattern Summary of Linuron on Rhubarb and Celeriac 3 Formulation Linex ® 50DF  dry flowable Linex ® 4L  liquid Pests annual grasses and broadleaf weeds Application methods Linex ® 50DF  groundboom sprayer Linex ® 4L  groundboom sprayer and chemigation Maximum application rate (AR) 1.5 lbs a. i./ acre (Maximum application per year is 2 lbs ai/ acre)

Number of applications per season 1 2 Timing/ frequency Rhubarb  after harvest but before the regrowth of crop Celeriac  before a height of 8 inches is reached and before annual grasses exceed 2 inches in height and before broadleaf weed exceed 6 inches in height Manufacturer Griffin LLC Toxicological Profile Table 2 presents the acute toxicity categories as outlined in the Linuron  Report of the Hazard Identification Assessment Review Committee (HIARC). 3 Table 2: Acute Toxicity of Linuron (ai)

Guideline No. Study Type MRIDs # Results Toxicity Category 870.110 Acute Oral (Rat) 00027625 LD50 = 2600 mg/ kg III 870.1200 Acute Dermal (Rabbit) 00027625 LD50 > 2,000 mg/ kg III 870.1300 Acute Inhalation (Rat) 00053769 LC50 > 218 mg/ L IV 870.2400 Primary Eye Irritation 42849001 Slight conjunctival redness at 24 hrs; clear at 72 hrs III 870.2500 Primary Skin Irritation 42849002 Not an irritant IV 870.2600 Dermal Sensitization 00146868 Not a sensitizer N/ A The HIARC memorandum, dated November 20, 2001, indicates that there are toxicological endpoints of concern for linuron. The endpoints, and associated uncertainty factors used in assessing the risks for linuron are presented in Table 3. 3 Table 3: Summary of Dose and Toxicological Endpoints for Linuron 4 Exposure Scenario NOAEL (mg/ kg/ day) Effect Study Uncertainty Factors Target MOE Short Term Dermal (1 30 days)

(Occupational/ Residential) Oral NOAEL = 5.8 a Statistically and biologically significant decrease in premating body weights in F0 and F1 animals 2 Generation Reproduction Study  Rat Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 IntermediateTerm Dermal (1  6 months)

(Occupational/ Residential) Oral NOAEL = 0.77 a Increased met and sulfhemoglobin levels after 3 and 6 months of treatment Chronic Feeding Study  Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Long Term Dermal (Longer than 6 months) (Occupational/ Residential) Oral NOAEL = 0.77 a Increased met and sulfhemoglobin levels Chronic Feeding Study  Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Short Term Inhalation (1 30 days)

(Occupational/ Residential) Oral NOAEL = 5.8 b statistically and biologically significant decrease in premating body weights in F0 and F1 animals 2 Generation Reproduction Study  Rat Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 IntermediateTerm Inhalation (1 to 6 months)

(Occupational/ Residential) Oral NOAEL = 0.77 b Increased met and sulfhemoglobin levels Chronic Feeding Study  Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Long Term Inhalation (Longer than 6 months)

(Occupational/ Residential) Oral NOAEL= 0.77 b Increased met and sulfhemoglobin levels Chronic Feeding Study  Dog Interspecies: 10x Intraspecies: 10x FQPA: 10x Occupational: 100 Footnote a = Assume 16% dermal absorption for route to route extrapolation b = Assume 100% inhalation absorption for route to route extrapolation FQPA Safety Factor The FQPA Safety Factor Committee memorandum, dated December 6, 2001, 5 recommended that the FQPA safety factor be retained at 10x for the following weight ofevidence considerations:

° a qualitative increase in susceptibility seen in the F1 males in the rat reproductive toxicity study; and ° a developmental neurotoxicity study in rats is required for the chemical because linuron is a potential endocrine disruptor and there is evidence for testicular lesions and decreased fertility in the rat reproductive toxicity study.

However, the Committee concluded that the safety factor could be reduced to 3x for linuron because:

° the toxicology database is complete; ° the dietary (food and water) exposure assessments will not underestimate the potential exposures for infants, children, and/ or women of childbearing age; and ° there are no residential uses.

When assessing acute dietary exposure of females 13 50 years of age, the safety factor should be reduced to 3x since the developmental neurotoxicity study in rats is required and may further define the neurotoxic (neuro endocrine) potential observed in rats that were exposed in pre and post natal time periods. However, when assessing chronic dietary exposure to all other population sub groups, the safety factor should be retained at 10x since there is concern for the qualitative increase in susceptibility observed in the rat reproductive toxicity study (a long term study), and, since the developmental neurotoxicity study in rats is required. The developmental neurotoxicity study may further define the neurotoxic (neuro endocrine) potential observed in rats due to pre and post natal exposure. 2 Cancer Determination The RfD/ Peer Review Committee has classified linuron as an unquantifiable Group C carcinogen (a possible human carcinogen for which there is limited animal evidence) requiring no quantification of human cancer risk.

Occupation Exposure Assessment Occupational Handler Exposures and Risk Estimates PHED Since no chemical specific data are available to assess potential exposure to workers, the exposure and risk assessment presented in this document are based on the Pesticide Handlers Exposure Database (PHED) Version 1.1. It is the policy of the HED to use data from PHED to assess handler exposures for regulatory actions when chemical specific monitoring data are not available. 7 6 PHED was designed by a task force of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts  a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals (i. e., replicates).

Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity (e. g., mixing/ loading, applying), formulation type (e. g., wettable powders, granulars), application method (e. g., aerial, groundboom), and clothing scenarios (e. g., gloves, double layer clothing).

Once the data for a given exposure scenario have been selected, the data are normalized (i. e., divided by) by the amount of pesticide handled resulting in standard unit exposures (milligrams of exposure per pound of active ingredient handled). Following normalization, the data are statistically summarized. The distribution of exposure values for each body part (e. g., chest upper arm) is categorized as normal, lognormal, or "other" (i. e., neither normal nor lognormal). A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all "other" distributions. Once selected, the central tendency values for each body part are composited into a "best fit" exposure value representing the entire body.

The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. To add consistency and quality control to the values produced from this system, the PHED Task Force has evaluated all data within the system and has developed a set of grading criteria to characterize the quality of the original study data. The assessment of data quality is based on the number of observations and the available quality control data. These evaluation criteria and the caveats specific to each exposure scenario are summarized in Table 6. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies (e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. 6 7 Occupational Handler Exposure Scenarios HED has determined that there are potential exposures to mixer, loader, applicator and other handlers during the usual use patterns associated with linuron. Based on the use patterns, three major occupational exposure scenarios were identified for linuron:

(1a) mixing/ loading liquids for ground application; (1b) mixing/ loading liquids for chemigation application; (2) mixing/ loading dry flowable for ground application; and (3) applying liquids with groundboom sprayer.

The current Linex ® 50DF and Linex ® 4L labels have the following PPE requirements for handlers: coveralls over short sleeved shirt and short pants, waterproof gloves, shoes plus socks, and chemical resistant headgear for overhead exposures.

