February 22, 2006 MEMORANDUM SUBJECT: Inert Ingredient Dietary and Non dietary Risk Assessments for O Phenylphenol and Salts Reregistration Eligibility Document ( RED)

TO: Rebecca Miller, Chemical Review Manager, Reregistration Team 36 Regulatory Management Branch II Antimicrobials Division ( 7510C)

FROM: Talia Milano, Chemist, Team II Cassi Walls, Ph. D., Chemist, Team III Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

THRU: Norm Cook, Branch Chief Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

Case No.: 2575 Chemical Name( s) CAS # PC Codes Ortho phenylphenol 90 43 7 064103 Sodium ortho phenylphenate 132 27 4 064104 Potassium ortho phenylphenol 13707 65 8 064108 As part of the overall risk assessment for Reregistration Case No. 2575: o phenylphenol, sodium o phenylphenate, and potassium o phenylphenate exposures resulting from the active ingredient uses are aggregated with exposures resulting from their uses as inert ingredients. This memorandum includes an assessment of dietary ( including both food and drinking water) and nondietary exposures for these inert ingredients.

Background Information This document is the inert dietary and residential non dietary exposure chapter of the reregistration eligibility decision document ( RED) for ortho phenylphenol ( OPP) and OPP salts, which include sodium o phenylphenate ( OPP Na salt) and potassium o phenylphenate ( OPP K salt). UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES Page 2 of 25 However, it is important to recognize that sodium o phenylphenate is the only chemical in this case that is formulated as inert ingredient. Sodium o phenylphenate is formulated as inert ingredient in approximately 123 registered end use products and is used primarily as a materials preservative. The types of products that contain sodium o phenylphenate as an inert ingredient include: turf insecticides and herbicides; garden and ornamental insecticides and herbicides; insect repellant for pets; and indoor/ outdoor crack and crevice insecticides. These products are formulated as soluble concentrates, gels, flowable concentrates, ready to use liquids, granular, and bait traps. The vast majority of these products contain sodium o phenylphenate as an inert ingredient in amounts less than 2% of the formulation.

Sodium ortho phenylphenate also can be used as pesticide inert ingredient in a number of agricultural insecticides and herbicides products. In these cases, the residues on food have an exemption from the requirement of a tolerance under the 40 CFR § 180.920 when used as an inert ingredient in pesticide formulations that are applied to growing crops ( see Table 1). Based on the inert ingredient use patterns, it was determined that dietary ( food and water) and residential nondietary exposure assessments were necessary to conduct.

Table 1 Tolerance Exemptions for Sodium o phenylphenate as Inert Ingredients Tolerance Exemption Expression/ Chemical Name CAS Reg. No. 40 CFR § 180. Limits Use Pattern Sodium o phenylphenate 132 27 4 920 Not more than 0.1% of pesticide formulation Preservative of formulation The toxicological endpoints ( Table 2) used in these assessment were selected by the Antimicrobial Division Toxicity Advisory Committee ( ADTAC).

Table 2 Summary of Toxicological Doses and Endpoints for Ortho Phenylphenol and Salts for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE, UF, Special FQPA SF, for Risk Assessment Study and Toxicological Effects Dietary Risk Assessments Acute Dietary ( all populations) No appropriate endpoints were identified that represent a single dose effect. Therefore, this risk assessment is not required.

Chronic Dietary ( all populations) NOAEL = 39 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation)

Chronic RfD Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201)

LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food Page 3 of 25 Table 2 Summary of Toxicological Doses and Endpoints for Ortho Phenylphenol and Salts for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE, UF, Special FQPA SF, for Risk Assessment Study and Toxicological Effects ( cPAD) = 0.39 mg/ kg/ day efficiency, increased clinical and gross pathological signs of toxicity.

Non Dietary Risk Assessments Incidental Oral Short Term ( 1  30 days) NOAEL ( maternal) = 100 mg/ kg/ day Target MOE = 100 ( 10x inter species extrapolation, 10x intra species variation) FQPA SF = 1 Developmental ( gavage) toxicity studies in rats ( MRID 00067616, 92154037) and rabbits ( MRID 41925003; co critical developmental toxicity study)

Maternal LOAEL of 300 mg/ kg/ day based upon clinical observations of toxicity, decreased weight gain, food consumption and food efficiency observed in the rat developmental toxicity study.

Incidental Oral Intermediate Term ( 1  6 months) NOAEL = 39 mg/ kg/ day Target MOE = 100 ( 10x inter species extrapolation, 10x intra species variation)

FQPA SF = 1 Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201)

LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food efficiency, increased clinical and gross pathological signs of toxicity.

Dermal Short Term ( 1  30 days)

( residential and occupational) NOAEL ( dermal) = 100 mg/ kg/ day Target MOE = 100 ( 10x inter species extrapolation, 10x intra species variation) 21 Day Dermal toxicity study in rats ( MRID 42881901)

LOAEL ( dermal) of 500 mg/ kg/ day based upon dermal irritation ( erythema, scaling) at the site of test substance application.

Dermal Intermediate and Long Term ( 1  6 months and > 6 months)

( residential and occupational) NOAEL = 39 mg/ kg/ day Target MOE = 100 ( 10x inter species extrapolation, 10x intra species variation) Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201)

LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food efficiency ( effects observed as early as 13 weeks in this study), increased clinical and gross pathological signs of toxicity.

Inhalation Short Term NOAEL ( maternal) = 100 mg/ kg/ day Target MOE = 100 Developmental ( gavage) toxicity studies in rats ( MRID 00067616, 92154037) and Page 4 of 25 Table 2 Summary of Toxicological Doses and Endpoints for Ortho Phenylphenol and Salts for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE, UF, Special FQPA SF, for Risk Assessment Study and Toxicological Effects ( 1  30 days)

( residential and occupational) ( 10x inter species extrapolation, 10x intra species variation).

An additional 10x factor for route toroute extrapolation is used to determine the need for an inhalation toxicity study rabbits ( MRID 41925003; co critical developmental toxicity study)

Maternal LOAEL of 300 mg/ kg/ day based upon clinical observations of toxicity, decreased weight gain, food consumption and food efficiency observed in the rat developmental toxicity study.

Inhalation Intermediate and Long Term ( 1  6 months and > 6 months)

( residential and occupational) NOAEL = 39 mg/ kg/ day Target MOE = 100 ( 10x interspecies extrapolation, 10x intra species variation)

An additional 10x factor for route toroute extrapolation is used to determine the need for an inhalation toxicity study. Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201)

LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food efficiency ( effects observed as early as 13 weeks in this study), increased clinical and gross pathological signs of toxicity.

Cancer Classification: ortho Phenylphenol is classified as ANot likely to be carcinogenic below a specific dose range." Quantitation of cancer risk is not required.

Dietary Exposure and Risk Assessments A dietary exposure analysis was conducted for the inert ingredient of sodium ophenylphenate used in agricultural pesticide products. This dietary assessment was conducted using the generic dietary screening model for estimating inert ingredients. The generic model's output was adjusted to reflect the tolerance exemption limitation given in 40 CFR § 180.920 ( i. e., no more than 0.1% of the pesticide formulation) and maximum application rates. Based on a review of the agricultural labels that contain sodium o phenylphenate as an inert ingredient, it appears that the maximum application rate ( in terms of the inert ingredient) is less than 0.05 lb/ acre. The generic screening model does not specifically include an application rate input; rather it is based on tolerances for pesticide active ingredients with application rates generally ranging from 1 to 5 lb ai/ acre. Therefore, to more accurately estimate residues resulting from the lower application rate of 0.05 lbs sodium o phenylphenate / acre, the results from the generic model were adjusted by a factor of 20 ( using the ratio of 1 lb. per acre ÷ 0.05 lbs per acre) and 100 ( using the ratio of 5 lbs. per acre ÷ 0.05 lbs/ acre). Page 5 of 25 It should be noted that the generic model output is unrefined and extremely conservative since it assumes that the inert ingredient is used on all commodities and that 100 percent of crops are treated with the inert ingredient. Further, the model assumes finite residues for every consumed commodity ( including meat, milk, poultry and eggs) that is included in the Dietary Exposure Evaluation Model ( DEEM   ) . A complete explanation of the assumptions used in the generic screening model for estimating inert ingredient dietary exposure is given in Appendix A.

