[ Federal Register: 2006 ( Volume , Number )] [ Notices] [ Page ]

ENVIRONMENTAL PROTECTION AGENCY [ ]

Pirimicarb: Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification ( ID) number OPP xxxxxx, must be received on or before xxxxxx, 2006.

ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: George LaRocca, Registration Division ( 7504P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 6100; e mail address: mailto: larocca. george@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: * Industry ( NAICS code 111) * Crop production ( NAICS code 112) * Animal production ( NAICS code 311) * Food manufacturing ( NAICS code 32532) 2 This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket ID number OPP xxxxxx. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. Xxx, One Potomac Yard, 2777 S. Crystal Drive, Arlington, VA 22202. This facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the    Federal Register'' listings at http:// www. epa. gov/ fedrgstr An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select    search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. 3 For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. When practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked    late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e mail address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket and follow the online instructions for submitting comments. Once in the system, select    search,'' and then key in docket ID number OPP xxxxxx. The system is an    anonymous access'' system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment. 4 ii. E mail. Comments may be sent by e mail to: opp docket@ epa. gov Attention: Docket ID number OPP xxxxxx. In contrast to EPA's electronic public docket, EPA's e mail system is not an    anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID number OPP xxxxxx. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. xxx, One Potomac Yard, 2777 S. Crystal Drive, Arlington, VA. Attention: Docket ID number OPP xxxxxx Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 5 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also, provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received pesticide petitions as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that these pesticide petitions contain data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of these pesticide petitions. Additional data may be needed before EPA rules on the pesticide petitions.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: xxxxxxxx, 2006 xxxxxxxxx Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner's summary of the pesticide petitions, PP 2E6388, PP 2E6509, and PP 0E6102, is printed below as required by FFDCA section 408( d)( 3). The summary of the pesticide petitions was prepared by Syngenta Crop Protection, Inc. and Interregional Research Project Number 4 and represents the view of the pesticide petitioners. The summary of the pesticide petitions 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.

Syngenta Crop Protection, Inc.

Interregional Research Project Number 4 PP 2E6388 ( Asparagus); PP 2E6509 ( Leaf Petioles Subgroup) and PP 0E6102 ( Hops) 6 EPA has received a pesticide petition from the International Research Project No. 4 ( IR 4) who are, on behalf of Syngenta Crop Protection, Inc, 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 a tolerance for combined residues of pirimicarb 2 ( dimethylamino) 5,6 dimethyl 4 pyrimidinyl dimethylcarbamate ( 9Cl) and its two carbamate metabolites: desmethyl pirimicarb and desmethylformamido pirimicarb, expressed as desmethyl pirimicarb in or on the raw agricultural commodities: asparagus at 0.01 ppm , hops at 4.0 ppm, and the leaf petioles subgroup at 1.0 ppm. 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.

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. Studies of the nature of residues in 3 diverse crops, potatoes, apples, and lettuce, have demonstrated that pirimicarb undergoes very extensive metabolism, with the residues of concern in primary crops being both pirimicarb and its carbamate metabolites. Syngenta Crop Protection, Inc. proposes that combined residues of pirimicarb, 2( dimethylamino) 5,6 dimethyl 4 pyrimidinyl dimethylcarbamate ( 9Cl), and its two carbamate metabolites ( desmethyl pirimicarb and desmethylformamido pirimicarb) expressed as desmethyl pirimicarb are to be included in the tolerance.

2. Analytical Method. The analytical enforcement method uses Gas Chromatography equipped with a thermionic nitrogen specific detector. Crop samples are macerated with methanol and then filtered. After filtration, the methanol is evaporated and the samples resuspended and partitioned with hexane and hydrochloric acid. The samples are left overnight to allow conversion of the desmethylforamido pirimicarb metabolite to the desmethyl pirimicarb metabolite. The hexane layer is discarded and the acidic aqueous layer is further partitioned with ethyl acetate. Sodium hydroxide is added to the aqueous layer and pirimicarb and its carbamate metabolites are extracted with dichloromethane. This method has been validated by an independent laboratory, with a limit of detection of 7 0.01 ppm.

