TXR NO. 0050634 April 3, 2002 MEMORANDUM SUBJECT: CARBARYL  3 rd Reassessment Report of the FQPA Safety Factor Committee.

NOTE: THIS REPORT REPLACES THE PREVIOUS REPORT OF THE FQPA SAFETY FACTOR COMMITTEE DATED APRIL 30, 2001 (HED DOC. NO. 014553).

FROM: Carol Christensen, Acting Executive Secretary And Brenda Tarplee, Executive Secretary FQPA Safety Factor Committee Health Effects Division (7509C)

THROUGH: Ed Zager, Chairman FQPA Safety Factor Committee Health Effects Division (7509C)

TO: Virginia Dobozy, Risk Assessor Reregistration Branch 1 Health Effects Division (7509C)

PC Code: 056801 The Health Effects Division (HED) FQPA Safety Factor Committee (SFC) met on January 14, 2002 and February 25, 2002 to re evaluate the hazard and exposure data for Carbaryl with regard to making a decision on the additional safety factor for the protection of infants and children. The SFC determined that reliable data demonstrate that the safety of infants and children will be protected by use of an additional safety factor of 3X. This report replaces the previous report of the FQPA Safety Factor Committee dated April 30, 2001 (HED Doc. No. 014553 ). 2 I. HAZARD ASSESSMENT (Correspondence: V. Dobozy to C. Christensen dated February 25, 2002)

Since the last FQPA SFC meeting (April 30, 2001), the toxicology data base for Carbaryl was reevaluated by the HED Hazard Identification Assessment Review Committee (HIARC) on December 18, 2001 and February 19, 2002.

1. Adequacy of the Toxicology Database The toxicology data base for Carbaryl is complete for FQPA assessment. There are acceptable guideline developmental studies in the rat and rabbit and a 2 generation reproduction study in rats. The toxicology data base was reviewed by the Hazard Science Assessment Review Committee (HIARC) on July 7, 1998, April 7, 1999, November 2, 1999, March 1, 2001, December 18, 2001 and February 19, 2002.

2. Determination of Susceptibility There was no evidence of quantitative or qualitative susceptibility following in utero exposures in developmental studies in the rat and rabbit.

In the reproduction study, there was evidence of quantitative susceptibility of the offspring. The LOAEL for parental systemic toxicity was based on decreased body weight, weight gain, and food consumption; the NOAEL was 27 mg/ kg/ day in males and 30 mg/ kg/ day in females. In the offspring the LOAEL was based on increased numbers of F2 pups with no milk in the stomach and decreased pup survival; the NOAEL was 5 mg/ kg/ day in males and 6 mg/ kg/ day in females. No adverse effects were observed in the reproductive parameters; the NOAEL was the highest dose tested.

In the developmental neurotoxicity study, there was evidence of qualitative susceptibility. For maternal toxicity, the LOAEL was based on decreased body weight gain, alterations in Functional Observational Battery measurements and inhibition of plasma, whole blood and brain cholinesterase activity; the NOAEL was 1 mg/ kg/ day. For developmental neurotoxicity, the LOAEL was based on the morphometric changes seen in the brain of the offsprings; the NOAEL was 1 mg/ kg/ day.

3. Degree of Concern and Residual Uncertainties Since there is evidence of increased susceptibility of the young following exposure to Carbaryl in the 2 generation reproduction study and in the developmental neurotoxicity study, HIARC performed a Degree of Concern Analysis to: 1) determine the level of concern for the effects observed when considered in the context of all available toxicity data; and 2) identify any residual concerns after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment of this chemical. If residual concerns are identified, HIARC examines whether these residual concerns can 3 be addressed by a special FQPA safety factor and, if so, the size of the factor needed. The results of the HIARC Degree of Concern analyses for Carbaryl follow.

A. 2 Generation Reproduction Study The HIARC concluded that there are no residual concerns related to the 2 generation reproduction study because the dose response for the offspring effects is wellcharacterized and these effects occurred at a dose level which is above that used for establishing the Chronic Reference Dose (cRfD) for chronic dietary risk assessment.

The HIARC established the Chronic RfD using the LOAEL of 3.1 mg/ kg/ day in the chronic toxicity study in dogs. Since a NOAEL was not established in this study, an additional uncertainty factor of 3X was applied to the LOAEL (i. e, UFL). The HIARC determined that 3X is adequate to account for the lack of a NOAEL in this case because: 1) the study was well conducted and there are sufficient data from subchronic and other chronic studies in other species that support cholinesterase inhibition as the critical effect for Carbaryl; 2.) the data indicate that the dog is more sensitive to the cholinergic effects of Carbaryl and using this species to establish the RfD provides additional protection for the effects seen in the rat (including the reproduction and developmental neurotoxicity studies); 3.) the magnitude of inhibition of plasma cholinesterase inhibition (12 23% decrease) seen in this study was comparable to the magnitude of inhibition (22%) seen in the 5 week study in dogs  indicating no cumulative effect following long term exposure; 4.) The cholinesterase inhibition seen in females at the LOAEL in this study was not accompanied by clinical signs (response was not judged to be severe); and 5.) no inhibition was seen for any cholinesterase compartment in males at this dose (response was seen in only one sex).

The HIARC concluded that the extrapolated NOAEL of 1 mg/ kg/ day used to establish the Chronic RfD for Carbaryl is below the NOAEL for offspring toxicity (5 mg/ kg/ day) in the 2 generation reproduction study and is protective of chronic dietary exposures to infants and children.

B. Developmental Neurotoxicity Study The HIARC concluded that there was a low level of concern for the developmental effects seen in the developmental neurotoxicity study and no residual uncertainties with respect to this study based on the following evidence:

° Any concern for the lack of brain morphometric measurements in the offspring at the mid dose (1 mg/ kg/ day) was negated since even at the high dose of 10 mg/ kg/ day, the morphometric changes were minimal and therefore, it is unlikely that adverse effects would be seen at the mid dose level (1 mg/ kg/ day  10% of the LOAEL).

° Any concern for the lack of comparative data in adults and offspring for cholinesterase inhibition was negated since no FOB alterations were seen in pups. 4 Other studies in the data base show that when cholinesterase inhibition was seen in adult animals, it usually was accompanied by FOB alterations. Additionally, the results of the National Institute for Environmental Health Sciences study (discussed below) indicate that there is no difference in cholinesterase inhibition in pups and adults. The dose related decrease in cholinesterase activity in the brain and blood of dams at gestation day 19 was very similar to the fetal brain cholinesterase levels taken at the same time.