Assumptions for Handler Exposure Scenarios The following assumptions and factors were used in order to complete this exposure assessment:

C average body weight of an adult handler is 70 kg;

° average work day interval represents an 8 hour workday (e. g., the acres treated or volume of spray solution prepared in a typical day);

° for groundboom equipment use on rhubarb and celeriac, 80 acres per day was used to assess handler exposure; 8 ° for chemigation application to rhubarb and celeriac, 350 acres per day was used; 8 ° aerial application will be prohibited on the label for application to rhubarb and celeriac;

° calculations are completed at the maximum application rates for crops as stated on the designated linuron labels; and ° due to a lack of scenario specific data, HED calculates unit exposure values using generic protection factors that are applied to represent various risk mitigation options (i. e., the use of PPE and engineering controls). 8 Occupational Handler Exposures and Non Cancer Risk Assessment Equations to Calculate Handler Exposure Daily dermal exposure is calculated using the following formula:

Daily inhalation exposure is calculated using the following formula:

The daily dermal and inhalation dose is calculated as follows using a 70 kg body weight:

The dermal and inhalation MOEs were calculated using the following formulas:

Based on the available toxicity data, it is appropriate to combine short term dermal and inhalation MOEs because the effects observed at the LOAEL were identical. The total MOE 9 were calculated using the following formula:

Based on the proposed use patterns, short term (1 to 30 days) dermal and inhalation exposures are expected for private applicators (farmers treating their own crops) and commercial applicators. Since linuron may be applied only one to two times per year and has a limited crop production (for celeriac  only 750 acres are grown in the United States; for rhubarb  only 860 acres are grown in the United States), intermediate term (30 days to 6 months) and long term (longer than 6 months) exposures are not expected from the proposed use. Table 4 presents the summary of occupational handler short term (1 30 days) dermal and inhalation exposures at baseline, with additional personal protective equipment, and with engineering controls. Table 5 lists the caveats and parameters specific to the surrogate data used for each scenario and corresponding exposure/ risk assessment. See appendix tables A, B, C, and D for additional information. 10 Table 4. Summary of Occupational Handler Short term Dermal and Inhalation Total Exposure Variables Exposure Scenario (Scenario #) Crop Application rates a Area Treated Total Short term MOE Baseline b, f Total Short term MOE Min PPE c, f Total Short term MOE Max PPE d, f Total Short term MOE Eng. Control e, f Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1a) Rhubarb and Celeriac 1.50 lb ai per acre 80 Acres per day 7. 3 860

Mixing/ Loading Liquids for Chemigation application (1b) Rhubarb and Celeriac 1.50 lb ai per acre 350 Acres per day 1. 7 200

Dry Flowables for Groundboom application (2) Rhubarb and Celeriac 1.50 lb ai per acre 80 Acres per day 300

Applicator Sprays for Groundboom application (3) Rhubarb and Celeriac 1.50 lb ai per acre 80 Acres per day 1100

Footnotes :

a Application Rates are based on the maximum application rates listed on the proposed linuron labels.

b Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, open cab tractor and baseline inhalation unit exposure represents no respirator 8 .

c Minimum PPE for all dermal scenarios include chemical resistant gloves (90% Protection Factor) and minimum PPE for all inhalation scenarios include a dust/ mist respirator (5 fold Protection Factor).

d Maximum PPE for all dermal scenarios include double layer of clothing (50% Protection Factor for clothing) and chemical resistant gloves (90% Protection Factor) and maximum PPE for all inhalation scenarios include an organic vapor respirator (90% Protection Factor).

e Engineering Controls for mixer/ loader include closed mixing/ loading, single layer clothing and scenario 1a and 1b also include chemical resistant gloves. Engineering Controls for applicators and flaggers include enclosed cockpit, cab or truck, single layer clothing, no gloves.

f Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE))

 Scenario's calculated MOE exceeds the target MOE at the previous level of mitigation (MOE> 100)

Table 5. Occupational Handler Exposure Scenario Descriptions for the Use of Linuron 11 Exposure Scenario (Scenario Number) Data Source Standard Assumption a (8 hr work day) Comments b MIXER/ LOADER DESCRIPTORS Mixing/ Loading Liquid Formulations (1a, b) PHED V1.1 ° 80 acres for groundboom to rhubarb and celeriac ° 350 acres for chemigation application to rhubarb and celeriac Baseline: Hand, dermal, and inhalation data are AB grades. Hand = 72 to 122 replicates; dermal = 53 replicates;

and inhalation = 85 replicates. High confidence in hand/ dermal and inhalation data. No protection factor was needed to define the unit exposure value.

PPE: The same dermal and inhalation data are used as for the baseline coupled with a 50% protection factor to account for an additional layer of clothing, and an 80% protection factor to account for the use of a dust/ mist respirator and 90% protection factor to account for the use of an organic vapor respirator, respectively. Hand data are AB grades, with 59 replicates. High confidence in hand/ dermal data.

Engineering Controls: Hand, dermal, and inhalation data are AB grades. Hand = 31 replicates; dermal =16 to 22 replicates; inhalation = 27 replicates. High confidence in hand/ dermal and inhalation data.

Mixing/ Loading Dry Flowable Formulations (2) PHED V1.1 ° 80 acres for groundboom to rhubarb and celeriac Baseline: Hand, dermal and inhalation data are AB grades. Hand = 7 replicates; dermal = 16 to 26 replicates; and inhalation = 23 replicates. Low confidence in hand/ dermal data and high confidence in inhalation data.

PPE: Hand/ dermal data are AB grades. The same inhalation data are used as for the baseline coupled with an 80%

protection factor to account for the use of a dust/ mist respirator and 90% protection factor to account for the use of an organic vapor respirator. Hand = 21 replicates and dermal = 16 to26 replicates. High confidence in hand/ dermal data.

Engineering Controls: No data APPLICATOR DESCRIPTORS Applying Sprays with a Groundboom Sprayer (3) PHED V1.1 ° 80 acres for groundboom to rhubarb and celeriac Baseline: Hand, dermal, and inhalation data are AB grades. Hand = 29 replicates; dermal = 23 to 42 replicates;

and inhalation = 22 replicates. High confidence in hand/ dermal and inhalation data. No protection factor was needed to define the unit exposure value.

PPE: The same dermal and inhalation data are used as for the baseline coupled with a 50% protection factor to account for an additional layer of clothing, and an 80% protection factor to account for the use of a dust/ mist respirator and 90% protection factor to account for the use of an organic vapor respirator, respectively. Hand data are ABC grades, with 21 replicates. Medium confidence in hand/ dermal data.

Engineering Controls: Hand and dermal data are ABC grades, and inhalation are AB grades. Hand = 16 replicates; dermal =20 to 31 replicates; inhalation = 16 replicates. Medium confidence in hand/ dermal data, and high confidence in inhalation data.

Footnotes a Standard Assumptions based on an 8 hour work day as estimated by HED. BEAD data were not available.

b All handler exposure assessments in this document are based on the "Best Available" data as defined by OREB SOP for meeting Subdivision U Guidelines. Best available grades are assigned to data as follows: matrices with grades A and B data and a minimum of 15 replicates; if not available, then grades A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the quality (i. e., All Grade Data) and number of replicates. High quality data with a protection factor take precedence over low quality data with no protection factor. Generic data confidence categories are assigned as follows: 12 High = grades A and B and 15 or more replicates per body part Medium = grades A, B, and C and 15 or more replicates per body part Low = grades A, B, C, D and E or any combination of grades with less than 15 replicates Summary of Non Cancer Risk Concerns for Occupational Handlers For the dermal and inhalation, short term exposure, the target MOE is 100. The calculated dermal and inhalation MOE values were combined for short term because the dermal and inhalation endpoints were the same. MOEs are calculated for all scenarios at baseline, minimum PPE, maximum PPE, and engineering control level exposures.

Baseline Level The calculations of short term combined dermal and inhalation risk indicate that the only scenarios with MOEs that are less than the target MOE of 100 at the baseline level are the following:

° (1a) mixing/ loading liquids for groundboom application to rhubarb and celeriac at 80 acres per day; and ° (1b) mixing/ loading liquids for chemigation application to rhubarb and celeriac at 350 acres per day.

Additional PPE The calculations of short term combined dermal and inhalation risk indicate that all the scenarios have MOEs that exceed the target MOE of 100 at the additional PPE level.

Engineering Controls The calculations of short term combined dermal and inhalation risk indicate that all the scenarios have MOEs that exceed the target MOE of 100 at the engineering control level.

