[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Notices]
[Page 67292]
[DOCID:fr28no07-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket Nos. EL05-25-005, EL05-26-005, EL05-27-005]

Southern Company Services, Inc.; Notice of Filing

November 20, 2007.
    Take notice that on November 15, 2007, Southern Company Services,
acting as agent for Alabama Power Company and Georgia Power Company,
filed a compliance filing pursuant to the Commission Order issued
October 31, 2007, Tenaska Alabama II Partners, et al., v. Alabama Power
Company, et al., 121 FERC ] 61,124 (2007).
    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, 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 on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    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>.
    Comment Date: 5 p.m. Eastern Time on December 6, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-23067 Filed 11-27-07; 8:45 am]

BILLING CODE 6717-01-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Proposed Decisions for the Remaining Uses of Azinphos methyl June 9, 2006 Part I: Summary and Background Proposed Decision and Comment Opportunity Based on its reevaluation of the risks and benefits of the 10 remaining uses of azinphosmethyl ( AZM), the Agency is proposing to phase out AZM use on almonds, pistachios, walnuts, Brussels sprouts, and nursery stock in 2007, and phase out use on apples/ crabapples, blueberries, cherries, pears and parsley in 2010. The purpose of this document is to outline the Agency's rationale for these proposals and solicit comment. Comments are specifically requested on the time frame for phasing out uses, the terms and conditions of the phase out, and what mitigation and monitoring should be required during the phase out. All supporting documents, including the worker and ecological risk assessments, the crop by crop grower impact assessments, comments received to date, and EPA's response to comments can be found at: www. regulations. gov under docket number EPA HQ OPP 2005 0061. Public comments will be accepted for 60 days following publication of a Federal Register Notice of Availability on June 9, 2006. After the close of the comment period ( August 9, 2006), the Agency will review all comments received and issue its final decision later this Fall. That final decision will include consideration of the results of the cumulative risk assessment of the organophosphate ( OP) pesticides.

This document is divided into two parts. Part I contains general background information and summaries of risk concerns. Part II contains the crop by crop proposed decisions and rationale.

Regulatory Context/ Background AZM, an organophosphate insecticide first registered in 1959, is currently used only on orchard fruits, berries, nuts, and other crops. In connection with the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) reregistration and the Federal Food, Drug, and Cosmetic Act ( FFDCA) tolerance reassessment processes, EPA issued an Interim Reregistration Eligibility Decision ( IRED) for AZM in October 2001. 2 In the azinphos methyl IRED, the Agency concluded, based on evaluation of the risks and benefits of the use of AZM, that 35 uses should either be immediately canceled ( Group 1) or phased out over a four year period ( Group 2). The remaining ten timelimited AZM uses ( Group 3: almonds, apples/ crabapples, highbush and lowbush blueberries, Brussels sprouts, cherries, nursery stock, parsley, pears, pistachios, and walnuts) were eligible for reregistration for a period of four years, contingent on the submission of additional data and pending completion of the cumulative risk assessment for OPs. Subsequent to the IRED, a Memorandum of Agreement ( MOA) in 2002 between EPA and the AZM registrants, Bayer Corporation, Gowan Company, Makhteshim Agan of North America, Inc, Micro Flo Corporation, and Platte Chemical Company, provided among other things, that registrants could submit applications for amended registration to extend the life of their azinphos methyl registrations beyond the four year period. EPA would consider applications to remove the time limitation on the registrations taking into account additional data EPA required the registrants to submit. In July 2004, the AZM registrants submitted applications to remove the time limitation for the ten uses. The Agency intends to publish its final decision later this Fall which will also serve as the response to the registration amendment requests.

New Information The Data Call In associated with the 2001 IRED required usage information, ecological effects data as well as biomonitoring of agricultural workers. These data have been submitted by registrants, reviewed by the Agency, and incorporated into the revised grower impact, worker and ecological risk assessments. The Agency has also updated ecological and worker exposure incident information, consulted with other EPA offices, USDA, states and stakeholders, and evaluated national water monitoring data.

The ecological assessment and grower impact assessments for the individual Group 3 crops were made available for public comment on December 7, 2005. The Agency has considered the public comments received on those documents for this proposed decision. The revised worker assessment is being made available for comment along with this proposed decision. The revised worker assessment includes a discussion of a repeat dose human toxicity study conducted in 1999 that was submitted to the Human Studies Review Board in April, 2006.

United Farm Workers v. Johnson This proposed decision is also being issued in response to a settlement agreement with the United Farm Workers and the other plaintiffs who sued the Agency in January 2004 in the U. S. District Court for the Western District of Washington regarding the pesticides azinphos methyl and phosmet. The suit alleged that the azinphos methyl and phosmet Interim Reregistration Eligibility Decisions ( IREDs) were inconsistent with the requirements of FIFRA because EPA did not appropriately consider the risks and benefits of these pesticides. The settlement agreement effectively stays the legal challenge pending EPA's reconsideration of the " time limited" uses of these pesticides. Prior to finalizing the settlement agreement, EPA took public comment on it 3 The settlement agreement established milestones for EPA to propose decisions on the reevaluation of the ten azinphos methyl time limited uses, take comment, and then finalize its decision on these remaining uses by August 3, 2006. EPA has informed the plaintiffs that it now intends to issue its final decision by the Fall of this year.

EPA is preparing a detailed response to issues raised in declarations supporting the United Farm Workers suit that will be completed and released along with EPA's final decisions on azinphos methyl.

This document explains the logic and considerations behind EPA's risk/ benefit decisions in the crop by crop discussions in Part II. In general, EPA has ranked ecological and worker risk as high, medium or low and explained the rationale for these rankings. Similarly, impacts to growers have been ranked high to low based on availability, cost and performance of alternatives.

Summary of Ecological Risk Concerns ( For more information, see the Ecological Risk Assessment for the Use of AZM, dated September 29, 2005, and located in the AZM docket ( EPA HQ OPP 2005 0061) located on the internet at www. regulations. gov.)

EPA's ecological assessment explored multiple lines of evidence including laboratory toxicity data for surrogate species, modeled exposure estimates ( taking into account buffer strips and application rates on current labels), field studies, and ecological monitoring information. The ecological assessment shows concerns for both aquatic and terrestrial animals, even taking into account the ecological risk mitigation implemented as a result of the IRED in 2001.

AZM is mobile and relatively persistent; aquatic exposures are predominantly driven by runoff from treated orchards. AZM is very highly toxic to freshwater and marine fish and invertebrates as well as to birds, mammals, and beneficial insects, such as honey bees. All of the assessed Group 3 uses are likely to result in azinphos methyl exposures that exceed known toxicity thresholds for fish ( surrogate for aquatic phase amphibians), aquatic invertebrates, birds ( surrogate for reptiles and terrestrial phase amphibians), mammals, and beneficial insects. Depending on the magnitude and duration of exposure, acute ( i. e. mortality) and/ or chronic ( i. e. reproductive) effects are expected.

Further, five water bodies are listed as impaired by azinphos methyl under the Clean Water Act section 303( d). Section 303( d) requires states to identify impaired waters and develop allocations of the maximum amount of a pollutant each water body can receive and still meet water quality standards. The Agency considered these impairments in its decision on AZM.

Table 1. Impaired Water Bodies Associated with Azinphos methyl Use State Impaired Water Body Predominant Crops Cycle 4 CA Colusa Basin Drain ( Central Valley) Nuts, stone fruits 2002 CA Orestimba Creek  above Kilburn Road ( Central Valley) Nuts, stone fruits 2002 CA Orestimba Creek  below Kilburn Road ( Central Valley) Nuts, stone fruits 2002 OR Neal Creek Pears, apples 2002 WA Mission Creek Apples 1998 A recently published USGS National Water Quality Assessment Program ( NAWQA) 10 year report1 indicates 14 of 83 agricultural watersheds monitored had AZM concentrations that exceeded EPA's levels of concern for aquatic species. Eight of these watersheds are in apple production states ( 2 in CA, 2 in OR, 1 in PA, and 3 in WA).

Because of the acute and chronic risks to aquatic animals identified in the IRED and subsequent litigation, a risk assessment2 was conducted to determine whether AZM may affect threatened and endangered Pacific anadromous salmonids and their designated critical habitat. The endangered species assessment concluded that in spite of the mitigation measures taken ( i. e. reduction of maximum application rates, cancellations, phase outs), AZM may affect 25 out of 26 salmonid evolutionarily significant units of concern ( ESUs) listed as threatened or endangered under the Endangered Species Act. One of those ESUs has since been delisted.

Azinphos methyl has an extensive history of adverse ecological incidents. EPA databases document report of 148 fish kills and 15 honey bee kills. Ecological incidents have declined in the past several years, presumably in part because many of the use sites associated with a large number of incidents have been cancelled ( e. g. cotton, sugar cane). Nevertheless, predicted environmental exposures, monitoring data, and field studies support EPA's risk conclusions for the Group 3 uses.