The HIARC established the Acute RfD for Carbaryl using the NOAEL of 1 mg/ kg/ day in the developmental neurotoxicity study in rats which is protective of single dose exposures to infants and children.

4. Summary of Open Literature Findings In the scientific literature, there are two relatively recent studies which demonstrated effects on sperm at high doses (50 and 100 mg/ kg/ day) of Carbaryl. The results of these two studies indicated that Carbaryl caused weight reductions in the testes, epididymides, seminal vesicles, prostate and coagulating glands of young rats; changes in testicular enzymes; decreased sperm counts and sperm motility; increased sperm morphological abnormalities; and moderate atrophy of seminiferous tubules of the testes.

In a published developmental study in Fisher 344 rats conducted by EPA's Health Effects Research Laboratory, Carbaryl was administered from gestation day 6 through 19 at doses of 78 or 104 mg/ kg/ day. Clinical signs related to cholinesterase inhibition (tremor, motor depression, jaw clonus and lacrimation) were observed in dams but it is unclear if they occurred at both dose levels. There was also increased prenatal mortality at the high dose (104 mg/ kg/ day) and decreased pup weights at the low (78 mg/ kg/ day) doses.

In an unpublished developmental neurotoxicity study in SD rats from the National Health and Ecological Effects Research Laboratories at EPA and the National Institute for Environmental Health Sciences/ National Toxicology Program Carbaryl was administered by gavage at doses of 0, 6, 12 or 25 mg/ kg/ day. The chemical or its metabolite 1 naphthol was not present in pups' plasma above the limit of detection at any exposure concentration (0, 6, 12 or 25 mg/ kg/ day). There was a dose related decrease in ChE activity in the brain and blood of dams at GD 19, and fetuses taken at that time also showed a very similar level of inhibition in fetal brain cholinesterase. There was a decrease in the number of live pups/ litter at the high dose. There were no changes in cognitive function. Equivocal changes in Functional Observational Battery parameters were observed in male and female offspring.

II. EXPOSURE ASSESSMENT 1. Dietary (Food) Exposure Considerations (Correspondence: V. Dobozy to C. Christensen dated January 7, 2002) 5 Carbaryl is used late in the season at maximum seasonal rates of 6 12 lb of active ingredient (a. i.) per acre. Pre harvest intervals (PHIs) range from 1 29 days, but most PHIs are one week or less. Single application rates are 1 5 lb ai/ A with repeated applications on a weekly basis. U. S. tolerances range from 10 100 ppm. Codex MRLs have been established for numerous commodities, including fruits, grains, forage/ fodder, and livestock commodities. The limits range from 0.1/ 0.5 for livestock commodities to 100 ppm for forage/ hay. Most fruit and vegetable limits range from 1 to 10 ppm.

Carbaryl is registered for use on almost all crop groups and miscellaneous commodities including pome fruit, stone fruit, legumes, cereal grains and fruiting vegetables. Residues are expected in meat and milk. The qualitative nature of the residue of Carbaryl in plants and animals is adequately understood. Based on the results of plant and animal metabolism studies, the HED Metabolism Committee concluded that the Carbaryl residue to be regulated in plants is Carbaryl per se (DP Barcode D221979, S. Hummel, 2/ 8/ 96). The Metabolism Committee also concluded that the residues of concern in meat and milk are the free and conjugated forms of Carbaryl, 5,6 dihydro 5,6 dihydroxy carbaryl, and 5 methoxy 6 hydroxy carbaryl (C. Olinger, D255855, 6/ 21/ 99). Residues are primarily surface residues.

DEEM analyses are being conducted at the highest level of refinement available (Tier IV). Adequate PDP and FDA monitoring data are available for the vast majority (> 80%) of the commodities. These commodities include those which are considered to be significant in the diets of children such as apples, potatoes, carrots, succulent beans, soybean, orange, orange juice, apple, apple juice, pear, peach, wheat, banana, grape, grape juice and milk. For those commodities not monitored by FDA and PDP, field trial data will be used. These include garden beets, turnips, mustards, dried beans, almonds, pecans, walnuts, field corn grain, rice, flax seed, okra, olive, peanuts, pistachio, and sunflower. Carbaryl residues from field trials were <LOQ in/ on sweet potato, sugar beets, corn grain, flax seed, and peanuts. Quantifiable residues were detected in all other raw agricultural commodities (RACs). For a given crop, residue levels were quite variable overall, probably owing to climactic variations, but were generally consistent within any specific field trial location. Percent of crop treated will also be incorporated. Crops with the highest percent of the crop treated include apples, (30%), avocados (85%), blueberries( 45%), cherries (36%), asparagus (87%), among others. Carbamate market basket data are also available for the commodities, orange, apple, peach, broccoli, lettuce, tomato, bananas, and grapes.

Additional data were required for the dermal use of Carbaryl on poultry and its use in poultry houses; however, the registrant has stated that they are no longer supporting these uses. In the previously conducted dietary assessment, the current tolerance for poultry was used, and as a result, poultry was determined to be a significant contributor to the risk estimate. When poultry is not included in the diet, the results of the Critical 6 Exposure Contribution analysis showed no specific commodity comprised a large percentage of the residues found in the tail end of acute exposure.

2. Dietary (Drinking Water) Exposure Considerations (Correspondence: V. Dobozy to C. Christensen dated January 7, 2002)

The environmental fate data base for Carbaryl is adequate for the characterization of drinking water exposure. Fate data indicate that parent Carbaryl and its degradate 1 naphthol are fairly mobile and slightly persistent. In general they are not likely to persist or accumulate in the environment, however, under acidic conditions with limited microbial activity they may persist.

Because of the relatively limited persistence of the compound in the environment it is unlikely that non targeted monitoring studies will detect the maximum concentrations that occur. Some non targeted monitoring data are available but are of limited utility in developing EECs for ecological and human health risk assessment. Therefore modeling was used to estimate surface water and groundwater concentrations that could be expected from normal agricultural use. The results of the modeling are supported by the available monitoring data.

For developing surface water, EECs computer modeling with the EPA PRZM3.12 and EXAMS 2.97.7 programs were used to estimate the concentration of Carbaryl in surface water. Index reservoir scenarios corrected for Percent Cropped Area (PCA) for representative crops were used. SCI GROW was used to calculate a groundwater screening exposure value to be used in determining the potential risk to human health.

