[ Federal Register: June 5, 2002 ( Volume 67, Number 108)] [ Notices] [ Page 38660 38664] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr05jn02 42]

ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0065; FRL 7177 4]

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 a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number OPP 2002 0065, must be received on or before July 5, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 2002 0065 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 7610; e mail address: jackson. Sidney@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

 Examples of Categories NAICS codes potentially affected entities  Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing

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 the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select    Laws and Regulations,''    Regulations and Proposed Rules,'' and then look up the entry for this document under the    Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0065. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 2002 0065 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. 3. Electronically. You may submit your comments electronically by e mail to: opp docket@ epa. gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP 2002 0065. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 [[ Page 38661]]

information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified 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. 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 control 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 a pesticide petition 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 this petition contains data or information regarding the elements set forth in 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 the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 17, 2002. Robert Forrest, Acting Director, Registration Division, Office of Pesticide Programs.

III. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by section 408( d)( 3) of the FFDCA. The summary of the petition was prepared by Valent U. S. A. Corporation, P. O. Box 8025, Walnut Creek, CA 94596 8025 and represents the view of Valent U. S. A. Corporation. EPA is publishing the petition summary verbatim without editing it in any way. 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.

PP 1E6272, 1E6285, and 2E6353 EPA has received pesticide petitions ( PP) 1E6272, 1E6285, and 2E6353 from the Interregional Research Project Number 4 ( IR 4), Technology Centre of New Jersey, Rutgers, the State University of New Jersey, 681 U. S. Highway No. 1 South, North Brunswick, NJ 08902 3390 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing tolerances for residues of pyriproxyfen, 2[ 1 methyl 2( 4 phenoxyphenoxy) ethoxy] pyridine, in or on the raw agricultural commodities as follows: 1. PP 1E6272 proposes tolerances for lychee, longan, Spanish lime, rambutan, and pulasan at 0.3 parts per million ( ppm). 2. PP 1E6285 proposes tolerances for guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, and acerola at 0.1 ppm, and 3. PP 2E6353 proposes tolerances for Bushberry subgroup 13 B at 1.0 ppm and lingonberry, juneberry, and salal at 1.0 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the Federal Food Drug and Cosmetic Act ( FFDCA); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petitions. Additional data may be needed before EPA rules on the petitions. Pyriproxyfen is manufactured by Sumitomo Chemical Company, represented in the United States by Valent U. S. A. Corporation.

A. Residue Chemistry 1. Plant metabolism. Metabolism of 14C pyriproxyfen labelled in the phenoxyphenyl ring and in the pyridyl ring has been studied in cotton, apples, tomatoes, lactating goats, laying hens and rats. The major metabolic pathways in plants is aryl hydroxylation and cleavage of the ether linkage, followed by further metabolism into more polar products by further oxidation and/ or conjugation reactions. However, the bulk of the radiochemical residue on raw agricultural commodities ( RAC) samples remained as parent. Comparing metabolites detected and quantified from cotton, apple, tomato, goat, hen and rat shows that there are no significant aglycones in plants which are not also present in the excreta or tissues of animals. The residue of concern is best defined as the parent, pyriproxyfen. Ruminant and poultry metabolism studies demonstrated that transfer of administered 14C residues to tissues was low. Total 14C residues in goat milk, muscle and tissues accounted for less than 2% of the administered dose, and were less than 1 ppm in all cases. In poultry, total 14C residues in eggs, muscle and tissues accounted for about 2.7% of the administered dose, and were less than 1 ppm in all cases except for gizzard. 2. Analytical method. Practical analytical methods for detecting and measuring levels of pyriproxyfen ( and relevant metabolites) have been developed and validated in/ on all appropriate agricultural commodities, respective processing fractions, milk, animal tissues, and environmental samples. The extraction methodology has been validated using aged radiochemical residue samples from metabolism studies. The methods have been validated in cottonseed, apples, soil, and oranges at independent laboratories. EPA has successfully validated the analytical methods for analysis of cottonseed, pome fruit, nutmeats, almond hulls, and fruiting vegetables. The limit of detection of pyriproxyfen in the methods is 0.01 ppm which will allow monitoring of food with residues at the levels proposed for the tolerances. 3. Magnitude of residues  i. Lychee. Three lychee field residue trials were conducted in 1998 in EPA Region 13. Each field site received two pyriproxyfen applications at 0.11 lb active ingredient/ acre ( a. i./ A), with an interval of 10 to 11 days between applications, and a preharvest interval of 11 to 13 days. Pyriproxyfen residues on treated lychee samples ranged from [[ Page 38662]]

0.0759 to 0.272 ppm. These data support a tolerance for pyriproxyfen in or on lychee of 0.3 ppm. ii. Guava. Three guava field residue trials were conducted in 1999 in EPA Region 13. Each field site received two pyriproxyfen applications at 0.11 lb a. i./ A, with an interval of 13 days between applications, and a pre harvest interval of 14 to 15 days. Pyriproxyfen residues on treated guava samples ranged from < 0.025 to 0.055 ppm. The data support a tolerance for pyriproxyfen in or on guava of 0.1 ppm. iii. Blueberry. Eight blueberry field residue trials were conducted in 1999. Three trials were conducted in EPA Region 2, three trials in EPA Region 5, one trial in EPA Region 1, and one trial in EPA Region 12. Each field site received two pyriproxyfen applications at 0.1 lb ai/ A with a retreatment interval ranging between 13 to 15 days. At seven trial locations samples were collected 6 to 8 days after the last application. At one trial location, samples were collected at 2, 7, 10, 14 and 21 days after the last application. Pyriproxyfen residues ranged from 0.14 ppm to 0.64 ppm for treated samples collected 6 to 8 days after the last application. In the residue decline study, pyriproxyfen residues ranged from 0.10 ppm to 0.22 ppm in treated samples collected at the first three sampling intervals, declining to as low as 0.03 ppm after 21 days after the last application. These data support a tolerance for pyriproxyfen in or on blueberries and commodities within the bushberry subgroup of 1.0 ppm.

