Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes.  I was smoking over a pack a day ever since I was able to buy them.  Since I began vaping Electronic Cigarettes I have been tobacco free for over three months. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


Unit Exposures: The unit exposure values calculated by PHED generally range from the geometric mean to the median of the selected data set. To add consistency and quality control to the values produced from this system, the PHED Task Force has evaluated all data within the system and has developed a set of grading criteria to characterize the quality of the original study data. The assessment of data quality is based on the number of observations and the available quality control data. While data from PHED provides the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases.

Amount Handled: Based on the daily acres treated.

Personal Protective Equipment ( PPE): HED calculated Margins of Exposure ( MOEs) for the baseline, minimum PPE, PPE1, PPE2 and engineering controls for each occupational exposure scenario under the following assumptions:

All Scenarios: All occupational handlers are wearing footwear ( socks plus shoes or boots). Footwear is assumed to provide 100 percent exposure protection.

Baseline Attire: All handlers are wearing long sleeved shirts and long pants, but no gloves or respirator.

Minimum PPE ( PPE 1): All handlers are wearing long sleeved shirts, long pants and gloves, but no respirator.

PPE 2: All handlers are wearing long sleeved shirts, long pants, gloves and a PF5 respirator ( dust/ mist respirator with a protection factor of 5). Note: Current labels require this level of protection.

Engineering Controls: Indicates the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids.

Occupational Handler Exposure and Risk Estimates:

Summaries of the short and intermediate term inhalation risks at each level of protection ( baseline , PPE1, PPE2 and Engineering Controls) are presented below in Tables 9.1b through 9.1d. The short and intermediate term MOEs are the same because the toxicological endpoints for both exposure durations are the same for tau fluvalinate. Page 47 of 59 * Note: Baseline Attire and Minimum PPE ( PPE1) differ only in the use of gloves, which would not affect inhalation exposure. Therefore, the estimated inhalation exposures and risks for these levels of protection would be the same and are presented together in Table 9.1b.

Table 9.1b Short and Intermediate Term Inhalation Exposures and Risks Assuming Baseline PPE or PPE1 Exposure Scenario ( Scenario #) Inhalation Unit Exposure ( Ug/ lb ai) 1 Crop2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Mixer/ Loader Mixing/ Loading Liquids for Aerial application ( 1) 1.2 Carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day 0.0009 560 Applicator Sprays for Aerial application ( 2) Not Applicable ( see engineering controls) carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day Not Applicable ( see engineering controls) Not Applicable ( see engineering controls)

Sprays for Groundboom Application ( 3) 0.74 carrots & brassica crop group grown for seed 0.15 lb ai per acre 80 acres per day 0.00013 3900 Flagger Flagging for Sprays application ( 4) 0.35 Carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day 0.00026 1900 Mixer/ Loader/ App Mixing/ Loading/ Applying Liquids for High Pressure HandWand application ( 5) 120 nonagricultural areas; nonresidential ind ustrial outdoor areas; buildings, structures. 0.0016 lb ai per gallon 1000 Gallons per day 0.0027 180 Mixing/ Loading/ Applying Liquids for High Pressure HandWand application ( 6) 120 greenhouses 0.0016 lb ai per gallon 1000 Gallons per day 0.0027 180 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 7) 30 outdoor ornamentals 0.0016 lb ai per gallon 40 Gallons per day 0.000027 18000 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 8) 30 ant mounds 0.0016 lb ai per gallon 40 Gallons per day 0.000027 18000 1Baseline and PPE1 inhalation unit exposures represent no respirator. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2Crops and use patterns are from product labeling & LUIS Report. 3Application rates are based on maximum values found in various sources including LUIS and various labels. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are Page 48 of 59 presented as lb ai/ A. In some cases, the application rate is based on applying a solution at concentrations specified by the label ( i. e., presented as lb ai/ gallon). 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5 Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ ug unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = 0.5 mg/ kg/ day ( oral NOAEL) / Daily Inhalation Dose. Target Inhalation MOE is 100.

Table 9.1c Short and Intermediate Term Inhalation Exposures and Risks Assuming PPE2 Exposure Scenario ( Scenario #) Inhalation Unit Exposure ( Ug/ lb ai) 1 Crop2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Mixer/ Loader Mixing/ Loading Liquids for Aerial application ( 1) 0.24 Carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day 0.00018 2800 Applicator Sprays for Aerial application ( 2) Not Applicable ( see engineering controls) carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day Not Applicable ( see engineering controls) Not Applicable ( see engineering controls)

Sprays for Groundboom Application ( 3) 0.15 carrots & brassica crop group grown for seed 0.15 lb ai per acre 80 Acres per day 0.000026 19000 Flagger Flagging for Sprays application ( 4) 0.07 Carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day 0.000053 9500 Mixer/ Loader/ App Mixing/ Loading/ Applying Liquids for High Pressure HandWand application ( 5) 24 nonagricultural areas; nonresidential ind ustrial outdoor areas; buildings, structures. 0.0016 lb ai per gallon 1000 Gallons per day 0.00055 910 Mixing/ Loading/ Applying Liquids for High Pressure HandWand application ( 6) 24 greenhouses 0.0016 lb ai per gallon 1000 Gallons per day 0.00055 910 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 7) 6 outdoor ornamentals 0.0016 lb ai per gallon 40 Gallons per day 0.0000055 91000 Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 8) 6 ant mounds 0.0016 lb ai per gallon 40 Gallons per day 0.0000055 91000 1PPE2 inhalation unit exposures represent a dust/ mist respirator with a protection factor of 5. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2Crops and use patterns are from product labeling & LUIS Report. Page 49 of 59 3Application rates are based on maximum values found in various sources including LUIS and various labels. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are presented as lb ai/ A. In some cases, the application rate is based on applying a solution at concentrations specified by the label ( i. e., presented as lb ai/ gallon). 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5 Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ ug unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = 0.5 mg/ kg/ day ( oral NOAEL) / Daily Inhalation Dose. Target Inhalation MOE is 100.