3. Residential Exposure Considerations (Correspondence: V. Dobozy to C. Christensen dated January 7, 2002)

Carbaryl is currently registered for many residential uses. Homeowner handler exposure scenarios exist for a variety of use patterns including applications of dusts to vegetables, ornamentals, and pets (dogs & cats); applications of ready to use products for nuisance insect control; applications of liquid sprays with a variety of hand equipment to gardens, trees, vegetables, and turf; and applications of granular formulations to turf. Carbaryl can be used in outdoor residential areas and to treat pets. Therefore, a number of residential post application exposure scenarios exist for toddlers and children.

Several chemical and scenario specific studies designed to quantify exposures to homeowner applicators are available. There are a number of dislodgeable foliar residue studies for Carbaryl that have been used for home gardening activities. Also, there are TTR data from 3 sites (CA, PA, GA) that have been used for the dermal risk assessments (i. e., transferability is >1%). Mouthing behaviors have been addressed using the new 5% factor for wet hands and not the TTRs as stipulated in the latest updates to the Residential SOPs. These data will be used, where appropriate, to calculate residue concentrations 7 and exposures over time instead of using the Agency default assumptions. In addition, the latest Outdoor Residential Exposure Task Force (ORETF) data for homeowner applications to turf have been used which are also the same values that have been incorporated in the Residential SOPs. For any other remaining scenarios not addressed by the Aventis or ORETF data, PHED or the Residential SOPs were used.

III. SAFETY FACTOR RECOMMENDATION AND RATIONALE 1. FQPA Safety Factor Recommendations The FQPA SFC recommends that OPP depart from the default 10X additional safety factor and instead use a different additional safety factor of 3X. This recommendation is based on reliable data supporting the findings set forth below.

A. Traditional Additional Safety Factor (Addressing Data Deficiencies)

The FQPA SFC concurs with the HIARC recommendation for the use of a 3X additional safety factor to address the use of a LOAEL in establishing the Acute and Chronic RfDs, and the toxicity endpoints selected to assess short and long term residential exposure scenarios (oral, dermal, and inhalation). The rationale as to why reliable data support the safety of using a 3X to address this data deficiency is discussed above in Section I. 3.

B. Special FQPA Safety Factors Taking into account the HIARC recommendation regarding the data deficiency, the FQPA SFC recommends that no Special FQPA Safety Factor is necessary to protect the safety of infants and children in assessing Carbaryl exposure and risks.

2. Rationale and Findings Regarding Recommendation on Special FQPA Safety Factor The Committee concluded that no Special FQPA safety factor was needed because:

The toxicology database is complete and there is no quantitative or qualitative evidence of increased susceptibility in rat or rabbit fetuses following in utero in the standard developmental studies. Although there is evidence of qualitative susceptibility developmental neurotoxicity study, HIARC concluded there is a low level of concern for the effects in the developmental neurotoxicity study, as discussed in Section I. 3. The RfDs established would account for any uncertainties and are protective of prepre postnatal toxicity following acute and chronic exposures. Similarly, although there is evidence of increased susceptibility in the offspring in the 2 generation reproduction study, there are no residual uncertainties (Refer to Section I. 3.). The chronic RfD would be protective of the pre pre/ post natal toxicity following chronic dietary exposures. The 8 doses/ endpoints selected for residential exposures, are also protective of any pre pre/ post natal toxicity resulting from non dietary exposures.

There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment utilizes estimates derived from monitoring data (PDP, FDA), the carbamate market basket survey, percent crop treated information (as applicable), and processing data. The dietary drinking water assessment includes a complete environmental fate database for both the parent and the major metabolite (1 napthol) and uses modeling results based on detailed chemical specific data. The modeling results are supported by drinking water monitoring data and do not underestimate the exposure and risks posed by Carbaryl. The residential exposure assessment includes chemical specific dislodgeable foliar residue studies (DFRs), ORETF data, a registrant submitted use and usage study, and chemical specific total transferable residue (TTR) studies for the handler and post application scenarios. In addition, there are human biomonitoring data to support the results of the residential exposure estimate.

3. Application of the FQPA Safety Factors (Population Subgroups / Risk Assessment Scenarios)

The FQPA safety factor recommendation is for a 3X traditional safety factor to address data deficiencies and no additional Special FQPA safety factor. The 3X traditional safety factor should be applied to the Chronic RfD and to long term residential exposure scenarios (dermal, and inhalation). No other FQPA safety factor would be appropriate for Carbaryl. 9 4. Summary of FQPA Safety Factors Summary of FQPA Safety Factors for Carbaryl LOAEL to NOAEL (UFL) Subchronic to Chronic (UFS) Incomplete Database (UFDB) Special FQPA Safety Factor (Hazard and Exposure)

Magnitude of Factor 3X 1X 1X 1X Rationale for the Factor Use of a LOAEL to establish toxicity endpoint (i. e, a NOAEL was not identified in the critical study). Refer to Section I. 3. No subchronic to Chronic extrapolations performed Toxicity Database is complete No residual concerns regarding pre or post natal toxicity or completeness of the toxicity or exposure databases Endpoints to which the Factor is Applied Chronic dietary and Long term residential exposures (Dermal and Inhalation) Not Applicable Not Applicable Not Applicable


0.000250   1.000      1.000

                210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.000250   1.000      1.000

                211-Cooked; Fresh or N/S; Baked  0.000250   1.000      1.000

                212-Cooked; Fresh or N/S; Boiled

                                                 0.000250   1.000      1.000

                213-Cooked; Fresh or N/S; Fried  0.000250   1.000      1.000

                221-Cooked; Frozen; Baked        0.000250   1.000      1.000

                222-Cooked; Frozen; Boiled       0.000250   1.000      1.000

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000250   1.000      1.000

                242-Cooked; Canned; Boiled       0.000250   1.000      1.000

06022551 6B   Pea, succulent-babyfood

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000250   1.000      1.000

06032560 6C   Pea, dry                           0.025000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.025000   1.000      1.000

06012570 6A   Pea, edible podded, succulent

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.000250   1.000      1.000

                210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.000250   1.000      1.000