Summary of Worker Risk Concerns ( For more information see the Revised Occupational Exposure and Risk Assessment for Azinphos Methyl, dated June 6, 2006)

The toxicity endpoints used for estimating risks from dermal ( 0.56 mg/ kg/ day) and inhalation ( 0.2 mg/ kg/ day) exposures using PHED ( Pesticide Handlers Exposure Database) data are the same as those used in the 2001 assessment. These endpoints are from route specific toxicity studies in animals. The recent biomonitoring studies have allowed EPA to refine many of the exposure estimates. The toxicity endpoint used to estimate risks from worker exposures based on an internal dose from biomonitoring data 1 Gilliom, Robert J., Jack E. Barbash, Charles G. Crawford, Pixie A. Hamilton, Jeffrey D. Martin, Naomi Nakagaki, Lisa H. Nowell, Jonathan C. Scott, Paul E. Stackelberg, Gail P. Thelin, and David M. Wolock. 2006. The Quality of Our Nations Waters: Pesticides in the Nations's Streams and Groundwater, 1992 2001. U. S. Geological Survery Circular 1291. 172 p. 2 U. S. E. P. A., Office of Pesticide Programs, Environmental Field Branch. 2003. Azinphos methyl: Analysis of Risks to Endangered and Threatened Salmon and Steelhead. 5 is from an oral study in the dog ( 0.15 mg/ kg/ day). This is considered a protective endpoint, and is supported by a weight of evidence re evaluation of the entire toxicity data base. In comparison, the endpoint in the repeat dose human study was 0.25 mg/ kg/ day, within the range of endpoints that have been selected for use in the occupational risk assessment. All worker endpoints used in the assessment are based on cholinesterase inhibition, a sensitive marker of exposure. EPA's " level of concern" for AZM is a margin of exposure ( MOE) of 100. That is, EPA believes there is some concern that workers may show cholinesterase inhibition when they are exposed to AZM at levels that are not at least 100 fold below the " no effect" level measured in animal data. EPA considered a repeat dose study with human subjects, and presented it to the Human Studies Review Board ( HSRB). The Agency had proposed to use the study, both as an endpoint for risk assessment and to reduce the inter species uncertainty factor from 10 to 1. At the HSRB public meeting and in their draft final report, the HSRB raised some issues that caused EPA to question reliance on that study. Further, the Agency's revisit of the entire toxicity data base indicates that in the absence of the human study, there is no basis to reduce the inter species uncertainty factor and in fact a relatively steep dose response curve argues for retaining it.

EPA used biomonitoring data for airblast application for all the Group 3 crops. MOEs using the biomonitoring airblast study range from 14 18 for all open cab scenarios for mixing/ loading/ applying azinphos methyl to apple, pear, crabapple, almond, pistachio and walnut. For closed cab scenarios MOEs range 80 102. MOEs for cherry and nursery stock range are 205 and 155 respectively, with closed cabs.

For post application workers, EPA used the 2003 AZM biomonitoring data for blueberry, apple, and walnut to estimate risk for all Group 3 uses except parsley. Walnuts and almonds are the only group 3 crops with MOEs of at least 100 for current REI ( 30 days). Other Group 3 crops would require significantly longer REIs for MOEs to reach 100. The MOEs for apples, cherries, blueberries, and pears range from 7 to 30. Currently labeled REIs are considered to be the maximum feasible for growers due to the need to perform certain crop maintenance tasks at specific stages in the growth cycle of the crops.

In addition to the risk estimates based on biomonitoring and other data, EPA has considered incidents reports and Washington state medical monitoring information. Limited information from Poison Control Centers shows a decline of about 50% in reported poisonings involving azinphos methyl from 1993 2003 or a reduction in average number of reported poisonings per year from 19 to 10. Washington state medical monitoring found two workers with inhibition reported in 2004 related to azninphosmethyl exposure alone out of 580 workers tested (% ChE inhibition was not provided). In 2005, the second year of Washington state's monitoring program, one worker was reported with inhibition related to AZM exposure alone, out of 611 workers tested. ( It is not known how many of the 611 workers were exposed to AZM.) His red blood cell acetyl ChE inhibition varied from 8 to 21% over a 3 month period.

Summary of Usage 6 Table 2. Comparison of AZM Usage Information in the 2001 and 2006 Assessments Crop 2001 Assessment 2006 Assessment Pounds Applied Percent Crop Treated Pounds Applied Percent Crop Treated Apples 932,792 72 945,272 73 Sweet Cherries 30,200 44 33,100 46 Tart Cherries 39,400 77 33,700 68 Blueberries ( lowbush) 2,700 36 no data no data Blueberries ( highbush) 8,300 44 7,037 52 Pears 65,552 42 66,345 50 Almonds 83,076 10 89,000 10 Pistachios 31,000 21 35,000 24 Walnuts 33,123 10 17,000 5 Brussels sprouts  41  7 Nursery stock 1,400 1 1,700 1 Parsley no data no data   400 < 1 Total Pounds Applied   1,227,543   1,228,554    1,011 pounds 7 Part II: Crop Specific Considerations, Proposed Decisions and Rationale ( For more information on usage, alternatives and impacts, see the crop specific grower impact assessments located in the AZM docket ( EPA HQ OPP 2005 0061) located on the internet at www. regulations. gov.)

Apples Current Use Parameters Label rate: 1.0  1.5 lbs ai/ A per application Max application rate: 4.5 lbs ai/ A per season; 7 days between applications Typical rate: 0.78 lbs ai/ A per application, 3 applications per season Current REI: 14 days for hand harvesting, and hand thinning, 2 days for all other activities Current PHI: 14 days (< 1.0 lb ai/ A), 21 days (> 1.0 lb ai/ A)

Worker Risks Of particular concern are the relatively low margins of exposure ( MOE) for post application activities in apple orchards. As explained above in the summary of worker risk, the target MOE for these activities is 100. After 14 days, the MOE for thinning apples in Oregon is 24 and the MOE is only 7 for harvesting apples in either New York or Oregon. These results are based on refined data, including consideration of actual biomonitoring of workers performing these activities. Based on the grower impact assessment, setting the REI longer than 14 days, to achieve an MOE that does not present risks of concern, would not be feasible for this chemical on apples. Further, additional worker protection measures such as more clothing or gloves for these activities are not considered feasible due to heat stress and other factors associated with these activities.

Also, EPA has concluded that the MOE is 18 for applicatiors using an open cab airblast application to apples. This result was also based on biomonitoring data of current use practices. This risk can be mitigated through the use of closed cabs. With closed cabs, the MOEs for these pesticide handlers would be 102.

Ecological Risks ( See the above Summary of Ecological Risk Concerns for more information.)

The use of AZM on apples poses the most significant ecological risks of all the remaining uses due to application rate, timing, volume of use, and use pattern. At nearly 1 million pounds applied yearly, the apple use is the largest remaining use of AZM.

Aquatic exposures were estimated for western ( OR) and eastern ( PA) apples and took into account the current label rate and buffer strips. Air blast exposures for apples in the 8 Pacific Northwest ( OR) are estimated to be 8 times the median lethal dose for brook trout ( a salmonid species), and 32 times the chronic no effect level for a common freshwater invertebrates species. Even if spray drift could be completely eliminated from apple orchard applications, runoff of the pesticide into aquatic environments would still result in acute and chronic risk quotients for aquatic animals that exceed the Agency's levels of concern at 2 times the median lethal dose for brook trout, and 7 times the chronic noeffect level for freshwater invertebrates. Risks to aquatic animals are even greater for eastern ( PA) apples due to increased runoff potential. As a result, EPA believes there is a high risk of mortality for aquatic species.

EPA's modeling predictions are confirmed by recent NAWQA monitoring data indicate that there continue to be AZM detections above the level of concern in apple growing areas, and two of five impaired water bodies are associated with azinphos methyl applications to apples, as noted in Table 1, above. ( See the following website for more information: http:// infotrek. er. usgs. gov/ traverse/ f? p= NAWQA: HOME: 4416958071450237443]

Further, the endangered salmonid species assessment concluded that counties where apples are grown in the Pacific Northwest overlap with the spawning, rearing, and/ or migration corridors for more than 20 listed salmon groups.

The use of AZM on apples also poses acute and chronic risks to terrestrial animals, such as mammals, birds, and beneficial insects, particularly honey bees. Predicted dietary exposures for animals in and around apple orchards exceed known acute and chronic toxicity thresholds. Further, field studies in Washington and Michigan apple orchards have documented the poisoning of a variety of terrestrial animals following exposure to spray applications of AZM at rates that are very similar to the current label rate. These studies also show that there is concordance between EPA's predicted dietary exposures and actual measured field residues. In addition, the are six known honey bee kills specifically associated with the use of AZM on fruit orchards in Washington State.

Grower Impacts AZM use on apples accounts for 76% of the total Group 3 uses; 73 % of the apple crop is treated with AZM. If AZM were not available the estimated biological and economic impact of each alternative scenario varies by region. The following is a summary of EPA's evaluation of grower impacts for eastern and western US apple production.

In the Eastern US, 49% of apples grown go to the fresh market and 51% are processed. EPA considered two alternative scenarios: 1. Phosmet as an alternative resulted in 3 % quality loss plus increase in control costs, and a 12 % reduction in per acre net revenue. 2. Using a combination of phosmet and non OP alternatives ( thiacloprid, novaluron, acetamiprid) resulted in no yield or quality loss but significant increase in control costs, and a 6% reduction in per acre net revenue. Estimated aggregate losses to growers range from $ 9 million to $ 31 million across all 9 scenarios.