3. Magnitude of residues.

Hops: Three field trials were conducted in hops: one each in Idaho, Oregon, and Washington. Pirimor 50   DF was applied 2 times at an interval of 21(   2) days and harvests were 7(   1) days and 14(   1) days after the second application. There were some exceptions that had no impact on the proposed tolerance: in the Idaho trial, the second sampling was 22 days after the first harvest date and in the Washington trials the application rate was approximately 6% and 10% higher than the intended rate. Combined residues of pirimicarb and its metabolites in hop cones harvested 6 8 days after the second application were highest in the Washington samples, at approx. 3.1 ppm. Combined residues of pirimicarb and its metabolites in hop cones harvested 14 15 days after the second application were also highest in the Washington samples, at approx. 2.2 ppm. The second harvest in the Idaho trial at 22 days after the last application produced a combined residue of approx. 0.8 ppm. Asparagus: Trials were conducted in California ( 3 trials), Washington ( 2 trials), Wisconsin ( 2 trials), and New Jersey. Asparagus plots were treated 3 times after the last harvest with Pirimor ® 50 DF at approx. 0.25 lb ai/ A, except in the two trials conducted in Washington in which the application rate was approx. 0.2 lb ai/ A which is the proposed application rate . Spear samples were taken the following growing season for analysis to determine the magnitude of combined residues of pirimicarb and its metabolites. No residues of pirimicarb or its carbamate metabolites above the limit of quantitation ( 0.01 ppm) were found in any of the treated samples from this study. Leaf Petioles Subgroup: Celery is the representative commodity for the leaf petioles subgroup. Crop residue field trials were conducted in celery in California ( 3 trials), Florida ( 2 trials), Oregon ( 2 trials), Ohio, and Ontario, Canada. Pirimor ® 50 DF was applied as a foliar spray at approx. 0.25 lb ai/ acre three times at intervals of 6 8 days. There were some exceptions: in the Ontario trial, the treatment intervals were 7 and 9 days, and the first application was 0.313 lb ai/ acre, in one of the Florida trials ( FL16), a total of five applications were made because the crop was not ready for harvest after the first three sprays. In all of the trials, treated and untreated samples were collected 2 3 days after the last application. Residues of pirimicarb were in the range 0.0533 0.703 ppm. Desmethyl pirimicarb residues were in the range 0.0230 0.858. No detectable residues of R238177 were found in any of the treated samples. The highest residues were found in samples from trial FL16, in which 5 applications were made. The residue data support application of Pirimor 50 DF at 0.5 lb ( 0.25 lb active) per acre up to a maximum of 0.75 lb ai/ A per year with a 3 day PHI.

B. Toxicological Profile 1. Acute toxicity. Like other N methyl carbamate insecticides, pirimicarb induces toxic signs that are characteristic of cholinesterase inhibition. These effects are rapidly reversed when exposure ceases and recovery is usually complete. The acute toxicity of technical pirimicarb is classified as acute toxicity Category II based on the acute oral toxicity in the rat. 8 Pirimicarb Technical Toxicity Summary:

Toxicity Test Results Toxicity Category Acute Oral Rat LD50 152 mg/ kg ( m), 142 mg/ kg ( f) II Acute Dermal Rat LD50 > 1000 mg/ kg ( f) III Acute Inhalation Rat 0.95 mg/ L ( m); 0.86 mg/ L ( f) III Eye Irritation Rabbit Non irritant IV Skin Irritation Rabbit slight irritant IV Skin Sensitization moderate may cause allergic reaction The acute toxicity of the formulated product, Pirimor ® 50 DF is classified as acute toxicity Category II based on acute oral toxicity in the rat and eye irritation in the rabbit.