B. Toxicological Profile An assessment of toxic effects caused by pyriproxyfen is discussed in Unit III. A. and Unit III. B. of the Federal Register dated April 4, 2001, ( FRL 6772 4) ( 66 FR 17883). 1. Animal metabolism. The absorption, tissue distribution, metabolism and excretion of 14C labeled pyriproxyfen were studied in rats after single oral doses of 2 or 1,000 milligrams/ kilograms body weight ( mg/ kg bw) ( phenoxyphenyl and pyridyl label), and after a single oral dose of 2 mg/ kg bw, phenoxyphenyl label only, following 14 daily oral doses at 2 mg/ kg bw of unlabelled material. For all dose groups, most ( 88 96%) of the administered radiolabel was excreted in the urine and feces within two days after radiolabeled test material dosing, and 92 98% of the administered dose was excreted within seven days. Seven days after dosing, tissue residues were generally low, accounting for no more than 0.3% of the dosed 14C. Radiocarbon concentrations in fat were the higher than in other tissues analyzed. Recovery in tissues over time indicates that the potential for bioaccumulation is minimal. There were no significant sex or dose related differences in excretion or metabolism. 2. Metabolite toxicology. Metabolism studies of pyriproxyfen in rats, goats and hens, as well as the fish bioaccumulation study demonstrate that the parent is very rapidly metabolized and eliminated. In the rat, most ( 88 96%) of the administered radiolabel was excreted in the urine and feces within 2 days of dosing, and 92 98% of the administered dose was excreted within 7 days. Tissue residues were low 7 days after dosing, accounting for no more than 0.3% of the dosed 14C. Because parent and metabolites are not retained in the body, the potential for acute toxicity from in situ formed metabolites is low. The potential for chronic toxicity is adequately tested by chronic exposure to the parent at the maximum tolerated dose ( MTD) and consequent chronic exposure to the internally formed metabolites. Seven metabolites of pyriproxyfen, 4' OH pyriproxyfen, 5'' OH pyriproxyfen, desphenyl pyriproxyfen, POPA, PYPAC, 2 OH pyridine and 2,5 diOH pyridine, have been tested for mutagenicity, via Ames Assay, and acute oral toxicity to mice. All seven metabolites were tested in the Ames assay with and without S9 at doses up to 5,000 micro grams per plate or up to the growth inhibitory dose. The metabolites did not induce any significant increases in revertible colonies in any of the test strains. Positive control chemicals showed marked increases in reverting colonies. The acute toxicity to mice of 4' OH pyriproxyfen, 5'' OH pyriproxyfen, desphenyl pyriproxyfen, POPA, and PYPAC did not appear to markedly differ from pyriproxyfen, with all metabolites having acute oral Lethal Dose ( LD50) values greater than 2,000 mg/ kg bw. The two pyridines, 2 OH pyridine and 2,5 diOH pyridine, gave acute oral LD50 values of 124 ( male) and 166 ( female) mg/ kg bw, and 1,105 ( male) and 1,000 ( female) mg/ kg bw, respectively. 3. Endocrine disruption. Pyriproxyfen is specifically designed to be an insect growth regulator and is known to produce juvenoid effects on arthropod development. However, this mechanism of action in target insects and some other arthropods has no relevance to any mammalian endocrine system. While specific tests, uniquely designed to evaluate the potential effects of pyriproxyfen on mammalian endocrine systems have not been conducted, the toxicology of pyriproxyfen has been extensively evaluated in acute, sub chronic, chronic, developmental, and reproductive toxicology studies including detailed histopathology of numerous tissues. The results of these studies show no evidence of any endocrine mediated effects and no pathology of the endocrine organs. Consequently, Valent concludes that pyriproxyfen does not possess estrogenic or endocrine disrupting properties applicable to mammals.

C. Aggregate Exposure 1. Dietary exposure. An evaluation of chronic dietary exposure including both food and drinking water has been performed for the U. S. population and various sub populations including infants and children. No acute dietary endpoint and dose was identified in the toxicology data base for pyriproxyfen, therefore, the Valent Corporation concludes that there is a reasonable certainty of no harm from acute dietary exposure. i. Food. Chronic dietary exposure to pyriproxyfen residues was calculated for the U. S. population and 25 population subgroups assuming tolerance level residues, processing factors from residue studies, and 100% of the crop treated. The analyses included residue data for all existing uses, pending uses, and proposed new uses. The results from several representative subgroups are listed below. Chronic exposure to the overall U. S. population is estimated to be 0.002984 mg/ kg bw/ day, representing 0.9% of the Reference Dose ( RfD). For the most highly exposed sub population, children 1 to 6 years of age, exposure is calculated to be 0.007438 mg/ kg bw/ day, or 2.1% of the RfD. Generally speaking, the Agency has no cause for concern if total residue contribution for established and proposed tolerances is less than 100% of the RfD.