In the Western US 70% of apples grown go to the fresh market and 30% are processed. 1. Phosmet as an alternative resulted in 1 % yield and 5 % quality loss plus increase in control costs, and an 18% reduction in net revenue. 2. Using a combination of phosmet and non OP alternatives showed no yield or quality loss but significant increase in control costs, and a 4% reduction in net revenue. Estimated aggregate losses to growers range from $ 9 million to $ 50 million across all scenarios.

Estimated losses to the apple industry nationally range from $ 18 million to $ 81 million across all scenarios. Total impacts are estimated to range from 5%  18% of current net revenues.

In addition to grower impacts for domestic apple production, EPA also evaluated the effect the loss of AZM would have on the export market. In order for US growers to export apples that have pesticide residues, there must be established maximum residue levels (" MRL") which are similar to the requirements of US tolerances. The Agency researched whether there are established MRLs for the alternatives to AZM in the countries that receive US apples. The absence of MRLs for multiple AZM alternatives could have major impacts that are not included in the loss estimates given above. The following is a summary of the current status of MRLs in key export markets.

Status of MRLs for AZM Alternatives   The US Apple trade association indicates that leading markets for US apples include Canada, Mexico, Taiwan, Hong Kong, and Malaysia.   The main alternatives discussed by BEAD in its 2005 assessment are phosmet, acetamiprid, novaluron, and thiacloprid.   Phosmet has an MRL in all apple export markets. The largest single export market, Mexico, has an MRL for all key alternatives. However, the other countries have few MRLs established for materials other than phosmet.

Table 3. Apples: Availability of MRLs for selected alternatives to AZM Country Phosmet Acetamiprid Novaluron Thiacloprid Mexico 10 1 2 0.3 Canada 10 1 b   Taiwan 2a 1 a   Hong Kong 10    Malaysia 10 a

US 10 1 2 0.3 Codex c 10  { 3}    It should be noted that the UK does NOT have an MRL for phosmet. Sources: USDA Foreign Agricultural Services ( FAS), Agricultural and Tropical Products Division ( www. mrldatabase. com); Northwest Horticultural Council ( www. nwhort. org). 10 Notes: a From Northwest Horticultural website. b Proposed as per the Canadian PMRA Website http:// www. pmra arla. gc. ca/ english/ legis/ max re e. html. c From the Codex Alimentarius website: http:// www. codexalimentarius. net/ mrls/ pestdes/ jsp/ pest_ q e. jsp. {} = under development according to the Report of the Thirty Eighth Session of the Codex Committee on Pesticide Residues, Fortaleza Brazil, 3 8 April, 2006. Available at http:// www. codexalimentarius. net.  = MRL not listed. * MRL figures are given in parts per million ( ppm); Codex values, are in mg/ kg, which are equivalent Proposed Decision/ Mitigation/ Rationale As explained above, EPA believes there is a high risk of mortality to numerous aquatic and terrestrial species from the apple use of AZM. Additional label mitigation can reduce this risk but EPA's assessment indicates it is insufficient to reduce the risk to acceptable levels. The Worker risk assessment indicates that existing MOEs at current label rates are insufficient to ensure that there is not a concern that workers will be exposed to levels of AZM that will result in cholinesterase depression   a precursor of adverse neurological effects. Current label restricted entry intervals likely cannot be extended in light of the need for field re entry to conduct necessary cropping practices.

In the short term, EPA believes that the benefits of the apple are use are high and with the additional mitigation measures outlined below, these benefits outweigh the risks, largely for four reasons: ( 1) While there are now numerous efficacious registered alternatives to AZM, many of the alternatives that are the most likely to be used lack maximum residue level regulations ( known as " MRLs") that allow for residues of these pesticides on apples sold in countries to which U. S. apples are exported, leaving growers at risk, in some cases, of losing the export market for lack of an appropriate alternative. EPA's " worstcase estimate is that loss of certain export markets could result in a loss to the apple industry of well over $ 100 million. ( 2) Development of effective alternative pest control practices using new pesticides often takes multiple use seasons to perfect. With 73% of apples treated with AZM, most growers will need to switch to new practices and would have no experience or guidance regarding such practices were EPA to cancel this use immediately or allow only for a more limited phase out. Without prior development of such practices, there is a risk that grower impacts would exceed EPA's estimates. ( 3) While EPA believes the risk concerns from AZM use are significant, EPA is not aware of incident information, monitoring data or other sources of information that suggest AZM is having immediate large scale environmental impacts ( such as a clear link to species population declines or extirpations) or that severe worker poisoning incidents are occurring. Although incident and monitoring databases are not sufficiently robust to capture the extent of likely adverse effects, EPA believes that if severe adverse human health and environmental effects were occurring on a broad scale, these databases would reflect that fact. ( 4) EPA believes the risk mitigation measures outlined below are feasible and will reduce the existing risks to some extent.

EPA believes, however, that with the development of MRLs for newer pesticides and with the development of alternative pest control practices, this risk benefit balance for apples changes. EPA believes it is reasonable to assume that a number of export countries will adopt additional MRLs for the newer pesticides within 4 years, and that 11 growers will have at their disposal appropriate guidance and practice with using these alternatives effectively by that time. At that point, EPA believes the benefits of AZM will track the grower impact scenarios outlined above and that the risk associated with AZM will outweigh those benefits. While these impacts will remain in the millions of dollars nationally, it is important to note that the overall impact on grower revenue is relatively small. These numbers should decline further as additional alternatives become available over the next four years. Further, EPA has not reviewed any information that suggests there will be a measurable impact on consumers in the price or availability of apples from the cancellation of AZM. Indeed, the loss of a single agricultural pesticide rarely translates into consumer level impacts.

As discussed above, EPA believes it is likely that by 2010 there will be in place additional MRLs for AZM alternatives in export countries for apples, that will eliminate the concern for possible impacts to the US export market. Should that not be the case, however, EPA would consider appropriate, time limited requests to extend AZM use on apples for a period necessary for the development of the critical additional MRLs for AZM alternatives.

During the phase out period, EPA is proposing to put in place the following mitigation measures:

 require label amendments to increase buffer zones around permanent water bodies from 25 to 100 feet;  require label amendments to reduce yearly maximum application rate from 4 to 3 lbs/ ai/ A  require label amendments to establish buffer zones around houses and occupied buildings  issue a data call in for the registrant to conduct medical monitoring of post application workers to provide information to better assess the full nature of the risks to such workers and to help determine, as a result, the need for any regulatory action during the phase out period.

Pears Current Use parameters Label rate: 1.0   1.5 lbs ai/ A per application Max application rate: 3.0 lbs ai/ A per year; 7 days between applications Typical rate: 1.05 lbs ai/ A, 3 applications per season Current REI: 14 days for hand harvesting, and hand thinning, 7 days for fireblight pruning with PPE. Current PHI: 14 days (< 1.0 lbs ai/ A), 21 days (> 1.0 lbs ai/ A)

Worker Risks 12 Like apples, of particular concern are the relatively low margins of exposure ( MOE) for post application activities on pears. As explained above, the target MOE for these activities is 100. After 14 days, the MOE for thinning pears in Oregon is 24 and only 7 for harvesting pears in either New York or Oregon. These results are based on refined data, including consideration of actual biomonitoring of workers performing these activities. Although the biomonitoring study used for pears was conducted with apples, the Agency believes that apples are an appropriate surrogate for pears.

Also of concern is the MOE of 18 for open cab airblast applications to pears, based on apple biomonitoring data of current use practices. This risk can be mitigated through the use of closed cabs. With closed cabs, the MOEs for these pesticide handlers would be 102.

Ecological Risks ( See the above Summary of Ecological Risk Concerns for more information.)

The use of AZM on pears poses acute and chronic risks to all aquatic and terrestrial animals. Aquatic exposures were estimated for Oregon pears, and predicted exposures exceed known toxicity thresholds.

The states of California, Oregon, and Washington have declared water bodies in their state as impaired due to AZM use ( a total of 5 water bodies). One of the five impaired water bodies is listed because of AZM use on pears ( Neal Creek in Oregon).

The endangered salmonid species assessment concluded that counties where pears are grown in the Pacific Northwest overlap with the spawning, rearing, and/ or migration corridors for more than 20 listed salmon groups.

Grower Impacts Pears are produced on about 64,500 total bearing acres in the U. S. Washington, Oregon, and California represent about 94% of the national production of pears. Washington State alone accounts for 40 percent of the total acreage. Approximately 66,000 pounds of AZM are applied annually to pears with 50 % of the pear crop treated with this pesticide.

AZM is applied to pears primarily for the control of codling moth ( Cydia pomonella) and, to a lesser extent, for the suppression of grape mealybug ( Pseudococcus maritimus) populations.

Several new insecticides have been registered on pears since the 2001 AZM IRED. The following insecticides are potential alternatives to AZM: abamectin, acetamiprid, buprofezin, diflubenzuron, indoxacarb, lambda cyhalothrin, methoxyfenozide, novaluron, pyriproxyfen, spinosad, thiacloprid, and thiamethoxam. With the exception of diflubenzuron, indoxacarb, lambda cyhalothrin, novaluron, and spinosad all of these 13 insecticides have been adopted to some degree by pear growers for codling moth control and/ or grape mealybug.