Formulated Material ( PIRIMOR ® 50 DF) Toxicity Summary:

Toxicity Test Results Toxicity Category Acute Oral Rat LD50 87 mg/ kg II Acute Dermal Rat LD50 > 2000 mg/ kg III Acute Inhalation Rat 1.7 mg/ L ( f) III Eye Irritation Rabbit moderate irritant II Skin Irritation Rabbit slight irritant IV Skin Sensitization not a sensitizer

2. Genotoxicity. Pirimicarb has been evaluated for genotoxicity and mutagenicity. As reported in the EPA's Cancer Assessment Review Committee ( CARC) report for pirimicarb ( July 13, 2005), pirimicarb was not mutagenic in bacteria and did not induce a clastogenic response in mammalian cell in vitro or micronuclei in the bone marrow of treated mice. However, there was a positive response in an in vitro mammaliancell gene mutation assayy with L5178Y mouse lymphoma cells; mutagenic activity was reproducible, confined to the S9 activated portion of the assay, concentrated related and occurred at severly cytotoxic levels ( causing 10% survival) to levels where > 50% of the cells survived. 3. Reproductive and developmental toxicity. Pirimicarb was not teratogenic to rats when tested in a study using oral gavage dose levels of 0, 10, 25 and 75 mg/ kg/ day. Fetotoxicity in the presence of maternal toxicity was observed at 75 mg/ kg/ day, but there 9 were no effects on mother or fetus at a dose level of 25 mg/ kg/ day. The overall NOEL for fetotoxicity was therefore 25 mg/ kg/ day in the rat. Pirimicarb was not teratogenic in the rabbit when tested in a study using oral gavage dose levels of 0, 2, 10 or 60 mg/ kg/ day. Maternal toxicity was observed at 60 mg/ kg/ day, but there were no effects on the fetus at any dose level. There was no evidence of fetotoxicity or teratogenicity in the rabbit at doses up to and including a maternally toxic dose of 60 mg/ kg/ day. Neither study showed effects on the fetus in the absence of effects on the mother, and thus there was no evidence of enhanced fetal susceptibility to pirimicarb. Pirimicarb showed no evidence of reproductive toxicity to rats in a 2 generation reproductive toxicity study using dose levels of 0, 50, 200 or 750 ppm. There were no effects on reproductive parameters at 750 ppm ( 88 mg/ kg/ day), the highest dose tested ( HDT)

4. Subchronic toxicity. a. Rat: 90 day feeding studies. In a number of repeat dose studies, male and female rats were fed diets containing 0, 175, 250, or 750 ppm of pirimicarb for a period of 56  90 days. There were no adverse clinical, hematological, or pathological effects. The only effect was a reduction in body weight gain that was clearly evident in 2 studiesat 750 ppm; in another study slight effects were seen at 250 ppm. The NOEL for subchronic toxicity in the rat was concluded to be 175 ppm ( 17.5 mg/ kg/ day).

b Dog: 90 day feeding study Groups of 4 male and 4 female beagle dogs were dosed with pirimicarb by capsule at 0, 0.4 or 1.8 mg/ kg/ day as an oral dose for a period of at least 90 days; a further group received pirimicarb at 4 mg/ kg/ day for 180 days. There were no adverse clinical or pathological effects, but the animals receiving 4 mg/ kg/ day showed evidence of increased erythropoetic activity in the bone marrow. The NOEL in this study was 1.8 mg/ kg/ day.

c. Rat: 21 day dermal study. Pirimicarb was assessed for its sub acute dermal toxicity in the rat. . Over a period of 21 days groups of 5 male and 5 female rats received15, 6 hour dermal applications of pirimicarb applied as a paste in deionized water at dosages of 40, 200, or 1000 mg/ kg . There were no signs of skin irritation and no indications of systemic toxicity. Test animals that received the 1000 mg/ kg dose showed a small reduction in brain cholinesterase. The NOAEL was 200 mg/ kg.

5. Neurotoxicity. i. Acute neurotoxicity. In an acute neurotoxicity study, pirimicarb was administered as a single oral dose at levels of 0, 10, 40, or 110 mg/ kg body weight. The animals were observed up to 14 days. A neurotoxicity screening battery of tests including a functional observational battery and quantitative measurement of motor activity was evaluated one week prior to the study, and on days 1, 8, and 15. Administration of 110 mg/ kg resulted in early mortalities and adverse clinical signs. Brain neurotoxic esterase activity was not affected by treatment. Changes at the 40 mg/ kg dose were transient and not accompanied by biologically significant reductions in brain or erythrocyte cholinesterase activity. It is concluded that pirimicarb shows reversible clinical signs of neurotoxicity following administration of a single oral dose of 110 mg/ kg. The NOEL for clinical signs of transient acute neurotoxicity is 40 mg/ kg/ day. The NOEL for this study is 10 mg/ kg/ day 10 ii. Subchronic neurotoxicity. A subchronic rat neurotoxicity study was performed in which pirimicarb was fed to rats at levels of 0, 75, 250, and 1000 ppm for 90 days. A neurotoxicity screening battery of tests, including a functional observational battery and a quantitative assessment of motor activity was evaluated in weeks 1, 5, 9, and 14. After 90 days neurotoxic esterase activity in the brain and histopathological assessment were performed . Reduced growth and food consumption/ utilization were observed at 250 and 1000 ppm. There were no treatment related effects on the functional observational battery, motor activity, cholinesterase, neurotoxic esterase activities and neuropathology. The NOEL for subchronic neurotoxicity was 1000 ppm ( approximately 81 mg/ kg/ day).