                212-Cooked; Fresh or N/S; Boiled

                                                 0.000250   1.000      1.000

                213-Cooked; Fresh or N/S; Fried  0.000250   1.000      1.000

                220-Cooked; Frozen; Cook Meth N/S

                                                 0.000250   1.000      1.000

                221-Cooked; Frozen; Baked        0.000250   1.000      1.000

06032580 6C   Pea, pigeon, seed                  0.025000   1.000      1.000

06022590 6B   Pea, pigeon, succulent

                212-Cooked; Fresh or N/S; Boiled

                                                 0.000250   1.000      1.000

                232-Cooked; Dried; Boiled        0.000250   1.000      1.000

                242-Cooked; Canned; Boiled       0.000250   1.000      1.000

12002600 12   Peach                              0.005000   1.000      1.000   FHE

12002601 12   Peach-babyfood                     0.005000   1.000      1.000   FHE

12002610 12   Peach, dried                       0.005000   1.000      1.000   FHE

12002611 12   Peach, dried-babyfood              0.005000   1.000      1.000   FHE

12002620 12   Peach, juice                       0.005000   1.000      1.000   FHE

12002621 12   Peach, juice-babyfood              0.005000   1.000      1.000   FHE

95002630 O    Peanut                             0.005000   1.000      1.000

95002640 O    Peanut, butter                     0.005000   1.890      1.000

95002650 O    Peanut, oil                        0.005000   2.200      1.000

11002660 11   Pear

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                211-Cooked; Fresh or N/S; Baked  0.000100   1.000      1.000

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000025   1.000      1.000

11002661 11   Pear-babyfood

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000025   1.000      1.000

11002670 11   Pear, dried

                130-Uncooked; Dried; Cook Meth N/S

                                                 0.000100   6.250      1.000

                230-Cooked; Dried; Cook Meth N/S

                                                 0.000100   6.250      1.000

11002680 11   Pear, juice

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                120-Uncooked; Frozen; Cook Meth N/S

                                                 0.000100   1.000      1.000

                130-Uncooked; Dried; Cook Meth N/S

                                                 0.000100   1.000      1.000

                221-Cooked; Frozen; Baked        0.000100   1.000      1.000

                230-Cooked; Dried; Cook Meth N/S

                                                 0.000100   1.000      1.000

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000025   1.000      1.000

11002681 11   Pear, juice-babyfood

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000025   1.000      1.000

14002690 14   Pecan                              0.025000   1.000      0.010

08002700 8    Pepper, bell                       0.002000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.002000   1.000      1.000

08002710 8    Pepper, bell, dried                0.002000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.002000   1.000      1.000

08002720 8    Pepper, nonbell                    0.155000   1.000      0.050

08002721 8    Pepper, nonbell-babyfood           0.155000   1.000      0.050

08002730 8    Pepper, nonbell, dried             0.155000   1.000      0.050

19022740 19B  Pepper, black and white            0.005000   1.000      1.000   FHE

19022741 19B  Pepper, black and white-babyfood   0.005000   1.000      1.000   FHE

95002750 O    Peppermint                         0.005000   1.000      1.000   FHE

95002760 O    Peppermint, oil                    0.005000   1.000      1.000   FHE

95002770 O    Persimmon                          0.005000   1.000      1.000   FHE

95002780 O    Pine nut                           0.005000   1.000      1.000   FHE

95002790 O    Pineapple                          0.005000   1.000      1.000   FHE

95002791 O    Pineapple-babyfood                 0.005000   1.000      1.000   FHE

95002800 O    Pineapple, dried                   0.005000   1.000      1.000   FHE

95002810 O    Pineapple, juice                   0.005000   1.000      1.000   FHE

95002811 O    Pineapple, juice-babyfood          0.005000   1.000      1.000   FHE

14002820 14   Pistachio                          0.025000   1.000      0.010

95002830 O    Plantain                           0.100000   1.000      1.000

95002840 O    Plantain, dried                    0.100000   3.900      1.000

12002850 12   Plum                               0.005000   1.000      1.000   FHE

12002851 12   Plum-babyfood                      0.005000   1.000      1.000   FHE

12002860 12   Plum, prune, fresh                 0.005000   1.000      1.000   FHE

12002861 12   Plum, prune, fresh-babyfood        0.005000   1.000      1.000   FHE

12002870 12   Plum, prune, dried                 0.005000   1.000      1.000   FHE

12002871 12   Plum, prune, dried-babyfood        0.005000   1.000      1.000   FHE

12002880 12   Plum, prune, juice                 0.005000   1.000      1.000   FHE

12002881 12   Plum, prune, juice-babyfood        0.005000   1.000      1.000   FHE

95002890 O    Pomegranate                        0.005000   1.000      1.000   FHE

25002900 M    Pork, meat                         0.054000   1.000      1.000

25002901 M    Pork, meat-babyfood                0.054000   1.000      1.000

25002910 M    Pork, skin                         0.350000   1.000      1.000

25002920 M    Pork, meat byproducts              0.030000   1.000      1.000

25002921 M    Pork, meat byproducts-babyfood     0.030000   1.000      1.000

25002930 M    Pork, fat                          0.350000   1.000      1.000

25002931 M    Pork, fat-babyfood                 0.350000   1.000      1.000

25002940 M    Pork, kidney                       0.030000   1.000      1.000

25002950 M    Pork, liver                        0.005500   1.000      1.000

01032960 1C   Potato, chips                      0.025000   1.000      0.010

01032970 1C   Potato, dry (granules/ flakes)     0.025000   6.500      0.010

01032971 1C   Potato, dry (granules/ flakes)-b   0.025000   6.500      0.010

01032980 1C   Potato, flour                      0.025000   1.000      0.010

01032981 1C   Potato, flour-babyfood             0.025000   1.000      0.010

01032990 1C   Potato, tuber, w/peel              0.025000   1.000      0.010

01032991 1C   Potato, tuber, w/peel-babyfood     0.025000   1.000      0.010

01033000 1C   Potato, tuber, w/o peel            0.025000   1.000      0.010

01033001 1C   Potato, tuber, w/o peel-babyfood   0.025000   1.000      0.010

60003010 P    Poultry, other, meat               0.009000   1.000      1.000

60003020 P    Poultry, other, liver              0.133000   1.000      1.000

60003030 P    Poultry, other, meat byproducts    0.133000   1.000      1.000

60003040 P    Poultry, other, fat                0.133000   1.000      1.000

60003050 P    Poultry, other, skin               0.133000   1.000      1.000

95003060 O    Psyllium, seed                     0.005000   1.000      1.000   FHE

10003070 10   Pummelo                            0.000100   1.000      1.000

09023080 9B   Pumpkin                            0.001000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.001000   1.000      1.000