The dietary risks were estimated using the toxicity endpoints selected by the ADTAC. The ADTAC did not select an endpoint for acute dietary exposures as no effects are attributable to a single dose, therefore acute dietary ( food) risk estimate for the inert ingredient use was not performed. The ADTAC selected an endpoint for chronic dietary exposure to OPP and salts of 0.39 mg/ kg/ day. The table below ( Table 3) provides a summary of the results of chronic dietary risk estimates for the inert ingredient use of sodium o phenylphenate.

Table 3. Estimated Chronic Dietary Exposure for Inert Ingredients : Sodium o phenylphenate Population Subgroup2 Generic Estimated Exposure1 ( mg/ kg/ day) OPP/ salts Estimated Exposure3 ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.120 0.0012  0.006 0.31%  1.5% All infants (< 1 year) 0.245 0.0025  0.012 0.63%  3.1% Children ( 1 2 years) 0.422 0.0042  0.021 1.1%  5.4% Children ( 3 5 years) 0.310 0.0031  0.016 0.79%  4.0% Children ( 6 12 years) 0.174 0.0017  0.009 0.45%  2.2% Youth ( 13 19 years) 0.100 0.0010  0.005 0.26%  1.3% Adults ( 20 49 years) 0.087 0.00087  0.004 0.22%  1.1% Adults ( 50+ years) 0.086 0.00086  0.004 0.22%  1.1% Females ( 13 49 years) 0.087 0.00087  0.004 0.22%  1.1% 1Exposure estimates are based on highest tolerance level residues of high use active ingredients for all food forms, including meat, milk, poultry, and eggs 2 Only representative population subgroups are shown 3 Generic exposures based on application rates of 1  5 lb ai/ acre were adjusted for the tolerance exemption limitation of 0.1% maximum formulation and maximum application rates ( 0.05 lb inert/ acre); the generic exposures were divided by a factor of 20 ( 1/ 0.05) and 100 ( 5/ 0.05) cPAD = 0.39 mg/ kg/ day Based on the results of the screening level inert ingredient dietary exposure model, there are no concerns for risks associated with dietary ( food) exposures since the estimated dietary exposures for the U. S. population and all population subgroups are well below 100% of the cPAD.

Drinking Water Exposure and Risk Assessments A September 20, 2005, memorandum from Najm Shamim to Ben Chambliss and Killian Swift entitled " Science Chapter on: Environmental Fate Studies and Environmental Fate Assessment of Orthophenylphenol" provided information on environmental fate data. These environmental fate data are also used to characterize the environmental fate of sodium o phenylphenate. Based on the environmental fate data presented in that assessment, these chemicals are stable and persistent in abiotic aqueous medium at pHs 5, 7 and 9. It degrades completely in 14 days when exposed to Page 6 of 25 sunlight and is therefore photolytically unstable in neutral aqueous medium. It degrades when exposed to UV light ( 253.7 nm). Its half life ( measured against hydroxyl radical) is 14 hours, and it is unstable in the atmosphere. It has a high KOC value of 10,000, and is immobile in soils. Its major degradation pathway appears to be through biodegradation under aerobic and anaerobic conditions. Even though it is likely to stay on soil surfaces, it biodegrades under aerobic and anaerobic soil conditions and is not likely to contaminate surface water ( drinking water) or migrate into ground water.

Considering o phenylphenol and its salts' tendency to degrade under environmental conditions and the small amount ( 0.05 lbs. per acre) that may be applied to crops via the inert use, sodium o phenylphenate is not likely to be present in drinking water sources at substantial concentrations. Therefore a quantitative drinking water assessment was not necessary to conduct and drinking water risks are not of concern.

Residential Non dietary Exposure and Risk Assessments Based on the inert ingredient use patterns of sodium o phenylphenate, it was determined residential non dietary exposure assessments were necessary to conduct. An inert non dietary exposure assessment was conducted for several high end, representative residential products such as various formulations of turf and garden products as well as, insect repellant pet spray products. It should be noted that the non dietary inert assessment did not specifically evaluate indoor/ outdoor crack and crevice uses since it was anticipated the applicator exposures resulting from the outdoor lawn products would result in higher exposures based on the amount used per day. Additionally, it was also anticipated the post application exposures resulting from the use of turf products would result in higher exposures than from indoor/ outdoor crack and crevice residues when considering the fact that exposure to residues on a lawn are much more accessible than residues applied in cracks/ crevices and along baseboards.

U. S. EPA's Pesticide Inert Risk Assessment Tool ( PiRat) was used to estimate applicator and post application exposure and risk from the use of sodium o phenylphenate as an inert ingredient in representative residential products. Background information and the downloadable executable file for PiRat can be found at http:// www. epa. gov/ opptintr/ exposure/ docs/ pirat. htm. All of PiRat's default values were used in each run. Based on a review of the confidential statements of formulas ( CSFs) for various types of sodium o phenylphenate inert products, 2% was selected as a high end representative value and was used in all of the model simulations. As previously discussed, since sodium o phenylphenate is used in numerous types of products, only exposures from representative high end scenarios were estimated using PiRat. These scenarios include applicator dermal and inhalation exposures to liquid turf and garden products and toddler post application dermal and incidental ingestion exposures to liquid turf products. It should be noted that the post application inhalation exposure scenario was not assessed because sodium o phenylphenate has a low vapor pressure ( 1.8 x 10 9 mm Hg @ 25 E C). Again, it is expected that the crack and crevice applicator and post applicator exposure scenarios would result in lower exposures and higher MOEs. The applicator exposures and risks are presented in Table 4 while the post application exposures and risks are presented in Table 5. All of the MOEs were greater than or equal to the target MOE of 100. Page 7 of 25 Table 4: Applicator Short term Dermal and Inhalation Exposures and MOEs for sodium ophenylphenate when used as an inert ingredientd Product Use Application Method Dermal Exposure ( mg/ kg/ day) a Inhalation Exposure ( mg/ kg/ day) a Dermal MOE ( Target MOE = 100) b Inhalation MOE ( Target MOE = 100) b low pressure handwand; MLAP 1.84E 03 9.86E 07 5.4 E+ 04 1.0 E+ 08 backpack; MLAP 9.40E 05 1.29E 06 1.1 E+ 06 7.8 E+ 07 sprinkling can, MLAP 5.53E 04 4.07E 07 1.8 E+ 05 2.5 E+ 08 Garden ( concentrate) c hose end sprayer; MLAP 5.53E 04 4.07E 07 1.8 E+ 05 2.5 E+ 08 low pressure handwand; MLAP 1.84E 03 1.29E 06 5.4 E+ 04 7.8 E+ 07 backpack; MLAP 9.40E 05 1.29E 06 1.1 E+ 06 7.8 E+ 07 sprinkling can; MLAP 5.53E 04 4.07E 07 1.8 E+ 05 2.5 E+ 08 Turf ( concentrate) c hose end sprayer; MLAP 1.11E 02 8.14E 06 9,000 1.2 E+ 07 a: an application rate of 0.00015 lb product/ ft2 was assumed for all of the scenarios; body weight of an adult = 70 kg; dermal absorption factor = 43% b: MOE = NOAEL / exposure where dermal and inhalation NOAELs = 100 mg/ kg/ day and the target MOEs = 100 c: For the handler assessment, it is assumed that the uses of a concentrate on either a garden or a turf are the high end representative scenarios. d: Standard PiRat model input parameters were used, for complete model output see Appendix B and C.

Table 5: Toddler Short term Dermal and Oral Post application Exposures and MOEs for sodium o phenylphenate when used as an inert ingredientc Product Use Route of Exposure Exposure ( mg/ kg/ day) a MOEb dermal contact with residues on turf 0.15 680 incidental oral ingestion of turf residues ( object to mouth) 4.90E 04 2.0 E+ 05 Turf ( concentrate)

incidental oral ingestion of turf residues hand to mouth transfer 1.96E 03 51,000 a: an application rate of 0.00015 lb product/ ft2 was assumed for all of the scenarios assessed; body weight of a toddler = 15kg; dermal absorption factor = 43% b: MOE = NOAEL / exposure where dermal and oral NOAELs = 100 mg/ kg/ day and the target MOEs = 100 c: Standard PiRat model input parameters were used, for complete model output see Appendix D and E.