Occupational Handler Exposure and Risk Estimates for Cancer Linuron cancer classification is "Suggestive evidence of carcinogenic potential by all routes of exposure, but not sufficient to assess human carcinogenic potential" therefore a occupational handler cancer assessment was not conducted. Occupational Post Application Exposures and Non Cancer Risk Estimates Linuron is in toxicity category III and IV for the dermal route of exposure, primary eye irritation, and primary skin irritation. Linuron is not a dermal sensitizer. Based on the Worker 13 Protection Standard (WPS), an interim REI of 12 hours is sufficient to protect workers performing re entry activities for the proposed use of linuron.

The WPS prohibits routine entry to perform hand labor tasks during the REI and requires PPE to be worn for other early entry tasks that require contact with treated surfaces. The linuron labels specify the following early entry PPE: coveralls over short sleeved shirt and short pants, waterproof gloves, shoes, socks, and chemical resistant headgear for overhead exposure.

The transfer coefficients used in this assessment for the use on rhubarb and celeriac are from the Agricultural Re entry Task Force (ARTF) database. An interim transfer coefficient policy was developed by HED's Science Advisory Council for Exposure using the ARTF database. It is the intention of HED's Science Advisory Council for Exposure that this policy will be periodically updated to incorporate additional information about agricultural practices in crops and new data on transfer coefficients. Much of this information will originate from exposure studies currently being conducted by the ARTF, from the further analysis of studies already submitted to the Agency, and from the studies in the published scientific literature. 8,9 Although rhubarb and celeriac are not specifically listed in the EPA Policy 3.1, the transfer coefficient for celery, a similar crop, was used as a surrogate.

The rhubarb and celeriac surrogate assessments use a low transfer coefficient of 500 cm 2 /hr for activities such as scouting during minimal foliage development. 8 The linuron labels indicates that it is applied pre emergent to rhubarb and post emergent but before a height of eight inches is reached to celeriac. 4,5 Therefore, the high transfer coefficient for activities, such as scouting during full foliage, will not be used. No chemical specific dislodgeable foliar residue (DFR) or turf transferable residue (TTR) data exist. The DFR is derived from using an estimated 20 percent of the rate applied as initial dislodgeable residues for rhubarb and celeriac. An estimated 10 percent dissipation rate per day for rhubarb and celeriac. The duration of postapplication exposure is assumed to be short term.

The equations used to calculate the post application in Table 6 are presented below:

Surrogate DFR calculation (rhubarb and celeriac):

Where: AR = Application rate (1.5 lbs ai/ acre for rhubarb and celeriac) DR = Daily dissipation rate (10 percent/ day) t = Days after treatment CF = Conversion factor (11.2 µg per cm 2 /lb ai per A) F = Fraction retained on foliage (20% for rhubarb and celeriac) 14 Dose calculation:

Where: DFR = Initial DFR or daily DFR (µg/ cm 2 ) Tc = Transfer coefficient (500 cm 2 /hr for rhubarb and celeriac) CF = Conversion factor (1 mg/ 1,000 µg) ED = Exposure duration (8 hours per day) BW = Body weight (70 kg)

Where: NOAEL = 5.8 mg/ kg/ day Dose = Calculated dose (mg/ kg/ day)

Occupational Post application Non cancer Risk Summary For non cancer risks, the calculated MOE for rhubarb and celeriac exceeds the target MOE on the day of application for activities such as handweeding, scouting, and irrigating (see table 6). 15 Table 6. Linuron Non Cancer Post application Assessment Crop Maximum Label Application Rate (lbs ai/ acre) a Transfer Coefficient b (cm 2 /hr) Activity c DAT d DFR e (µg/ cm 2 ) MOE f Rhubarb and Celeriac 1.5 500 hand weeding, scouting, and irrigating 0 (12 hours) 3.36 190 Footnotes: a Maximum application rates as proposed for linuron use on rhubarb and celeriac. b Transfer Coefficients from Science Advisory Council on Exposure Policy 3.1. 7 c Activities from Science Advisory Council on Exposure Policy 3.1. 7 Every activity listed may not occur for every crop in the group. d DAT is "days after treatment" e Initial DFR (µg/ cm 2 ) = Application rate (lbs ai/ A) x Conversion factor (1 lb ai/ acre= 11.209 µg/ cm2) x Fraction of initial ai retained on foliage (20%) f MOE = NOAEL (mg/ kg/ day) / Dermal dose (mg/ kg/ day). Target MOE = 100.

Occupational Post application Exposure and Risk Estimates for Cancer Linuron was classified as an unquantifiable Group C carcinogen (a possible human carcinogen for which there is limited animal evidence) requiring no quantification of human cancer risk; therefore, an occupational handler cancer assessment was not conducted.

Residential Exposure and Risks Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application, but to a lesser extent, groundboom application methods could also be a potential source of exposure. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off target drift and risks associated with aerial as well as other application types where appropriate.

HED has determined that, other than the possibility of spray drift exposure, there are no potential post application exposures to residents because linuron is not used in any residential areas. 16 Incident Reports The Agency searched several databases for reports of poisoning incident data for linuron. These databases include the OPP Incident Data System, the Poison Control Centers database, the California Department of Pesticide Regulation, and the National Pesticide Telecommunications Network. Relatively few incidents of illness have been reported. Three cases were submitted to the California Pesticide Illness Surveillance Program (1982 1999) concerning possible linuron poisoning. Effects reported in these cases include chemical conjuctivitis when linuron was splashed into the eyes, headache, nausea, swollen tongue and blurred vision, and itchy hives. According to the fifth edition of "Recognition and Management of Pesticide Poisonings" (EPA 1999), systemic toxicity is unlikely unless large amounts have been ingested. No recommendations can be made based on the few incident reports available for linuron. 1 17 References 1. Blondell, J. and M. Spann (2001) Review of Linuron Incident Reports DP Barcode D280196, Chemical #035506. U. S. Environmental Protection Agency, Office of Pesticide Programs. January 11, 2001.

2. Christensen, C. (2001) Linuron  Report of the FQPA Safety Factor Committee. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. December 6, 2001.

3. Fricke, R. (2001) Linuron: Report of the Hazard Identification Assessment Review Committee. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. November 20, 2001.

4. Interregional Research Project No. 4 (1998) Petition Re: Linuron/ Rhubarb/ PR# 06591, New Use, No date for review. Interregional Research Project No. 4. Center for Minor Crop Pest Management. Letter from Edith Lurvey (IR 4) to Hoyt Jamerson (MUERIB/ RD/ OPP), August 20, 1998.

5. Interregional Research Project No. 4 (1998) Petition Re: Linuron/ Celeriac/ PR# 03557, New Use, No date for review. Interregional Research Project No. 4. Center for Minor Crop Pest Management. Letter from Edith Lurvey (IR 4) to Hoyt Jamerson (MUERIB/ RD/ OPP), August 20, 1998.

6. U. S. EPA (1998) PHED Surrogate Exposure Guide, Version 1.1. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. August 1998.

7. U. S. EPA (1999) Use of Values from the PHED Surrogate Table and Chemical specific Data, Science Advisory Council for Exposure Policy No. 7. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. January 28, 1999.

8. U. S. EPA (2001) Agricultural Transfer Coefficients, Science Advisory Council for Exposure Policy No. 3.1. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. August 7, 2000.