Table 9.1d Short and Intermediate Term Inhalation Exposures and Risks Assuming Use of Engineering Controls Exposure Scenario ( Scenario #) Inhalation Unit Exposure ( Ug/ lb ai) 1 Crop2 Application Rate3 Daily Area Treated4 Inhalation Dose ( mg/ kg/ day) 5 Inhalation MOE6 Mixer/ Loader Mixing/ Loading Liquids for Aerial application ( 1) 0.083 carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day 0.000062 8000 Applicator Sprays for Aerial application ( 2) 0.068 carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day 0.000051 9800 Sprays for Groundboom Application ( 3) 0.43 carrots & brassica crop group grown for seed 0.15 lb ai per acre 80 Acres per day 0.0000074 68000 Flagger Flagging for Sprays application ( 4) 0.07 carrots & brassica crop group grown for seed 0.15 lb ai per acre 350 Acres per day 0.0000053 95000 Mixer/ Loader/ App Mixing/ Loading/ Applying Liquids for High Pressure HandWand ( 5) Not Applicable ( NA) nonagricultural areas; nonresidential ind ustrial outdoor areas; buildings, structures 0.0016 lb ai per gallon 1000 Gallons per day Data not available Data not available Mixing/ Loading/ Applying Liquids for High Pressure HandWand application ( 6) NA greenhouses 0.0016 lb ai per gallon 1000 Gallons per day Data not available Data not available Mixing/ Loading/ Applying Liquids for High Pressure HandWand application ( 7) NA outdoor ornamentals 0.0016 lb ai per gallon 40 Gallons per day Data not available Data not available Mixing/ Loading/ Applying Liquids for Low Pressure Handwand application ( 8) NA ant mounds 0.0016 lb ai per gallon 40 Gallons per day Data not available Data not available 1Engineering controls inhalation unit exposures represent no respirator. Values are reported in the PHED Surrogate Exposure Guide dated August 1998 or are from data submitted by the Outdoor Residential Exposure Task Force dated May 2000. 2Crops and use patterns are from product labeling & LUIS Report. Page 50 of 59 3Application rates are based on maximum values found in various sources including LUIS and various labels. In most scenarios, a range of maximum application rates is used to represent the range of rates for different crops/ sites/ uses. Most application rates upon which the analysis is based are presented as lb ai/ A. In some cases, the application rate is based on applying a solution at concentrations specified by the label ( i. e., presented as lb ai/ gallon). 4Amount treated is based on the area or gallons that can be reasonably applied in a single day for each exposure scenario of concern based on the application method and formulation/ packaging type. ( Standard EPA/ OPP/ HED values). 5 Inhalation dose ( mg/ kg/ day) = [ unit exposure ( ug/ lb ai) * 0.001 mg/ g unit conversion * Inhalation absorption ( 100%) * Application rate ( lb ai/ acre or lb ai/ gallon) * Daily area treated ( acres or gallons)] / Body weight ( 70 kg). 6Inhalation MOE = 0.5 mg/ kg/ day ( oral NOAEL) / Daily Inhalation Dose. Target Inhalation MOE is 100.

HED believes that the risk values presented in this occupational assessment represent the best quality results that could be produced given the exposure, use and toxicology data that are available. HED also believes that the risks represent reasonable worse case estimates of handler exposure, because maximum application rates are coupled with medium to high end estimates of area treated daily to define risk estimates that likely fall in the upper percentiles of the actual exposure distributions. Using these worst case assumptions, estimated occupational handler MOEs for all exposure scenarios at all protection levels are greater than 100 and are, therefore, not of concern.

Estimated inhalation exposures at the baseline and PPE1 levels of protection are particularly conservative, since they assume respirators are not being used by handlers. In fact, current labels require handlers to wear NIOSH approved respirators ( in addition to long sleeved shirt, long pants, chemical resistant gloves, shoes and socks) for both indoor and outdoor applications.

9.2 Short/ Intermediate/ Long Term Postapplication Risk Post application dermal exposure to tau fluvalinate is expected to be largely self limiting due to the irritation that occurs on contact with the pesticide as a result of the characteristic " pyrethroid reaction" ( see sec. 9.1). Therefore, post application dermal exposure and risk were not assessed.

With the exception of the greenhouse uses, post application inhalation exposure to tau fluvalinate is expected to be minimal. Potential post application inhalation exposure in greenhouses is likely mitigated by the ventilation requirements of the Worker Protection Standard ( WPS). For these reasons, a post application inhalation exposure assessment was not deemed necessary for taufluvalinate However, to confirm that the established re entry interval ( REI) of 12 hours is adequate, HED is requiring the registrant to conduct an inhalation post application exposure study ( OPPTS Guideline 875.2500). The study should be conducted in exact accordance with the use directions on the product label, including ventilation criteria. The study should be designed in such a way that it will be of sufficient duration for the pesticidal residue levels to dissipate to zero ( 0) or to the level of detection in two separate, distinct parts of the treated area. The registrant should submit a study protocol developed under the aforementioned guidelines for Agency review prior to conducting the study.

10.0 Data Needs and Label Requirements 10.1 Toxicology Page 51 of 59  90 Day Inhalation Study ( OPPTS Guideline 870.3465)  This study requirement is reserved pending outcome of the airborne residue dissipation study for greenhouses ( see below).

10.2 Residue Chemistry  None 10.3 Occupational and Residential Exposure  Post application occupational exposure data for greenhouse exposure scenarios ( OPPTS Guideline 875.2500)

References:

Tau Fluvalinate. RED  Reregistration Eligibility Decision Document. Residue Chemistry Considerations. Case No. 2295; D300204; J. Morales; 02/ 22/ 05 Tau Fluvalinate RED  Reregistration Eligibility Decision. Product Chemistry Considerations. Case No. 2295; D311824; J. Morales; 02/ 22/ 05 Tau fluvalinate Acute and Chronic Dietary Exposure Assessments for the Reregistration Eligibility Decision; D300203; S. Stanton; 03/ 11/ 05 Tier II Estimated Environmental Concentration for the Use of Tau Fluvalinate for Apiary Uses, Carrots for Seed ( 24 C SLNs), Building Perimeters, Nurseries, Ornamentals, Indoor Landscapes and Honey for the Human Health Drinking Water Risk Assessment; D304067; Mark Corbin; 02/ 03/ 2005 Revised, Corrected Tau Fluvalinate. Occupational and Residential Exposure Chapter of the Reregistration Eligibility Decision Document ( RED); D319595; R. Travaglini; 06/ 26/ 05 Review of Fluvalinate Incident Reports, D300199, Jerome Blondell, 03/ 14/ 2005 Page 52 of 59 Appendices 1.0 TOXICOLOGY DATA REQUIREMENTS The toxicology data requirements ( 40 CFR 158.340) for tau fluvalinate are in Table 1. Use of the new guideline numbers does not imply that the new ( 1998) guideline protocols were used.