As previously indicated, sodium o phenylphenate is also used as an inert ingredient in pet insect repellant products. Therefore, applicator dermal and inhalation exposures as well as, toddler post application dermal and incidental oral exposures were evaluated. Although PiRat has a Page 8 of 25 module that can estimate exposures to pet products, it was not used since HED's screening level methodologies have changed since the development of PiRat. Therefore, the most recent methodologies were utilized to assess exposure to sodium o phenylphenate when used as an inert ingredient in pet products. In addition, aerosol application was the methodology chosen as the representative worst case scenario for this assessment.

The following equation and assumptions were used to estimate dermal and inhalation residential applicator exposures to pet product residues:

Exposure = UE x AR x N / BW where, AR = Application rate ( lb ai/ can) UE = Unit exposure ( mg/ lb ai) N = Number of cans ( cans/ day) BW = Body weight ( kg)

All of the input parameters are defaults provided in HEDs Residential SOPs ( US EPA, 1997 and 2001) and AD standard assumptions. The percent formulation of 0.2% was used in this assessment and was selected based on the review of the confidential statements of formulas ( CSFs) for labels containing sodium o phenylphenate as an inert ingredient. All of the MOEs were greater than or equal to the target MOE of 100. Table 6 provides the input parameters and resulting exposures and MOEs.

Table 6. Applicator Short term Exposures and MOEs for sodium o phenylphenate used as Inert Ingredients in Aerosol Pet Products Exposure = UE x AR x N / BW Dermal Inhalation Unit Exposure ( mg / lb ai) 1 UE 220 2.4 Application Rate ( lb ai/ can) 2 AR 0.008 0.008 Number of cans/ day 1 N 0.5 0.5 Percent Absorption 43% 100%

Body weight ( kg) 1 BW 70 70 Daily Dose ( mg/ kg/ day) 5.28E 04 1.34E 05 NOAEL ( mg/ kg/ day) 100 100 Target MOE 100 100 MOE4 190,000 7.5E+ 06 1 US EPA, 1997 and 2001 ( HED= s Residential SOPs) 2 6 oz/ can x 0.2% ai x 1gal/ 128oz x 8.34lb/ gal ( assuming density of water). 3AD assumption 4 MOEs = NOAEL / exposure, where the ST dermal and inhalation NOAELs = 100 mg/ kg/ day Page 9 of 25 The following equation and assumptions were used to estimate toddler post application dermal exposure to pet product residues:

Exposure = AR x ( 1 DR) t x T x SA x DA / BW where, AR = Application rate ( mg/ cm2 animal) t = Time after application ( days) T = Transfer fraction from treated pet (%) DR = Daily dissipation (%) SA = Surface area of a child =

s hug ( cm2/ event) DA = Dermal absorption ( if applicable) BW = Body weight ( kg)

All of the input parameters are defaults provided in HEDs Residential SOPs ( US EPA, 1997 and 2001). The percent formulation of 0.2% was used in this assessment. All of the MOEs were greater than or equal to the target MOE of 100. Table 7 provides the input parameters and resulting exposures and MOEs.

Table 7. Toddler Short term Post application Dermal Exposure and MOE to sodium ophenylphenate when used as an Inert Ingredient in Aerosol Flea and Tick Pet Products Exposure = AR x ( 1 DR) t x T x SA x DA / BW Application Rate ( mg/ cm2 of animal) 1 AR 0.030 Transferable Fraction2 T 20%

Time after application ( days) t 0 Daily dissipation (%) 2 DR 5%

Surface area of a child= s hug ( cm2) 2 SA 1875 Dermal absorption DA 43%

Body weight ( kg) 2 BW 15 Daily Dose ( mg/ kg/ day) 0.32 Oral NOAEL ( mg/ kg/ day) 100 Target MOE 100 MOE4 310 1 3 oz x 0.2% ai/ 6000cm2 x 1gal/ 128oz x 8.34lb/ gal x 1kg/ 2.2lb x 1000g/ kg x 1000mg/ g where it was assumed that 2 of 6 oz spray container is applied to a 30 lb animal having a surface area of 6000cm2 2 US EPA, 1997 and 2001 ( HED= s Residential SOPs)

The following equation and assumptions were used to estimate toddler incidental oral residential post application exposure to pet product residues:

Exposure = AR x T x SA x SE x FQ / BW where, AR = Application rate ( mg/ cm2 animal) T = Transfer fraction from treated pet (%) SA = Surface area of a child =

s hands ( cm2/ event) Page 10 of 25 SE = Saliva extraction (%) FQ = Frequency of contact ( event/ day) BW = Body weight ( kg)

All of the input parameters are defaults provided in HEDs Residential SOPs ( US EPA, 1997 and 2001). The percent formulation of 0.2% was used in this assessment. The MOE was greater than or equal to the target MOE of 100. Table 8 provides the input parameters and resulting exposures and MOEs.

Table 8. Toddler Short term Post application Incidental Oral Exposure and MOE to sodium o phenylphenate when used as an Inert Ingredient in Aerosol Flea and Tick Pet Products Exposure = AR x T x SA x SE x FQ / BW Application Rate ( mg/ cm2 of animal) 1 AR 0.030 Transferable Fraction2 T 20%

Surface area of a child= s hand ( cm2) 2 SA 20 Saliva Extraction2 SE 50%

Frequency ( events/ day) 3 FQ 1 Body weight ( kg) 2 BW 15 Daily Dose ( mg/ kg/ day) 0.0039 Oral NOAEL ( mg/ kg/ day) 100 Target MOE 100 MOE4 25,000 1 3 oz x 0.2% ai/ 6000cm2 x 1gal/ 128oz x 8.34lb/ gal x 1kg/ 2.2lb x 1000g/ kg x 1000mg/ g where it was assumed that 2 of 6 oz spray container is applied to a 30 lb animal having a surface area of 6000cm2 2 US EPA, 1997 and 2001 ( HED= s Residential SOPs) 3 frequency was modified to reflect transferable residue assumptions which is based on a 5 minute heavy rubbing/ petting technique that would lead to significantly higher hand concentrations than would result from a single contact 4 MOE = NOAEL / exposure Appendix A: Dietary Exposure Model for Inert Ingredients Dietary Exposure Model for Inert Ingredients A screening level model for predicting dietary exposure to inert ingredients was developed and is based on the following assumptions and inputs:

Model Assumptions   Actual crop specific residue data for active ingredients can be utilized as surrogate data for inert ingredient residue levels ( including secondary residues in meat, milk, poultry and eggs).   Inert ingredients are used on all crops and 100% of all crops are " treated" with inert ingredients   No adjustment made for % of inert in formulation, application rate, or multiple applications of different active ingredient formulations   Considers only preharvest applications Model Inputs A group of 57 of the most " significant" active ingredients were considered. These active ingredients included substances in the insecticide ( 20), fungicide ( 17), and herbicide class ( 20) and were selected based on an overall ranking scheme that included the following components:   Overall Use  Based on 1999 data for active ingredient use ( in lbs/ yr). ( All herbicides at > 5 million lbs/ yr and all fungicides and insecticides at > 1 million lbs/ yr were included)   Use on crops that are significant contributors to diet ( All a. i. s which had substantial use on crops that make up the " Top 25" kids diet were included).   Use on specific crops ( crop by crop pesticide use information was evaluated to identify the most frequently used active ingredients)   Actual residue monitoring studies ( active ingredients with the highest frequency of detection)

Model Construct A DEEM    type analysis was performed utilizing the highest established tolerance level residue for each commodity. In those cases where DEEM listed a commodity for which a published tolerance did not exist, the input value was selected based on representative crops or other " default" values ( e. g, use of standard processing factors). A DEEM FCID   , Version 1.3 analyses were performed for both acute and chronic dietary exposure scenarios and the results for each are given in Table 1 and 2.

DEEM FCID   Program and Consumption Information Generic inert ingredient acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEMFCID   , Version 1.3), which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998. The 1994 96 and 998 CSFII data are based on the reported consumption of more than 20,000 individuals over two non consecutive survey days. Foods " as consumed" ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. Consumption data are averaged for the entire U. S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment.