Calculated Chronic Dietary Exposures to the Total U. S. Population and Selected Sub Populations to Pyriproxyfen Residues in Food  Exposure ( mg/ kg bw/ Population Subgroup day) Percent of RfD  Total U. S. population ( all 0.002984 0.853 seasons) Children ( 1 6 years) 0.007438 2.125 Non Nursing infants (< 1 year 0.006483 1.852 old) All infants (< 1 year old) 0.005604 1.601 Children ( 7 12 years) 0.004159 1.188 [[ Page 38663]]

Females ( 13+/ nursing) 0.002964 0.847 Nursing infants (< 1 year old) 0.002601 0.743

ii. Drinking water. Since pyriproxyfen is applied outdoors to growing agricultural crops, the potential exists for pyriproxyfen or its metabolites to reach ground or surface water that may be used for drinking water. Because of the physical properties of pyriproxyfen, it is unlikely that pyriproxyfen or its metabolites can leach to potable ground water. To quantify potential exposure from drinking water, surface water concentrations for pyriproxyfen were estimated using GENEEC 1.3. The average 56 day concentration predicted in the simulated pond water was 0.16 parts per billion ( ppb). Using standard assumptions about body weight and water consumption, the chronic exposure to pyriproxyfen from this drinking water would be 4.57 x 10 6 and 1.6 x 10 5 mg/ kg bw/ day for adults and children, respectively; 0.0046% of the RfD ( 0.35 mg/ kg/ day) for children. Based on this worse case analysis, the contribution of water to the dietary risk is negligible. 2. Non dietary exposure. Pyriproxyfen is currently registered for use on residential non food sites. Pyriproxyfen is the active ingredient in numerous registered products for flea and tick control. Formulations include foggers, aerosol sprays, emulsifiable concentrates, and impregnated materials ( pet collars). With the exception of the pet collar uses, consumer use of pyriproxyfen typically results in acute and short term intermittent exposures. No acute dermal, or inhalation dose or endpoint was identified in the toxicity data for pyriproxyfen. Similarly, doses and endpoints were not identified for short and intermediate term dermal or inhalation exposure to pyriproxyfen. The Valent Corporation has concluded that there are reasonable certainties of no harm from acute, short term, and intermediate term dermal and inhalation occupational and residential exposures due to the lack of significant toxicological effects observed. Chronic residential post application exposure and risk assessments were conducted to estimate the potential risks from pet collar uses. The risk assessment was conducted using the following assumptions: application rate of 0.58 mg active ingredient ( ai)/ day, average bw for a 1 6 year old child of 10 kg, the a. i. dissipates uniformly through 365 days ( the label instruct to change collar once a year), 1% of the active ingredient is available for dermal and inhalation exposure per day ( assumption from Draft EPA Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, December 18, 1997). The assessment also assumes an absorption rate of 100%. This is a conservative assumption since the dermal absorption was estimated to be 10%. The estimated chronic term MOE was 61,000 for children, and 430,000 for adults. The risk estimates indicate that potential risks from pet collar uses do not exceed the Agency's level of concern.

D. Cumulative Effects Section 408( b)( 2)( D)( v) requires that the Agency must consider    available information'' concerning the cumulative effects of a particular pesticide's residues and    other substances that have a common mechanism of toxicity.'' Available information in this context include not only toxicity, chemistry, and exposure data, but also scientific policies and methodologies for understanding common mechanisms of toxicity and conducting cumulative risk assessments. For most pesticides, although the Agency has some information in its files that may turn out to be helpful in eventually determining whether a pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this time have the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity in a meaningful way. There are no other pesticidal compounds that are structurally related to pyriproxyfen and have similar effects on animals. In consideration of potential cumulative effects of pyriproxyfen and other substances that may have a common mechanism of toxicity, there are currently no available data or other reliable information indicating that any toxic effects produced by pyriproxyfen would be cumulative with those of other chemical compounds. Thus, only the potential risks of pyriproxyfen have been considered in this assessment of aggregate exposure and effects. Valent will submit information for EPA to consider concerning potential cumulative effects of pyriproxyfen consistent with the schedule established by EPA at 62 FR 42020 ( Aug. 4, 1997) and other subsequent EPA publications pursuant to the Food Quality Protection Act.

E. Safety Determination 1. U. S. population.  i. Chronic dietary exposure and risk adult sub populations. The results of the chronic dietary exposure assessment described above demonstrate that estimates of chronic dietary exposure for all existing, pending and proposed uses of pyriproxyfen are well below the chronic RfD of 0.35 mg/ kg bw/ day. The estimated chronic dietary exposure from food for the overall U. S. population and many non child/ infant subgroups is from 0.002123 to 0.003884 mg/ kg bw/ day, 0.607 to 1.100% of the RfD. Addition of the small but worse case potential chronic exposure from drinking water ( calculated above) increases exposure by only 4.57 x 10 6 mg/ kg bw/ day and does not change the maximum occupancy of the RfD significantly. Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the RfD. Valent concludes that there is a reasonable certainty that no harm will result to the overall U. S. Population or any non child/ infant subgroups from aggregate, chronic dietary exposure to pyriproxyfen residues. ii. Acute dietary exposure and risk adult sub populations. No acute dietary endpoint and dose were identified in the toxicology data base for pyriproxyfen; therefore, it can be concluded that there is a reasonable certainty that no harm will result to the overall U. S. population or any non child/ infant subgroups from aggregate, acute dietary exposure to pyriproxyfen residues. iii. Non dietary exposure and aggregate risk adult sub populations. Acute, short term, and intermediate term dermal and inhalation risk assessments for residential exposure are not required due to the lack of significant toxicological effects observed. The results of a chronic residential post application exposure and risk assessment for pet collar uses demonstrate that potential risks from pet collar uses do not exceed the Agency's level of concern. The estimated chronic term MOE for adults was 430,000. 2. Infants and children  i. Safety factor for infants and children. In assessing the potential for additional sensitivity of infants and children to residues of pyriproxyfen, FFDCA section 408 provides that EPA shall apply an additional margin of safety, up to 10 fold, for added protection for infants and children in the case of threshold effects unless EPA determines [[ Page 38664]]