6. Chronic toxicity. In two chronic feeding studies, dogs were dosed at levels up to 25 mg/ kg/ day for either 1 or 2 years. Pirimicarb produced hemolytic anemia or related hematological changes in a very small proportion of dogs. Prolonged administration of pirimicarb was required to produce this effect and it was reversible when exposure to pirimicarb ceased. This effect was not observed in toxicity studies in the rat and mouse. A clear NOEL of 3.5 mg/ kg/ day was established based on hematological changes in all of the available studies.

As reported in the EPA's Cancer Assesssment Review Committee ( CARC) report for pirmicarb ( July 2005), three carcinogenicity studies were conducted with pirimicarb: one rat study and two mice studies. In a 2 year rat chronic toxicity pirimicarb was fed for up to two years at 0, 75, 250 and 750 ppm. The maximum tolerated dose was 750 ppm, with no carcinogenic response over 2 years. A NOEL was established at 250 ppm ( 12.3 mg/ kg/ day).

In one mouse carcinogenicity study, mice were fed pirimicarb at 0, 200, 400, and 1600 ppm. The CARC considered the resulting male and female liver and lung tumors, and the female ovarian papillary and mammary gland tumors to be treatment related.

In the other mouse carcinogenicity study mice were fed pirimicarb at 0, 50, 200, and 700 ppm. It was concluded that there was an increase of incidence of benign lung tumors in female mice at the top dose of 700 ppm only. The EPA categorized pirmicarb as " likely to be carcinogenic to humans" based on multiple benign and/ or malignant tumors in mice. The CARC recommended that a linear low dose extrapolation approach ( Q1*) be used to estimate human cancer risk. Based on the tumor response in mice the Q1* was determined to be 3.526 x 10 2 6. Animal metabolism. Studies in the rat and dog with radiolabeled pirimicarb demonstrated that following oral administration, pirimicarb is well absorbed, extensively metabolized, and the metabolites are rapidly eliminated. Metabolism following a single oral dose is quantitatively similar in rats and dogs and there is no evidence of bioaccumulation.

7. Metabolite toxicology. Pirimicarb and its carbamate metabolites are associated with acute effects of cholinesterase inhibition.

8. Endocrine disruption. Pirimicarb shows no evidence of hormonal effects. Therefore there is no evidence of endocrine disruption. There are no toxicity endpoints involving reproductive organs in either male or female animals in any of these studies. 11 C. Aggregate Exposure 1. Dietary exposure. Currently there are no food use tolerances established for pirmicarb; the current EPA approved use for pirmicarb is limited to alfalfa grown for seed and is classified as a non food use. Syngenta Crop Protection, Inc. has already filed a petition for tolerances for pirimicarb in or on apples, lettuce and potatoes. The purpose of this Notice of Filing is to include the petition for tolerances for pirimicarb in or on asparagus, the leaf petioles subgroup 4B, and hops.