For chronic exposure and risk assessment, an estimate of the residue level in each food or foodform ( e. g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/ day. This procedure is performed for each population subgroup.

For acute exposure assessments, individual one day food consumption data are used on an individual by individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic ( Tier 1 or Tier 2) exposure assessment, or " matched" in multiple random pairings with residue values and then summed in a probabilistic ( Tier 3/ 4) assessment. For this screeninglevel assessment, only a Tier 1 analysis was performed.

Use of Model in Inert Risk Assessment The results of this model would likely represent an upper bound estimate of likely potential dietary exposure to an inert ingredient resulting from preharvest use. These values could be compared to the expected toxicity in a qualitative ( Tier 1 substance) assessment, or, in those cases where a bounding level risk assessment is necessary, these exposure values could be compared to the selected toxicity endpoints in a % PAD or MOE type approach ( see Figure 1). In cases where this model would yield dietary risk values below the level of concern, no further refinements would be necessary, and the potential dietary exposure and risk could be considered adequately characterized. If this model results in dietary risk, above the level of concern, then additional data, use limitations, and/ or / further refinements would be necessary. Additionally, the use of this model could allow apportionment of the amount of remaining ` acceptable' risk to other routes of exposure.

Figure 1. Fictional Example of Use of Dietary Exposure Model in % PAD Approach Dose selected= 500 mg/ kg bw/ day Uncertainty factor= 1000 cPAD= 0.5 mg/ kg bw/ day Dietary exposure= 0.12 mg/ kg/ day % cPAD= 0.12 mg/ kg/ day/ 0.5 mg/ kg bw/ day x100 = 24 Model Limitations and Areas for Further Consideration   Actual inert ingredient residue levels While the selected group of active ingredients possesses some chemical structural diversity, could inert ingredients ( by virtue of their uptake into plants and environmental persistence) differ greatly from active ingredients in terms of the nature and magnitude of their plant and animal residues? What about degradates  would they be of concern or need to be separately assessed?   Concentration of inert in formulation Initial analysis of " benchmark" products for many of the 57 most " significant" active ingredients indicates that the concentration of the a. i   any single inert ingredient. If this can be further confirmed, it may allow for a " maximum % inert" adjustment to be used in the model.   Differences in product use rate and impacts on residue level. While there are a few outliers, most of these a. i.' s are used in the 1 5 lb ( AI basis) per season use rate.   " Generic" inert  The model makes no distinction as to formulation type or timing of application. It may be possible to develop other models for more specific inert use ( e. g., preemergent use only, soil incorporation only).   Residues in meat, milk, poultry and eggs  This model used the highest tolerance level residues for input into DEEM   , but it may be possible to utilize residues in livestock feed items and chemical specific information related to uptake or accumulation of secondary residues develop a different set of values on a per inert basis for meat, milk, poultry and eggs.

Table 1. Estimated Chronic Dietary Exposure1 for a Generic Inert. Population Subgroup2 Estimated Exposure, mg/ kg/ day U. S. Population ( total) 0.120 All infants (< 1 year) 0.245 Children ( 1 2 years) 0.422 Children ( 3 5 years) 0.310 Children ( 6_ 12 years) 0.174 Youth ( 13 19 years) 0.100 Adults ( 20 49 years) 0.087 Adults ( 50+ years) 0.086 Females ( 13_ 49 years) 0.087 1Exposure estimates are based on highest tolerance level residues of high use active ingredients for all food forms, including meat, milk, poultry, and eggs. 2Only representative population subgroups are shown.

Table 2. Estimated Acute Dietary Exposure1 for a Generic Inert. Population Subgroup2 Estimated Exposure, mg/ kg/ day 95th Percentile 99th Percentile 99.9th Percentile U. S. Population ( total) 0.336 0.643 1.164 All infants (< 1 year) 0.701 1.060 2.056 Children ( 1 2 years) 0.939 1.382 2.106 Children ( 3 5 years) 0.683 1.010 1.476 Children ( 6_ 12 years) 0.395 0.563 0.827 Youth ( 13 19 years) 0.239 0.357 0.815 Adults ( 20 49 years) 0.199 0.295 0.468 Adults ( 50+ years) 0.191 0.263 0.357 Females ( 13_ 49 years) 0.198 0.287 0.415 1Exposure estimates are based on highest tolerance level residues of high use active ingredients for all food forms, including meat, milk, poultry, and eggs. 2Only representative population subgroups are shown. Appendix B: PiRat Output Handler Dermal Exposures PiRat Handler Report for Formulation Type Soluble Concentrate ( GARDEN)

Functional Use: Antimicrobial / Preservatives ( antimicrobial agent, bacteriacide, preservative) Toxicity Value: 100 Body Weight: 70.0 kg Weight Fraction: 2.00E 02 Duration: Short Term Absorption Value: 43 %

Scenario # 1 Scenario # 2 Scenario # 3 Scenario # 4 Product Use: garden garden garden garden Application Method: low pressure handwand; MLAP backpack; MLAP sprinkling can, MLAP hose end sprayer; MLAP Dermal PDR ( mg/ kg/ day): 1.84E 03 9.40E 05 5.53E 04 5.53E 04 Inhalation PDR ( mg/ kg/ day) N/ A N/ A N/ A N/ A Dermal Unit Exposure ( mg/ lb): 100.00 Low 9 80 reps 5.10 Low 9 11 reps 30.00 Low 8 reps 30.00 Low 8 reps Inhalation Unit Exposure ( mg/ lb): N/ A N/ A N/ A N/ A Application Rate: 1.50E 04* lb/ ft2 1.50E 04* lb/ ft2 1.50E 04* mg/ kg/ day 1.50E 04* lb/ ft2 Fraction Exposed: N/ A N/ A N/ A N/ A Amount used: 1000.00 ft2/ day ( spot) 1000.00 ft2/ day ( spot) 1000.00 ft2/ day 1000.00 ft2/ day Density ( lb/ gal): N/ A N/ A N/ A N/ A MOE: 54000 1100000 180000 180000 Exposure Frequency ( yrs) N/ A N/ A N/ A N/ A Exposure Duration ( yrs) N/ A N/ A N/ A N/ A Averaging Time ( yrs) N/ A N/ A N/ A N/ A LADD N/ A N/ A N/ A N/ A Cancer Risk N/ A N/ A N/ A N/ A Dose Calculation: Scenario # 1 4 PDR=( UE* AR* WF* A)/ BW Assumptions: Scenario # 1, 2 1,000 ft2/ day assumed to be equivalent to 5 gal/ day; SAC Policy 11 Scenario # 3 assumed based on hose end; SOPs Scenario # 4 SAC Policy 11 * Modified by user PiRat Handler Report for Formulation Type Soluble Concentrate ( TURF)

Functional Use: Antimicrobial / Preservatives ( antimicrobial agent, bacteriacide, preservative) Toxicity Value: 100 Body Weight: 70 kg Weight Fraction: 2.00E 02 Duration: Short Term Absorption Value: 43 %

Scenario # 1 Scenario # 2 Scenario # 3 Scenario # 4 Product Use: turf turf turf turf Application Method: low pressure handwand; MLAP backpack; MLAP sprinkling can; MLAP hose end sprayer; MLAP Dermal PDR ( mg/ kg/ day): 1.84E 03 9.40E 05 5.53E 04 1.11E 02 Inhalation PDR ( mg/ kg/ day) N/ A N/ A N/ A N/ A Dermal Unit Exposure ( mg/ lb): 100.00 Low 9 80 reps 5.10 Low 9 11 reps 30.00 Low 8 reps 30.00 Low 8 reps Inhalation Unit Exposure ( mg/ lb): N/ A N/ A N/ A N/ A Application Rate: 1.50E 04* lb/ ft2 1.50E 04* lb/ ft2 1.50E 04* mg/ kg/ day 1.50E 04* lb/ ft2 Fraction Exposed: N/ A N/ A N/ A N/ A Amount used: 1000.00 ft2/ day ( spot) 1000.00 ft2/ day ( spot) 1000.00 ft2/ day 2.00E+ 04 ft2/ day ( full broadcast)