Based on the latest information available with respect to alternative insecticides for AZM, no yield or quality losses are expected if AZM is not available for use on pears. However, alternative pest control scenarios ( phosmet or acetamiprid and methoxyfenozide) are more expensive than AZM. Nationally, the increased control costs are estimated to decrease the value of production by less than 1% for pear growers. Regionally, the Pacific Northwest will experience the greatest losses with a reduction in per acre net revenues from 1.5% to 1.6% if AZM is not available.

These new alternatives give growers more treatment options and may be useful for resistance management when rotated with phosmet, the primary alternative to AZM.

Status of MRLs for AZM Alternatives   The leading export markets for pears include Mexico, Canada, Brazil, Sweden, and Russia.   The main alternatives listed by BEAD in its 2005 assessment are phosmet, acetamiprid, novaluron, and methoxyfenozide.   Mexico has established MRLs for all the main alternative to AZM. Canada has MRLs established or proposed for 3 of the 4 main alternatives.

Table 4. Pears: Availability of MRLs for selected alternatives to AZM Country Phosmet Acetamiprid Novaluron Methoxyfenozide Mexico 10 1 2 1.5 Canada 10 1 b  1.5 Brazil     Sweden 2c    Russia

US 10 1 2 1.5 Codex b 10  { 3} 2 Sources: USDA Foreign Agricultural Services ( FAS), Agricultural and Tropical Products Division ( www. mrldatabase. com); Northwest Horticultural Council ( www. nwhort. org). Notes: a From Northwest Horticultural website only. b From the Codex Alimentarius website: http:// www. codexalimentarius. net/ mrls/ pestdes/ jsp/ pest_ q e. jsp. c EU MRL d Proposed per PMRA Website http:// www. pmra arla. gc. ca/ english/ legis/ max re e. html {} = under development according to the Report of the Thirty Eighth Session of the Codex Committee on Pesticide Residues, Fortaleza Brazil, 3 8 April, 2006. Available at http:// www. codexalimentarius. net.  = MRL not listed. * MRL figures are given in parts per million ( ppm): Codex values are in mg/ kg, which are equivalent.

Proposed decision/ Mitigation Rationale 14 For the reasons outlined above in the discussion regarding apples, EPA believes that AZM use on pears should similarly be phased out in 2010. While the Agency assessment indicates that there will be fewer domestic impacts on pear growers than apple growers, the concerns regarding MRLs for pears in export markets are similar, and in some cases greater, than the concern for apples.

As discussed above, EPA believes it is likely that by 2010 there will be in place additional MRLs for AZM alternatives in export countries for pears, that will eliminate the concern for possible impacts to the US export market. Should that not be the case, however, EPA would consider appropriate, time limited requests to extend AZM use on pears for a period necessary for the development of the critical additional MRLs for AZM alternatives.

In addition, during the phase out period, the following mitigation is proposed:

 require label amendments to establish buffer zones houses and occupied buildings  increase existing 25 foot buffer zone around water bodies to 100 feet.

 issue a data call in to conduct medical monitoring of post application workers  require label amendments to eliminate u pick operations.

Blueberries ( lowbush and highbush)

Current Use parameters Label rate: 0.5   0.75 lbs ai/ A per application ( lowbush and highbush) Max application rate: 0.75 lbs ai/ A per season Typical rate: 0.25 lbs ai/ a for lowbush and 0.39 lbs ai/ A for highbush, 2 applications per crop per season Current REI: 10 days for lowbush and 7 days for highbush, u pick is 30 days Current PHI: 10 days for lowbush and 7 days for highbush Worker Risks Of particular concern are the relatively low margins of exposure ( MOE) for post application activities on blueberries. As explained above, the target MOE for these activities is 100. After seven days, the MOE for harvesting highbush blueberries in Michigan is 30. These results are based on refined data, including consideration of actual biomonitoring or workers performing these activities.

Based on PHED data, the MOEs for mixing/ loading for aerial or groundboom applications are less than 1. With a closed system the MOEs would increase to 9 and 40, respectively. For goundboom application of AZM to blueberries the MOE is 25 for open cab applications. The MOEs for these pesticide handlers could be raised to 80 with the use of closed cabs and elimination of aerial applications. 15 Ecological Risks ( See the above Summary of Ecological Risk Concerns for more information.)

Blueberries are grown across the U. S., and fresh and saltwater ecosystems may be exposed to AZM by runoff and spray drift. Aquatic exposures were modeled for Michigan blueberries and various drift scenarios were considered. Aerial application of AZM to blueberries is particularly concerning due to the increased likelihood of drift to aquatic resources. Even if drift could be reduced to 1%, there still would be acute and chronic concerns.

For terrestrial animals, modeled dietary exposures for small, medium and large birds and mammals are at risk regardless of preferred food items. Mean dietary residues are also likely to exceed known acute and chronic thresholds for birds and mammals.

Based on these multiple lines of evidence, EPA considers the ecological risk of AZM on blueberries to be high.

Grower Impacts There are two primary types of blueberries ( Vaccinium spp.), lowbush and highbush. The U. S. production of lowbush ( also called " wild") blueberries occurs almost entirely in Maine, while highbush blueberry production occurs primarily in three regions: the Pacific Northwest ( Oregon and Washington), the North Central ( Michigan and Indiana), and the East ( New York, New Jersey, Florida, Georgia, North Carolina, Alabama, and Arkansas).

Approximately 7,000 pounds of AZM are applied to highbush blueberries. There are no data on the amount of AZM applied to lowbush blueberries. However, information from crop experts indicates that AZM use has decreased since 2001 and it appears that most growers have already switched to other alternatives, primarily phosmet. In the absence of AZM, the likely pest management scenarios indicate that lowbush blueberry producers in the absence of AZM should be able to substitute phosmet with low losses in net cash returns since it is comparable to AZM in terms of cost and efficacy.

There appears to be virtually no use of AZM in Pacific Northwest blueberries. Highbush blueberry growers in the North Central region ( primarily Michigan) will have to use more treatments of a set of alternative insecticides to substitute for the average of approximately 2 sprays of AZM they have been using. Similarly, growers in the other major highbush blueberry producing region, the Eastern US ( represented by New Jersey), will also have to use multiple alternatives in place of AZM. EPA's 2005 grower impact assessments concluded that in both regions pest management costs will rise, along with an estimated 1 2 % yield loss and 1 2 % quality loss. Therefore, for both regions, losses ranging from $ 51 to $ 116 per acre at the grower level ( in terms of returns above variable 16 costs per acre) are predicted, while at the regional level losses of approximately $ 2.3 million are expected.

Status of MRLs for AZM Alternatives   The leading export markets for blueberries include Japan, Canada, Australia, Korea, and the UK.   The main alternatives are phosmet, esfenvalerate, and tebufenozide.   Japan and Canada have an established MRL for phosmet and Japan also has an established MRL for tebufenozide.

Table 5. Blueberries ( lowbush and highbush): Availability of MRLs for selected alternatives to AZM Country Phosmet Esfenvalerate Tebufenozide Japan 10  3 Canada 5   Australia    Korea    UK

US 10 3b 3 Codex a 10 1c 3 Sources: USDA Foreign Agricultural Services ( FAS), Agricultural and Tropical Products Division ( www. mrldatabase. com). Notes: UK defers to EU MRL levels for pesticides if the country has not set its own MRL. In the same context, Korea defers to CODEX MRL levels. Australia follows only its own MRL levels.  = MRL not listed. a From the Codex Alimentarius website: http:// www. codexalimentarius. net/ mrls/ pestdes/ jsp/ pest_ q e. jsp. b Listed in CFR but not in FAS. c Expressed as fenvalerate in CODEX database. * MRL figures are given in parts per million ( ppm); Codex values, are in mg/ kg, which are equivalent.

Proposed decision/ Mitigation Rationale The blueberry use of AZM presents high ecological risks and potentially high risk to workers especially re entry workers engaged in harvesting activities. While the impact to growers of losing AZM is less than with the apple and pear uses, EPA ranks these impacts as medium, in large part because the absence of MRLs for alternatives in certain blueberry export markets could have a potentially significant impact on growers selling for the export market. Accordingly, as with apples and pears, EPA is proposing to phaseout the use of AZM on blueberries in 2010.

As discussed above, EPA believes it is likely that by 2010 there will be in place additional MRLs for AZM alternatives in export countries for blueberries, that will eliminate the concern for possible impacts to the US export market. Should that not be the case, however, EPA would consider appropriate, time limited requests to extend AZM use on blueberries for a period necessary for the development of the critical additional MRLs for AZM alternatives. 17 The Agency is also proposing the following mitigation measures to reduce the risks during this phase out period.

 require label amendments reducing the application rate to 1 lb ai/ A/ year  require label amendments increasing the REI to 14 days for both lowbush and highbush blueberries  require label amendments to establish buffer zones around houses and occupied buildings  increase buffer zones around water bodies from 25 to 100 feet  issue a data call in to conduct medical monitoring of post application workers  require label amendments to eliminate u pick operations  eliminate aerial application.