that a different margin of safety will be safe for infants and children. The toxicological data base for evaluating pre natal and post natal toxicity for pyriproxyfen is complete with respect to current data requirements. There are no special prenatal or postnatal toxicity concerns for infants and children, based on the results of the rat and rabbit developmental toxicity studies or the 2 generation reproductive toxicity study in rats. Valent concludes that reliable data support use of the standard 100 fold uncertainty factor and that an additional uncertainty factor is not needed for pyriproxyfen to be further protective of infants and children. ii. Chronic dietary exposure and risk infants and children. Using the conservative exposure assumptions described above, the percentage of the RfD that will be utilized by chronic dietary ( food only) exposure to residues of pyriproxyfen ranges from 0.002601 mg/ kg bw/ day for nursing infants, up to 0.007438 mg/ kg bw/ day for children ( 1 to 6 years of age), 0.743 to 2.125% of the RfD, respectively. Adding the worse case potential incremental exposure to infants and children from pyriproxyfen in drinking water ( 1.6 x 10 5 mg/ kg bw/ day) does not materially increase the aggregate, chronic dietary exposure and only increases the occupancy of the RfD by 0.0046% to 2.130% for Children ( 1 to 6 years of age). EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Valent concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate, chronic dietary exposure to pyriproxyfen residues. iii. Acute dietary exposure and risk infants and children. No acute dietary endpoint and dose were identified in the toxicology data base for pyriproxyfen; therefore, Valent believes that there is a reasonable certainty that no harm will result to infants and children from aggregate, acute dietary exposure to pyriproxyfen residues. iv. Non dietary exposure and aggregate risk infants and children. Acute, short term, and intermediate term dermal and inhalation risk assessments for residential exposure are not required due to the lack of significant toxicological effects observed. The results of a chronic residential post application exposure and risk assessment for pet collar uses demonstrate that potential risks from pet collar uses do not exceed the Agency's level of concern. The estimated chronic term MOE for children was 61,000.

F. International Tolerances There are no presently existing Codex maximum residue levels ( MRLs) for pyriproxyfen.

[ FR Doc. 02 13810 Filed 6 4 02; 8: 45 am] BILLING CODE 6560 50 S


Page 1 of 4 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING DECEMBER 2, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0343 USE OF PHARMACOKINETIC DATA TO REFINE CARBARYL RISK ESTIMATES FROM ORAL & DERMAL EXPOSURE Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 Telephone: ( 703) 807 2000 PANEL MEMBERS FIFRA SAP Session Chair:

Steven G. Heeringa, Ph. D. Research Scientist & Director for Statistical Design Institute for Social Research University of Michigan P. O. Box 1248 426 Thompson Street EP 419 Ann Arbor, MI 48106 1248 Designated Federal Official:

Mr. Joseph E. Bailey FIFRA Scientific Advisory Panel Office of Science Coordination and Policy U. S. Environmental Protection Agency EPA East Building 1200 Pennsylvania Avenue, N. W. ( 7201M) Washington, D. C. 20460 Phone: 202 564 8450, Fax: 202 564 8382 bailey. joseph@ epa. gov Page 2 of 4 FIFRA SAP Members:

Janice E. Chambers, Ph. D., D. A. B. T. William L. Giles Distinguished Professor Director, Center for Environmental Health Sciences College of Veterinary Medicine Mississippi State University P. O. Box 6100 Mississippi State, MS 39762 6100 Stuart Handwerger, M. D. Professor of Pediatrics University of Cincinnati Children's Hospital Medical Center 3333 Burnet Avenue Cincinnati, OH 45229 3039 Gary E. Isom, Ph. D. Professor of Toxicology School of Pharmacy & Pharmacal Sciences Purdue University 575 Stadium Mall Drive West Lafayette, IN 47907 2091 Kenneth M. Portier, Ph. D. Associate Professor, Statistics Institute of Food and Agricultural Sciences University of Florida 522 McCarty Hall C, P. O. Box 110339 Gainesville, FL 32611 0339 FQPA Science Review Board Members:

William Brimijoin, Ph. D. Chair, Department of Pharmacology Mayo Clinic and Medical School 201 1ST Street, SW Rochester, MN 55905 Annette L. Bunge, Ph. D. Professor Department of Chemical Engineering Colorado School of Mines 1613 Illinois, Ste. 451 Golden, CO 80401 Page 3 of 4 Lutz Edler, Ph. D. Head, Biostatistics Unit C060 German Cancer Research Center Im Neuenheimer Feld 280 D 69120 Heidelberg Germany Lawrence J. Fischer, Ph. D. Director, Center for Integrative Toxicology Michigan State University C 231 Holden Hall East Lansing, MI 48824 Gaylia Jean Harry, Ph. D. Neurotoxicology Group Leader National Institute of Environmental Health Sciences 111 Alexander Drive, P. O. Box 12233 Research Triangle Park, NC 27709 Dale Hattis, Ph. D. Research Professor, Center for Technology, Environment & Development ( CENTED) George Perkins Marsh Institute Clark University Worcester, MA 01610 James P. Kehrer, Ph. D. Director, Center for Molecular & Cellular Toxicology College of Pharmacy The University of Texas at Austin 1 University Station A1915 Austin, TX 78712 1025 Chensheng Lu, Ph. D. Assistant Professor Department of Environmental & Occupational Health Rollins School of Public Health Emory University Grace Crum Rollins Building 1518 Clifton Road, NE Atlanta, GA 30322 Page 4 of 4 Peter D. M. Macdonald, D. Phil. Professor of Mathematics & Statistics McMaster University 1280 Main Street West Hamilton, Ontario Canada L8S 4K1 Isaac N. Pessah, Ph. D. Professor, Department of Molecular Biosciences Director, Center for Children's Environmental Health & Disease Prevention University of California at Davis One Shields Avenue Davis, CA 95616 Nu may Ruby Reed, Ph. D., D. A. B. T. Staff Toxicologist Department of Pesticide Regulation California Environmental Protection Agency 1001 I Street Sacramento, CA 95812 4015 Jim E. Riviere, D. V. M., Ph. D. Director, Center for Chemical Toxicology Research & Pharmacokinetics College of Veterinary Medicine North Carolina State University 4700 Hillsborough Street Raleigh, NC 27606 Audra L. Stinchcomb, Ph. D. Assistant Professor Department of Pharmaceutical Sciences University of Kentucky College of Pharmacy, Building 0082 900 S. Limestone Street, Room 459 Lexington, KY 40536 0200 Michael D. Wheeler, Ph. D. Assistant Professor Departments of Pharmacology & Medicine University of North Carolina Skipper Bowles Center for Alcohol Studies 3011 Thurston Bowles Building Campus Box 7178 Chapel Hill, NC 27599