Density ( lb/ gal): N/ A N/ A N/ A N/ A MOE: 54000 1100000 180000 9000 Exposure Frequency ( yrs) N/ A N/ A N/ A N/ A Exposure Duration ( yrs) N/ A N/ A N/ A N/ A Averaging Time ( yrs) N/ A N/ A N/ A N/ A LADD N/ A N/ A N/ A N/ A Cancer Risk N/ A N/ A N/ A N/ A Dose Calculation: Scenario # 1 4 PDR=( UE* AR* WF* A)/ BW Assumptions: Scenario # 1,2 1,000 ft2/ day assumed to be equivalent to 5 gal/ day; SAC Policy 11 Scenario # 3 assumed based on hose end; SOPs Scenario # 4 upper percentile lawn size ( SAC Policy 11)

* Modified by user Appendix C: PiRat Output Handler Inhalation Exposures PiRat Handler Report for Formulation Type Soluble Concentrate ( GARDEN)

Functional Use: Antimicrobial / Preservatives ( antimicrobial agent, bacteriacide, preservative) Toxicity Value: 100 Body Weight: 70.0 kg Weight Fraction: 2.00E 02 Duration: Short Term Absorption Value: 100 %

Scenario # 1 Scenario # 2 Scenario # 3 Scenario # 4 Product Use: garden garden garden garden Application Method: low pressure handwand; MLAP backpack; MLAP sprinkling can, MLAP hose end sprayer; MLAP Dermal PDR ( mg/ kg/ day): N/ A N/ A N/ A N/ A Inhalation PDR ( mg/ kg/ day) 9.86E 07 1.29E 06 4.07E 07 4.07E 07 Dermal Unit Exposure ( mg/ lb): N/ A N/ A N/ A N/ A Inhalation Unit Exposure ( mg/ lb): 3.00E 02 Medium 80 reps 3.00E 02 Low 11 reps 9.50E 03 Low 8 reps 9.50E 03 Low 8 reps Application Rate: 1.15E 04* lb/ ft2 1.50E 04* lb/ ft2 1.50E 04* mg/ kg/ day 1.50E 04* lb/ ft2 Fraction Exposed: N/ A N/ A N/ A N/ A Amount used: 1000.00 ft2/ day ( spot) 1000.00 ft2/ day ( spot) 1000.00 ft2/ day 1000.00 ft2/ day Density ( lb/ gal): N/ A N/ A N/ A N/ A MOE: 100000000 78000000 250000000 250000000 Exposure Frequency ( yrs) N/ A N/ A N/ A N/ A Exposure Duration ( yrs) N/ A N/ A N/ A N/ A Averaging Time ( yrs) N/ A N/ A N/ A N/ A LADD N/ A N/ A N/ A N/ A Cancer Risk N/ A N/ A N/ A N/ A Dose Calculation: Scenario # 1 4 PDR=( UE* AR* WF* A)/ BW Assumptions: Scenario # 1,2 1,000 ft2/ day assumed to be equivalent to 5 gal/ day; SAC Policy 11 Scenario # 3 assumed based on hose end; SOPs Scenario # 4 SAC Policy 11 * Modified by user PiRat Handler Report for Formulation Type Soluble Concentrate ( TURF)

Functional Use: Antimicrobial / Preservatives ( antimicrobial agent, bacteriacide, preservative) Toxicity Value: 100 Body Weight: 70 kg Weight Fraction: 2.00E 02 Duration: Short Term Absorption Value: 100 %

Scenario # 1 Scenario # 2 Scenario # 3 Scenario # 4 Product Use: turf turf turf turf Application Method: low pressure handwand; MLAP backpack; MLAP sprinkling can; MLAP hose end sprayer; MLAP Dermal PDR ( mg/ kg/ day): N/ A N/ A N/ A N/ A Inhalation PDR ( mg/ kg/ day) 1.29E 06 1.29E 06 4.07E 07 8.14E 06 Dermal Unit Exposure ( mg/ lb): N/ A N/ A N/ A N/ A Inhalation Unit Exposure ( mg/ lb): 3.00E 02 Medium 80 reps 3.00E 02 Low 11 reps 9.50E 03 Low 8 reps 9.50E 03 Low 8 reps Application Rate: 1.50E 04* lb/ ft2 1.50E 04* lb/ ft2 1.50E 04* mg/ kg/ day 1.50E 04* lb/ ft2 Fraction Exposed: N/ A N/ A N/ A N/ A Amount used: 1000.00 ft2/ day ( spot) 1000.00 ft2/ day ( spot) 1000.00 ft2/ day 2.00E+ 04 ft2/ day ( full broadcast)

Density ( lb/ gal): N/ A N/ A N/ A N/ A MOE: 78000000 78000000 250000000 12000000 Exposure Frequency ( yrs) N/ A N/ A N/ A N/ A Exposure Duration ( yrs) N/ A N/ A N/ A N/ A Averaging Time ( yrs) N/ A N/ A N/ A N/ A LADD N/ A N/ A N/ A N/ A Cancer Risk N/ A N/ A N/ A N/ A Dose Calculation: Scenario # 1 4 PDR=( UE* AR* WF* A)/ BW Assumptions: Scenario # 1,2 1,000 ft2/ day assumed to be equivalent to 5 gal/ day; SAC Policy 11 Scenario # 3 assumed based on hose end; SOPs Scenario # 4 upper percentile lawn size ( SAC Policy 11)

* Modified by user Appendix D: PiRat Output Dermal Post application Exposures Scenario # 1 Product Use: turf Activity: dermal contact with residues on turf Population: toddlers ( 3 years)

PDR ( mg/ kg/ day) 0.15 Ingestion Rate: N/ A T ( or Tc) 8700.00 cm2/ hr Application Rate: 1.50E 04* lb/ ft2 Weight Fraction: 2.00E 02 Fraction Exposed: 0.20 Surface Area ( cm2/ event): N/ A Exposure Time ( hrs/ day): 2.00 Frequency ( ev/ hr) N/ A Kp ( cm/ hr) N/ A Vp ( torr) N/ A Molecular Weight ( g/ mole) N/ A Room Volume ( m3) N/ A MOE: 680 Exposure Frequency ( days/ yr) 0.00 Exposure Duration ( yrs) 0.00 Averaging Time ( yrs) 70.00 LADD ( mg/ kg/ day) N/ A Cancer Risk N/ A Density ( lbs/ gal) N/ A Body Wt ( postapp) ( kg) 15.00 Treated area N/ A Dose Calculation: PDR=( AR* WF* F* 4.54e5 mg/ lb* 1.08e 3 ft2/ cm2* Tc* ET)/ BW* ABS * Modified by user PIRAT Post Application Report for Formulation Type Soluble Concentrate ( TURF)

Functional Use: Antimicrobial / Preservatives ( antimicrobial agent, bacteriacide, preservative) Toxicity Value: 100 Body Weight: 15 kg Weight Fraction: 2.00E 02 Duration: Short Term Absorption Value: 43 % Appendix E: PiRat Output Oral Post application Exposures PIRAT Post Application Report for Formulation Type Soluble Concentrate ( TURF)

Functional Use: Antimicrobial / Preservatives ( antimicrobial agent, bacteriacide, preservative) Toxicity Value: 100 Body Weight: 15 kg Weight Fraction: 2.00E 02 Duration: Short Term Absorption Value: 100 %

Scenario # 1 Scenario # 2 Product Use: turf turf Activity: ingestion of turf residues ( object to mouth) hand to mouth transfer Population: toddlers ( 3 years) toddlers ( 3 years)

PDR ( mg/ kg/ day) 4.90E 04 1.96E 03 Ingestion Rate: 25.00 cm2/ day 0.50 ( saliva extraction factor)