Cherries ( sweet and tart)

Current Use parameters Label rate: 0.75 lbs ai/ A per application Max application rate: 1.5 lbs ai/ A per season Minimum 14 days between applications Typical rate: 0.64 lbs ai/ A for tart cherries, 2.7 applications per year 0.46 lbs ai/ A for sweet cherries, 2 applications per year Current REI: tart cherries: 2 days for all activities sweet cherries: 15 days for hand harvesting, 2 days for all other activities and 30 days for u pick Current PHI: 15 days Worker Risks Of particular concern are the relatively low margins of exposure ( MOE) for post application activities in cherry orchards. As explained above in the summary of worker risk, the target MOE for these activities is 100. After 14 days, the MOE for harvesting cherries in New York or Oregon is 14. These results are based on refined data, including consideration of actual biomonitoring of workers performing these activities. Based on the grower impact assessment, setting the REI longer than 14 days to achieve an MOE that does not present risks of concern would not be feasible for this chemical on cherries. Further, additional worker protection mitigation measures such as more clothing or gloves for these activities are not considered feasible due to heat stress and other factors associated with these activities.

Also EPA has estimated an MOE of 36 for mixer/ loader/ applicators using an open cab for airblast application to cherries. This result was also based on biomonitoring data of current use practices. This risk can be mitigated through the use of engineering controls such as closed systems and closed cabs. With closed systems and closed cabs, the MOEs for these pesticide handlers would be 205. 18 Ecological Risks ( See the above Summary of Ecological Risk Concerns for more information.)

The use of AZM on cherries poses risks to aquatic and terrestrial animals. Aquatic exposures were modeled for Michigan cherries, and various drift scenarios were considered. Even if drift could be reduced to 1%, there still would be acute and chronic concerns.

For terrestrial animals, modeled dietary exposures for small, medium and large birds and mammals are at risk regardless of preferred food items. Mean dietary residues are also likely to exceed known acute and chronic thresholds for birds and mammals.

The states of California, Oregon, and Washington have declared water bodies in their state as impaired due to AZM use ( a total of five water bodies). Three of the five impaired water bodies are associated with AZM treatments on stone fruits such as cherries ( Colusa Basin Drain ( Central Valley), Orestimba Creek   above Kilburn Road ( Central Valley), and Orestimba Creek   below Kilburn Road ( Central Valley) in California).

The endangered slamonid species assessment concluded that counties where cherries are grown in the Pacific Northwest overlap with the spawning, rearing and/ or migration corridors for more than 20 listed salmon groups.

Grower Impacts  Sweet Cherries Sweet cherries are primarily produced in four states: California, Michigan, Oregon, and Washington.

The cost of currently available AZM alternatives and recent efficacy data on these pesticides suggests that grower level ( per acre) impacts of the loss of AZM for eastern ( largely Michigan) sweet cherry growers may be as high as 11 % loss in net cash returns, while in Washington such losses are approximately 2 %. It appears that effective new pest control alternatives ( such as thiamethoxam, multiple sprays of synthetic pyrethroids, and spinosad) now exist that should allow growers to meet the stringent quality standards required by the sweet cherry market. However, increases in production costs are potentially significant for individual growers, at least in the eastern U. S. Calculated losses reflect the increased production costs incurred by the need to apply multiple treatments of some alternatives, or the much higher costs of other materials. Phosmet is not an alternative to AZM for sweet cherries because of phytotoxicity concerns.

Grower Impacts  Tart Cherries Michigan is the primary producer of tart cherries, accounting for over 70 percent, followed by Washington, Utah, and New York. Less than one percent of production is 19 marketed as fresh; the primary processed use is as frozen cherries although a significant portion is canned. Bearing acreage of tart cherries have been declining steadily in the U. S. for at least the past decade, although the decline has lessened in recent years and may even have stabilized.

Based on the current availability of efficacious alternatives to AZM to control plum curculio and cherry fruit fly in tart cherries the benefits derived from the use of AZM are likely to be small. In the absence of AZM, growers would most likely use phosmet to maintain the local, state, and federal mandated zero tolerance for these pests. Use of phosmet would likely raise production costs by around $ 10 to $ 25 per acre. This could amount to two to four percent of a grower's net cash returns ( gross revenue minus operating costs). However, recent increases in the price of tart cherries may mean that the benefits of AZM as a percent of net cash returns are smaller.

Status of MRLs for AZM Alternatives   The leading export markets for cherries include Japan, Canada, Taiwan, the United Kingdom, and Australia.   The main alternatives listed by BEAD in its 2005 assessment are phosmet, lambda cyhalothrin, imidacloprid, spinosad, and thiamethoxam.   The top 5 export countries have an MRL established for phosmet. Japan has MRLs established for all the main AZM alternatives. Australia and Canada have MRLs established or proposed for 4 of the 5 main alternatives.

Table 6. Cherries ( sweet and tart): Availability of MRLs for selected alternatives to AZM Country Phosmet Lambda Cyhalothrin Imidacloprid Spinosad Thiamethoxam Japan 0.1 0.5 3 0.2 5 Canada 7  3 0.1b 0.02b Taiwan 2 a     UK 2d   0.2 a  Australia 1 a 0.1 0.5 a 1.0a

US 10 0.5 3 0.2 0.5 Codex c 10  { 0.5} 0.2 Sources: USDA Foreign Agricultural Services ( FAS), Agricultural and Tropical Products Division ( www. mrldatabase. com); Northwest Horticultural Council ( www. nwhort. org). Notes: a From Northwest Horticultural website only. b Proposed per PMRA Website http:// www. pmra arla. gc. ca/ english/ legis/ max re e. html. c From the Codex Alimentarius website: http:// www. codexalimentarius. net/ mrls/ pestdes/ jsp/ pest_ q e. jsp. d EU MRL {} = under development according to the Report of the Thirty Eighth Session of the Codex Committee on Pesticide Residues, Fortaleza Brazil, 3 8 April, 2006. Available at http:// www. codexalimentarius. net.  = MRL not listed in the databases examined. * MRL figures are given in parts per million ( ppm),; Codex values are in mg/ kg., which are equivalent.

Proposed decision/ Mitigation Rationale 20 The cherry use of AZM presents high ecological risks and potentially high risk to workers, especially re entry workers. While the impact to growers of losing AZM is less than with the apple and pear uses, the absence of certain MRLs in certain export markets could have an impact on growers selling to those markets, Accordingly, as with apples, pears, and blueberries, EPA is proposing to phase out the use of AZM on cherries in 2010.

As discussed above, EPA believes it is likely that by 2010 there will be in place additional MRLs for AZM alternatives in export countries for cherries, that will eliminate the concern for possible impacts to the US export market. Should that not be the case, however, EPA would consider appropriate, time limited requests to extend AZM use on cherries for a period necessary for the development of the critical additional MRLs for AZM alternatives.

In addition, during the phase out period, the following mitigation is proposed:

 require label amendment to increase buffer zones around water bodies from 25 to 100 feet  require label amendment to establish buffer zones around houses and occupied buildings  issue a data call in to conduct medical monitoring of post application workers  require label amendment to eliminate u pick operations Almonds Current Use Parameters Label rate: 1.5   2.0 lbs lbs ai/ A per application, maximum of one application per season Typical rate: 1.85 lbs ai/ A per application Current REI: 30 days Current PHI: 30 days Worker Risks For post application activities on almonds, MOEs range from 170 to 790 for rakers, sweepers, and shakers at the labeled restricted entry interval ( REI) of 30 days. These results are based on refined data, including consideration of actual biomonitoring of workers performing these activities.

The calculated MOE of 14 for open cab applications to almonds is of concern. This estimate is also based on biomonitoring of current use practices. With closed cabs, the MOEs for these pesticide handlers would be 80. 21 Ecological Risks ( See the above Summary of Ecological Risk Concerns for more information.)

The use of AZM on almonds poses risks to aquatic and terrestrial animals. Aquatic exposures were modeled for California almonds, and various drift scenarios were considered. Even if drift could be reduced to 1%, there would still be acute and chronic concerns.

Recent NAWQA monitoring data indicate that there continue to be AZM detections above the level of concern in nut growing areas, three of five impaired water bodies are associated with AZM treatments on nuts ( Colusa Basin Drain ( Central Valley), Orestimba Creek   above Kilburn Road ( Central Valley), and Orestimba Creek   below Kilburn Road ( Central Valley) in California).

The endangered slamonid species assessment concluded that counties where almonds are grown in California overlap with the spawning, rearing and/ or migration corridors for four listed salmon groups.

Grower Impacts The loss of AZM use is unlikely to have significant impacts on the almond industry because there are several alternative chemicals that can be used for the pests of concern. AZM is applied to about 10% of the total almond acreage in the US. Almond growers have several alternatives to AZM that are currently being used, and the Agency's economic analysis shows minimal loss if growers switch to these alternatives.

The main alternatives for AZM use on almonds listed by BEAD in its scenarios in 2005 assessment are chlorpyrifos, phosmet, spinosad, esfenvalerate, and permethrin. The Agency's economic analysis shows minimal loss if growers switch to these alternatives. The following is a summary of the impacts on revenue as a result of switching to each of these alternatives.