Test Technical Required Satisfied 870.1100 Acute Oral Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . 870.1200 Acute Dermal Toxicity . . . . . . . . . . . . . . . . . . . . . . 870.1300 Acute Inhalation Toxicity . . . . . . . . . . . . . . . . . . . . 870.2400 Primary Eye Irritation . . . . . . . . . . . . . . . . . . . . . . . 870.2500 Primary Dermal Irritation . . . . . . . . . . . . . . . . . . . . 870.2600 Dermal Sensitization . . . . . . . . . . . . . . . . . . . . . . . . yes yes no yes yes yes yes yes no yes yes yes 870.3100 Oral Subchronic ( rodent) . . . . . . . . . . . . . . . . . . . . . 870.3150 Oral Subchronic ( nonrodent) . . . . . . . . . . . . . . . . . . 870.3200 21 Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3250 90 Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3465 90 Day Inhalation . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes no reserved ( 2) yes yes ( 1) yes

870.3700a Developmental Toxicity ( rodent) . . . . . . . . . . . . . . . 870.3700b Developmental Toxicity ( nonrodent) . . . . . . . . . . . . 870.3800 Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes 870.4100a Chronic Toxicity ( rodent) . . . . . . . . . . . . . . . . . . . . 870.4100b Chronic Toxicity ( nonrodent) . . . . . . . . . . . . . . . . . 870.4200a Oncogenicity ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . 870.4200b Oncogenicity ( mouse) . . . . . . . . . . . . . . . . . . . . . . . 870.4300 Chronic/ Oncogenicity . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes yes yes yes yes 870.5100 Mutagenicity   Gene Mutation  bacterial . . . . . . . . 870.5300 Mutagenicity   Gene Mutation  mammalian . . . . . . 870.5xxx Mutagenicity   Structural Chromosomal Aberrations 870.5xxx Mutagenicity   Other Genotoxic Effects . . . . . . . . . . yes yes yes yes yes yes yes yes 870.6100a Acute Delayed Neurotox. ( hen) . . . . . . . . . . . . . . . . 870.6100b 90 Day Neurotoxicity ( hen) . . . . . . . . . . . . . . . . . . . 870.6200a Acute Neurotox. Screening Battery ( rat) . . . . . . . . . 870.6200b 90 Day Neuro. Screening Battery ( rat) . . . . . . . . . . . 870.6300 Develop. Neuro . . . . . . . . . . . . . . . . . . . . . . . . . . . . no no yes yes no   Partial ( 3) yes

870.7485 General Metabolism . . . . . . . . . . . . . . . . . . . . . . . . 870.7600 Dermal Penetration . . . . . . . . . . . . . . . . . . . . . . . . . yes no yes

Special Studies for Ocular Effects Acute Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Subchronic Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . Six month Oral ( dog) . . . . . . . . . . . . . . . . . . . . . . . no no no

( 1)  Satisfied by the chronic dog study. ( 2)  Reserved pending outcome of the greenhouse fogger/ mist study ( i. e., airborne residue dissipation study). ( 3)  A non guideline study is available for partial fulfillment of this requirement; an additional study is not required. Page 53 of 59 2.0 NON CRITICAL TOXICOLOGY STUDIES 1. ( 82 1a) 13 Week Feeding Study in Rats. Zoecon Corporation. 1981. MRID No. 00094109, 92069032. HED Doc. No. 002256.

In a 90 day subchronic feeding study in rats ( 1981, MRID 00094109), groups of 20 male and 20 female 21 day old Charles River COBS CD rats were administered 0.3, 1.0, 3.0, 30.0 or 50.0 mg/ kg b. w./ day tau fluvalinate ( 88.2 93.1.%, Lot # 455 95, 468 27, Run 23) in the diet which was adjusted weekly for concentration.

Salivation and abnormal gait were observed in the 50.0 mg/ kg/ day group. Skin lesions were observed in males at 3.0 mg/ kg/ day and higher dose levels. Skin lesions were observed in females beginning at 30.0 mg/ kg/ day. Body weights were 15.8 and 25.3% less than controls in males in the 30.0 and 50.0 mg/ kg/ day groups, respectively. Body weights were 6.3 and 11.9% less than controls in females in the 30.0 and 50.0 mg/ kg/ day groups, respectively. The hematocyte, hemoglobin levels and erythrocyte counts were decreased at 30.0 and 50.0 mg/ kg/ day. The BUN was increased somewhat in the 30.0 and 50.0 mg/ kg/ day groups. Albumin and total bilirubin were decreased at 30.0 and 50.0 mg/ kg/ day. On histological examination of the tissues, there was significant damage to the skin characterized by focal ulceration and inflammation extending to the muscularis. The Systemic LOEL was 3.0 mg/ kg/ day based on the occurrence of skin lesions ( due to systemic neurotoxicity). The Systemic NOEL was 1.0 mg/ kg/ day.

The study is acceptable and satisfies the requirement for a guideline series 82 1( a) 90 day subchronic feeding study in rats.

2. ( 82 1a) 13 Week Feeding Study in Mice. Zoecon Corporation. 1981. MRID No. 00094113. HED Doc. No. 004705.

In a 13 week subchronic feeding study in mice ( 1981, MRID 00094113), groups of 10 male and 10 female 41 day old CD 1 mice were administered 0, 1, 3, 30, 50 or 100 mg/ kg b. w./ day of taufluvalinate ( 89.9 93.1%, Anal 10801 91, Anal 0281037, Run 23R) in the diet. Compound related effects noted included infected skin lesions, related effects, and their sequelae ( increased WBC counts, enlarged lymph nodes, infected eyes, and splenic changes in all dosage groups). Male body weights were significantly decreased in groups receiving 30 mg/ kg/ day or more. Female HCT, HGB, RBC and reticulocytes were significantly decreased in the 100 mg/ kg/ day group. The ovaries in the 100 mg/ kg/ day group were significantly decreased and had ovarian cysts. Histological examinations of the ovaries were not performed in the other groups. The NOEL and LOEL were not determined.

The study is supplementary and does not satisfy the requirement for a guideline series 82 1( a) 90 day subchronic feeding study in rodents.

3. ( 82 1a) 14 Day Range Finding Study in Mice. Zoecon Corporation. 1981. MRID No. 00094105. HED Doc No. 002256. ( also racemic mixture) Page 54 of 59 In a 14 day rangefinding toxicity study in mice ( 1981, MRID 00094105), groups of 5 male and 5 female CD 1 mice were administered 0, 0.2, 0.7, 2.0, 7.0, 20.0, 70.0. 200.0 or 700.0 ( doses approximately 0, 0.03, 0.10, 0.30, 1.00, 3.00, 10.00, 30.00 or 100.00 mg/ kg/ day) of taufluvalinate ( 89.9%, # 1080 91) in the diet. Another group of 5 male and 5 female mice per group were administered 0, 20.0, 70.0, 200.0 or 700.0 ppm ( doses approximately 0, 3.0, 10.0, 30.0 or 100.0 mg/ kg/ day) of fluvalinate ( racemic) ( 93.8%, Anal 0979 069, Run # 7) in the diet.

Tau fluvalinate  Hair loss, local crusting and skin ulceration were note at 10 ( F) and 30 mg/ kg/ day ( M and F) and above. Excessive salivation, ataxia, reduced motor activity, skin paleness and death occurred at 100 mg/ kg/ day. Body weight was reduced at 100 mg/ kg/ day.