11003100 11   Quince                             0.005000   1.000      1.000   FHE

95003110 O    Quinoa, grain                      0.005000   1.000      1.000   FHE

29003120 M    Rabbit, meat                       0.054000   1.000      1.000

04013130 4A   Radicchio                          0.005000   1.000      1.000   FHE

01013140 1AB  Radish, roots                      0.034000   1.000      1.000

02003150 2    Radish, tops                       1.510000   1.000      1.000

01013160 1AB  Radish, Oriental, roots            0.005000   1.000      1.000   FHE

02003170 2    Radish, Oriental, tops             0.005000   1.000      1.000   FHE

05023180 5B   Rape greens                        1.080000   1.000      1.000

20003190 20   Rapeseed, oil                      0.050000   1.000      1.000

20003191 20   Rapeseed, oil-babyfood             0.050000   1.000      1.000

13013200 13A  Raspberry                          0.019000   1.000      1.000

13013201 13A  Raspberry-babyfood                 0.019000   1.000      1.000

13013210 13A  Raspberry, juice                   0.019000   1.000      1.000

13013211 13A  Raspberry, juice-babyfood          0.019000   1.000      1.000

04023220 4B   Rhubarb                            0.005000   1.000      1.000   FHE

15003230 15   Rice, white                        0.005000   1.000      1.000   FHE

15003231 15   Rice, white-babyfood               0.005000   1.000      1.000   FHE

15003240 15   Rice, brown                        0.005000   1.000      1.000   FHE

15003241 15   Rice, brown-babyfood               0.005000   1.000      1.000   FHE

15003250 15   Rice, flour                        0.005000   1.000      1.000   FHE

15003251 15   Rice, flour-babyfood               0.005000   1.000      1.000   FHE

15003260 15   Rice, bran                         0.005000   1.000      1.000   FHE

15003261 15   Rice, bran-babyfood                0.005000   1.000      1.000   FHE

01013270 1AB  Rutabaga                           1.510000   1.000      1.000

15003280 15   Rye, grain                         0.005000   1.000      1.000   FHE

15003290 15   Rye, flour                         0.005000   1.000      1.000   FHE

20003300 20   Safflower, oil                     0.005000   1.000      1.000   FHE

20003301 20   Safflower, oil-babyfood            0.005000   1.000      1.000   FHE

01013310 1AB  Salsify, roots                     0.025000   1.000      1.000

02003320 2    Salsify, tops                      0.025000   1.000      1.000

95003330 O    Sapote, Mamey                      0.005000   1.000      1.000   FHE

19013340 19A  Savory                             0.050000   1.000      1.000

95003350 O    Seaweed                            0.005000   1.000      1.000   FHE

95003351 O    Seaweed-babyfood                   0.005000   1.000      1.000   FHE

95003360 O    Sesame, seed                       0.005000   1.000      1.000   FHE

95003361 O    Sesame, seed-babyfood              0.005000   1.000      1.000   FHE

95003370 O    Sesame, oil                        0.005000   1.000      1.000   FHE

95003371 O    Sesame, oil-babyfood               0.005000   1.000      1.000   FHE

03003380 3    Shallot                            0.005000   1.000      1.000   FHE

26003390 M    Sheep, meat                        0.054000   1.000      1.000

26003391 M    Sheep, meat-babyfood               0.054000   1.000      1.000

26003400 M    Sheep, meat byproducts             0.030000   1.000      1.000

26003410 M    Sheep, fat                         0.350000   1.000      1.000

26003411 M    Sheep, fat-babyfood                0.350000   1.000      1.000

26003420 M    Sheep, kidney                      0.030000   1.000      1.000   FHE

26003430 M    Sheep, liver                       0.005500   1.000      1.000   FHE

15003440 15   Sorghum, grain                     0.005000   1.000      1.000   FHE

15003450 15   Sorghum, syrup                     0.005000   1.000      1.000   FHE

95003460 O    Soursop                            0.005000   1.000      1.000   FHE

06003470 6    Soybean, seed                      0.039000   1.000      1.000

06003480 6    Soybean, flour                     0.039000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.039000   1.000      1.000

06003490 6    Soybean, soy milk                  0.039000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.039000   1.000      1.000

06003500 6    Soybean, oil                       0.039000   1.600      1.000

06003501 6    Soybean, oil-babyfood              0.039000   1.600      1.000

95003510 O    Spanish lime                       0.005000   1.000      1.000   FHE

95003520 O    Spearmint                          0.005000   1.000      1.000   FHE

95003530 O    Spearmint, oil                     0.005000   1.000      1.000   FHE

19023540 19B  Spices, other                      0.005000   1.000      1.000   FHE

19023541 19B  Spices, other-babyfood             0.005000   1.000      1.000   FHE

04013550 4A   Spinach

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                211-Cooked; Fresh or N/S; Baked  0.000100   1.000      1.000

                212-Cooked; Fresh or N/S; Boiled

                                                 0.000100   1.000      1.000

                213-Cooked; Fresh or N/S; Fried  0.000100   1.000      1.000

                215-Cooked; Fresh or N/S; Boiled/baked

                                                 0.000100   1.000      1.000

                220-Cooked; Frozen; Cook Meth N/S

                                                 0.000100   1.000      1.000

                221-Cooked; Frozen; Baked        0.000100   1.000      1.000

                222-Cooked; Frozen; Boiled       0.000100   1.000      1.000

                232-Cooked; Dried; Boiled        0.000100   1.000      1.000

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000100   1.000      1.000

                242-Cooked; Canned; Boiled       0.000100   1.000      1.000

04013551 4A   Spinach-babyfood

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000100   1.000      1.000

09023560 9B   Squash, summer                     0.001000   1.000      1.000

09023561 9B   Squash, summer-babyfood            0.001000   1.000      1.000

09023570 9B   Squash, winter                     0.001000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.001000   1.000      1.000