1. Phosmet alternative: 0.1%  0.3% reduction in per acre net revenue. 2. Chlorpyrifos alternative: 2.0%  2.8% increase in per acre net revenue. 3. Non OPs ( spinosad, esfenvalerate, permethrin): 0.2% reduction in per acre net revenue to 5.3% increase in per acre net revenue.

There are minimal estimated losses from the elimination of AZM as a pesticide on almonds, in fact, growers may see an increase in their net revenues when they move away from AZM and use lower cost alternatives. The Agency did not assess the availability of MRLs for AZM alternatives used on almonds. However, because only 10 percent of the crop is currently treated with AZM and the crop is being treated with numerous other alternative insecticides, EPA assumes that the loss of AZM will have no significant impact on the almond export market. 22 Proposed Decision/ Mitigation/ Rationale Based on high ecological risks and low impacts to growers, the Agency finds that the risks outweigh the benefits of the use of AZM on almonds and therefore is proposing to phase out the use of AZM on almonds in 2007.

Pistachios Current Use Parameters Label rate: 2.0 lbs lbs ai/ A per application, maximum of one application per season Typical rate: 1.85 lbs ai/ A per application Current REI: 21 days Current PHI: 21 days Worker Risks For post application activities on pistachios, the MOE for rakers, sweepers, and shakers at 18 days is 102. As explained in the summary of worker risk, the target MOE is 100. The labeled REI requirement for pistachios is 21 days, so there are no risks of concern for workers as long as they adhere to the labeled REI. These results are based on refined data, including consideration of actual biomonitoring of workers performing these activities.

The calculated MOE of 14 for open cab applications to pistachios is of concern. This estimate is also based on biomonitoring of current use practices. With closed cabs, the MOEs for these pesticide handlers would be 80.

Ecological Risks ( See the above Summary of Ecological Risk Concerns for more information.)

The use of AZM on pistachios poses risks to aquatic and terrestrial animals. Aquatic exposures were modeled for California pistachios and various drift scenarios were considered. Even if drift could be reduced to 1%, there would still be acute and chronic concerns.

Recent NAWQA monitoring data indicate that there continue to be AZM detections above the level of concern in nut growing areas, three of five impaired water bodies are associated with AZM treatments on nuts ( Colusa Basin Drain ( Central Valley), Orestimba Creek   above Kilburn Road ( Central Valley), and Orestimba Creek   below Kilburn Road ( Central Valley) in California). 23 The endangered slamonid species assessment concluded that counties where pistachios are grown in California overlap with the spawning, rearing and/ or migration corridors for one listed salmon group.

Grower Impacts The loss of AZM use is unlikely to have a large impact on the pistachio industry because there are several alternative chemicals that can be used for pests of concern and are less expensive than AZM. Although AZM is applied to about 24% of the total pistachio acreage in the US, pistachio growers have several alternatives to AZM that are currently being used. Because efficacious alternatives exist, EPA assumes there will be no yield or quality loss from using another chemical in place of AZM. The Agency's economic analysis shows no loss if growers switch to these alternatives.

The main alternatives listed by BEAD in its 2005 impact assessment are permethrin, phosmet, tebufenozide, and methoxyfenozide.

There are no estimated losses from the elimination of AZM as a pesticide on pistachios.

Proposed Decision/ Mitigation/ Rationale Based on high ecological risks and low impacts to growers, the Agency finds that the risks outweigh the benefits of the use of AZM on pistacios, and is therefore proposing to phase out this use in 2007.

Walnuts Current Use Parameters Label rate: 1.5  2.0 lbs lbs ai/ A per application, maximum of one application per season Typical rate: 1.23 lbs ai/ A per application Current REI: 30 days Current PHI: 30 days Worker Risks For post application activities on walnuts, MOEs range from 170 to 790 for rakers, sweepers, and shakers at the labeled REI requirement of 30 days. These results are based on refined data, including consideration of actual biomonitoring of workers performing these activities.

The calculated MOE of 14 for open cab applications to walnuts is of concern. This estimate is also based on biomonitoring of current use practices. With closed cabs, the MOEs for these pesticide handlers would be 80. 24 Ecological Risks ( See the above Summary of Ecological Risk Concerns for more information.)

The use of AZM on walnuts poses risks to aquatic and terrestrial animals. Aquatic exposures were modeled for California walnuts, and various drift scenarios were considered. Even if drift could be reduced to 1%, there would still be acute and chronic concerns.

Recent NAWQA monitoring data indicate that there continue to be AZM detections above the level of concern in nut growing areas, three of five impaired water bodies are associated with AZM treatments on nuts ( Colusa Basin Drain ( Central Valley), Orestimba Creek   above Kilburn Road ( Central Valley), and Orestimba Creek   below Kilburn Road ( Central Valley) in California).

The endangered salmonid species assessment concluded that counties where walnuts are grown in California overlap with the spawning, rearing and/ or migration corridors for more than 20 listed salmon groups.

Grower Impacts The loss of AZM is unlikely to have a large impact on the walnut industry because there are several alternative chemicals that can be used for pests of concern and are less expensive than AZM. Additionally, AZM is only applied to about 5% of the total walnut acreage in the U. S. Walnut growers have several alternatives to AZM that are currently being used. Because efficacious alternatives exist, in some cases at lower prices, EPA assumes there will be no significant yield or quality loss from using other chemicals in place of AZM. The Agency's economic analysis shows little to no loss if growers switch to these alternatives. Additionally, walnut acreage in the U. S. has increased in recent years, and AZM use has decreased in recent years, indicating that growers have decreased reliance on AZM.

The main alternatives listed by BEAD in its scenarios in 2005 are methyl parathion, methidathion, phosmet, carbaryl, esfenvalerate, permethrin, lambda cyhalothrin, spinosad, Bt, tebufenozide, methoxyfenozide, and diflubenzuron.

The elimination of AZM as a pesticide on walnuts may result in an increase or decrease in per acre net revenue depending upon the alternative chosen.

Proposed Decision/ Mitigation/ Rationale Based on high ecological risks and low impacts to growers, EPA is proposing to phaseout the use of AZM on walnuts in 2007, because the Agency finds that the risks outweigh the benefits of this use. 25 Brussels sprouts, Nursery Stock, and Parsley Current Use Parameters Brussels sprouts Label rate: 0.75 lb ai/ A per application; maximum of one application per season to soil at transplant Current REI: 7 days Current PHI: 7 days Nursery Stock Label rate: 1 lb ai/ A per application; maximum of 4 applications per season in association with state nursery stock inspection and certification requirements only. Current REI: 4 days Current PHI: 30 days between treatment and sale of plants Parsley Label rate: 0.5 lb ai/ A per application; maximum of 3 applications per season Current REI: 7 days Current PHI: 7 days Use restrictions: Restricted to New Jersey and Ohio Worker Risks Brussels sprouts As explained in the summary of worker risk, the target MOE is 100. For occupational handlers, the calculated MOE for mixer/ loaders supporting groundboom applications on Brussels sprouts is 62 with engineering controls. For applicators applying sprays for groundboom application, the MOE with engineering controls is 127. These estimates are based on default Agency assumptions and may overestimate risk.

No post application exposure is expected from AZM use on Brussels sprouts; therefore no post application scenarios were assessed.

Nursery Stock The calculated MOE of 20 for open cab applications to nursery stock is of concern. This estimate is based on surrogate biomonitoring. MOEs for these pesticide handlers could be raised to 140 with the use of closed cabs.

For post application activities on nursery stock, the MOE is 23 at 7 days. The labeled REI is currently 4 days. The MOE would be below the Agency's level of concern if there were an REI of 18 days ( MOE would be 102). These results are based on refined data, including consideration of actual biomonitoring of workers.

Parsley 26 As explained in the summary of worker risk, the target MOE is 100. For occupational handlers, the calculated MOEs for mixer/ loaders supporting groundboom applications on parsley are 93 with engineering controls. For applicators applying sprays for groundboom application, the MOE with engineering controls ( enclosed cabs) is 191. These estimates are based on default Agency assumptions and may overestimate risk.

For post application activities on parsley, the MOE at 42 days is 100. The labeled REI is currently 30 days. These estimates are based on default Agency assumptions as no appropriate biomonitoring data were available.

Ecological Risks See the above Summary of Ecological Risk Concerns for more information. Due to the small acreage of these crops, ecological risk is of somewhat less concern than for larger acreage crops.

Grower Impacts Brussels sprouts The loss of AZM use is unlikely to have a large impact on the Brussels sprouts industry because there are alternative chemicals that can be used for pests of concern and are less expensive than AZM. AZM is applied to about 7% of the total Brussels sprouts acreage in the U. S. Brussels sprouts growers have several alternatives to AZM that are currently being used. Many of these alternatives cost the same or less than AZM.

The main alternatives listed by BEAD in its scenarios in 2005 are chlorpyrifos, acetamiprid, pyretrozine, and fenpropathrin.

EPA does not anticipate any export or MRL issues for Brussels sprouts due to the loss of AZM.

Nursery Stock The loss of AZM use is unlikely to have a large impact on the nursery stock industry because there are alternative chemicals that can be used for pests of concern. AZM is applied to about 1% of the total nursery stock acreage in the U. S. Several comments from the Southern Integrated Pest Management Center indicate that AZM use in nursery stock is currently not critical for any major insect pest. Nursery stock growers have several alternatives to AZM that are currently being used.