Fluvalinate ( racemic)  Hair loss, local crusting and skin ulceration were observed in females at 10 mg/ kg/ day and in males at 100 mg/ kg/ day.

Tau fluvalinate is more toxic on a mg/ kg basis than the racemic technical. Females appear to be more sensitive than males. Quantitative differences in observations can be attributed to compound potency. There do not appear to be any qualitative differences between the two mixtures.

The study is supplementary ( by design  rangefinding) and does not satisfy the requirement for a guideline series 82 1( a) 90 day subchronic feeding study in mice.

4. ( 82 2) 21 Day Dermal Toxicity Study in Rabbits. Zoecon Corporation. 1981. MRID No. 00094115. HED Doc. No. 002256 In a 3 week dermal toxicity study ( 1981, MRID 00094115), groups of 10 male and 10 female young adult New Zealand White rabbits were administered 0, 100, 500 or 2000 mg/ kg/ day of taufluvalinate ( 93.1%, Lot 23R, # 0281037, ZTS 0029). The skin on the backs of one half of the animals was abraded.

A well defined erythema was observed in all treated animals. A barely perceptible edema was noted in all treated males and females. Skin sores were noted at dose levels of 100 mg/ kg/ day and above. Males in the 2000 mg/ kg/ day group had decreased body weights. Food consumption was decreased in males in the 500 and 2000 mg/ kg/ day groups and in females in the 2000 mg/ kg/ day group. Histological lesions including acanthosis, hyperkeratosis, acute and chronic dermal inflammation and epidermal ulceration were observed in all treated animals. The NOEL is less than 100 mg/ kg/ day. The LOEL is 100 mg/ kg/ day based on skin irritation ( possibly a systemic neurologic effect as well). The systemic NOEL is 100 mg/ kg/ day and the LOEL is 500 mg/ kg/ day based on decreased food intake.

The study is acceptable and satisfies the requirement for a guideline series 82 2 21 day dermal study in rabbits.

5. ( 83 3) Chronic dosing study in dogs. Covance Laboratories Inc., 9200 Leesburg Pike, Vienna, VA 22182 1699. Covance 6398 117, December 17, 1998. MRID 44743201. Unpublished. Page 55 of 59 In a chronic toxicity study ( 1998, MRID 44743201), tau fluvalinate ( 88.4% purity) was administered to 4 beagle dogs/ sex/ dose in capsules at dose levels of 0, 3, 12, and 50 mg/ kg/ day for 52 weeks.

There was no effect on mortality in either sex of dogs. Clinical signs with a possible relationship to test substance exposure included salivation in 3/ 4 males and females and a marked increase in the frequency of emesis ( observed in all dogs), mainly postdose, in the high dose male and female groups, signs consistent with CNS toxicity. The body weights of the high dose males were significantly reduced reaching 85% of controls at week 40; those of the mid and high dose females were consistently less than controls with effects biologically although not statistically significant, 89 and 93% at 52 weeks, respectively. The overall body weight gains of the high dose males ( 40% of controls, p< 0.05) and mid and high dose females ( 47 and 63%, N. S., respectively) were also reduced by exposure to Tau Fluvalinate for 52 weeks. There were no compoundrelated effects on food consumption, hematology, clinical chemistry, or gross and histologic pathology. Liver weights, absolute and relative to body and brain weight, were significantly increased by exposure to the test compound in the high dose male ( 120, 138, and 121%, respectively, all p< 0.05) and females ( 124, 129, and 127%, respectively, p< 0.05 for relative body weight) and possibly in the mid dose female group ( 110,110, and 104%, respectively, all N. S.). The Tau fluvalinate LOAEL for female dogs is 12 mg/ kg/ day based on decreased body weight and body weight gain and increased liver weight. The NOAEL for female dogs is 3 mg/ kg/ day. The Tau fluvalinate LOAEL for male dogs is 50 mg/ kg/ day, based on decreased body weight and body weight gain, increased liver weight, and increased emesis and salivation. The NOAEL for males is 12 mg/ kg/ day.

This chronic study in the dog is Acceptable/ Guideline and satisfies the guideline requirement for a chronic oral study [ OPPTS 870l4100, OECD 452] in the dog.

6. ( 83 5) 2 Year Dosing/ Carcinogenicity Study in Mice. Zoecon Corporation. 1984. MRID No. 00094889, 00128336, 00144628, 92069036. HED Doc. No. 004705.

In a 24 month combined chronic/ carcinogenicity study ( 1984, MRID 00094889, 00128336, 00144628, 92069036), groups of 60 49 day old Charles River CD 1 mice ( except for a second control group containing 50 animals/ sex/ dose) were administered 0, 2, 10 or 20 mg/ kg b. w./ day of tau fluvalinate ( 92.1%. Run 23, Anal # 0281028) in the diet which was frequently adjusted to achieve the appropriate concentrations. Ten animals/ sex/ dose were sacrificed from the 2 control groups and the 10 and 20 mg/ kg/ day groups at week 52.

Skin lesions were noted in the 10 and 20 mg/ kg/ day groups. Chronic nephritis was increased in males in the 20 mg/ kg/ day group. There was no indication that tau fluvalinate was carcinogenic in mice.

The NOEL is 2 mg/ kg/ day. The LOEL is 10 mg/ kg/ day based on dermal lesions ( due to systemic neurotoxicity). Tau fluvalinate is not carcinogenic in mice. Page 56 of 59 The study is acceptable and satisfies the requirement for a guideline series 83 2 carcinogenic study in mice. The study is supplementary and does not satisfy the requirement for a guideline series 83 1 chronic feeding study in mice.

7. ( 85 1). Metabolism study in mice. Zoecon Corporation, Palo Alto, CA; No. 3760 2 02 84; dated February 21, 1984. Accession No. 072918. Unpublished.

In a metabolism study ( 1984, MRID No. 072918) [ trifluoromethy 14C] tau fluvalinate and nonlabeled tau fluvalinate, were administered in feed to male and female mice ( ICR strain, Simonsens Laboratories, Gilroy, CA). Treatment groups consisted of 3 rats/ sex given at doses of approximately 26 mg/ kg/ day for six days.

Tau fluvalinate was rapidly absorbed, metabolized, distributed and excreted following oral administration and most material was recovered in the urine and feces in both male and female mice pre fed unlabelled tau fluvalinate at approximately 26 mg/ kg/ day. Approximately 59 percent and 30 percent of the applied dose was excreted in the feces and urine, respectively, during the 4 day experiment, with most of the radioactivity eliminated during the first day. The major products identified in the urine included 2[ 2 chloro 4( trifluoromethyl) anilino] 3 methyl butanoic acid ( anilino acid) and the taurine conjugate of the anilino acid, which accounted for 8.2 12.0 and 1.7 3.2 percent of day 1 radioactivity in urine, respectively. In addition, 7 urinary metabolites were found but not identified. Parent tau fluvalinate represented 15 23% of the radioactivity in the day 1 fecal extracts, and the anilino acid represented approximately 11 percent of fecal radioactivity. In addition, five fecal metabolites were found but not identified. Little radioactivity was found in any of the tissues or carcasses and no major sex differences were observed. This metabolism study in the mice is classified acceptable/ non guideline and does not satisfy the guideline requirement for a metabolism study [ OPPTS 870.7485, OECD 417] in mice. The limiting factor is the study used only 3 mice/ sex whereas the Guidelines require 4 mice/ sex.