T ( or Tc) N/ A N/ A Application Rate: 1.50E 04* lb/ ft2 1.50E 04* lb/ ft2 Weight Fraction: 2.00E 02 2.00E 02 Fraction Exposed: 0.20 5.00E 02 Surface Area ( cm2/ event): N/ A 20.00 Exposure Time ( hrs/ day): N/ A 2.00 Frequency ( ev/ hr) N/ A 20.00 Kp ( cm/ hr) N/ A N/ A Vp ( torr) N/ A N/ A Molecular Weight ( g/ mole) N/ A N/ A Room Volume ( m3) N/ A N/ A MOE: 200000 51000 Exposure Frequency ( days/ yr) 0.00 0.00 Exposure Duration ( yrs) 0.00 0.00 Averaging Time ( yrs) 70.00 70.00 LADD ( mg/ kg/ day) N/ A N/ A Cancer Risk N/ A N/ A Density ( lbs/ gal) N/ A N/ A Body Wt ( postapp) ( kg) 15.00 15.00 Treated area N/ A N/ A Dose Calculation: PDR=( IgR* AR* WF* F* 4.54E5 mg/ lb* 1.08e 3 ft2/ cm2)/ BW* ABS PDR=( AR* WF* F* 4.54e5 mg/ lb* 1.08E 3 ft2/ cm2* SA* IgR* FQ* ET)/ BW* ABS * Modified by user


[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Rules and Regulations]
[Pages 43989-43990]
[FR Doc No: 2020-15718]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2017-D-6146]

Regulatory Considerations for Human Cells, Tissues, and Cellular
and Tissue-Based Products: Minimal Manipulation and Homologous Use;
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry and FDA staff
entitled ``Regulatory Considerations for Human Cells, Tissues, and
Cellular and Tissue-Based Products: Minimal Manipulation and Homologous
Use.'' The guidance does not alter FDA's current thinking on the
regulatory criteria of minimal manipulation and homologous use for
human cells, tissues, and cellular and tissue-based product (HCT/P).
The guidance announced in this notice supersedes the guidance of the
same title dated November 2017 and corrected December 2017. The
guidance revises section V of the November 2017 guidance to communicate
that the Agency is extending the period of time during which FDA
intends to exercise enforcement discretion regarding certain regulatory
requirements for certain HCT/Ps; this time period will run through May
31, 2021, instead of November 30, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on July 21, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6146 for ``Regulatory Considerations for Human Cells,
Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation
and Homologous Use.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica Walker Udechukwu, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911; or Andrew Yeatts, Office of Device Evaluation, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5510, Silver Spring, MD 20993-0002,
301-796-4539; or Leigh Hayes, Office of Combination Products, Office of
the Commissioner, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5127, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Regulatory Considerations for Human Cells, Tissues, Cellular and
Tissue-Based Products: Minimal Manipulation and Homologous Use.'' This
guidance is being issued consistent with FDA's good guidance practices
regulation (Sec.  10.115 (21 CFR 10.115)). The Agency is soliciting
public comment, but is implementing this guidance immediately, because
the Agency has determined that prior public participation is not
feasible or appropriate. Although this guidance document is immediately
in effect, it remains subject to comment in accordance with FDA's good
guidance practices regulation.
    The guidance does not alter FDA's current thinking on the
regulatory criteria of minimal manipulation and homologous use for
human cells, tissues, and cellular and tissue-based product (HCT/P) as
described in the November 2017 guidance of the same name and corrected
in December 2017. The only substantive change to this guidance is to
revise section V of the November 2017 guidance to communicate that FDA
intends to exercise enforcement discretion for certain regulatory
requirements for certain HCT/Ps for a longer period of time, i.e.,
through May 31, 2021, instead of November 30, 2020. This will give
manufacturers additional time to determine if they need to submit an
investigational new drug (IND) or marketing application and, if such an
application is needed, to prepare the IND or marketing application.
Such additional time is warranted in light of the Coronavirus Disease
2019 (COVID-19) public health emergency, which has presented unique
challenges in recruiting clinical trial participants and carrying out
clinical trials.
    As described in the guidance, FDA generally intends to exercise
enforcement discretion with respect to the IND and the premarket
approval requirements for HCT/Ps that do not meet one or more of the 21
CFR 1271.10(a) criteria, provided that use of the HCT/P does not raise
reported safety concerns or potential significant safety concerns. FDA
intends to continue to focus enforcement actions on products with
higher risk, including based on the route and site of administration.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115(g)(2)). The guidance represents the
current thinking of FDA on ``Regulatory Considerations for Human Cells,
Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation
and Homologous Use.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
    However, this guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by OMB under the PRA. The collections of
information in 21 CFR part 1271 have been approved under OMB control
number 0910-0543.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances; https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products; https://www.fda.gov/combination-products/guidance-regulatory-information; or https://www.regulations.gov.

    Dated: July 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15718 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23024-23026]
[FR Doc No: 2017-10187]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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

SUMMARY: Flood hazard determinations, which may include additions or
modifications of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where
applicable, in the supporting Flood Insurance Study (FIS) reports have
been made final for the communities listed in the table below.
    The FIRM and FIS report are the basis of the floodplain management
measures that a community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the Federal Emergency Management Agency's (FEMA's)
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report are used by insurance agents and others to calculate appropriate
flood insurance premium rates for buildings and the contents of those
buildings.

DATES: The effective date of June 7, 2017 which has been established
for the FIRM and, where applicable, the supporting FIS report showing
the new or modified flood hazard information for each community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at www.msc.fema.gov by the effective date indicated
above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov. The flood hazard determinations are made
final in the watersheds and/or communities listed in the table below.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: April 25, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

    I. Watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
                        Upper Ocmulgee Watershed
------------------------------------------------------------------------
              Butts County, Georgia and Incorporated Areas
                         Docket No.: FEMA-B-1551
------------------------------------------------------------------------
City of Flovilla.......................  Butts County Community Services
                                          Department, 625 West 3rd
                                          Street, Suite 3, Jackson, GA
                                          30233.
City of Jackson........................  Butts County Community Services
                                          Department, 625 West 3rd
                                          Street, Suite 3, Jackson, GA
                                          30233.
City of Jenkinsburg....................  Butts County Community Services
                                          Department, 625 West 3rd
                                          Street, Suite 3, Jackson, GA
                                          30233.
Unincorporated Areas of Butts County...  Butts County Community Services
                                          Department, 625 West 3rd
                                          Street, Suite 3, Jackson, GA
                                          30233.
------------------------------------------------------------------------
              Jasper County, Georgia and Incorporated Areas
                         Docket No.: FEMA-B-1551
------------------------------------------------------------------------
Unincorporated Areas of Jasper County..  Jasper County Courthouse,
                                          Planning and Zoning
                                          Department, 126 West Greene
                                          Street, Suite 17, Monticello,
                                          GA 31064.
------------------------------------------------------------------------

              Jones County, Georgia and Incorporated Areas
                         Docket No.: FEMA-B-1551
------------------------------------------------------------------------
City of Gray...........................  Jones County Planning and
                                          Zoning Department, 166
                                          Industrial Boulevard, Gray, GA
                                          31032.
Unincorporated Areas of Jones County...  Jones County Planning and
                                          Zoning Department, 166
                                          Industrial Boulevard, Gray, GA
                                          31032.
------------------------------------------------------------------------
          Macon-Bibb County, Georgia (Consolidated Government)
                         Docket No.: FEMA-B-1551
------------------------------------------------------------------------
Macon-Bibb County (Consolidated          Macon-Bibb County Engineer's
 Government).                             Office, 780 3rd Street, Macon,
                                          GA 31201.
------------------------------------------------------------------------
              Monroe County, Georgia and Incorporated Areas
                         Docket No.: FEMA-B-1551
------------------------------------------------------------------------
City of Forsyth........................  City Hall, 26 North Jackson
                                          Street, Forsyth, GA 31029.
Unincorporated Areas of Monroe County..  Board of Commissioners
                                          Building, 38 West Main Street,
                                          Forsyth, GA 31029.
------------------------------------------------------------------------
             Spalding County, Georgia and Incorporated Areas
                         Docket No.: FEMA-B-1551
------------------------------------------------------------------------
City of Griffin........................  City Hall, 100 South Hill
                                          Street, Griffin, GA 30223.
City of Orchard Hill...................  Orchard Hill City Hall, 2972
                                          Macon Road, Griffin, GA 30224.
Unincorporated Areas of Spalding County  Spalding County Community
                                          Development Center, 119 East
                                          Solomon Street, Suite 203,
                                          Griffin, GA 30223.
------------------------------------------------------------------------
                       James Headwaters Watershed
------------------------------------------------------------------------
            Eddy County, North Dakota and Incorporated Areas
                         Docket No.: FEMA-B-1547
------------------------------------------------------------------------
City of New Rockford...................  City Hall, 117 1st South, New
                                          Rockford, ND 58356.
Unincorporated Areas of Eddy County....  Eddy County Courthouse, 524
                                          Central Avenue, New Rockford,
                                          ND 58356.
------------------------------------------------------------------------
          Stutsman County, North Dakota and Incorporated Areas
                         Docket No.: FEMA-B-1547
------------------------------------------------------------------------
City of Jamestown......................  City Hall, 102 3rd Avenue
                                          Southeast, Jamestown, ND
                                          58401.
Unincorporated Areas of Stutsman County  Stutsman County Courthouse, 511
                                          2nd Avenue Southeast,
                                          Jamestown, ND 58401.
------------------------------------------------------------------------