The main alternatives listed by BEAD in its scenarios in 2005 are acephate, cryolite, cyfluthrin + imidacloprid, chlorpyrifos, bifenthrin, imidacloprid, and parasitic nematodes.

The Agency does not anticipate any export or MRL issues for nursery stock due to the loss of AZM.

Parsley 27 AZM is used on less than 1% of the national parsley crop. Most of the nation's domestic parsley crop is grown in California, with scattered production in other states, such as Ohio and Arizona. In parsley, AZM is labeled for the control of the carrot weevil ( Listronotus oregonensis), which is a pest unique to parsley in Ohio. There are few alternative insecticides with the carrot weevil specifically listed on their labels. For example, spinosad does not list the weevil as a target pest, but may have efficacy for its control. Pyrethrins does list the weevil, but apparently is effective only during cold weather. Cultural controls also play a role in reducing the survival of the carrot weevil. Based on the very low recent usage of AZM, and the availability of alternative chemical and cultural controls, for the majority of U. S. parsley production, the impact of the loss of AZM will be minimal, with possibly greater impacts in Ohio due to constraints on available alternatives EPA does not anticipate any export issues for parsley due to the loss of AZM.

Proposed Decision/ Mitigation/ Rationale Based on ecological risks and minimal impacts to growers, EPA is proposing to phaseout the use of AZM on Brussels sprouts and nursery stock in 2007. EPA is proposing to phase out AZM use on parsley in 2010 because while it too presents ecological risks of concern, it also appears to have relatively high regional benefits, and a phase out will allow those few parsley growers in Ohio and other eastern states to transition to alternatives.

Debra Edwards, Ph. D., Director Special Review and Reregistration Division


[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Page 5764]
[FR Doc No: 2016-01885]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0915]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on
Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry on
Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application'' has been approved
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On July 2, 2015, the Agency submitted a
proposed collection of information entitled ``Guidance for Industry on
Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application'' to OMB for review
and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information collection and has assigned OMB
control number 0910-0636. The approval expires on December 31, 2018. A
copy of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01885 Filed 2-2-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Page 52790]
[FR Doc No: 2022-18523]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0895]

Notice of Approval of Product Under Voucher: Material Threat
Medical Countermeasure Priority Review Voucher

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
approval of a product redeeming a priority review voucher. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century
Cures Act, authorizes FDA to award priority review vouchers to sponsors
of a material threat medical countermeasure application that meets
certain criteria upon approval of such application. FDA is required to
publish notice of the issuance of priority review vouchers as well as
the approval of products redeeming a priority review voucher. FDA has
determined that the application for MOUNJARO (tirzepatide) injection,
approved May 13, 2022, meets the redemption criteria.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>
(this is not a toll-free number), email: [email protected].

SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21
U.S.C. 360bbb-4a), which was added by section 3086 of the 21st Century
Cures Act (Pub. L. 114-255), FDA will report the issuance of material
threat medical countermeasure priority review vouchers and the approval
of products for which a voucher was redeemed. FDA has determined that
the application for MOUNJARO (tirzepatide) injection, approved May 13,
2022, meets the redemption criteria.
    For further information about the Material Threat Medical
Countermeasure Priority Review Voucher Program and for a link to the
full text of section 565A of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions. For
further information about MOUNJARO (tirzepatide) injection, go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: August 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18523 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Notices]
[Page 16869]
[FR Doc No: 2017-06784]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 8c-1, SEC File No. 270-455, OMB Control No. 3235-0514.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 8c-1
(17 CFR 240.8c-1), under the Securities Exchange Act of 1934
(``Exchange Act'') (15 U.S.C. 78a et seq.).
    Rule 8c-1 generally prohibits a broker-dealer from using its
customers' securities as collateral to finance its own trading,
speculating, or underwriting transactions. More specifically, Rule 8c-1
states three main principles: (1) A broker-dealer is prohibited from
commingling the securities of different customers as collateral for a
loan without the consent of each customer; (2) a broker-dealer cannot
commingle customers' securities with its own securities under the same
pledge; and (3) a broker-dealer can only pledge its customers'
securities to the extent that customers are in debt to the broker-
dealer.\1\
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    \1\ See Exchange Act Release No. 2690 (November 15, 1940);
Exchange Act Release No. 9428 (December 29, 1971).
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    The information required by Rule 8c-1 is necessary for the
execution of the Commission's mandate under the Exchange Act to prevent
broker-dealers from hypothecating or arranging for the hypothecation of
any securities carried for the account of any customer under certain
circumstances. In addition, the information required by Rule 8c-1
provides important investor protections.
    There are approximately 60 respondents as of year-end 2015 (i.e.,
broker-dealers that conducted business with the public, filed Part II
of the FOCUS Report, did not claim an exemption from the Reserve
Formula computation, and reported that they had a bank loan during at
least one quarter of the current year). Each respondent makes an
estimated 45 annual responses, for an aggregate total of 2,700
responses per year.\2\ Each response takes approximately 0.5 hours to
complete. Therefore, the total third-party reporting burden per year is
1,350 burden hours.\3\
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    \2\ 60 respondents x 45 annual responses = 2,700 aggregate total
of annual responses.
    \3\ 2,700 responses x 0.5 hours = 1,350 hours.
---------------------------------------------------------------------------

    The retention period for the recordkeeping requirement under Rule
8c-1 is three years. The recordkeeping requirement under Rule 8c-1 is
mandatory to ensure that broker-dealers do not commingle their
securities or use them to finance the broker-dealers' proprietary
business. This rule does not involve the collection of confidential or
personal identifiable information.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following Web site: www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or by sending an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: March 31, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-06784 Filed 4-5-17; 8:45 am]
BILLING CODE 8011-01-P


MEMORADUM

TO:		DOCKET #: EPA - HQ - OAR - 2014 - 0198
FROM:	Rebecca von dem Hagen, EPA/Stratospheric Protection Division

RE: 		List of References and Associated Documents for the SNAP Status Change Rule

The following is a list of references and associated documents for this rulemaking.  They are included in this docket as attachments to this memo.