8. ( 85 1). Metabolism study in rats. Sandoz, Study No. 480605 13, May 20, 1992.

In this study ( 1992, MRID No.: 42322301), a single oral dose of 14C fluvalinate at 1 mg/ kg ( Group A), 200 mg/ kg ( Group C), or unlabelled tau fluvalinate at 1 mg/ kg/ day for 14 days followed by a single dose of 14C fluvalinate at 1 mg/ kg ( Group B) were administered to CD rats. The rats were sacrificed 96 hours later following. For groups A and B, approximately 75% of the dose was detected in the excreta by 24 hours after dosing. For the high dose rats ( Group C), however, elimination of the radioactivity was only 45% of the dose at 24 hours. By 96 hours after administration, approximately 90% of the dose in all groups was eliminated. Over the 4 day test period, fecal excretion was the dominant elimination pathway accounting for approximately 60 to 80% of the administered tau fluvalinate dose. The relative amounts of parent compound and the major fecal metabolite, anilino acid varied with dose. For groups A and B, the parent compound and anilino acid represented about 55 and 10% respectively, of the fecal radioactivity. For the high dose group ( 200 mg/ kg) the parent compound and anilino acid represented about 85% and 2% respectively, of the fecal radioactivity. Additional fecal metabolites, although less significant were haloaniline, 3 phenoxybenzoic acid, and 3( 4" hydroxyphenoxy) benzoic acid. With respect to urinary excretion, the low dose groups ( A and B), followed first order kinetics and urinary radioactivity accounted for 30 40% of the administered dose. The elimination half Page 57 of 59 life was estimated as 12 hours for male rats and 15 hours for females rats. For the high dose group, the urinary radio activity represented less than 20% of the administered dose, suggesting saturation of absorption or elimination processes. Urinary metabolites included haloaniline, 3 phenoxybenzoic acid A, lactone of anilino A, 3 phenoxybenzyl alcohol, diacid and 3( 4" hydroxyphenoxy) benzoic acid A. The major urinary metabolites were 3( 4" hydroxyphenoxy) benzoic acid A, and 3 phenoxybenzoic acid A. Residues in various tissues and the carcass at 96 hours after dosing, accounted for only 2 8% of the administered dose. Although sex related differences in the metabolism of tau fluvalinate were detected, none were considered significant. Pretreatment with the chemical ( Group B) did not significantly affect the metabolism and disposition of tau fluvalinate.

This study is classified as Acceptable/ Guideline and satisfies the requirement for a series 85 1 general metabolism study in rats. Page 58 of 59 3.0 Tolerance Reassessment Summary; Codex/ International Harmonization Tolerance Reassessment Summary for Tau Fluvalinate.

Commodity Current Tolerance ( ppm) Range of Residues ( ppm) Tolerance Reassessment ( ppm) Comment/[ Correct Commodity Definition]

Tolerance Listed Under 40 CFR § 180.427 ( a):

Honey 0.05 < 0.01 0.015 0.02 No Codex MRLs have been established for tau fluvalinate; therefore, issues of compatibility between Codex MRLs and U. S. tolerances do not exist. A Mexican MRL of 0.1 mg/ kg has been established for cottonseed. No Canadian MRLs have been established for fluvalinate or taufluvalinate We note that tau fluvalinate is registered for use in Canada in honey bee chambers; this use presumably falls under the PMRA General MRL of 0.1 mg/ kg. [ Regulation B. 15.002( 1) of the Canadian Food and Drugs Regulations ( FDR) establishes 0.1 ppm as the " General Maximum Residue Limit." This regulation states that a food is adulterated if it contains residues of a pesticide at a level greater than 0.1 ppm unless a specific MRL has been established in Table II, Division 15 of the FDR.] Page 59 of 59 Confidential Appendix This appendix has been removed to a separate file so that it can be stored on the RAD database.


[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50482-50486]
[FR Doc No: 2013-20004]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0183]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption from the diabetes mellitus
requirement; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 23 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before September 18, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0183 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue, SE., Room W64-
224, Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5
p.m., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds

``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 23 individuals listed
in this notice have recently requested such an exemption from the
diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers
of CMVs in interstate commerce. Accordingly, the Agency will evaluate
the qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by
statute.

Qualifications of Applicants

John K. Abels

    Mr. Abels, 23, has had ITDM since 1996. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Abels understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Abels meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Illinois.

Edmund Arays

    Mr. Arays, 62, has had ITDM since 2007. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Arays understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Arays meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from Ohio.

Dean A. Bacon

    Mr. Bacon, 60, has had ITDM since 2005. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bacon understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bacon meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Indiana.

Philip E. Banks

    Mr. Banks, 56, has had ITDM since 2009. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Banks understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Banks meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2012 and certified that he does not have
diabetic retinopathy. He holds a Class C CDL from Ohio.

Anthony M. Brida

    Mr. Brida, 75, has had ITDM since 1995. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Brida understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Brida meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from New Jersey.

Ronald H. Cathey

    Mr. Cathey, 59, has had ITDM since 2008. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Cathey understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Cathey meets the vision
requirements of 49 CFR 391.41(b)(10). His optometrist examined him in
2013 and certified that he does not have diabetic retinopathy. He holds
a Class A CDL from Texas.

William H. Conley

    Mr. Conley, 66, has had ITDM since 2010. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Conley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Conley meets the vision
requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2013 and certified that he has stable proliferative diabetic
retinopathy. He holds a Class A CDL from Indiana.

Charles E. Dailey

    Mr. Dailey, 39, has had ITDM since 2003. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Dailey understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Dailey meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013

and certified that he has stable proliferative diabetic retinopathy. He
holds a Class D operator's license from Alabama.

Kenneth D. Denny

    Mr. Denny, 61, has had ITDM since 2004. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Denny understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Denny meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Washington.

Kenneth D. Ferguson

    Mr. Ferguson, 51, has had ITDM since 2007. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Ferguson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ferguson meets the
vision requirements of 49 CFR 391.41(b)(10). His optometrist examined
him in 2013 and certified that he does not have diabetic retinopathy.
He holds an operator's license from Washington.

Adam M. Hogue

    Mr. Hogue, 29, has had ITDM since 2012. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hogue understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hogue meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Mississippi.