Using the Dietary Exposure Evaluation Model ( DEEM FCIDTM version 2.03) from Exponent, acute ( Tier 1) and chronic ( Tier III) dietary exposure was evaluated for pirimicarb in apples, asparagus, the leaf petioles subgroup, lettuce, hops, and potatoes All consumption data for these assessments was taken from the USDA's Continuing survey of Food Intake by individuals ( CSFII) with the 1994 96 consumption database and the Supplemental CSFII children's survey ( 1998) consumption database. The percent crop treated in the acute exposure assessment was assumed to be 100% for all comodities. For the chronic exposure assessments, residue values were taken from field trials in which pirimicarb was applied at the maximum intended use rate and samples were harvested at the minimum pre harvest interval ( PHI). Average field trial residue values were entered into the DEEM FCIDTM software with an adjustment for the predicted percent of the crop that would be treated. Secondary residues in animal commodities were not included in these exposure assessments based on the lack of residue in potentially fed commodities ( apples and potatoes) and the absence of either pirimicarb or any other metabolite containing the carbamate functionality at detectable limits in the animal metabolism studies. Drinking water estimates were incorporated directly into the dietary exposure assessment using the higher of the estimated drinking water concentrations ( EDWCs) for surface and ground water.

i. Food. Acute Exposure: The Tier I pirimicarb acute dietary risk assessment was performed for all population subgroups with acute exposure. For this assessment the following were used: acute reference dose of 0.010 mg/ kg/ day based on a rat neurotoxicity study with a no observable adverse effect level ( NOAEL) of 10 mg/ kg/ day, an uncertainty factor of 100X for intra and interspecies variations, and an FQPA safety factor of 10X for lack of a developmental neurotoxicity study.

For the purpose of aggregate risk assessment, the exposure values were expressed in terms of margin of exposure ( MOE) which was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a per cent of the reference dose (% RfD). Acute dietary ( food only) exposure to the US Population resulted in an MOE of 11,660 ( 9.6% of the acute RfD of 0.010 mg/ kg/ day). The most exposed sub population was children 1 2 years old with an MOE of 10,071 ( 9.9% of the acute RfD of 0.010 mg/ kg/ day). Since the benchmark MOE for this assessment is 1,000 and since the EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute dietary ( food only) exposure to residue arising from all current and proposed uses of pirimicarb. 12 Chronic Exposure: The Tier III chronic ( non cancer) dietary risk assessment for pirimicarb was performed for all population subgroups. The following values were used: a chronic reference dose of 0.0035 mg/ kg/ day based on a chronic feeding study in the dog with a no observable adverse effect level ( NOAEL) of 3.5 mg/ kg/ day; an uncertainty factor of 100X for intra and interspecies variations, and an FQPA safety factor of 10X based on the lack of a developmental neurotoxicity study. For the purpose of aggregate risk assessment, the exposure values were expressed in terms of margin of exposure ( MOE) which was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a percent of the reference dose ( RfD). Chronic dietary ( food only) exposure to the US population resulted in an MOE of 429,721 ( 0.2% of the chronic RfD of 0.0035 mg/ kg/ day). The most exposed sub population was children 1 2 years old with an MOE of 216,761 ( 0.5% of the chronic RfD of 0.0035 mg/ kg/ day. Since the benchmark MOE for this assessment is 1,000 and since the EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic ( non cancer) dietary ( food only) exposure to residues arising from all current and proposed uses of pirimicarb.

Cancer Exposure: The Tier III chronic ( cancer) dietary risk assessment for pirimicarb was performed for the US population with a carcinogenic potency factor ( Q1*) of 0.03526 ( mg/ kg/ day) 1 based on tumor responses in mice. Dietary ( food only) cancer exposure to pirimicarb resulted in a risk of 2.88 x 10 7.

ii. Drinking water.

Drinking water levels of comparison ( DWLOC) were calculated for pirimicarb for adults and children for both acute and chronic exposures, in accordance with EPA's Standard Operating Procedure ( SOP) for Drinking Water Exposure and Risk Assessments ( 11/ 20/ 97). Drinking water exposure from surface and groundwater for pirimicarb was estimated using Tier II model PRZM/ EXAMS and Tier I model SCI GROW, respectively. The exposure estimates and DWLOCs are summarized below:

Drinking Water Levels of Comparison and Acute Exposure Estimates for Pirimicarb Population Subgroup SCI GROW ( ug/ L)* PRZM/ EXAMS ( ug/ L)** Acute DWLOC ( ug/ L) Adult  US Population 0.25 4.66 3385 Children 0.25 4.66 980 * SCI GROW estimate based on highest water estimate from all crop uses ** PRZM/ EXAMS based on instantaneous concentration for total carbamate residues ( parent + metabolites) 13 Drinking Water Levels of Comparison and Chronic Exposure Estimates for Pirimicarb Population Subgroup SCI GROW ( ug/ L)* PRZM/ EXAMS ( ug/ L)** Chronic DWLOC ( ug/ L) Adult  US Population 0.25 0.88 1225 Children 0.25 0.88 350 * SCI GROW estimate based on highest water estimate from all crop uses ** PRZM/ EXAMS based on annualized average value for total carbamate residues ( parent + metabolites)

Based on the estimated dietary and water exposures for pirimicarb, Syngenta has concluded that there is a reasonable certainty of no harm to infants, children and adults resulting from potential acute or chronic aggregate exposure to pirimicarb.

2. Non dietary exposure. Pirimicarb is not registered for either indoor or outdoor residential uses. Therefore the aggregate risk includes drinking water and food exposure only.

D. Cumulative Effects Pirimicarb is a member of the N methyl carbamate class of chemistry. These carbamates' common mechanism of toxicity is the inhibition of acetylcholinesterase. The EPA's cumulative risk assessment for this group of carbamates is in progress with scheduled completion in 2006.

E. Safety Determination 1. U. S. population. Based on the available toxicity data, 0.0035 mg/ kg/ day is the chronic reference dose based on a chronic feeding study in the dog with a no observable adverse effect level ( NOAEL) of 3.5 mg/ kg/ day; an uncertainty factor of 100X for intra and interspecies variations, and an FQPA safety factor of 10X based on the lack of a developmental neurotoxicity study. The acute reference dose is 0.010 mg/ kg/ day based on a rat neurotoxicity study with a no observable adverse effect level ( NOAEL) of 10 mg/ kg/ day, an uncertainty factor of 100X for intra and interspecies variations, and an FQPA safety factor of 10X for lack of a developmental neurotoxicity study. : The Tier III chronic ( cancer) dietary risk assessment for pirimicarb was performed for the US population with a carcinogenic potency factor ( Q1*) of 0.03526 ( mg/ kg/ day) 1 based on tumor responses in mice. Dietary ( food only) cancer exposure to pirimicarb resulted in a risk of 2.88 x 10 7. Acute dietary ( food only) exposure to the US Population resulted in 9.6% of the acute RfD of 0.010 mg/ kg/ day). Chronic dietary ( food only) exposure to the US population resulted in 0.2% of the chronic RfD of 0.0035 mg/ kg/ day. Drinking water levels of comparison ( DWLOC) were calculated for pirimicarb for adults and children for both acute and chronic exposures, in accordance with EPA's Standard Operating Procedure ( SOP) for Drinking Water Exposure and Risk Assessments ( 11/ 20/ 97). Drinking water exposure from surface and groundwater for pirimicarb was estimated using Tier II model PRZM/ EXAMS and Tier I model SCI GROW, respectively 14 2. Infants and children. Developmental toxicity and reproductive toxicity studies have not shown fetal effects other than mild fetotoxicity in the rat ( reduced fetus/ litter weight and indications of delayed development) at doses which were also toxic to the mother. There was no evidence in these studies of any extra susceptibility of the fetus. Neither has there been any indication of any particular susceptibility of juvenile animals. Based on the database, there is no reason to consider human infants and children to be inherently more at risk of toxicity from pirimicarb than adults. Chronic dietary ( food only) exposure for most exposed sub population, children 1 2 years old, will be 0.5% of the chronic RfD of 0.0035 mg/ kg/ day.

FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for pre and post natal toxicity and the completeness of the database. Based on the current toxicological data requirements, the database relative to pre and post natal effects for children is complete. No additional FQPA safety factor is required for pirimicarb.

F. International Tolerances The CODEX maximum residue levels for pirimicarb and its carbamate metabolites ( desmethyl and desmethyl formamido pirimicarb) are: potatoes 0.05 ppm, lettuce 1.0 ppm, and apples ( pome fruit) 1.0 ppm.