9. U. S. EPA (2001) Revised  Standard Values for Daily Acres Treated in Agriculture, Science Advisory Council for Exposure Policy No. 9.1. Washington, D. C.: U. S. Environmental Protection Agency, Office of Pesticide Programs. September 25, 2001. 18 Appendix 19 Table A. Occupational Handler Short Term Risk to Linuron at Baseline Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 2.9 1. 2 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.80 7 0. 0021 2800 7.3 Dry Flowables for Groundboom application (2) 0.066 0.77 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.018 320 0.0013 4400 300.0 Mixing/ Loading Liquids for Chemigation application (3) 2.9 1. 2 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 3.5 2 0.009 640 1.7 Applicator Sprays for Groundboom application (4) 0.014 0.74 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0038 1500 0.0013 4600 1100.0 Footnotes: a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator.

c Application rates are based on the maximum application rates listed on the proposed linuron labels.

d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)).

e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100.

f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg).

g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100.

h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100. 20 Table B. Occupational Handler Short Term Risk to Linuron with Minimum PPE Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 0.023 0.24 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0063 920 0.00041 14000 860.0 Dry Flowables for Groundboom application (1b) 0.066 0.15 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.018 320 0.00026 23000 320.0 Mixing/ Loading Liquids for Chemigation application (2) 0.023 0.24 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 0.028 210 0.0018 3200 200.0 Applicator Sprays for Groundboom application (3) 0.014 0.15 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0038 1500 0.00026 23000 1400.0 Footnotes :

a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator.

c Application rates are based on the maximum application rates listed on the proposed linuron labels.

d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)).

e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100.

f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg).

g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100.

h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100. 21 Table C. Occupational Handler Short Term Risk to Linuron with Maximum PPE Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 0.017 0.12 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0047 1200 0.00021 28000 1200.0 Dry Flowables for Groundboom application (1b) 0.047 0.077 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.013 450 0.00013 44000 450.0 Mixing/ Loading Liquids for Chemigation application (2) 0.017 0.12 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 0.020 280 0.0009 6400 270.0 Applicator Sprays for Groundboom application (3) 0.011 0.074 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0030 1900 0.00013 46000 1800.0 Footnotes :

a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator.

c Application rates are based on the maximum application rates listed on the proposed linuron labels.

d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)).

e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100.

f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg).

g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100.

h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100. 22 Table D. Occupational Handler Short Term Risk to Linuron with Engineering Controls Exposure Scenario (Scenario #) Dermal Unit Exposure (mg/ lb ai) a Inhalation Unit Exposure b (Ug/ lb ai) Crop Application Rate c Amount Treated Dermal Dose (mg/ kg/ day) d Dermal MOE e Inhalation Dose (mg/ kg/ day) f Inhalation MOE g Total MOE h Mixer/ Loader Mixing/ Loading Liquids for Groundboom application (1) 0.0086 0.083 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0024 2500 0.00014 41000 2300.0 Dry Flowables for Groundboom application (1b) No Data No Data Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day No Data No Data No Data No Data Mixing/ Loading Liquids for Chemigation application (2) 0.0086 0.083 Rhubarb, Celeriac 1.50 lb ai per acre 350 Acres per day 0.010 560 0.00062 9300 530.0 Applicator Sprays for Groundboom application (3) 0.005 0.043 Rhubarb, Celeriac 1.50 lb ai per acre 80 Acres per day 0.0014 4200 0.000074 79000 4000.0 Footnotes :

a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, and open cab tractor b Baseline inhalation unit exposure represents no respirator.

c Application rates are based on the maximum application rates listed on the proposed linuron labels.

d Daily Dermal Dose (mg/ kg/ day) = Dermal Unit Exposure (mg/ lb ai)* Application Rate (lb ai/ acre)* Amount Treated (acres/ day)* dermal absorption (16%)/ Body Weight (70 kg)).

e Dermal MOE = NOAEL (5.8 mg/ kg/ day) / Daily Dermal Dose (mg/ kg/ day) . The target MOE value is 100.

f Daily Inhalation Dose (mg/ kg/ day) = (Inhalation Unit Exposure (mg/ lb ai) * Application Rate (lb ai/ acre) * Amount Treated (acres/ day)* 1mg/ 1000µg) / Body weight (70kg).

g Inhalation MOE = NOAEL (5.8 mg/ kg/ day) / Daily Inhalation Dose (mg/ kg/ day). The target MOE value is 100.

h Total MOE (combined dermal and inhalation) = 1 / (( 1/ dermal MOE) + (1/ inhalation MOE)). The target MOE value is 100.


 Sodium Chlorite; Notice of Filing a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemical in or on Food

Summary of Petition

    The petitioner summary of the pesticide petition is printed below as
required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
The petition summary announces the availability of a description of the
analytical methods available to EPA for the detection and measurement of
the pesticide chemical residues or an explanation of why no such method
is needed.

Bi-oxide Crop Science LLC

PP __ _____

    EPA has received a pesticide petition (__ ____) from Bi-oxide Crop
Science LLC, 401 South Wall Street, Suite 103, Calhoun, Georgia 30703
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing an exemption from the requirement of a tolerance for
residues of sodium chlorite/chlorine dioxide in or on the raw
agricultural commodities wheat, barely, oats, grain, straw, and
aspirated grain fractions (wheat). Bi-oxide Crop Science LLC is seeking
to obtain a Formulator’s Exemption of Vulcan Chemical Technical Sodium
Chlorite Solution 31.25 (25% active ingredient chlorite) EPA Reg. No.
5382-43 and in doing so will expand the use of sodium chlorite on field
crops.  Consequently Bi-oxide Crop Science LLC relies on Vulcan Chemical
for supporting data. Vulcan Chemical is a member of the Chlorine Dioxide
Panel of the Chemical Manufacturers Association (CMA) of Arlington, VA.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of sodium chlorite and chlorine
dioxide in plants is adequately understood for the purposes of
establishing an exemption from the requirement of a tolerance.  Sodium
chlorite will convert to chlorine dioxide under acidic conditions.
Chlorine dioxide is a powerful oxidizing agent that will oxidize phenol,
amine, and organosulfur groups and in turn will be reduced to the
terminal residue, chloride.

    2. Analytical method. Chlorite residues can be determined by using
ion chromatography with a sodium borate/gluconate mobile phase and a UV
detector as described by Tsai et al. (J Food Science, 2001, 66:472-477).
The method cannot discriminate between chlorite and chlorate and the
limit of detection is 0.1ppm based on a signal-to-noise ratio of 3.

    3. Magnitude of residues. Bi-oxide Crop Science LLC requests a data
waiver for plant magnitude of residues.  This request is based on the
chemistry of sodium chlorite and chlorine dioxide.  Both of these
molecules are oxidizing agents.  Chlorine dioxide is a reactive gas that
when in contact with organic reducing agents such as phenol, amine, and
organosulfur functional groups will be reduced to chloride. When
chlorite is acidified, it is converted to chlorine dioxide and then
consequently be reduced to chloride.

B. Toxicological Profile

1. Acute toxicity.  The Bi-oxide Crop Sciences LLC 25% sodium chlorite
solution will rely on data developed by Vulcan Chemical for the 80%
technical sodium chlorite.  The oral LD50 values range from 255 to 270
mg/kg from male and female rats.  The acute dermal toxicity LD50 values
range from 129 to 140 for male and female rates.  Primary dermal
toxicity found severe necrosis that persisted for up to 14 days after
dosage for 4 out of 6 test animals.  Primary eye irritation and dermal
irritation were waived due to product corrosivity.