Allen D. LaFave

    Mr. LaFave, 65, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. LaFave understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. LaFave meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from North Dakota.

Greg P. Mason

    Mr. Mason, 48, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Mason understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mason meets the vision
requirements of 49 CFR 391.41(b)(10). His ophthalmologist examined him
in 2013 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from New York.

Thomas D. Miller

    Mr. Miller, 50, has had ITDM since 1990. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Miller understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Miller meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Montana.

Douglas A. Mulligan

    Mr. Mulligan, 50, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Mulligan understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mulligan meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Kentucky.

David G. Peters

    Mr. Peters, 49, has had ITDM since 2011. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Peters understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Peters meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he has stable
non-proliferative diabetic retinopathy. He holds a Class A CDL from
Pennsylvania.

Robert J. Rispoli, Jr.

    Mr. Rispoli, 23, has had ITDM since 2005. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Rispoli understands

diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Rispoli meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
New York.

Mike P. Senn

    Mr. Senn, 34, has had ITDM since 2001. His endocrinologist examined
him in 2013 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Senn understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Senn meets the vision requirements
of 49 CFR 391.41(b)(10). His optometrist examined him in 2013 and
certified that he does not have diabetic retinopathy. He holds a Class
D operator's license from Minnesota.

James H. Suttles

    Mr. Suttles, 68, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Suttles understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Suttles meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class DL operator's license from
Alabama.

Steven L. Tallaksen

    Mr. Tallaksen, 59, has had ITDM since approximately 1983. His
endocrinologist examined him in 2013 and certified that he has had no
severe hypoglycemic reactions resulting in loss of consciousness,
requiring the assistance of another person, or resulting in impaired
cognitive function that occurred without warning in the past 12 months
and no recurrent (2 or more) severe hypoglycemic episodes in the last 5
years. His endocrinologist certifies that Mr. Tallaksen understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Tallaksen meets
the requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2013 and certified that he has stable
non-proliferative diabetic retinopathy. He holds a Class A CDL from
Missouri.

Douglas M. Tiller, Sr.

    Mr. Tiller, 48, has had ITDM since 1995. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Tiller understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Tiller meets the vision requirements of 49 CFR 391.41(b)(10).
His optometrist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Virginia.

Gregory F. Wendt

    Mr. Wendt, 50, has had ITDM since 2013. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wendt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Wendt meets the vision requirements of 49 CFR 391.41(b)(10).
His ophthalmologist examined him in 2013 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Nebraska.

Michael J. Wickstrom

    Mr. Wickstrom, 60, has had ITDM since 2011. His endocrinologist
examined him in 2013 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wickstrom understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wickstrom meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2013 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Michigan.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441) \1\. The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) elimination of the requirement for 3
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C. 31136 (e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and

medical requirements that are deemed medically necessary.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2013-0183 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2013-0183 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Issued on: August 8, 2013.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2013-20004 Filed 8-16-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Rules and Regulations]
[Pages 68699-68702]
[FR Doc No: 2013-27404]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 95

[Docket No. 30931; Amdt. No. 510]

IFR Altitudes; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule

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SUMMARY: This amendment adopts miscellaneous amendments to the required
IFR (instrument flight rules) altitudes and changeover points for
certain Federal airways, jet routes, or direct routes for which a
minimum or maximum en route authorized IFR altitude is prescribed. This
regulatory action is needed because of changes occurring in the
National Airspace System. These changes are designed to provide for the
safe and efficient use of the navigable airspace under instrument
conditions in the affected areas.

DATES: Effective 0901 UTC, December 12, 2013.

FOR FURTHER INFORMATION CONTACT: Harry Hodges, Flight Procedure
Standards Branch (AMCAFS-420), Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal
Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR
altitudes governing the operation of all aircraft in flight over a
specified route or any portion of that route, as well as the changeover
points (COPs) for Federal airways, jet routes, or direct routes as
prescribed in part 95.

The Rule

    The specified IFR altitudes, when used in conjunction with the
prescribed changeover points for those routes, ensure navigation aid
coverage that is adequate for safe flight operations and free of
frequency interference. The reasons and circumstances that create the
need for this amendment involve matters of flight safety and
operational efficiency in the National Airspace System, are related to
published aeronautical charts that are essential to the user, and
provide for the safe and efficient use of the navigable airspace. In
addition, those various reasons or circumstances require making this
amendment effective before the next scheduled charting and publication
date of the flight information to assure its timely availability to the
user. The effective date of this amendment reflects those
considerations. In view of the close and immediate relationship between
these regulatory changes and safety in air commerce, I find that notice
and public procedure before adopting this amendment are impracticable
and contrary to the public interest and that good cause exists for
making the amendment effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial

number of small entities under the criteria of the Regulatory
Flexibility Act.

List of Subjects in 14 CFR Part 95

    Airspace, Navigation (air).

    Issued in Washington, DC, on November 8, 2013.
John Duncan,
Acting Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, part 95 of the Federal Aviation Regulations (14 CFR part
95) is amended as follows effective at 0901 UTC, June 30, 2011.

0
1. The authority citation for part 95 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44719, 44721.

0
2. Part 95 is amended to read as follows:

              Revisions to IFR Altitudes & Changeover Point
            [Amendment 510 Effective date, December 12, 2013]
------------------------------------------------------------------------
               From                           To                 MEA
------------------------------------------------------------------------
                    Sec.   95.6001 Victor Routes-U.S
     Sec.   95.6009 VOR Federal Airway V9 is Amended to Read in Part
------------------------------------------------------------------------
MC COMB, MS VORTAC...............  *ROMAR, MS FIX..........       **3000
    *4000--MRA
    **1900--MOCA
*ROMAR, MS FIX...................  MAGNOLIA, MS VORTAC.....       **3000
    *4000--MRA
    **1900--MOCA
------------------------------------------------------------------------
    Sec.   95.6018 VOR Federal Airway V18 is Amended to Read in Part
------------------------------------------------------------------------
MONROE, LA VORTAC................  MAGNOLIA, MS VORTAC.....         2500
------------------------------------------------------------------------
    Sec.   95.6048 VOR Federal Airway V48 is Amended to Read in Part
------------------------------------------------------------------------
PEORIA, IL VORTAC................  MAROC, IL FIX...........        *3000
    *2400--MOCA
MAROC, IL FIX....................  PONTIAC, IL VOR/DME.....         2500
------------------------------------------------------------------------
    Sec.   95.6066 VOR Federal Airway V66 is Amended to Read in Part
------------------------------------------------------------------------
BROOKWOOD, AL VORTAC.............  LAGRANGE, GA VORTAC.....         3400
------------------------------------------------------------------------
    Sec.   95.6070 VOR Federal Airway V70 is Amended to Read in Part
------------------------------------------------------------------------
U.S./MEXICO BORDER...............  BROWNSVILLE, TX VORTAC..        *5000
    *1600--MOCA
------------------------------------------------------------------------
    Sec.   95.6083 VOR Federal Airway V83 is Amended to Read in Part
------------------------------------------------------------------------
ALAMOSA, CO VORTAC...............  BLOKE, CO FIX...........
                                   E BND...................        14000
                                   W BND...................        10400
BLOKE, CO FIX....................  *GOSIP, CO FIX..........        14000
    *14000--MCA GOSIP, CO FIX, SW
     BND
------------------------------------------------------------------------
    Sec.   95.6091 VOR Federal Airway V91 is Amended to Read in Part
------------------------------------------------------------------------
GLENS FALLS, NY VORTAC...........  *ENSON, VT FIX..........      **10000
    *10000--MCA ENSON, VT FIX, SW
     BND
    **5000--GNSS MEA
ENSON, VT FIX....................  WEIGH, VT FIX...........        *4000
    *2800--MOCA
WEIGH, VT FIX....................  BURLINGTON, VT VOR/DME..
                                   N.......................     BND 3000
                                   S.......................     BND 4000
------------------------------------------------------------------------
    Sec.   95.6119 VOR Federal Airway V119 is Amended to Read in Part
------------------------------------------------------------------------
NEWCOMBE, KY VORTAC..............  *CROUP, OH FIX..........         2800
  *5500--MCA CROUP, OH FIX, NE
   BND
CROUP, OH FIX....................  HENDERSON, WV VORTAC....         5500
------------------------------------------------------------------------
    Sec.   95.6140 VOR Federal Airway V140 is Amended to Read in Part
------------------------------------------------------------------------
NASHVILLE, TN VORTAC.............  *LENON, TN FIX..........       **3000
  *6500--MRA
  **2400--MOCA
*LENON, TN FIX...................  HARME, TN FIX...........       **3000

  *6500--MRA
  **2400--MOCA
HARME, TN FIX....................  LIVINGSTON, TN VORTAC...         3200
------------------------------------------------------------------------
    Sec.   95.6141 VOR Federal Airway V141 is Amended to Read in Part
------------------------------------------------------------------------
RUCKY, VT FIX....................  *BURLINGTON, VT VOR/DME.         6300
    *4000--MCA BURLINGTON, VT VOR/
     DME, SE BND
------------------------------------------------------------------------
    Sec.   95.6161 VOR Federal Airway V161 is Amended to Read in Part
------------------------------------------------------------------------
LLANO, TX VORTAC.................  *BUILT, TX FIX..........       **6000
    *6000--MRA
    **3200--MOCA
*BUILT, TX FIX...................  DUFFA, TX FIX...........       **6000
    *6000--MRA
    **2900--MOCA
------------------------------------------------------------------------
    Sec.   95.6198 VOR Federal Airway V198 is Amended to Read in Part
------------------------------------------------------------------------
PEARL, LA FIX....................  MINNI, MS FIX...........        *2300
    *1300--MOCA
MINNI, MS FIX....................  ELSIE, MS FIX...........        *3500
    *1300--MOCA
ELSIE, MS FIX....................  *ROMMY, MS FIX..........       **2800
    *4000--MRA
    **1300--MOCA
SEMINOLE, FL VORTAC..............  LLOYD, FL FIX...........         2000
------------------------------------------------------------------------
    Sec.   95.6210 VOR Federal Airway V210 is Amended to Read in Part
------------------------------------------------------------------------
ALAMOSA, CO VORTAC...............  BLOKE, CO FIX...........
                                   E BND...................        14000
                                   W BND...................        10400
BLOKE, CO FIX....................  *GOSIP, CO FIX..........        14000
    *14000--MCA GOSIP, CO FIX, SW
     BND
------------------------------------------------------------------------
    Sec.   95.6229 VOR Federal Airway V229 is Amended to Read in Part
------------------------------------------------------------------------
MUDDI, VT FIX....................  *BURLINGTON, VT VOR/DME.         6000
    *3100--MCA BURLINGTON, VT VOR/
     DME, SE BND
------------------------------------------------------------------------
    Sec.   95.6240 VOR Federal Airway V240 is Amended to Read in Part
------------------------------------------------------------------------
PEARL, LA FIX....................  MINNI, MS FIX...........        *2300
    *1300--MOCA
MINNI, MS FIX....................  ELSIE, MS FIX...........        *3500
    *1300--MOCA
ELSIE, MS FIX....................  *ROMMY, MS FIX..........       **2800
    *4000--MRA
    **1300--MOCA
------------------------------------------------------------------------
    Sec.   95.6487 VOR Federal Airway V487 is Amended to Read in Part
------------------------------------------------------------------------
WEIGH, VT FIX....................  BURLINGTON, VT VOR/DME..
                                   N BND...................         3000
                                   S BND...................         4000
------------------------------------------------------------------------
    Sec.   95.6568 VOR Federal Airway V568 is Amended to Read in Part
------------------------------------------------------------------------
LLANO, TX VORTAC.................  *BUILT, TX FIX..........       **6000
    *6000--MRA
    **3200--MOCA
------------------------------------------------------------------------
    Sec.   95.6573 VOR Federal Airway V573 is Amended to Read in Part
------------------------------------------------------------------------
TEXARKANA, AR VORTAC.............  ELMMO, AR FIX...........
                                   SW BND..................        *3500
                                   NE BND..................        *5500
    *2600--MOCA
ELMMO, AR FIX....................  *MARKI, AR FIX..........       **5500

    *5500--MCA MARKI, AR FIX, SW
     BND
    **2600--MOCA
MARKI, AR FIX....................  HOT SPRINGS, AR VOR/DME.        *3500
    *2700--MOCA
------------------------------------------------------------------------
    Sec.   95.6586 VOR Federal Airway V586 is Amended to Read in Part
------------------------------------------------------------------------
MACON, MO VOR/DME................  QUINCY, IL VORTAC.......         2700
QUINCY, IL VORTAC................  PEORIA, IL VORTAC.......         2500
PEORIA, IL VORTAC................  MAROC, IL FIX...........        *3000
    *2400--MOCA
MAROC, IL FIX....................  PONTIAC, IL VOR/DME.....         2500
------------------------------------------------------------------------

                  From                                  To                    MEA                 MAA
----------------------------------------------------------------------------------------------------------------
                                            Sec.  95.7001 JET ROUTES
                          Sec.   95.7190 Jet Route J190 MAA is Amended to Read in Part
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SLATE RUN, PA VORTAC..........  BINGHAMTON, NY VORTAC..........        18000  45000
    USE SLATE RUN R-072 TO
     BINGHAMTON
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                             Airway Segment                                          Changeover points
----------------------------------------------------------------------------------------------------------------
                  From                                  To                  Distance              From
----------------------------------------------------------------------------------------------------------------
                               Sec.   95.8003 VOR Federal Airway Changeover Point
                                   V210 is Amended To Delete Changeover Point
----------------------------------------------------------------------------------------------------------------
ALAMOSA, CO VORTAC.....................  LAMAR, CO VOR/DME..............           60  ALAMOSA.
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[FR Doc. 2013-27404 Filed 11-14-13; 8:45 am]
BILLING CODE 4910-13-P