95003580 O    Starfruit                          1.000000   1.000      1.000

95003590 O    Strawberry                         0.006000   1.000      1.000

95003591 O    Strawberry-babyfood                0.006000   1.000      1.000

95003600 O    Strawberry, juice                  0.006000   1.000      1.000

95003601 O    Strawberry, juice-babyfood         0.006000   1.000      1.000

95003610 O    Sugar apple                        0.005000   1.000      1.000   FHE

95003620 O    Sugarcane, sugar                   0.005000   1.000      1.000   FHE

95003621 O    Sugarcane, sugar-babyfood          0.005000   1.000      1.000   FHE

95003630 O    Sugarcane, molasses                0.005000   1.000      1.000   FHE

95003631 O    Sugarcane, molasses-babyfood       0.005000   1.000      1.000   FHE

20003640 20   Sunflower, seed                    0.005000   1.000      1.000   FHE

20003650 20   Sunflower, oil                     0.005000   1.000      1.000   FHE

20003651 20   Sunflower, oil-babyfood            0.005000   1.000      1.000   FHE

01033660 1CD  Sweet potato                       0.025000   1.000      1.000

01033661 1CD  Sweet potato-babyfood              0.025000   1.000      1.000

04023670 4B   Swiss chard                        0.005000   1.000      1.000   FHE

95003680 O    Tamarind                           0.005000   1.000      1.000   FHE

10003690 10   Tangerine                          0.001000   1.000      1.000

10003700 10   Tangerine, juice                   0.001000   1.000      1.000

01033710 1CD  Tanier, corm                       0.005000   1.000      1.000

95003720 O    Tea, dried                         0.005000   1.000      1.000   FHE

95003730 O    Tea, instant                       0.005000   1.000      1.000   FHE

08003740 8    Tomatillo

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000500   1.000      1.000

08003750 8    Tomato

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                150-Uncooked; Cured etc; Cook Meth N/S

                                                 0.000100   1.000      1.000

                210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.000      1.000

                211-Cooked; Fresh or N/S; Baked  0.000100   1.000      1.000

                212-Cooked; Fresh or N/S; Boiled

                                                 0.000100   1.000      1.000

                213-Cooked; Fresh or N/S; Fried  0.000100   1.000      1.000

                214-Cooked; Fresh or N/S; Fried/baked

                                                 0.000100   1.000      1.000

                215-Cooked; Fresh or N/S; Boiled/baked

                                                 0.000100   1.000      1.000

                221-Cooked; Frozen; Baked        0.000100   1.000      1.000

                222-Cooked; Frozen; Boiled       0.000100   1.000      1.000

                232-Cooked; Dried; Boiled        0.000100   1.000      1.000

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000500   1.000      1.000

                242-Cooked; Canned; Boiled       0.000500   1.000      1.000

                252-Cooked; Cured etc; Boiled    0.000100   1.000      1.000

08003751 8    Tomato-babyfood

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000500   1.000      1.000

08003760 8    Tomato, paste                      0.000100   5.400      1.000

08003761 8    Tomato, paste-babyfood             0.000100   5.400      1.000

08003770 8    Tomato, puree                      0.000100   3.300      1.000

08003771 8    Tomato, puree-babyfood             0.000100   3.300      1.000

08003780 8    Tomato, dried                      0.000100  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.000500  14.300      1.000

08003790 8    Tomato, juice

                110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.500      1.000

                210-Cooked; Fresh or N/S; Cook Meth N/S

                                                 0.000100   1.500      1.000

                211-Cooked; Fresh or N/S; Baked  0.000100   1.500      1.000

                212-Cooked; Fresh or N/S; Boiled

                                                 0.000100   1.500      1.000

                240-Cooked; Canned; Cook Meth N/S

                                                 0.000500   1.500      1.000

                242-Cooked; Canned; Boiled       0.000500   1.500      1.000

95003800 O    Tomato, Tree                       0.005000   1.000      1.000   FHE

15003810 15   Triticale, flour                   0.005000   1.000      1.000   FHE

15003811 15   Triticale, flour-babyfood          0.005000   1.000      1.000   FHE

50003820 P    Turkey, meat                       0.133000   1.000      1.000

50003821 P    Turkey, meat-babyfood              0.133000   1.000      1.000

50003830 P    Turkey, liver                      0.133000   1.000      1.000

50003831 P    Turkey, liver-babyfood             0.133000   1.000      1.000

50003840 P    Turkey, meat byproducts            0.133000   1.000      1.000

50003841 P    Turkey, meat byproducts-babyfood   0.133000   1.000      1.000

50003850 P    Turkey, fat                        0.133000   1.000      1.000

50003851 P    Turkey, fat-babyfood               0.133000   1.000      1.000

50003860 P    Turkey, skin                       0.133000   1.000      1.000

50003861 P    Turkey, skin-babyfood              0.133000   1.000      1.000

01033870 1CD  Turmeric                           0.010000   1.000      1.000

01013880 1AB  Turnip, roots                      0.034000   1.000      1.000

05023890 5B   Turnip, greens                     1.080000   1.000      1.000

95003900 O    Vinegar                            0.005000   1.000      1.000   FHE

14003910 14   Walnut                             0.025000   1.000      0.010

86010000 O    Water, direct, all sources         0.000014   1.000      1.000

86020000 O    Water, indirect, all sources       0.000014   1.000      1.000

95003970 O    Water chestnut                     0.005000   1.000      1.000   FHE

95003980 O    Watercress                         0.005000   1.000      1.000   FHE

09013990 9A   Watermelon                         0.001000   1.000      1.000

09014000 9A   Watermelon, juice                  0.001000   1.000      1.000

15004010 15   Wheat, grain                       0.005000   1.000      1.000   FHE

15004011 15   Wheat, grain-babyfood              0.005000   1.000      1.000   FHE

15004020 15   Wheat, flour                       0.005000   1.000      1.000   FHE

15004021 15   Wheat, flour-babyfood              0.005000   1.000      1.000   FHE

15004030 15   Wheat, germ                        0.005000   1.000      1.000   FHE

15004040 15   Wheat, bran                        0.005000   1.000      1.000   FHE

15004050 15   Wild rice                          0.005000   1.000      1.000   FHE

01034060 1CD  Yam, true                          0.025000   1.000      1.000

01034070 1CD  Yam bean                           0.025000   1.000      1.000

Attachment 6: Chronic Result File DEEM-FCID

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for BIFENTHRIN                       (1994-98 data)

Residue file name: C:\Documents and Settings\spiper\SPIPER\Bifenthrin\bifenthrinchronic_2007.R98

                                                     Adjustment factor #2 used.