2. Genotoxicity.  Bi-oxide Crop Science LLC has not generated new
mutagenicity studies in support of sodium chlorite but instead is
relying on those studies that support the Vulcan product.  EPA, in the
Integrated Risk Assessment System (IRIS) for chlorite (sodium salt)
(CASRN 7758-19-2), assessed the genotoxicity of sodium chlorite.  The
following was listed in IRIS.  Chlorite was assessed for genotoxicity in
a number of in vitro and in vivo assays.  Chlorite induced reverse
mutations in Salmonella typhimurium (with activation) and chromosome
aberrations in Chinese hamster fibroblast (Ishidate et al., 1984, Food
Chem Toxicol. 22:623-636).  In general the in vivo results were
negative.  In a micronucleus assay, negative results were found in ddY
mice following an oral gavage (Hayashi et al., 1988, Food Chem. Toxicol.
26:487-500) and in Swiss CD-1 mice as treated by gavage for 5 days at 0,
8, 20, or 40 mg/kg/day (Meier et al., 1995. Environ. Mutagen 7:201-211).
 Meier also reported negative results in the sperm head abnormality
assay in B6CC3F1 mice and in the bone marrow chromosomal aberration
assay in Swiss CD-1 mice.  Positive results were reported for a
micronucleus assay of ddY mice when chlorite was administered by
intraperitoneal injection (Hayashi, 1988).

3. Reproductive and developmental neurotoxicity. The Chlorine Dioxide
Panel produced a rat two generation reproduction and development
neurotoxicity report as was reported by Gill et al.( J. Appl. Toxicol.
2000, 20:291-303). F0 and F1 rats were allowed free access to drinking
water containing 0, 35, 70, or 300 ppm sodium chlorite for a 10-week
prebreed period, for males and through mating, gestation, and lactation
for females. The drinking water concentrations were approximately 4, 8,
and 30 mg/kg/day for males and 5, 10, and 39 mg/kg/day for females. The
intake of sodium chlorite resulted in a decrease in water consumption in
all groups and a decrease in food consumption and body weights in the 70
and 300 ppm groups.  There was no evidence of reproductive toxicity.
Pup body weight decreased in the 300 ppm group.  Changes in the nervous
system were limited to small decrease in the auditory startle response
in pups in the 70 and 300 ppm groups and there was a small decrease in
absolute brain weight in pups the 300 ppm group.  The no-observed-effect
level (NOEL) for effects on reproduction and thyroid hormones was 300
ppm.  The no-observed-adverse-level (NOAEL) for neurotoxicity was 300
ppm.  Development toxicity of sodium chlorite in rabbit was reported by
Harrington et al. (J. Am. Coll. Toxicol. 1995, 14:108-118).  Mated New
Zealand female rabbits received 0, 200, 600, or 1,200 ppm sodium
chlorite in drinking water from day 7 to day 19 of pregnancy.  Maternal
food and water consumption decreased at 600 and 1,200 ppm, there were no
treatment-related maternal abnormalities.  There were no treatment
related fetal structural abnormalities.  The maternal and fetal NOEL was
200 ppm.  Sodium chlorite is not considered to be a teratogenic or a
selective development toxicant.

	4. Subchronic toxicity. A 13-week rat feeding study was reported by
Harrington et al. (J. Am. Coll. Toxicology. 1995, 14:21-33).  Rats were
daily gavaged with doses of sodium chlorite at 0, 10, or 80 mg/kg/day.
At the 80 mg/kg/day dose there were several treatment-related deaths and
morphological changes in the blood chemistry.  Mean erythrocyte counts
were decreased in both sexes.  Splenic extramedullary hemopoiesis was
observed in some animals at the 80 mg/kg/day dose.  At the 25 mg/kg/day
dose methemoglobin was increased in males.  No adverse toxicological
effects (NOAEL) were observed at the 10 mg/kg/day dose.

	5. Chronic toxicity. The EPA Integrated Risk Information System (IRIS)
reviewed the chronic toxicity of sodium chlorite.  The review (EPA,
1986) stated that chlorite is classified as Group D; not classifiable as
to human carcinogenicity.  Under the draft Carcinogen Assessment
Guidelines (EPA, 1996), the human carcinogenicity of chlorite cannot be
determined because of a lack of human data and limitations in animals
studies.  Kurokawa et al. (Environ. Health Perspect, 1986, 69:221-235)
conducted chronic oral studies with rats and found no evidence of
carcinogenic activity from chlorite.  Kurokawa’s study has limited use
since it involved an 85 week exposure period and the test animals had a
high incidence of Sendai viral infection.  Mouse studies by Kurokawa et
al. and Yokose et al. (Environ Health Perspect, 1987, 76:205-210) showed
an increase in liver and lung tumors in treated male mice; however the
short exposure duration and high incidence of early mortality in the
concurrent males from excessive fighting made statistical comparisons
between concurrent controls and treated animals difficult to interpret.
No increases in tumor incidence were seen in female mice.  Chlorite
induced skin tumors following initiation by DMBA, but the increase was
not statistically significant.  Chlorite has shown both positive and
negative results in in vitro and in vivo genotoxicity studies.

	6. Animal metabolism. The nature of chlorine dioxide and sodium
chlorite residue in animals is adequately understood. Chlorine dioxide
is rapidly reduced to form chloride.  Sodium chlorite, while under
acidic conditions in the digestive tract will convert to chlorine
dioxide, which in turn will be reduced to chloride.  Chloride will be
eliminated by urinary routes.

	7. Metabolite toxicology. The terminal metabolite is chloride.

	8. Endocrine disruption. Sodium chlorite and chlorine dioxide are
oxidizing agents, which in the presence of organic reducing groups will
be reduced to the terminal residue, chloride.  There were no indications
of effects on fetal developmental in either rats or rabbits. At doses
likely to be encountered from a field use of sodium chloride, is not
likely that either sodium chlorite or chlorine dioxide are endocrine
disruptors.

C. Aggregate Exposure

	1. Dietary exposure. The chronic reference dose (cRfD) and the acute
reference dose (aRfD) were determined as 0.3 mg/kg/day and 2.5
mg/kg/day, respectively.  These were based on the two generation rat
NOAEL of 30 mg/kg/day and the acute oral LD50 of 255 mg/kg/day and an
uncertainty factor of 100. These reference doses were calculated based
on EPA regulations concerning chlorite residue in drinking water since
chlorine dioxide is used in water treatment for sanitation purposes.

    i. Food. No residue of chlorite is expected in or on wheat, barley
or oat raw agricultural commodities following the labeled use pattern
and following standard agronomic practices.  Chlorite is expected to
convert to chlorine dioxide, which in turn will be reduced to the
terminal residue, chloride. Sodium chlorite is exempt from the
requirement of a tolerance when used in growing of the raw agricultural
commodities crop group Brassica (cole) leafy vegetables and radishes (40
CFR §180.1070). EPA (Brennis, Antimicrobial Division, August 5, 2003)
approved the post-harvest use of chlorine dioxide, as generated from
sodium chlorite solution on stored potatoes at use rates of up to 400
ppm.  EPA determined that it was unlikely that there would be a residue
on the treated potatoes so no food tolerance was required.  The U.S.
Food and Drug Administration (FDA) approved the use of chlorine dioxide
on cereal flour (including wheat and barley [malted flour]) in an
unspecified quantity not more than sufficient for bleaching purposes (21
CFR §137.105).  FDA approved the used of acidified sodium chlorite for
use on poultry carcasses, red meat, sea food, and fruits and vegetables
following a potable water rinse as a secondary direct food additive (21
CFR §173.325). Sodium chlorite and chorine dioxide are also used in the
manufacturing of paper and paper board for use in contact with food (21
CFR §186.1750).

    ii. Drinking water. EPA established a maximum concentration limit
(MCL) of chlorite in drinking water of 1.0 mg/L or 1 ppm.  Chlorine
dioxide is used to treat municipal drinking water supplies.  The EPA
FIRST model (FQPA Index Reservoir Screening Tool) was used to determine
a conservative estimate of how much chlorite would move from a 427 acre
watershed to a 13 acre 9 ft deep pond.  The estimate considered 50% of
the applied material of a total of 0.2 lb ai/acre as being in the
chlorite form and further considered 8% of this moving to the pond and
that all material would be in an ionic solution form and not adsorbed to
sediment.  The total calculated residue is 10 ppb of chlorite.  The
estimated amount of chlorite that would be in solution is approximately
100 times less than that of the established MCL.