[Federal Register: March 15, 2006 (Volume 71, Number 50)]
[Notices]
[Page 13370-13371]
[DOCID:fr15mr06-82]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-242-000]

Natural Gas Pipeline Company of America; Notice of Proposed
Change in FERC Gas Tariff

March 8, 2006.
    Take notice that on February 28, 2006, Natural Gas Pipeline Company
of America (Natural) tendered for filing as part of its FERC Gas
Tariff, Sixth Revised Volume No. 1, the tariff sheets listed on
Appendix A to the filing, to become effective April 1, 2006.

    Natural states that copies of the filing are being mailed to its
customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-3665 Filed 3-14-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Pages 2240-2241]
[FR Doc No: 2018-00531]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82474; File No. SR-Phlx-2017-75]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Order Granting
Approval of a Proposed Rule Change To Amend Rule 1009 To Modify the
Criteria for Listing an Option on an Underlying Covered Security

January 9, 2018.

I. Introduction

    On September 27, 2017, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
amend the criteria for listing an option on an underlying covered
security in Phlx Rule 1009, Commentary .01. The proposed rule change
was published for comment in the Federal Register on October 11,
2017.\3\ On November 15, 2017 the Exchange submitted a comment letter
on the proposed rule change.\4\ The Commission received no other
comment letters. On November 22, 2017, pursuant to Section 19(b)(2) of
the Act,\5\ the Commission designated a longer period within which to
approve the proposed rule change, disapprove the proposed rule change,
or institute proceedings to determine whether the proposed rule change
should be disapproved.\6\ This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 81814 (Oct. 4,
2017), 82 FR 47254 (``Notice'').
    \4\ See Letter to Brett J. Fields, Secretary, Commission, from
Sun Kim, Assistant General Counsel, Exchange, dated November 15,
2017 (``Exchange Letter'').
    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 82147, 82 FR 47254
(November 25, 2017). The Commission designated January 9, 2017, as
the date by which it should approve, disapprove, or institute
proceedings to determine whether the proposed rule change should be
disapproved.
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II. Description of the Proposal

    The Exchange proposes to amend Phlx Rule 1009, Commentary .01 to
modify the criteria for listing options on an underlying security as
defined in Section 18(b)(1)(A) of the Securities Act of 1933
(hereinafter ``covered security''). In particular, the Exchange
proposes to modify Phlx Rule 1009, Commentary .01(4)(i) which currently
requires that to list an option, the underlying covered security has to
have a market price of at least $3.00 per share for the previous

five consecutive business days preceding the date on which the Exchange
submits a certificate to the Options Clearing Corporation (``OCC'') for
listing and trading. The Proposal would shorten the current ``look
back'' period of five consecutive business days to three consecutive
business days. The Exchange does not propose to amend any other
criteria in Phlx Rule 1009 and the accompanying Commentary to list an
option on the Exchange.

III. Discussion and Commission's Findings

    After careful review of the proposed rule change, the Commission
finds that the proposal is consistent with the requirements of the Act
and the rules and regulations thereunder that are applicable to a
national securities exchange.\7\ Specifically, the Commission finds
that the proposed rule change is consistent with Section 6(b)(5) of the
Act,\8\ which requires that the rules of a national securities exchange
be designed, among other things, to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and to protect investors and the public interest; and
are not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \7\ In approving this rule change, the Commission has considered
the rule's impact on efficiency, competition, and capital formation.
See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
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    As noted above, although the Exchange proposes to shorten the look
back period for listing options on the Exchange found in Phlx Rule
1009, Commentary .01(4)(i) from five consecutive business days \9\ to
three consecutive business days, it does not propose to change any
other listing provision found in Phlx Rule 1009 and the accompanying
Commentary, including the requirement of Phlx Rule 1009, Commentary
.01(2) that the Exchange verify the number of shareholders of a
security underlying an option. The Exchange states that the proposed
look back period of three consecutive business days is intended to
correspond to the securities industry's recent shortening of the
settlement period from T+3 to the current T+2.\10\ The Exchange
represents that stock trades would clear within T+2 of their trade date
(i.e., within three consecutive business days) and therefore the number
of shareholders could be verified within three consecutive business
days.\11\ This would facilitate options trading within four business
days of an IPO (three consecutive business days plus the day the
listing certificate is submitted to OCC).
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release Nos. 47190 (January 15,
2003), 68 FR 3072 (January 22, 2003) (SR-CBOE-2002-62) (Order
approving CBOE's proposal to, among other things, shorten the look
back period from the majority of business days during the preceding
three calendar months to the current five consecutive business
days); 47794 (May 5, 2003), 68 FR 25076 (May 9, 2003) (SR-Phlx-2003-
27) (Notice and immediate effectiveness of the Exchange's filing
adopting the same changes to its options listing standards).
    \10\ See Securities Exchange Act Release No. 80295 (March 22,
2017), 82 FR 15564 (March 29, 2017) (Securities Transaction
Settlement Cycle) (File No. S7-22-16).
    \11\ In addition to confirming through large clearing agencies
such as the Depository Trust and Clearing Corporation, the Exchange
also represents that it can verify the shareholder count with
various brokerage firms that have a large retail customer clientele,
and that it has confirmed with some of these brokerage firms who
provide shareholder numbers to the Exchange that they are able to
provide these numbers within T+2 after an IPO.
---------------------------------------------------------------------------