    II. Non-watershed-based studies:

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
             Jackson County, Arkansas and Incorporated Areas
                         Docket No.: FEMA-B-1551
------------------------------------------------------------------------
City of Amagon.........................  City Hall, 209 Amagon Avenue,
                                          Amagon, AR 72005.
City of Campbell Station...............  Campbell Station City Hall,
                                          5005 Keeter Circle, Tuckerman,
                                          AR 72473.
City of Diaz...........................  City Hall, 3401 South Main
                                          Street, Diaz, AR 72043.
City of Newport........................  City Hall, 615 Third Street,
                                          Newport, AR 72112.
City of Swifton........................  City Hall, 101 Highway 67
                                          South, Swifton, AR 72471.
City of Tuckerman......................  City Hall, 200 West Main
                                          Street, Tuckerman, AR 72473.
City of Tupelo.........................  City Hall and Community
                                          Building, 32 Pecan Circle,
                                          Tupelo, AR 72169.
Town of Beedeville.....................  Town Hall, 121 McFaddin Street,
                                          Beedeville, AR 72014.
Town of Grubbs.........................  City Hall, 420 North Main
                                          Street, Grubbs, AR 72431.
Town of Jacksonport....................  Town Hall, 304 Avenue Street,
                                          Jacksonport, AR 72075.
Town of Weldon.........................  Fire Station, 1125 Highway 17
                                          South, Weldon, AR 72112.
Unincorporated Areas of Jackson County.  Jackson County Office of
                                          Emergency Management, 3405
                                          South Main Street, Diaz, AR
                                          72043.
------------------------------------------------------------------------
             Clayton County, Georgia and Incorporated Areas
                         Docket No.: FEMA-B-1539
------------------------------------------------------------------------
City of Forest Park....................  City Hall, 745 Forest Parkway,
                                          Forest Park, GA 30297.
City of Jonesboro......................  City Hall, 124 North Avenue,
                                          Jonesboro, GA 30236.
City of Lake City......................  City Hall, 5455 Jonesboro Road,
                                          Lake City, GA 30260.
City of Lovejoy........................  City Hall, 2296 Talmadge Road,
                                          Lovejoy, GA 30250.

City of Morrow.........................  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
City of Riverdale......................  City Hall, 7200 Church Street,
                                          Riverdale, GA 30274.
Unincorporated Areas of Clayton County.  Clayton County Water Authority,
                                          1600 Battle Creek Road,
                                          Morrow, GA 30260.
------------------------------------------------------------------------
              Erie County, Pennsylvania (All Jurisdictions)
                         Docket No.: FEMA-B-1601
------------------------------------------------------------------------
Borough of Lake City...................  Borough Building, 2350 Main
                                          Street, Lake City, PA 16423.
City of Erie...........................  Mayor's Office, 626 State
                                          Street, Room 500, Erie, PA
                                          16501.
Township of Fairview...................  Township Building, 7471 McCray
                                          Road, Fairview, PA 16415.
Township of Girard.....................  Township Building, 10140 Ridge
                                          Road, Girard, PA 16417.
Township of Harborcreek................  Township Building, 5601 Buffalo
                                          Road, Harborcreek, PA 16421.
Township of Lawrence Park..............  Lawrence Park Township
                                          Building, 4230 Iroquois
                                          Avenue, Erie, PA 16511.
Township of Millcreek..................  Millcreek Township Municipal
                                          Building, 3608 West 26th
                                          Street, Erie, PA 16506.
Township of North East.................  Township Building, 10300 West
                                          Main Road, North East, PA
                                          16428.
Township of Springfield................  Springfield Township Building,
                                          13300 Ridge Road, West
                                          Springfield, PA 16443.
------------------------------------------------------------------------
               Collin County, Texas and Incorporated Areas
                 Docket No.: FEMA-B-1264 and FEMA-B-1471
------------------------------------------------------------------------
City of Allen..........................  City Hall, 305 Century Parkway,
                                          Allen, TX 75013.
City of Frisco.........................  George A. Purefoy Municipal
                                          Center, 6101 Frisco Square
                                          Boulevard, 3rd Floor, Frisco,
                                          TX 75034.
City of McKinney.......................  Engineering Department, 221
                                          North Tennessee Street,
                                          McKinney, TX 75069.
City of Plano..........................  City Hall, Engineering
                                          Department, 1520 K Avenue,
                                          Plano, TX 75074.
City of Richardson.....................  Civic Center/City Hall, 411
                                          West Arapaho Road, Room 204,
                                          Richardson, TX 75080.
Unincorporated Areas of Collin County..  Collin County Engineering
                                          Department, 4690 Community
                                          Avenue, Suite 200, McKinney,
                                          TX 75071.
------------------------------------------------------------------------

[FR Doc. 2017-10187 Filed 5-18-17; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 75 (Wednesday, April 18, 2018)]
[Rules and Regulations]
[Page 17078]
[FR Doc No: 2018-08109]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2018-0323]

Special Local Regulations for Marine Events; Blessing of the
Fleet, Tiburon, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the special local regulations in
the navigable waters of the San Francisco Bay for the annual Blessing
of the Fleet to be held on April 22, 2018. This action is necessary to
ensure the safety of event participants and spectators. During the
enforcement period, unauthorized persons or vessels are prohibited from
entering into, transiting through, or anchoring in the regulated area,
unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 100.1103, Table 1, Item number 3 will
be enforced from 9 a.m. to 1 p.m. on April 22, 2018.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
of enforcement, call or email Lieutenant Junior Grade Emily Rowan, U.S.
Coast Guard Sector San Francisco; telephone<PHONE_NUMBER> or email at
[email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation established in 33 CFR 100.1103, Table 1, Item number 3
on April 22, 2018. From 9 a.m. to 1 p.m. on April 22, 2018 the special
local regulation applies to the navigable waters from Bluff Point on
the southeastern side of Tiburon Peninsula to Point Campbell on the
northern edge of Angel Island, and from Peninsula Point on the southern
edge of Tiburon Peninsula to Point Stuart on the western edge of Angel
Island.
    Under the provisions of 33 CFR 100.1103, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the regulated area during all applicable effective dates
and times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
    This notice is issued under authority of 33 CFR 165.1103 and 5
U.S.C. 552(a). In addition to this notification in the Federal
Register, the Coast Guard plans to provide the maritime community with
extensive advance notification of the regulated area and its
enforcement period via the Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notification, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: April 12, 2018.
Anthony J. Ceraolo,
Captain, U.S. Coast Guard, Captain of the Port of San Francisco.
[FR Doc. 2018-08109 Filed 4-17-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: June 23, 2009 (Volume 74, Number 119)]
[Notices]
[Page 29735]
[DOCID:fr23jn09-98]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

Federal Register Citation of Previous Announcement: [to be published]

Status: Closed Meeting.

Place: 100 F Street, NW., Washington, DC.

Date and Time of Previously Announced Meeting: June 19, 2009 at 11 a.m.