Analysis Date 07-16-2007/11:36:02     Residue file dated: 07-16-2007/11:35:03/8

Reference dose (RfD, Chronic) = .013 mg/kg bw/day

COMMENT 1: New Tox Info: acute remove 10x and chronic remove 3x

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.002620                20.2%

U.S. Population (spring season)             0.002713                20.9%

U.S. Population (summer season)             0.002550                19.6%

U.S. Population (autumn season)             0.002621                20.2%

U.S. Population (winter season)             0.002597                20.0%

Northeast region                            0.002482                19.1%

Midwest region                              0.002876                22.1%

Southern region                             0.002576                19.8%

Western region                              0.002540                19.5%

Hispanics                                   0.002582                19.9%

Non-hispanic whites                         0.002591                19.9%

Non-hispanic blacks                         0.002880                22.2%

Non-hisp/non-white/non-black                0.002453                18.9%

All infants (< 1 year)                      0.002748                21.1%

Nursing infants                             0.001222                 9.4%

Non-nursing infants                         0.003328                25.6%

Children 1-6  yrs                           0.006671                51.3%

Children 7-12 yrs                           0.004850                37.3%

Females 13-19 (not preg or nursing)         0.002399                18.5%

Females 20+ (not preg or nursing)           0.001700                13.1%

Females 13-50 yrs                           0.002044                15.7%

Females 13+ (preg/not nursing)              0.002497                19.2%

Females 13+ (nursing)                       0.002216                17.0%

Males 13-19 yrs                             0.002833                21.8%

Males 20+ yrs                               0.001883                14.5%

Seniors 55+                                 0.001647                12.7%

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Children 1-2 yrs                            0.006366                49.0%

Children 3-5 yrs                            0.006912                53.2%

Children 6-12 yrs                           0.005109                39.3%

Youth 13-19 yrs                             0.002621                20.2%

Adults 20-49 yrs                            0.001882                14.5%

Adults 50+ yrs                              0.001650                12.7%

Females 13-49 yrs                           0.001914                14.7%

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

Attachment 7: Percent Crop Treated Memo from BEAD

Attachment 8: Revised Projected Percent Crop Treated for Bifenthrin (A.Halvorson, DP329542, 28-JUN-2006)

Bifenthrin	Dietary Exposure and Risk Assessment	DP Number: 327552

PC Code: 128825

________________________________________________________________________ ______________

 PAGE

 PAGE   8

Bifenthrin	Dietary Exposure and Risk Assessment	DP Number: 327552

PC Code: 128825

________________________________________________________________________ ______________

Bifenthrin	Dietary Exposure and Risk Assessment	DP Number: 327552

PC Code: 128825

________________________________________________________________________ _____________


[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57937-57939]
[FR Doc No: 2014-22982]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0505]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recordkeeping and
Reporting Requirements for Human Food and Cosmetics Manufactured From,
Processed With, or Otherwise Containing Material From Cattle

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).

DATES: Submit either electronic or written comments on the collection
of information by October 27, 2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>
All comments should be identified with the OMB control number 0910-
0623. Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle--21 CFR 189.5 and 700.27 (OMB Control Number 0910-0623)--
Revision

    FDA's regulations in Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 and
700.27) set forth bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA-regulated human food and cosmetics. The
regulations designate certain materials from cattle as ``prohibited
cattle materials,'' including specified risk materials (SRMs), the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, and mechanically separated (MS) beef. Sections 189.5(c) and
700.27(c) set forth the requirements for recordkeeping and records
access for FDA-regulated human food, including dietary supplements, and
cosmetics manufactured from, processed with, or otherwise containing
material derived from cattle. FDA issued these recordkeeping
regulations under the adulteration provisions in sections 402(a)(2)(C),
(a)(3), (a)(4), and (a)(5), 601(c), and 701(a) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3),
(a)(4), and (a)(5), 361(c), and 371(a)). Under section 701(a) of the
FD&C Act, FDA is authorized to issue regulations for the FD&C Act's
efficient enforcement. With regard to records concerning imported human
food and cosmetics, FDA relied on its authority under sections 701(b)
and 801(a) of the FD&C Act (21 U.S.C. 371(b) and 381(a)). Section
801(a) of the FD&C Act provides requirements with regard to imported
human food and cosmetics and provides for refusal of admission of human
food and cosmetics that appear to be adulterated into the United
States. Section 701(b) of the FD&C Act authorizes the Secretaries of
Treasury and Health and Human Services to jointly prescribe regulations
for the efficient enforcement of section 801 of the FD&C Act.
    These requirements are necessary because once materials are
separated from an animal, it may not be possible, without records, to
know the following: (1) Whether cattle material may contain SRMs (SRMs
include brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral
column (excluding the vertebrae of the tail, the transverse processes
of the thoracic and lumbar vertebrae and the wings of the sacrum), and
dorsal root ganglia from animals less than 30 months old and tonsils
and distal ileum of the small intestine from all animals of all ages);
(2) whether the source animal for cattle material was inspected and
passed; (3) whether the source animal for cattle material was
nonambulatory disabled or MS beef; and (4) whether tallow in a human
food or cosmetics contain less than 0.15 percent insoluble impurities.
    FDA's regulations in Sec. Sec.  189.5(c) and 700.27(c) require that
manufacturers and processors of human food and cosmetics manufactured
from, processed with, or otherwise containing material from cattle
establish and maintain records sufficient to demonstrate that the human
food or cosmetics are not manufactured from, processed with, or
otherwise containing prohibited cattle materials. These records must be
retained for 2 years at the manufacturing or processing establishment
or at a reasonably accessible location. Maintenance of electronic
records is acceptable, and electronic records are considered to be
reasonably accessible if they are accessible from an onsite location.
Records required by these sections and existing records relevant to
compliance with these sections must be available to FDA for inspection
and copying. Existing records may be used if they contain all of the
required information and are retained for the required time period.
    Because FDA does not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec.  189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection, the importer of record of human
food or cosmetics manufactured from, processed with, or otherwise
containing cattle material must affirm that the human food or cosmetics
were manufactured from, processed with, or otherwise contain cattle
material and must affirm that the human food or cosmetics were
manufactured in accordance with the applicable requirements of
Sec. Sec.  189.5 or 700.27. In addition, if human food or cosmetics are
manufactured from, processed with, or otherwise containing cattle
material, the importer of record must, if requested, provide within 5
business days records sufficient to demonstrate that the human food or
cosmetics are not manufactured from, processed with, or otherwise
containing prohibited cattle material.
    Upon review of the information collection requests supporting these
BSE-related regulations, FDA found that the burdens associated with the
requirements for recordkeeping and records access found in Sec. Sec.
189.5(c) and 700.27(c) are in use without current OMB approval. This
collection of information was previously approved by OMB under control
number 0910-0597. FDA submitted a timely information collection request
to extend the approval of 0910-0597, but the request was denied. To
most appropriately streamline this information collection and to
eliminate redundancy in information collection requests, FDA seeks to
revise the 0910-0623 collection to include the reporting and