    2. Non-dietary exposure. Sodium chlorite and chlorine dioxide are
currently not registered for use on any residential non-food site.
Therefore, residential exposure to sodium chlorite and chlorine dioxide
residues would be only through dietary exposure, including drinking
water.

D. Cumulative Effects

    There is no information currently available to indicate that toxic
effects produced by sodium chlorite and chlorine dioxide are cumulative
with those of any other compound.

E. Safety Determination

    1. U.S. population. Based on the conservative exposure assumptions
described above and on the completeness of the toxicology database, it
can be concluded that total aggregate exposure from food and water to
the U.S. population and all evaluated population subgroups from sodium
chlorite from all proposed uses will be well below the chronic and acute
RfDs. EPA generally has no concerns for estimated exposures below 100%
of the RfD, since the RfD represents the level at or below which daily
aggregate exposure will not pose an appreciable risk to human health.
Thus, Bi-oxide Crop Sciences LLC believes it can be concluded that there
is reasonable certainty that no harm will result from aggregate exposure
to sodium chlorite residues.

    2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of sodium chlorite, the
data from developmental toxicity studies in both the rat and rabbit and
a two generation reproduction study in rats have been considered. The
developmental toxicity studies evaluate potential adverse effects on the
developing animal resulting from pesticide exposure to the mother during
prenatal development. The reproduction study evaluates effects from
exposure to the pesticide on the reproductive capability of mating
animals through two generations, as well as any observed systemic
toxicity. Since none of the studies indicate the offspring to be more
sensitive and all effects were secondary to severe for maternal
toxicity, Bi-oxide Crop Sciences LLC believes that infants and children
are protected and that an additional uncertainty factor for infants and
children is not warranted.

F. International Tolerances

    No CODEX maximum residue levels (MRL's) have been established for
residues of chlorine dioxide or chlorite on any crops at this time.


[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32827-32828]
[FR Doc No: 2017-14998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0037]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Drug User Fee
Act Waivers and Reductions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
17, 2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0540.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Animal Drug User Fees and Fee Waivers and Reductions OMB Control Number
0910-0540--Extension

    Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L.
108-130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-12), which
requires that FDA assess and collect user fees with respect to new
animal drug applications for certain applications, products,
establishments, and sponsors. It also requires the Agency to grant a
waiver from, or a reduction of, those fees in certain circumstances.
Thus, to implement this statutory provision of ADUFA, FDA developed a
guidance entitled ``Guidance for Industry: Animal Drug User Fees and
Fee Waivers and Reductions.'' This document provides guidance on the
types of fees FDA is authorized to collect under ADUFA, and how to
request waivers and reductions from FDA's animal drug user fees.
Further, this guidance also describes the types of fees and fee waivers
and reductions; what information FDA recommends be submitted in support
of a request for a fee waiver or reduction; how to submit such a
request; and FDA's process for reviewing requests. FDA uses the
information submitted by respondents to determine whether to grant the
requested fee waiver or reduction.
    Respondents to this collection of information are new animal drug
sponsors. Requests for waivers or reductions may be submitted by a
person paying any of the animal drug user fees assessed, including
application fees, product fees, establishment fees, or sponsor fees.
    In the  Federal Register of October 17, 2016 (81 FR 71506), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
  FD&C act section/activity       Number of      responses per    Total annual    Average burden    Total hours
                                 respondents      respondent        responses      per response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A); significant                  55  1 time for each               55  2..............             110
 barrier to innovation.                         application.
740(d)(1)(B); fees exceed                   8  3.75............              30  .5 (30 minutes)              15
 cost.
740(d)(1)(C); free choice                   5  1 time for each                5  2..............              10
 feeds.                                         application.
740(d)(1)(D); minor use or                 69  1 time for each               69  2..............             138
 minor species.                                 application.
740(d)(1)(E); small business.               1  1 time for each                1  2..............               2
                                                application.
Request for reconsideration                 1  1 time for each                1  2..............               2
 of a decision.                                 application.
Request for review (user fee                0  1 time for each                0  0..............               0
 appeal officer).                               application.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ................  ..............  ...............             277
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA's database system, from fiscal year (FY) 2014 to 2016
there were an estimated 177 sponsors subject to ADUFA. However, not all
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of waiver requests is based on
the average number of submission types received by FDA in FY 2014 to
2016. The burden has not changed since the last OMB approval.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14998 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 176 (Thursday, September 11, 2014)]
[Notices]
[Pages 54331-54333]
[FR Doc No: 2014-21646]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73007; File No. SR-ICC-2014-11]

Self-Regulatory Organizations; ICE Clear Credit LLC; Order
Approving Proposed Rule Change, As Modified by Amendment No. 2 Thereto,
To Revise Rules To Provide for the 2014 ISDA Definitions

September 5, 2014.

I. Introduction

    On July 24, 2014, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change SR-ICC-2014-11 pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The
proposed rule change was published for comment in the Federal Register
on August 5, 2014.\3\ The Commission did not receive comments on the
proposed rule change. On September 2, 2014, ICC filed Amendment No. 2
to the proposed rule change to correct a factual inaccuracy in a
statement made in its filing.\4\ For the reasons described below, the
Commission is approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78(s)(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-72701 (Jul. 29,
2014); 79 FR 45565 (Aug. 5, 2014) (SR-ICC-2014-11).
    \4\ On August 28, 2014, ICC filed Amendment No. 1 to the
proposed rule change. ICC withdrew Amendment No. 1 on September 2,
2014. ICC subsequently filed Amendment No. 2 on September 2, 2014.
In Amendment No. 2, ICC clarified that CDS contracts on sovereigns
cleared at ICC will be Converting Contracts (as discussed herein).
ICC stated that its implementation of the 2014 ISDA definitions is
intended to be fully consistent with the planned ISDA protocol
implementation. ICC noted that, on August 15, 2014, ISDA published a
memorandum and FAQ that, in relevant part, explains that based on
industry feedback related to the draft protocol, the protocol would
be amended to include certain emerging market sovereign single
names. Following the protocol amendment, all sovereign single names
cleared at ICC will now be included in the protocol. Amendment No. 2
corrects a factual inaccuracy in a statement made in ICC's filing,
and because it does not materially affect the substance of the
proposed rule change, the Commission is not publishing it for
comment.

---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    ICC has stated that the principal purpose of the proposed rule
change is to amend ICC rules to incorporate references to revised
Credit Derivatives Definitions, as published by the International Swaps
and Derivatives Association, Inc. (``ISDA'') on February 21, 2014 (the
``2014 ISDA Definitions''). ICC has stated that, as described by ISDA,
the 2014 ISDA Definitions make a number of changes from the ISDA Credit
Derivatives Definitions published previously in 2003 (as amended in
2009, the ``2003 ISDA Definitions'') to the standard terms for CDS
Contracts, including (i) introduction of new terms applicable to credit
events involving financial reference entities and settlement of such
credit events, (ii) introduction of new terms applicable to credit
events involving sovereign reference entities and settlement of such
credit events, (iii) implementation of standard reference obligations
applicable to certain reference entities, and (iv) various other
improvements and drafting updates that reflect market experience and
developments since the 2009 amendments to the 2003 ISDA Definitions.
The 2014 ISDA Definitions will become effective on the industry
implementation date of September 22, 2014.
    ICC has proposed that, consistent with the approach being taken
throughout the CDS market, the 2014 ISDA Definitions will be applicable
to certain products cleared by ICC beginning on September 22, 2014. In
addition, the proposed amendments will provide for the conversion of
certain existing contracts (so-called ``Converting Contracts''),
currently based on the 2003 ISDA Definitions, into contracts based on
the 2014 ISDA Definitions. ICC asserts that this approach is consistent
with expected industry practice for similar contracts not cleared by
ICC, which will be subject to a multilateral amendment ``protocol''
sponsored by ISDA, and that ICC Participants plan to adhere to the ISDA
protocol and would desire ICC to convert certain contracts cleared at
ICC into contracts based on the 2014 ISDA Definitions, consistent with
the ISDA protocol. For contracts that are not Converting Contracts, ICC
expects to continue to accept for clearing both new transactions
referencing the 2014 ISDA Definitions and new transactions referencing
the 2003 ISDA Definitions (and such contracts based on different
definitions will not be fungible). ICC proposes to publish on its Web
site a list of Converting Contracts, which is expected to be the same
as the list of contracts subject to the ISDA protocol. ICC anticipates
that most ICC Contracts will be Converting Contracts with certain
exceptions including certain financial reference entities.
    To this end, ICC has proposed to (i) revise the ICC Clearing Rules
(``Rules'') to make proper distinctions between the 2014 ISDA
Definitions and the 2003 ISDA Definitions and related documentation and
(ii) make conforming changes throughout the ICC Rules to reference
provisions from the proper ISDA Definitions. ICC has proposed changes
to Chapters 20, 21, 22 and 26 of the ICC Rules. ICC has also submitted
revisions to the ICC Restructuring Procedures, which ICC states reflect
proper distinctions between the 2003 ISDA Definitions and the 2014 ISDA
Definitions.\5\
---------------------------------------------------------------------------