Attachments:
   1) Akerman, Nancy H.	Hydrofluorocarbons and Climate Change: Summaries of Recent Scientific Studies and Papers, 2013.
   2) Ben & Jerry's, 2014. Cleaner, Greener Freezers. This document is accessible at http://www.benjerry.com/values/how-we-do-business/cleaner-greener-freezers.
   3) CCAC, 2012.	Technology Forum on Climate-Friendly Alternatives in Commercial Refrigeration. Meeting Summary. 8 December 2012. This document is accessible at http://www.unep.org/ccac/Portals/50162/docs/TechForum/FINAL%20REPORT%20Commercial%20Technology%20Forum%20final.pdf
   4) Coca Cola, 2012.  2012/2013 GRI Report. This document is accessible at:
      http://assets.coca-colacompany.com/44/d4/e4eb8b6f4682804bdf6ba2ca89b8/2012-2013-gri-report.pdf
   5) Coca-Cola, 2014. Coca-Cola Installs 1 Millionth HFC-Free Cooler Globally, Preventing 5.25MM Metrics Tons of CO2, January 22, 2014. This document is accessible at http://www.coca-colacompany.com/press-center/press-releases/coca-cola-installs-1-millionth-hfc-free-cooler-globally-preventing-525mm-metrics-tons-of-co2.
   6) Consumer Specialty Products Association (CSPA), 2012. 2011 Aerosol Pressurized Products Survey- 61[st] Annual Products Survey. April 15, 2012.
   7) Daimler, "Climate Change: EU Scientists Say Daimler's Safety Concerns About New Auto Refrigerant Are Unwarranted," Stephen Gardner, BNA Inc., Daily Environment Report, March 11, 2014. This document is accessible at http://news.bna.com/deln/DELNWB/split_display.adp?fedfid=42760350&vname=dennotallissues&jd=a0e7p0q0q7&split=0
   8) Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 (EU MAC Directive). This document is accessible at
      http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006L0040:EN:HTM
   9) Emerson Climate Technologies, 2014. Refrigerants. March 13, 2014.
   10) EPA, 2009.	Endangerment and Cause or Contribute Findings for Greenhouse Gases under Section 202 (a) of the Clean Air Act. Technical Support Document. December 7, 2009. This document is accessible at:
   www.epa.gov/climatechange/Downloads/endangerment/Endangerment_TSD.pdf
   11) EPA, 2012.	Factsheet: Summary of Refrigerant Reclamation 2000-2012. This data is accessible at: www.epa.gov/spdpublc/title6/608/reclamation/recsum.pdf
   12) EPA, 2013.	Benefits of Addressing HFCs under the Montreal Protocol, June, 2013.
   13) EPA, 2013. Global Mitigation of Non-CO2 Greenhouse Gases: 2010  -  2030. September 2013. This document is accessible at http://www.epa.gov/climatechange/EPAactivities/economics/nonco2mitigation.html
   14) EPA, 2013.	Greenchill. "Advanced Refrigeration". This document is accessible at: http://www2.epa.gov/sites/production/files/documents/gc_storecertprogram08232011.pdf
   15) EPA, 2014.	Climate Benefits of the SNAP Program Status Change Rule, June, 2014.
   16) EPA, 2014.	Global Mitigation of Non-CO2 Greenhouse Gases: 2010  -  2030. Executive Summary. April 2014. This document is accessible at http://www.epa.gov/climatechange/EPAactivities/economics/nonco2mitigation.html
   17) EPA, 2014.	Memorandum: "Notes from Meeting with Nissan Concerning Alternative Refrigerant Transition", Tad Wysor, April, 2014.
   18) GE, 2008.	General Electric. Significant New Alternatives Policy Program Submission to the United States Environmental Protection Agency, October 2008
   19) Honeywell, 2014.  Aerosols Overview- Honeywell Solstice(R) Propellant. EPA meeting. February 27, 2014.
   20) ICF, 2014a.	Market Characterization of the U.S. Aerosols Industry. Prepared for the U.S. Environmental Protection Agency. May, 2014.
   21) ICF, 2014b.	Market Characterization of the U.S. Foams Industry. Prepared for the U.S. Environmental Protection Agency. May, 2014.
   22) ICF, 2014c.	Market Characterization of the U.S Commercial Refrigeration Industry. Prepared for the U.S. Environmental Protection Agency. May, 2014.
   23) ICF, 2014d.	Market Characterization of the Motor Vehicle Air Conditioning Industry. Prepared for the U.S. Environmental Protection Agency. May, 2014.
   24) ICF, 2014e.	Assessment of the Potential Impact of Hydrocarbon Refrigerants on Ground Level Ozone Concentrations. February, 2014.
   25) ICF, 2014f.	Economic Impact Screening Analysis for Regulatory Options to Change Listing Status of High-GWP Alternatives. June, 2014.
   26) ICF, 2014g.	Revised Preliminary Cost-Analysis for Regulatory Options to Change Listing Status of High-GWP Alternatives. June, 2014.
   27) IPCC, 2006.	2006 IPCC Guidelines for National Greenhouse Gas Inventories, Prepared by the National Greenhouse Gas Inventories Programme, Eggleston H.S., Buendia L., Miwa K., Ngara T. and Tanabe K. (eds). Published: Institute for Global Environmental Strategies (IGES), Japan. This document is accessible at http://www.ipcc-nggip.iges.or.jp/public/2006gl/index.html.
   28) IPCC, 2007. Climate Change 2007: The Physical Science Basis. Contribution of Working Group I to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Solomon, S., D. Qin, M. Manning, Z. Chen, M. Marquis, K.B. Averyt, M.Tignor and H.L. Miller (eds.). Cambridge University Press, Cambridge, United Kingdom and New York, NY, USA. This document is accessible at http://www.ipcc.ch/publications_and_data/ar4/wg1/en/contents.html
   29) IPCC, 2013.	Annex II: Climate System Scenario Tables [Prather, M., G. Flato, P. Friedlingstein, C. Jones, J.-F. Lamarque, H. Liao and P. Rasch (eds.)]. In: Climate Change 2013: The Physical Science Basis. Contribution of Working Group I to the Fifth Assessment Report of the Intergovernmental Panel on Climate Change [Stocker, T.F., D. Qin, G.-K. Plattner, M. Tignor, S.K. Allen, J. Boschung, A. Nauels, Y. Xia, V. Bex and P.M. Midgley (eds.)]. Cambridge University Press, Cambridge, United Kingdom and New York, NY, USA.
   30) IPCC/TEAP, 2005.	Special Report: Safeguarding the Ozone Layer and the Global Climate System: Issues Related to Hydrofluorocarbons and Perfluorocarbons (Cambridge Univ Press, New York).
   31) Montzka, S.A.	HFCs in the Atmosphere: Concentrations, Emissions and Impacts, ASHRAE/NIST Conference 2012.
   32) Nelson, Gabe.	"Automakers' switch to new refrigerant will accelerate with EPA credits, European mandate," Automobile News, December 30, 2013. This document is accessible at http://www.autonews.com/article/20131230/OEM01/312309996/warmingto-the-idea
   33) NOAA.  This data is accessible at ftp://ftp.cmdl.noaa.gov/hats/hfcs/
   34) Patten and Wuebbles, 2010. "Atmospheric Lifetimes and Ozone Depletion Potentials of trans-1-chloro-3,3,3-trichloropropylene and trans-1,2-dichloroethylene in a three-dimensional model." Atmos. Chem. Phys., 10, 10867 - 10874, 2010.
   35) UNEP, 2010. Rigid and Flexible Foams Technical Option Committee Assessment Report, 2010. This document is accessible at http://ozone.unep.org/Assessment_Panels/TEAP/Reports/FTOC/FTOC-2010-Assessment-Report.pdf
   36) UNEP, 2011.	HFCs: A Critical Link in Protecting Climate and the Ozone Layer, A UNEP Synthesis Report. November, 2011. This document is accessible at http://www.unep.org/dewa/portals/67/pdf/HFC_report.pdf
   37) UNEP, 2013.	Report of the Technology and Economic Assessment Panel, Volume 2: Decision XXIV/7 Task Force Report, Additional Information on Alternatives to ODS. May, 2013. This document is accessible at http://ozone.unep.org/Assessment_Panels/TEAP/Reports/TEAP_Reports/TEAP_TaskForce%20XXIV-7-May2013.pdf
   38) UNEP, 2014. Technology and Economic Assessment Panel Decision XXV/5 Task Force Report: Additional Information to Alternatives on ODS. May, 2014. This document is accessible at  http://conf.montreal-protocol.org/meeting/oewg/oewg-34/presession/Background%20Documents%20are%20available%20in%20English%20o1/TEAP_Task%20Force%20XXV5-May2014.pdf
   39) Velders, G. J. M., D. W. Fahey, J. S. Daniel, M. McFarland, S. O. Andersen (2009) The large contribution of projected HFC emissions to future climate forcing. Proceedings of the National Academy of Sciences USA 106: 10949 - 10954.
   40) Wang D., Olsen S., Wuebbles D. 2011. "Preliminary Report: Analyses of tCFP's Potential Impact on Atmospheric Ozone." Department of Atmospheric Sciences. University of Illinois, Urbana, IL. September 26, 2011.
   41) Weissler, Paul, "A/C Industry Faces Challenges From Daimler R-1234yf Issue, Explores Other Options," Automotive Engineering International, April 2, 2013. This document is accessible at
      http://articles.sae.org/11870/
   42) WMO, 2010. World Meteorological Organization. Scientific Assessment of Ozone Depletion: 2010, Global Ozone Research and Monitoring Project -- Report No. 52, 516 pp., Geneva, Switzerland, 2011.


[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Notices]
[Pages 9346-9347]
[FR Doc No: 2022-03512]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2018-0543, FRL-9588-01-OMS]

Information Collection Requestion Submitted to OMB for Review and
Approval; Comment Request; Hazardous Remediation Waste Management
Requirements (HWIR) Contaminated Media (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Hazardous Remediation Waste
Management Requirements (HWIR) Contaminated Media (EPA ICR Number
1775.09, OMB Control Number 2050-0161 to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act. This is a proposed extension of the ICR, which is
currently approved through April 30, 2022. Public comments were
previously requested via the Federal Register on September 28, 2021
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before March 21,
2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-
2018-0543, online using www.regulations.gov (our preferred method) or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Peggy Vyas, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov. For further information and updates on EPA Docket
Center services, please visit us online at https://www.epa.gov/dockets.
The telephone number for the Docket Center is<PHONE_NUMBER>.
    Abstract: The Resource Conservation and Recovery Act (RCRA)
requires EPA to establish a national regulatory program to ensure that
hazardous wastes are managed in a manner protective of human health and
the environment. Under this program, EPA regulates newly generated
hazardous wastes, as well as hazardous remediation wastes (i.e.,
hazardous wastes managed during cleanup). Hazardous remediation waste
management sites must comply with all parts of 40 CFR part 264 except
subparts B, C, and D. In place of these requirements, they need to
comply with performance standards based on the general requirement
goals in these sections, which are codified at 40 CFR 264.1(j).
    Under Sec.  264.1(j), owners/operators of remediation waste
management sites must develop and maintain procedures to prevent
accidents. These procedures must address proper design, construction,
maintenance, and operation of hazardous remediation waste management
units at the site. In addition, owners/operators must develop and
maintain a contingency and emergency plan to control accidents that
occur. The plan must explain specifically how to treat, store, and
dispose of the hazardous remediation waste in question, and must be
implemented immediately whenever fire, explosion, or release of
hazardous waste or hazardous waste constituents that could threaten
human health or the environment. In addition, the Remedial Action Plan
streamlines the permitting process for remediation waste management
sites to allow cleanups to take place more quickly.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are the private sector, as well as State, Local, or Tribal
governments.
    Respondent's obligation to respond: Mandatory (RCRA Sec.  3004(u)).
    Estimated number of respondents: 170.
    Frequency of response: One-time.
    Total estimated burden: 5,114 hours per year. Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $348,088 (per year), which includes $53,693
in annualized capital or operation & maintenance costs.
    Changes in the estimates: There is a decrease of 1,247 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to an adjustment in Agency
calculations.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-03512 Filed 2-17-22; 8:45 am]
BILLING CODE 6560-50-P