[Federal Register: July 13, 2006 (Volume 71, Number 134)]
[Notices]
[Page 39681-39682]
[DOCID:fr13jy06-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP01-245-016]

Transcontinental Gas Pipe Line Corporation; Notice of Technical
Conference

June 27, 2006.
    Take notice that the Commission will convene a technical conference
on Monday, July 24, 2006, at 9 a.m. (EDT), in a room to be designated
at the offices of the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington DC 20426.
    The Commission's May 30, 2006 order in this proceeding established
a technical conference to address the issue of the appropriate method
of conducting pooling in Transco's Zone 4.\1\ The order found that
there are certain aspects of the operation of the current Zone 4 pool
at Station 85 that were unclear from the present record. The Commission
found that a technical conference will provide an opportunity to
clarify the present operation of the Station 85 pooling point and
consider whether improvements could be made

in the way pooling is conducted in Zone 4.
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    \1\ Transcontinental Gas Pipe Line Corporation, 115 FERC ] 61,
268 (2006).
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    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    All interested persons are permitted to attend.
    For Further Information Contact:
    David Faerberg at<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
 [FR Doc. E6-10990 Filed 7-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45293-45295]
[FR Doc No: 2017-20791]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1119]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Canning
Establishment Registration, Process Filing, and Recordkeeping for
Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically
Sealed Containers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 October
30, 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 0910-0037.
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, 10A-12M, 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.

I. Background

Food Canning Establishment Registration, Process Filing, and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers 21 CFR 108.25 and 108.35, and
Parts 113 and 114

OMB Control Number 0910-0037--Extension

    Section 402 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 342) deems a food to be adulterated, in part, if the
food bears or contains any poisonous or deleterious substance that may
render it injurious to health. Section 301(a) of the FD&C Act (21
U.S.C. 331(a)) prohibits the introduction or delivery for introduction
into interstate commerce of adulterated food. Under section 404 of the
FD&C Act (21 U.S.C. 344), our regulations require registration of food
processing establishments, filing of process or other data, and
maintenance of processing and production records for acidified foods
and thermally processed low-acid foods in hermetically sealed
containers. These requirements are intended to ensure safe
manufacturing, processing, and packing procedures, and to permit us to
verify that these procedures are being followed. Improperly processed
low-acid foods present life-threatening hazards if contaminated with
foodborne microorganisms, especially Clostridium botulinum. The spores
of C. botulinum need to be destroyed or inhibited to avoid production
of the deadly toxin that causes botulism. This is accomplished with
good manufacturing procedures, which must include the use of adequate
heat processes or other means of preservation.
    To protect the public health, our regulations require that each
firm that manufactures, processes, or packs acidified foods or
thermally processed low-acid foods in hermetically sealed containers
for introduction into interstate commerce register the establishment
with us using Form FDA 2541 (Sec. Sec.  108.25(c)(1) and 108.35(c)(2)
(21 CFR 108.25(c)(1) and 108.35(c)(2)). In addition to registering the
plant, each firm is required to provide data on the processes used to
produce these foods, using Forms FDA 2541d, FDA 2541e,