MEMORANDUM

Date:		June 5, 2013

Subject:	Report of May 29, 2013 Site Visit to Clean Harbors Inc., Dolton, IL

From:		Lesley Stobert, EC/R Incorporated

To:		Mary Tom Kissell, U.S. Environmental Protection Agency

      This memo summarizes the site visit to the Clean Harbors Inc. facility in Dolton, IL, which was conducted on May 29, 2013.  The purposes of this visit were to:

          * Enhance understanding of current processes and emission controls for the off-site waste and recovery operations (OSWRO) at the facility.
          * Gain an understanding of the other applicable Clean Air Act regulations for the facility, including 40 CFR 264, 265, 279 and 40 CFR Parts 60, 61 and 63.
          * Clarify any questions the U.S. EPA has regarding the response received from the recent information collection request for this facility.

	The participants in the site visit included the following:

      Clean Harbors Inc.
      James Laubsted  -  Facility Compliance Manager
      Bill Schade  -  Facility Manager

      US EPA
      Mary Tom Kissell

      EC/R Incorporated
      Lesley Stobert
      Tanya Parise

This memo includes a brief overview of this project, an overview of the Clean Harbors facility, and is followed by a description of the specific information gathered during the visit.

BACKGROUND

      Section 112 of the Clean Air Act (CAA) establishes a two-stage regulatory process to address emissions of hazardous air pollutants (HAP) from stationary sources. In the first stage, CAA section 112(d) requires us to promulgate technology-based national emission standards for each major source category listed under section 112(c).  These technology-based standards are often referred to as maximum achievable control technology, or MACT, standards.  The National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Off- Site Waste and Recovery Operations were promulgated on July 1, 1996 (61 FR 34140), and codified at 40 CFR part 63, subpart DD. The final rule was amended on July 20, 1999 (64 FR 38950).

      In the second stage of the regulatory process, the EPA is then required under CAA section 112(d)(6) to review these technology-based standards and revise them "as necessary (taking into account developments in practices, processes, and control technologies)" no less frequently than every eight years. In addition, within 8 years after promulgation of the MACT standards, CAA section 112(f)(2) requires the EPA to promulgate standards, if required, to provide an ample margin of safety to protect public health or to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.
This second stage in standard setting is referred to as the residual risk and technology review (RTR) for the standards.

      The EPA is in the process of conducting the RTR for the OSWRO MACT standards. As part of the RTR process, this Clean Harbors Inc. production facility was selected for a site visit for three primary reasons: (1) it is one of several OSWRO facilities in the Chicago, IL area, which would enable the EPA to see several facilities in one trip, (2) based on available emissions data in the EPA's National Emissions Inventory (NEI), this facility had one of the higher emission rates of the OSWRO facilities identified in that database, and (3) discussion with Clean Harbors company representatives suggested that this facility had more diverse operations than the other Chicago-area Clean Harbors facility.

PLANT SITE OVERVIEW

      The Clean Harbors Inc. facility is located at 633 East 138[th] Street, Dolton, IL, which is in the greater Chicago, IL area. At this site, Clean Harbors receives waste, including solvents, solvent mixtures, solid and semi-solid materials, and aqueous chemicals, and processes the waste through material handling, evaporation, and fractional distillation equipment for resale where possible. Where this is not possible, the waste is sent offsite for incineration or other means of disposal. Some of the primary business lines for this facility include aqueous and solvent parts cleaning, waste processing and fuel blending. The operations are continuous, with operations occurring 24 hours a day, 7 days a week. The facility receives waste from many businesses (i.e., over 1,000). This facility is subject to the OSWRO MACT (subpart DD) and also Resource Conservation and Recovery Act (RCRA) regulations. Clean Harbors facility representatives stated that the closest residential area is a few hundred feet away on the south side, and there is a small fishing lake where some people fish south of the facility across the train tracks.

INFORMATION GATHERED DURING VISIT

	The following section describes the information gathered in relation to the three stated purposes of the visit.

   1. Enhance understanding of current processes and emission controls for the off-site waste and recovery operations (OSWRO) at the facility.

 This facility was a Safety Kleen facility, which was recently acquired by Clean Harbors, Inc.  Due to the acquisition of Safety Kleen by Clean Harbors, some changes may be made in the future regarding the types of operations that will be performed at the various facilities now owned by Clean Harbors.
 Most material received is liquid in small quantities rather than bulk quantities, with 80% of the materials received in 50 gallon drums or smaller.
 The facility samples every container received, or composites of up to 20 drums, to test for material characteristics, such as BTU value, and also for VOCs, PCBs and non-conforming material.
 The facility has a 35,000 CFM regenerative thermal oxidizer that is the primary control device for most operations. There is a flare that is used a back-up when the thermal oxidizer is not operational. The facility representatives indicated that the use of the flare is very rare, and that the plant operations stop if the thermal oxidizer is not working.
 The facility has 110 tanks, most of which are 15,000 gallons in size.  Some of these tanks have pressure relief devices, and some are vapor balanced.
 The facility has three LUWA thin film evaporators. One of these is routed to the thermal oxidizer, and the other two are routed to glycol condensers, but they will be routed to the thermal oxidizer in the future (expected during 2015).
 The facility has pot stills that are also controlled with thermal oxidizer.
 Emissions from the distillation column at the facility are controlled with the thermal oxidizer. The "lights" from this process are sold to customers, and the "bottoms" are sent to cement kilns to be used as a fuel.
 The facility has a metal shredding tower, and this operation is routed to the thermal oxidizer for emissions control. The clean metal is sold as scrap.
 The facility has received approval to operate a dry metal wash system that is also routed to the thermal oxidizer.

   1. Gain an understanding of the other applicable Clean Air Act regulations for the facility, including 40 CFR 264, 265, 279 and 40 CFR Parts 60, 61 and 63.

 The facility complies with the RCRA standards at 40 CFR part 264, subparts AA, BB, and CC. The facility representatives indicated that the requirements of the RCRA standards were nearly identical to the 40 CFR part 63, subpart DD standards, and that by complying with the RCRA standards, only an additional report or two was required to comply with subpart DD.

   1. Clarify any questions the U.S. EPA has regarding the response received from the recent information collection request for this facility.

 In response to questions about missing information in the company's ICR response for this facility, Mr. Laubsted stated that he would provide the EPA and EC/R with the requested tank information.