Change In the Meeting: Deletion of an Item.
    The following item will not be considered during the Closed Meeting
on Friday, June 19, 2009: Formal order of investigation.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: June 17, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-14656 Filed 6-22-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Page 24947]
[FR Doc No: 2012-10069]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13324-001]

 Cedar Creek Hydro, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On April 2, 2011, Cedar Creek Hydro, LLC filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Cedar Creek Pumped
Storage Project to be located in Briscoe, Armstrong, and Randall
Counties, Texas. The sole purpose of a preliminary permit, if issued,
is to grant the permit holder priority to file a license application
during the permit term. A preliminary permit does not authorize the
permit holder to perform any land-disturbing activities or otherwise
enter upon lands or waters owned by others without the owners' express
permission.
    The proposed pumped storage project would consist of: (1) A 60-
foot-high, 12,700-foot-long earth embankment upper dam; (2) an upper
reservoir with a surface area of 283.0 acre and a storage capacity of
7,660 acre-feet; (3) a 28-foot-diameter, 3,720-foot-long steel
penstock; (4) a powerhouse/pumping station containing three pump/
generating units with a total capacity of 660.0 megawatts; (5) a 140-
foot-high, 1,600-foot-long earth embankment lower dam; (6) a lower
reservoir with a surface area of 151 acres and a storage capacity of
8,550 acre-feet; and (7) a 26-mile-long, 240 kilo-volt (KV)
transmission line. The project would have an estimated average annual
generation of 1,816,000 megawatt-hours and the project power would be
sold.
    Applicant Contact: Mr. Brent L. Smith, Symbiotics, LLC, 811 SW
Naito Parkway Ste 120, Portland OR 97204.<PHONE_NUMBER>.
    FERC Contact: Michael Spencer<EMAIL_ADDRESS>(202) 502-
6093.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13324-001) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: April 19, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-10069 Filed 4-25-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7143-7146]
[FR Doc No: 2012-3151]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-SFUND-2012-0104; FRL-9629-9]

Agency Information Collection Activities; Proposed Collection;
Comment Request; EPA ICR No. 2104.04

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44

U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on July 31, 2012. Before submitting the ICR to OMB
for review and approval, EPA is soliciting comments on specific aspects
of the proposed information collection as described below.

DATES: Comments must be submitted on or before April 10, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-2012-0104 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: EPA Docket Center, Environmental Protection Agency,
Mailcode: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, Environmental Protection
Agency, Room 3334, 1301 Constitution Ave. NW., Washington, DC. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
2012-0104. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Rachel Lentz, Office of Brownfields
and Land Revitalization, (5105T), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202)
566-2745; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-SFUND-2012-0104, which is available for online viewing at
www.regulations.gov, or in person viewing at the Superfund Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Superfund Docket is<PHONE_NUMBER>.
    Use www.regulations.gov to obtain a copy of the draft collection of
information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    2. Evaluate the accuracy of the Agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to
be collected; and
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for EPA?

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

What information collection activity or ICR does this apply to?

    Affected entities: Entities potentially affected by this action are
general purpose units of local government; land clearance authorities
or other quasi-governmental entities that operate under the supervision
and control of, or as an agent of, a general purpose unit of local
government; government entities created by State legislature; regional
councils or groups of general purpose units of local government;
redevelopment agencies that are chartered or otherwise sanctioned by
the State; States; Indian Tribes other than in Alaska; Alaska Native
Regional Corporations, Alaska Native Village Corporations, and
Metlakatla Indian Communities; and non-profit organizations.
    Title: Brownfields Program--Accomplishment Reporting (Renewal).
    ICR numbers: EPA ICR No. 2104.04, OMB Control No. 2050-0192.

    ICR status: This ICR is currently scheduled to expire on July 31,
2012. 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. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The Small Business Liability Relief and Brownfields
Revitalization Act (Pub. L. 107-118) (``the Brownfields Amendments'')
was signed into law on January 11, 2002. The Act amends the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA), as amended, and authorizes EPA to award cooperative
agreements to states, tribes, local governments, and other eligible
entities to assess and clean up brownfields sites. Under the
Brownfields Amendments, a brownfields site means real property, the
expansion, redevelopment, or reuse of which may be complicated by the
presence or potential presence of a hazardous substance, pollutant, or
contaminant. For funding purposes, EPA uses the term ``brownfields
property(ies)'' synonymously with the term ``brownfields sites.'' The
Brownfields Amendments authorize EPA to award several types of
cooperative agreements to eligible entities on a competitive basis.
    Under subtitle A of the Small Business Liability Relief and
Brownfields Revitalization Act, States, tribes, local governments, and
other eligible entities can receive assessment cooperative agreements
to inventory, characterize, assess, and conduct planning and community
involvement related to brownfields properties; cleanup cooperative
agreements to carry out cleanup activities at brownfields properties;
cooperative agreements to capitalize revolving loan funds and provide
subgrants for cleanup activities; and job training cooperative
agreements to support the creation and implementation of environmental
job training and placement programs. Under subtitle C of the Small
Business Liability Relief and Brownfields Revitalization Act, State and
tribes can receive cooperative agreements to establish and enhance
their response programs. The cooperative agreements support activities
necessary to establish or enhance four elements of state and tribal
response programs and to meet the public record requirements under the
statute. The four elements eligible for funding include: (a) Timely
survey and inventory of brownfield sites in the State or in the tribal
land; (b) oversight and enforcement authorities or other mechanisms and
resources; (c) mechanisms and resources to provide meaningful
opportunities for public participation; and (d) mechanisms for approval
of a cleanup plan and verification and certification that cleanup is
complete. States and tribes that receive funding under subtitle C must
establish a public record system during the funding period unless an
adequate public record system is already established.
    Cooperative agreement recipients (recipients) have general
reporting and record keeping requirements as a condition of their
cooperative agreement that result in burden. A portion of this
reporting and record keeping burden is authorized under 40 CFR Parts 30
and 31 and identified in the EPA's general grants ICR (OMB Control
Number 2030-0020). EPA requires Brownfields program recipients to
maintain and report additional information to EPA on the uses and
accomplishments associated with the funded brownfields activities. EPA
uses several forms to assist recipients in reporting the information
and to ensure consistency of the information collected. EPA uses this
information to meet Federal stewardship responsibilities to manage and
track how program funds are being spent, to evaluate the performance of
the Brownfields Cleanup and Redevelopment Program, to meet the Agency's
reporting requirements under the Government Performance Results Act,
and to report to Congress and other program stakeholders on the status
and accomplishments of the program.
    This ICR addresses the burden imposed on recipients that are
associated with those reporting and recordkeeping requirements that are
specific to cooperative agreements awarded under the Small Business
Liability Relief and Brownfields Revitalization Act. This ICR renewal
modifies the annual reporting and recordkeeping burden under the
previous ICR. The modified burden reflects an increase in the number of
respondents subject to the reporting and recordkeeping requirements,
lower number of responses based on previous three years of data
submissions, and improvements to the reporting forms based on EPA's
experience. By using the same form to report information on recipient
activities, EPA is adopting a streamlined approach that avoids
potential confusion among recipients and allows the Agency to collect
and report program information consistently across all brownfields
cooperative agreements. EPA is also modifying the reporting form to
simplify and clarify the reporting requirements, which will improve the
accuracy of information reported and minimize the burden to recipients.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.25
hours per response for the Property Profile Form and 4 hours per
response for the Job Training Reporting Form. Burden means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements which have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 1007.
    Frequency of response: Bi-annual for subtitle C recipients;
quarterly for subtitle A recipients.
    Estimated total average number of responses for each respondent:
20.
    Estimated total annual burden hours: 3,167 hours.
    Estimated total annual costs: $308,911. This includes an estimated
burden cost of $308,911 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

Are there changes in the estimates from the last approval?

    There is a decrease of one hour in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This decrease reflects EPA's updating of burden estimates for this
collection based on an, increase in number of experienced recipients
familiar with reporting requirements, a lowered

number of responses based on previous data submission, and improvements
in the ACRES reporting database.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: February 2, 2012.
David R. Lloyd,
Director, Office of Brownfields and Land Revitalization.
[FR Doc. 2012-3151 Filed 2-9-12; 8:45 am]
BILLING CODE 6560-50-P


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

General Comment:Dear Mr. Zeller:

I am writing as an individual passionate ecigarette 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 and my wife, 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. This decision will effect my life and health as a taxpayer and voter and that of my family and my employees.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life.I believe they could have also saved my mothers life who died of cancer as a smoker.  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.