and FDA 2541f for all methods except aseptic processing, or Form FDA
2541g for aseptic processing of low-acid foods in hermetically sealed
containers (Sec. Sec.  108.25(c)(2) and 108.35(c)(2)). Plant
registration and process filing may be accomplished simultaneously.
Process data must be filed prior to packing any new product, and
operating processes and procedures must be posted near the processing
equipment or made available to the operator (21 CFR 113.87(a)).
    Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and
114) require firms to maintain records showing adherence to the
substantive requirements of the regulations. These records must be made
available to FDA on request. Firms also must document corrective
actions when process controls and procedures do not fall within
specified limits (Sec. Sec.  113.89, 114.89, and 114.100(c)); to report
any instance of potential health-endangering spoilage, process
deviation, or contamination with microorganisms where any lot of the
food has entered distribution in commerce (Sec. Sec.  108.25(d) and
108.35(d) and (e)); and to develop and keep on file plans for recalling
products that may endanger the public health (Sec. Sec.  108.25(e) and
108.35(f)). To permit lots to be traced after distribution, acidified
foods and thermally processed low-acid foods in hermetically sealed
containers must be marked with an identifying code (Sec.  113.60(c))
(thermally processed foods) and Sec.  114.80(b) (acidified foods)).
    The records of processing information are periodically reviewed
during factory inspections by FDA to verify fulfillment of the
requirements in parts 113 or 114. Scheduled thermal processes are
examined and reviewed to determine their adequacy to protect public
health. In the event of a public health emergency, records are used to
pinpoint potentially hazardous foods rapidly and thus limit recall
activity to affected lots.
    As described in our regulations, processors may obtain the paper
versions of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA
2541g by contacting us at a particular address or by visiting https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. Processors mail completed
paper forms to us. However, processors who are subject to Sec.  108.25,
Sec.  108.35, or both, have an option to submit Forms FDA 2541, FDA
2541d, FDA 2541e, FDA 2541f, and FDA 2541g electronically (Ref. 1).
    Although we encourage commercial processors to use the electronic
submission system for plant registration and process filing, we will
continue to make paper-based forms available. To standardize the burden
associated with process filing, regardless of whether the process
filing is submitted electronically or using a paper form, we are
offering the public the opportunity to use four forms, each of which
pertains to a specific type of commercial processing and is available
both on the electronic submission system and as a paper-based form. The
electronic submission system and paper-based form ``mirror'' each other
to the extent practicable. The four process filing forms are as
follows:
     Form FDA 2541d (Food Process Filing for Low-Acid Retorted
Method) (Ref. 2);
     Form FDA 2541e (Food Process Filing for Acidified Method)
(Ref. 3);
     Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method) (Ref. 4); and
     Form FDA 2541g (Food Process Filing for Low-Acid Aseptic
Systems) (Ref. 5).
    At this time, the paper-based versions of the four forms and their
instructions are all available for review as references to this
document (Refs. 2 through 5) or at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm.
    Description of Respondents: The respondents to this information
collection are commercial processors and packers of acidified foods and
thermally processed low-acid foods in hermetically sealed containers.
    In the Federal Register of June 20, 2017 (82 FR 28069), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. While no comments were submitted to the
docket, it was noted that the notice included an inadvertent reference
to outdated forms. We regret this oversight and have made appropriate
corrections in this notice. The forms developed in support of the
information collection are intended to minimize burden on respondents
while maximizing utility for FDA, and thus we are continuously open to
suggestions on how they might be improved.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Average
                                                             FDA  form       Number of       Number of     Total  annual    burden per
                     21 CFR section                           number        respondents    responses per     responses       response       Total hours
                                                                                respondent                       (minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   108.25(c)(1) and 108.35(c)(2); Food canning            2541             645               1             645            0.17             110
 establishment registration.............................                                                                            (10)
Sec.   108.25(c)(2); Food process filing for acidified             2541e             726              11           7,986           0.333           2,659
 method.................................................                                                                            (20)
Sec.   108.35(c)(2); Food process filing for low-acid              2541d             336              12           4,032           0.333           1,343
 retorted method........................................                                                                            (20)
Sec.   108.35(c)(2); Food process filing for water                 2541f              37               6             222           0.333              74
 activity/formulation control method....................                                                                            (20)
Sec.   108.35(c)(2); Food process filing for low-acid              2541g              42              22             924            0.75             693
 aseptic systems........................................                                                                            (45)

Sec.  Sec.   108.25(d) and 108.35(d) and (e); Report of              N/A               1               1               1               4               4
 any instance of potential health endangering spoilage,
 process deviation, or contamination with microorganisms
 where any lot of the food has entered distribution in
 commerce...............................................
    Total...............................................  ..............  ..............  ..............  ..............           4,883
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate of the number of respondents in table 1 on
registrations, process filings, and reports received over the past 3
years. The hours per response reporting estimates are based on our
experience with similar programs and information received from
industry. The reporting burden for Sec. Sec.  108.25(d) and 108.35(d)
and (e) is minimal because notification of spoilage, process deviation,
or contamination of product in distribution occurs less than once a
year. Most firms discover these problems before the product is
distributed, and are therefore not required to report the occurrence.
We estimate that we will receive one report annually under Sec. Sec.
108.25(d) and 108.35(d) and (e). The report is expected to take 4 hours
per response, for a total of 4 hours.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                Number of                       Average  burden
                           21 CFR part                                Number of        records per      Total annual          per          Total hours
                                                                    recordkeepers     recordkeeper        records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
108, 113, and 114...............................................           10,392                 1           10,392               250        2,598,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate of 10,392 recordkeepers in table 2 on its
records of the number of registered firms, excluding firms that were
inactive or out of business, yet still registered. To avoid double-
counting, we have not included estimates for Sec. Sec.  108.25(g),
108.35(c)(2)(ii), and 108.35(h) because they merely cross-reference
recordkeeping requirements contained in parts 113 and 114 and have been
accounted for in the recordkeeping burden estimate. We estimate that
10,392 firms will expend approximately 250 hours per year to fully
satisfy the recordkeeping requirements in parts 108, 113 and 114, for a
total of 2,598,000 hours.
    Finally, our regulations require that processors mark thermally
processed low-acid foods in hermetically sealed containers (Sec.
113.60(c)) and acidified foods (Sec.  114.80(b)) with an identifying
code to permit lots to be traced after distribution. We seek OMB
approval of the third-party disclosure requirements in Sec. Sec.
113.60(c) and 114.80(b). However, we have not included a separate table
to report the estimated burden of these regulations. No burden has been
estimated for the third-party disclosure requirements in Sec. Sec.
113.60(c) and 114.80(b) because the coding process is done as a usual
and customary part of normal business activities. Coding is a business
practice in foods for liability purposes, inventory control, and
process control in the event of a problem. Under 5 CFR 1320.3(b)(2),
the time, effort, and financial resources necessary to comply with a
collection of information are excluded from the burden estimate if the
reporting, recordkeeping, or disclosure activities needed to comply are
usual and customary because they would occur in the normal course of
activities. The burden for this information collection has not changed
since the last OMB approval.

II. References

    The following references are on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov/. FDA has
verified the Web site addresses as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA 2016. ``Guidance for Industry: Submitting Form FDA 2541 (Food
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e,
FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in
Electronic or Paper Format.'' Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541d. Food Process Filing for Low-Acid Retorted Method.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465591.pdf.
3. Form FDA 2541e. Food Process Filing for Acidified Method.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465593.pdf.
4. Form FDA 2541f. Food Process Filing for Water Activity/
Formulation Control Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465595.pdf.
5. Form FDA 2541g. Food Process Filing for Low-Acid Aseptic Systems.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465598.pdf.

    Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20791 Filed 9-27-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25235-25236]
[FR Doc No: 2022-09126]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2800-052]

Essex Company, LLC; Notice of Application for Amendment of
License, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Proceeding: Application non-capacity amendment of
license.
    b. Project No.: 2800-052.

    c. Date Filed: August 31, 2020 and supplemented March 22, 2022.
    d. Licensee: Essex Company, LLC.
    e. Name of Project: Lawrence Hydroelectric Project.
    f. Location: The project is located on the Merrimack River in the
City of Lawrence in Essex County, Massachusetts.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Kevin M. Webb, Essex Company, LLC, 670 N
Commercial Street, Suite 204, Manchester, NH, 03101,<PHONE_NUMBER>,
[email protected].
    i. FERC Contact: Rebecca Martin,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, interventions, and protests
Deadline for filing comments, motions to intervene, and protests: May
23, 2022.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket number P-2800-052. Comments emailed to Commission staff
are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The Licensee proposes to remove the
historic North and South Canals from the project because they are not
needed for project purposes.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: April 22, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-09126 Filed 4-27-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67154-67155]
[FR Doc No: 2016-23633]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA 2016-N-2677]

Medical Devices; Neurological Devices; Classification of the
Evoked Photon Image Capture Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
Evoked Photon Image Capture Device into class I (general controls). The
Agency is classifying the device into class I (general controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective September 30, 2016. The classification
was applicable on July 15, 2016.

FOR FURTHER INFORMATION CONTACT: Kristen Bowsher, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2646, Silver Spring, MD 20993-0002, 301-
796-6448<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i), to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)), as
amended by section 607 of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), provides two procedures by which a
person may request FDA to classify a device under the criteria set
forth in section 513(a)(1). Under the first procedure, the person
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified and, within 30
days of receiving an order classifying the device into class III under
section 513(f)(1), the person requests a classification under section
513(f)(2). Under the second procedure, rather than first submitting a
premarket notification under section 510(k) and then a request for
classification under the first procedure, the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA shall
classify the device by written order within 120 days. This
classification will be the initial classification of the device. On
January 12, 2015, EPIC Research & Diagnostics, Inc. submitted a request
for classification of the EPIC ClearView\TM\ System under section
513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class I if general controls by themselves are sufficient to
provide reasonable assurance of safety and effectiveness of the device
for its intended use. After review of the information submitted in the
de novo request, FDA determined that the device can be classified into
class I. FDA believes general controls will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on July 15, 2016, FDA issued an order to the requestor
classifying the device into class I. FDA is codifying the
classification of the device by adding 21 CFR 882.1561.
    The device is assigned the generic name evoked photon image capture
device, and it is identified as a prescription, electrically-powered
device intended for use as a non-invasive measurement tool that applies
electricity to detect electrophysiological signals emanating from the
skin, which are reported numerically and as images without clinical
interpretation. The device is not intended for diagnostic purposes.
    FDA has identified the following risks to health associated
specifically with this type of device: Adverse tissue reaction,
electromagnetic incompatibility, and electromagnetic malfunction (e.g.,
shock).
    Evoked photon image capture devices are not safe for use except
under the supervision of a practitioner licensed by law to direct the
use of the device. As such, the device is a prescription device and
must satisfy prescription labeling requirements (see 21 CFR 801.109
Prescription devices).

II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in other FDA regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in part 807, subpart E, regarding
premarket notification submissions have been approved under OMB control
number 0910-0120, and the collections of information in 21 CFR part
801, regarding labeling have been approved under OMB control number
0910-0485.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  882.1561 to subpart B to read as follows:

Sec.  882.1561  Evoked photon image capture device.

    (a) Identification. An evoked photon image capture device is a
prescription, electrically powered device intended for use as a
noninvasive measurement tool that applies electricity to detect
electrophysiological signals emanating from the skin, which are
reported numerically and as images without clinical interpretation. The
device is not intended for diagnostic purposes.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec.  882.9.

    Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23633 Filed 9-29-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 215 (Wednesday, November 8, 2023)]
[Notices]
[Pages 77143-77144]
[FR Doc No: 2023-24643]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2015-0036]

Petition for Extension of Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on October 13, 2023, Union
Pacific Railroad Company (UPRR) petitioned the Federal Railroad
Administration (FRA) for an extension of a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR part 232 (Brake

System Safety Standards for Freight and Other Non-Passenger Trains and
Equipment; End-of-Train Devices). The relevant Docket Number is FRA-
2015-0036.
    Specifically, UPRR requests to continue operating extended haul
trains for distances of up to 1,680 miles, beyond the limit of 1,500
miles stated in 49 CFR 232.213, Extended haul trains. In support of its
request, UPRR states that it reviews with FRA ``the list of trains
associated with this waiver at a frequency of no less than once per
quarter'' and ``adjustments are made accordingly.'' UPRR further
explains that ``over a 56-month period, the incident rate has been no
more than .055%[, which were] four events comprised of wheelset, axle,
and journal bearing defects.'' UPRR also notes that for the eight-year
history of this waiver, UPRR ``has not identified any adverse effect on
the safety of operations'' and that the waiver extension would
``continue to support personnel safety, reduce critical resource idle
time, and have a positive impact on the environment.''
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by January 8, 2024 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT)
solicits comments from the public to better inform its processes. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2023-24643 Filed 11-7-23; 8:45 am]
BILLING CODE 4910-06-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on August 31, 2004

NOTICE OF ACTION TAKEN -- DOCKETS OST-1995-736

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of AMERICA WEST AIRLINES, INC., filed 7/23/04, and amended
8/11/04, for:

XX Renewal of exemption for two years under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of persons, property, and mail
between (1) the terminal point Phoenix, Arizona, and the terminal point
San Jose del Cabo, Mexico; (2) the terminal point Phoenix, Arizona, and
the terminal point Mazatlan, Mexico; (3) the terminal point Phoenix,
Arizona, and the terminal point Mexico City, Mexico; (4) the terminal
point Phoenix, Arizona, and the terminal point Puerto Vallarta, Mexico;
(5) the terminal point Phoenix, Arizona, and the terminal point
Manzanillo, Mexico; (6) the terminal point Phoenix, Arizona, and the
terminal point Acapulco, Mexico; (7) the terminal point Phoenix,
Arizona, and the terminal point Cancun, Mexico; and (8) the terminal
point Phoenix, Arizona, and the terminal point Ixtapa/Zihuatanejo,
Mexico.  America West serves these markets on a seasonal basis.