    \5\ A more detailed description of the proposed changes to the
ICC Rules, ICC Restructuring Procedures, and Risk Management
Framework is set forth in the notice of filing of the proposed rule
change. See supra note 3.
---------------------------------------------------------------------------

    Finally, ICC has proposed revisions to the Risk Management
Framework to reflect appropriate portfolio treatment between CDS
Contracts cleared under the 2003 and 2014 ISDA Definitions. The
revisions to the ICC Risk Management Framework would introduce a ``Risk
Sub-Factor'' as a specific single name and any unique combination of
instrument attributes (e.g., restructuring clause, 2003 or 2014 ISDA
Definitions, debt tier, etc.). The union of all Risk Sub-Factors that
share the same underlying single name would form a single name Risk
Factor. The portfolio treatment at the Risk Sub-Factor level would be
provided for in the Risk Management Framework, as appropriate.
Additionally, the ICC Risk Management Framework would be revised to
include long and short positions of Risk Sub-Factors for a single name
Risk Factor in the Jump-to-Default requirement. The ICC Risk Management
Framework also would be revised to include other cleanup and
clarification changes (e.g., to address the difference in risk time
horizon between North American and European instruments).

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \6\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if the
Commission finds that such proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such self-regulatory organization. Section 17A(b)(3)(F)
of the Act \7\ requires, among other things, that the rules of a
clearing agency are designed to promote the prompt and accurate
clearance and settlement of securities transactions and, to the extent
applicable, derivative agreements, contracts, and transactions, to
assure the safeguarding of securities and funds which are in the
custody or control of the clearing agency or for which it is
responsible and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(C).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The Commission finds that the proposed revisions to the ICC Rules,
Restructuring Procedures and Risk Management Framework are consistent
with the requirements of Section 17A of the Act \8\ and the rules and
regulations thereunder applicable to ICC. The proposed rule change,
which is principally designed to incorporate and implement the 2014
ISDA Definitions, will permit clearing of contracts, both new and
existing, referencing the new definitions, while distinguishing, where
applicable, contracts cleared by ICC between those referencing the 2014
ISDA Definitions and those referencing the 2003 ISDA Definitions for
purposes of risk management and clearing operations. Additionally, ICC
states that the proposed rule change is necessary to provide the market
with the assurances that ICC plans to implement the standard credit
derivatives definitions consistent with industry practice, thereby
facilitating prompt and accurate clearance and settlement. The
Commission therefore believes that the proposed rule change is
reasonably designed to promote the prompt and accurate clearance and
settlement of securities transactions and, to the extent applicable,
derivative agreements, contracts, and transactions and to assure the
safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible,
consistent with Section 17A(b)(3)(F) of the Act.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78q-1.
    \9\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \10\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the

proposed rule change (SR-ICC-2014-11) as modified by Amendment No. 2
thereto be, and hereby is, approved.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).
    \12\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21646 Filed 9-10-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Pages 39696-39698]
[FR Doc No: 2012-16370]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-468-000]

Atlas Pipeline Mid-Continent WestTex, LLC; Pioneer Natural
Resources USA, Inc.; Notice of Intent To Prepare an Environmental
Assessment for the Proposed Driver Residue Pipeline Project and Request
for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Driver Residue Pipeline
Project involving construction and operation of facilities by Atlas
Pipeline Mid-Continent WestTex, LLC and Pioneer Natural Resources USA,
Inc. (Atlas and Pioneer), as joint applicants, in Midland County,
Texas. The Commission will use this EA in its decision-making process
to determine whether the project is in the public convenience and
necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. Your input will help the Commission staff
determine what issues they need to evaluate in the EA. Please note that
the scoping period will close on July 27, 2012.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    Atlas and Pioneer provided landowners with a fact sheet prepared by
the FERC entitled ``An Interstate Natural Gas Facility On My Land? What
Do I Need To Know?''. This fact sheet addresses a number of typically-
asked questions, including the use of eminent domain and how to
participate in the Commission's proceedings. It is also available for
viewing on the FERC Web site (www.ferc.gov).

Summary of the Proposed Project

    Atlas and Pioneer propose to construct and operate 10.2 miles of
16-inch-diameter pipeline in Midland County, Texas. According to Atlas
and Pioneer, increased natural gas production in the Permian Basin has
brought about the need for additional natural gas processing facilities
including the facilities to deliver residue gas to downstream markets
from the Driver Plant that is presently under construction. The Driver
Residue Pipeline Project would provide access to markets via two
intrastate and one interstate natural gas pipeline systems for
approximately 150 million standard cubic feet of natural gas per day.
    The Driver Residue Pipeline Project would consist of the following
facilities:
     Construction of 10.2 miles of 16-inch-diameter pipeline
and appurtenant facilities between the Driver Plant and
interconnections with Atmos Energy Corporation, Northern Natural Gas
Company, and Enterprise Products Partners, LP.
     Installation of a pig launcher \1\ east of the Driver
Plant at the south end of the proposed pipeline at milepost (MP) 0.0,
and a pig receiver at the north end at MP 10.2.
---------------------------------------------------------------------------

    \1\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
---------------------------------------------------------------------------

     Installation of about 40 feet of 6-inch-diameter pipeline
to connect the proposed pipeline to the existing Atlas/Pioneer
Shackleford Station near MP 8.3.
    The general location of the project facilities is shown in appendix
1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the proposed facilities would disturb about 93.4
acres of land. Following construction, Atlas and Pioneer would maintain
about 39.7 acres for permanent operation of the project's facilities;
the remaining acreage would be restored and revert to former uses. The
proposed pipeline would be installed using a 75-foot-wide construction
right-of-way, of which a 30-foot-wide strip would remain as permanent
right-of-way. The proposed pipeline route parallels existing pipeline
rights-of-way.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\3\ to discover and address concerns the

public may have about proposals. This process is referred to as
``scoping.'' The main goal of the scoping process is to focus the
analysis in the EA on the important environmental issues. By this
notice, the Commission requests public comments on the scope of the
issues to address in the EA. We will consider all filed comments during
the preparation of the EA.
---------------------------------------------------------------------------

    \3\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     Land use;
     Water resources, fisheries, and wetlands;
     Cultural resources;
     Vegetation and wildlife;
     Air quality and noise;
     Endangered and threatened species;
     Public safety; and
     Cumulative impacts
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section below.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\4\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.
---------------------------------------------------------------------------