    The Exchange also represents that its surveillance technologies and
procedures concerning manipulation provide adequate prevention or
detection of rule or securities law violations in relation to the
proposed shortened time frame, and specifically, that its existing
trading surveillances are adequate to monitor the trading in the
underlying security and subsequent trading of options.\12\ The
Commission notes the limited nature of the proposal to shorten the look
back period of Phlx Rule 1009, Commentary .01(4)(i) from the current
five consecutive business days to the proposed three consecutive
business days. In addition, the Exchange represents that its
surveillance program is comprehensive and adequate to monitor for
manipulation of the underlying security and overlying option. The
Commission also notes that it has not received any comments on the
proposal, aside from the Exchange Letter.
---------------------------------------------------------------------------

    \12\ See Notice, supra note 3 at 47255-256; Exchange Letter,
supra note 4 at 2-3.
---------------------------------------------------------------------------

    The Commission finds that the proposal, coupled with the recent
move to T+2 settlement, would facilitate transactions in securities,
while providing customers safeguards comparable to those provided under
the current five consecutive business day look back period.
Accordingly, the Commission finds that the proposed rule change is
consistent with the requirements of the Act, specifically the
requirements that the rules of an Exchange be designed to prevent
fraudulent and manipulative acts and practices.

IV. Conclusion

    It is therefore ordered that, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-Phlx-2017-75), be and hereby
is, approved.
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    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-00531 Filed 1-12-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Pages 44087-44088]
[FR Doc No: 2016-15991]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Flight
Operational Quality Assurance (FOQA) Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew a previously approved
information collection. Flight Operational Quality Assurance (FOQA) is
a program for the routine collection and analysis of digital flight
data from airline operations, including but not limited to digital
flight data currently collected pursuant to existing regulatory
provisions. The FAA requires certificate holders who voluntarily
establish approved FOQA programs to periodically provide aggregate
trend analysis information from such programs to the FAA.

DATES: Written comments should be submitted by September 6, 2016.

ADDRESSES: Send comments to the FAA at the following address: Ronda
Thompson, Room 441, Federal Aviation Administration, ASP-110, 950
L'Enfant Plaza SW., Washington, DC 20024.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson by email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0660.
    Title: Flight Operational Quality Assurance (FOQA) Program.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The purpose of collecting, analyzing, aggregating, and
reporting this information is to identify potential threats to safety,
and to enable early corrective action before such threats lead to
accidents. FOQA can provide an objective source of information for FAA
decision making, including identification of the need for new
rulemaking based on observed trends in FOQA data. Title 14, Code of
Federal Regulations (14 CFR), subpart 13.401, stipulates that the FAA
does not use FOQA information in punitive enforcement action against an
air carrier or its employees, when that air carrier has an FAA approved
FOQA program. There are no legal or administrative requirements that
necessitate this rule. The rule is intended to encourage the voluntary
implementation of FOQA programs in the interest of safety enhancement.
    Respondents: 60 airline operators.
    Frequency: Information is collected monthly.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 720 hours.

    Issued in Washington, DC, on June 29, 2016.
Ronda L. Thompson,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2016-15991 Filed 7-5-16; 8:45 am]
 BILLING CODE 4910-13-P