Applicant rep: David M. Kirstein<PHONE_NUMBER>  DOT Analyst: Linda L.
Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The authority granted was effective when taken: August 31, 2004, through
  August 31, 2006.

Action taken by: 	 Paul L. Gretch

			Office of International Aviation

XX   The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated: 		XX  Holder’s
certificates of public convenience and necessity

				XX  Standard Exemption Conditions (attached)

Conditions:   The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.

- see next page -											2

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3)

grant of the authority would not constitute a major regulatory action
under the Energy Policy and Conservation Act of 1975.  To the extent not
granted, we denied all requests in the referenced Docket.  We may amend,
modify, or revoke the authority granted in this Notice at any time
without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  05/2004

  In the amendment to its application, America West states that its
authority to serve the Las Vegas-Mexico City market (authority
previously granted in this docket), is dormant and that it does not seek
to renew that authority here.


[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35042-35043]
[FR Doc No: 2013-13854]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0407]

Merchant Marine Personnel Advisory Committee: Intercessional
Meeting

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee Working Group Meeting.

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SUMMARY: A working group of the Merchant Marine Personnel Advisory
Committee (MERPAC) will meet to work on Task Statement 78, entitled
``Consideration of the International Labor Organization's Maritime
Labour Convention, 2006.'' This meeting will be open to the public.

DATES: A MERPAC working group will meet on June 26, 2013, and June 27,
2013, from 8 a.m. until 4 p.m. Please note that the meeting may adjourn
early if all business is finished. Written comments to be distributed
to working group members and placed on MERPAC's Web site are due by
June 12, 2013.

ADDRESSES: The working group will meet at the Jemal Building of U.S.
Coast Guard Headquarters, Room 08-1419, 1900 Half St., SW., Washington,
DC 20593. Attendees will be required to provide a picture
identification card and pass through a magnetometer in order to gain
admittance to the Jemal Building. Visitors should also arrive at least
30 minutes in advance of the meeting in case of long lines at the
entrance.
    For further information about the Coast Guard facilities or
services for individuals with disabilities or to request special
assistance, contact Mr. Davis Breyer at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    To facilitate public participation, we are inviting public comment
on the issues to be considered by the work group, which are listed in
the ``Agenda'' section below. Written comments must be identified by
Docket No. USCG-2013-0407 and may be submitted by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments (preferred method to
avoid delays in processing).
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays. The
telephone number is<PHONE_NUMBER>.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov.
    This notice may be viewed in our online docket, USCG-2013-0407, at
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Davis Breyer, Alternate Designated
Federal Officer of MERPAC, telephone<PHONE_NUMBER>. If you have any
questions on viewing or submitting material to the docket, call Barbara
Hairston, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), 5 U.S.C. App. (Pub. L. 92-463).
    MERPAC is an advisory committee authorized under section 871 of the
Homeland Security Act of 2002, Title 6, United States Code, section
451, and chartered under the provisions of the FACA. The Committee acts
solely in an advisory capacity to the Secretary of the Department of
Homeland Security (DHS) through the Commandant of the Coast Guard and
the Director of Commercial Regulations and Standards on matters
relating to personnel in the U.S. merchant marine, including but not
limited to training, qualifications, certification, documentation, and
fitness standards. The Committee will advise, consult with, and make
recommendations reflecting its independent judgment to the Secretary.

Agenda

Day 1

    The agenda for the June 26, 2013, working group meeting is as
follows:
    (1) Prepare a document that outlines those areas of concern that
present the greatest challenge for U.S. maritime industry compliance
with the International Labor Organization's Maritime Labour Convention,
2006;
    (2) Public comment period;
    (3) Discuss and prepare proposed recommendations for the full
committee to consider with regards to Task Statement 78, entitled
``Consideration of the International Labor Organization's Maritime
Labour Convention, 2006''; and
    (4) Adjournment of meeting.

Day 2

    The agenda for the June 27, 2013, working group meeting is as
follows:
    (1) Continue discussion on proposed recommendations;
    (2) Public comment period;
    (3) Discuss and prepare final recommendations for the full
committee to consider with regards to Task Statement 78, entitled
``Consideration of the International Labor Organization's

Maritime Labour Convention, 2006''; and
    (4) Adjournment of meeting.
    Procedural: A copy of all meeting documentation, including the Task
Statement, is available at https://homeport.uscg.mil by using these key
strokes: Missions; Port and Waterways Safety; Advisory Committees;
MERPAC; and then use the event key. Alternatively, you may contact Mr.
Breyer as noted in the ADDRESSES section above.
    Public oral comment periods will be held during the working group
meeting. Speakers are requested to limit their comments to 3 minutes.
Please note that the public oral comment periods may end before the
prescribed ending time following the last call for comments. Contact
Davis Breyer no later than June 19, 2013 as indicated above to register
as a speaker.

    Dated: June 6, 2013.
J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2013-13854 Filed 6-10-13; 8:45 am]
BILLING CODE 9110-04-P