    \4\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Sec.  1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with applicable State Historic Preservation Office (SHPO), and to
solicit its views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\5\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EAS for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \5\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that the Commission receives them in Washington, DC on or before July
27, 2012.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the project docket number (CP12-468) with your submission.
The Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for interested persons to
submit brief, text-only comments on a project;
    (2) You can file your comments electronically using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials; Native
American Tribes; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If we publish and distribute the EA, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary

link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP12-
468). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: June 27, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-16370 Filed 7-3-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 169 (Tuesday, September 2, 2014)]
[Rules and Regulations]
[Pages 51887-51888]
[FR Doc No: 2014-20692]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 79, No. 169 / Tuesday, September 2, 2014 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Docket No. FAA-2014-0450; Amendment No. 71-46
RIN 2120-AA66

Airspace Designations; Incorporation by Reference

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This action amends Title 14 Code of Federal Regulations (14
CFR) part 71 relating to airspace designations to reflect the approval
by the Director of the Federal Register of the incorporation by
reference of FAA Order 7400.9Y, Airspace Designations and Reporting
Points. This action also explains the procedures the FAA will use to
amend the listings of Class A, B, C, D, and E airspace areas; air
traffic service routes; and reporting points incorporated by reference.

DATES: These regulations are effective September 15, 2014, through
September 15, 2015. The incorporation by reference of FAA Order 7400.9Y
is approved by the Director of the Federal Register as of September 15,
2014, through September 15, 2015.

FOR FURTHER INFORMATION CONTACT: Sarah A. Combs, Airspace Policy and
Regulations Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    FAA Order 7400.9X, Airspace Designations and Reporting Points,
effective September 15, 2013, listed Class A, B, C, D and E airspace
areas; air traffic service routes; and reporting points. Due to the
length of these descriptions, the FAA requested approval from the
Office of the Federal Register to incorporate the material by reference
in the Federal Aviation Regulations section 71.1, effective September
15, 2013, through September 15, 2014. During the incorporation by
reference period, the FAA processed all proposed changes of the
airspace listings in FAA Order 7400.9X in full text as proposed rule
documents in the Federal Register. Likewise, all amendments of these
listings were published in full text as final rules in the Federal
Register. This rule reflects the periodic integration of these final
rule amendments into a revised edition of Order 7400.9Y, Airspace
Designations and Reporting Points. The Director of the Federal Register
has approved the incorporation by reference of FAA Order 7400.9Y in
section 71.1, as of September 15, 2014, through September 15, 2015.
This rule also explains the procedures the FAA will use to amend the
airspace designations incorporated by reference in part 71. Sections
71.5, 71.15, 71.31, 71.33, 71.41, 71.51, 71.61, 71.71, and 71.901 are
also updated to reflect the incorporation by reference of FAA Order
7400.9Y.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 to reflect the approval by the Director of the Federal Register
of the incorporation by reference of FAA Order 7400.9Y, effective
September 15, 2014, through September 15, 2015. During the
incorporation by reference period, the FAA will continue to process all
proposed changes of the airspace listings in FAA Order 7400.9Y in full
text as proposed rule documents in the Federal Register. Likewise, all
amendments of these listings will be published in full text as final
rules in the Federal Register. The FAA will periodically integrate all
final rule amendments into a revised edition of the Order, and submit
the revised edition to the Director of the Federal Register for
approval for incorporation by reference in section 71.1.
    The FAA has determined that this action: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. This
action neither places any new restrictions or requirements on the
public, nor changes the dimensions or operation requirements of the
airspace listings incorporated by reference in part 71.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

0
2. Section 71.1 is revised to read as follows:

Sec.  71.1  Applicability.

    A listing for Class A, B, C, D, and E airspace areas; air traffic
service routes; and reporting points can be found in FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014. This
incorporation by reference was approved by the Director of the Federal
Registerin accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The
approval to incorporate by reference FAA Order 7400.9Y is effective
September 15, 2014, through September 15, 2015. During the
incorporation by reference period, proposed changes to the listings of
Class A, B, C, D, and E airspace areas; air traffic service routes; and
reporting points will be published in full text as proposed rule
documents in the Federal Register. Amendments to the listings of Class
A, B, C, D, and E airspace areas; air traffic service routes; and
reporting points will be published in full text as final rules in the
Federal Register. Periodically, the final rule amendments will be
integrated into a revised edition of the Order and submitted to the
Director of the Federal Register for approval for incorporation by
reference

in this section. Copies of FAA Order 7400.9Y may be obtained from
Airspace Policy and Regulations Group, Federal Aviation Administration,
800 Independence Avenue SW., Washington, DC 20591,<PHONE_NUMBER>. An
electronic version of the Order is available on the FAA Web site at
http://www.faa.gov/airtraffic/publications. Copies of FAA
Order 7400.9Y may be inspected in Docket No. FAA-2014-0450; Amendment
No. 71-46 on http://www.regulations.gov. A copy of FAA Order 7400.9Y
may be inspected at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

Sec.  71.5  [Amended]

0
3. Section 71.5 is amended by removing the words ``FAA Order 7400.9X''
and adding, in their place, the words ``FAA Order 7400.9Y.''

Sec.  71.15  [Amended]

0
4. Section 71.15 is amended by removing the words ``FAA Order 7400.9X''
and adding, in their place, the words ``FAA Order 7400.9Y.''

Sec.  71.31  [Amended]

0
5. Section 71.31 is amended by removing the words ``FAA Order 7400.9X''
and adding, in their place, the words ``FAA Order 7400.9Y.''

Sec.  71.33  [Amended]

0
6. Paragraph (c) of section 71.33 is amended by removing the words
``FAA Order 7400.9X'' and adding, in their place, the words ``FAA Order
7400.9Y.''

Sec.  71.41  [Amended]

0
7. Section 71.41 is amended by removing the words ``FAA Order 7400.9X''
and adding, in their place, the words ``FAA Order 7400.9Y.''

Sec.  71.51  [Amended]

0
8. Section 71.51 is amended by removing the words ``FAA Order 7400.9X''
and adding, in their place, the words ``FAA Order 7400.9Y.''

Sec.  71.61  [Amended]

0
9. Section 71.61 is amended by removing the words ``FAA Order 7400.9X''
and adding, in their place, the words ``FAA Order 7400.9Y.''

Sec.  71.71  [Amended]

0
10. Paragraphs (b), (c), (d), (e), and (f) of section 71.71 are amended
by removing the words ``FAA Order 7400.9X'' and adding, in their place,
the words ``FAA Order 7400.9Y.''

Sec.  71.901  [Amended]

0
11. Paragraph (a) of section 71.901 is amended by removing the words
``FAA Order 7400.9X'' and adding, in their place, the words ``FAA Order
7400.9Y.''

    Issued in Washington, DC, on August 26, 2014.
Ellen Crum,
Acting Manager, Airspace Policy and Regulations Group.
[FR Doc. 2014-20692 Filed 8-29-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Page 66967]
[FR Doc No: 2016-23514]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1143]

Use of Nucleic Acid Tests To Reduce the Risk of Transmission of
West Nile Virus From Living Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Guidance for Industry; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting
a notice that appeared in the Federal Register of Tuesday, September
13, 2016 (81 FR 62910). The document announced the availability of a
guidance for industry entitled ``Use of Nucleic Acid Tests to Reduce
the Risk of Transmission of West Nile Virus from Living Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The
document was published with incorrect information of a comment period
due date. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 13,
2016, in FR Doc. 2016-21969, on page 62910, the following correction is
made:
    On page 62910, in the first column under the DATES: caption, the
sentence is corrected to read, ``Submit either electronic or written
comments on Agency guidances at any time.''

    Dated: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23514 Filed 9-28-16; 8:45 am]
 BILLING CODE 4164-01-P