recordkeeping elements of 0910-0597. FDA has included these elements in
the burden estimates and discussion in this document.
    Under FDA's regulations, FDA may designate a country from which
cattle materials inspected and passed for human consumption are not
considered prohibited cattle materials, and their use does not render
human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e)
provide that a country seeking to be designated must send a written
request to the Director of the Center for Food Safety and Applied
Nutrition (CFSAN Director). The information the country is required to
submit includes information about a country's BSE case history, risk
factors, measures to prevent the introduction and transmission of BSE,
and other information relevant to determining whether SRMs, the small
intestine of cattle not otherwise excluded from being a prohibited
cattle material, material from nonambulatory disabled cattle, or MS
beef from the country seeking designation should be considered
prohibited cattle materials. FDA uses the information to determine
whether to grant a request for designation and whether to impose
conditions if a request is granted.
    Sections 189.5 and 700.27 further state that countries designated
under Sec. Sec.  189.5(e) and 700.27(e) will be subject to future
review by FDA to determine whether their designations remain
appropriate. As part of this process, FDA may ask designated countries
to confirm that their BSE situations and the information submitted by
them in support of their original application has remained unchanged.
FDA may revoke a country's designation if FDA determines that it is no
longer appropriate. Therefore, designated countries may respond to
periodic FDA requests by submitting information to confirm that their
designations remain appropriate. FDA uses the information to ensure the
designations remain appropriate.
    Description of Respondents: Respondents to this information
collection include manufacturers, processors, and importers of FDA-
regulated human food, including dietary supplements, and cosmetics
manufactured from, processed with, or otherwise containing material
derived from cattle, as well as, with regard to Sec. Sec.  189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
    In the Federal Register of August 1, 2014 (79 FR 44785), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it did
not respond to the four collection of information topics solicited, and
therefore, it will not be discussed in this document.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR Section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 700.27(c)(6)..          54,825               1          54,825  .033 (2 minutes)           1,809
189.5(e) and 700.27(e);                      1               1               1  80..............              80
 Request for designation.
189.5(e) and 700.27(e);                      1               1               1  26..............              26
 Response to request for
 review by FDA.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
 21 CFR Sec.  Sec.   189.5(c)      Number of      records per    Total annual          per          Total hours
         and 700.27(c)           recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
Domestic facilities...........             697              52          36,244  0.25 (15                   9,061
                                                                                minutes).
Foreign facilities............             916              52          47,632  0.25 (15                  11,908
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          20,969
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Except where otherwise noted, this estimate is based on FDA's
estimate of the number of facilities affected by the final rule
entitled ``Recordkeeping Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
From Cattle,'' published in the Federal Register of October 11, 2006
(71 FR 59653 at 59667).

Reporting

    FDA's regulations in Sec. Sec.  189.5(c)(6) and 700.27(c)(6) impose
a reporting burden on importers of human food and cosmetics
manufactured from, processed with, or otherwise containing cattle
material. Importers of these products must affirm that the human food
or cosmetics are not manufactured from, processed with, or otherwise
containing prohibited cattle materials and must affirm that the human
food or cosmetics were manufactured in accordance with the applicable
requirements of Sec. Sec.  189.5 or 700.27. The affirmation is made by
the importer of record to FDA through FDA's Operational and
Administrative System for Import Support. Affirmation by importers is
expected to take approximately 2 minutes per entry line. Table 2 of
this document shows 54,825 lines of human food and cosmetics likely to
contain cattle materials are imported annually. The reporting burden of
affirming whether import entry lines contain cattle-derived materials
is estimated to take 1,809 hours annually (54,825 lines multiplied by
0.033 (2 minutes) per line).
    FDA's estimate of the reporting burden for designation under
Sec. Sec.  189.5 and 700.27 is based on its experience and the average
number of requests for designation received in the past 3 years. In the
last 3 years, FDA has not received

any requests for designation. Thus, FDA estimates that one or fewer
will be received annually in the future. Based on this experience, FDA
estimates the annual number of new requests for designation will be
one. FDA estimates that preparing the information required by
Sec. Sec.  189.5 and 700.27 and submitting it to FDA in the form of a
written request to the CFSAN Director will require a burden of
approximately 80 hours per request. Thus, the burden for new requests
for designation is estimated to be 80 hours annually, as shown in table
1, row 1 of this document.
    Under Sec. Sec.  189.5(e) and 700.27(e), designated countries are
subject to future review by FDA and may respond to periodic FDA
requests by submitting information to confirm their designations remain
appropriate. In the last 3 years, FDA has not requested any reviews.
Thus, FDA estimates that one or fewer will occur annually in the
future. FDA estimates that the designated country undergoing a review
in the future will need one-third of the time it took preparing its
request for designation to respond to FDA's request for review, or 26
hours (80 hours multiplied by 0.33 (2 minutes) = 26.4 hours, rounded to
26). The annual burden for reviews is estimated to be 26 hours, as
shown in table 1, row 2 of this document. The total annual reporting
burden for this information collection is estimated to be 1,915 hours.

Recordkeeping

    FDA estimates that there are 697 domestic facility relationships
and 916 foreign facility relationships consisting of the following
facilities: An input supplier of cattle-derived materials that requires
records (the upstream facility) and a purchaser of cattle-derived
materials requiring documentation (this may be a human food or
cosmetics manufacturer or processor). The recordkeeping burden of FDA's
regulations in Sec. Sec.  189.5(c) and 700.27(c) is the burden of
sending, verifying, and storing documents regarding shipments of cattle
material that is to be used in human food and cosmetics.
    In this estimate of the recordkeeping burden, FDA treats these
recordkeeping activities as shared activities between the upstream and
downstream facilities. It is in the best interests of both facilities
in the relationship to share the burden necessary to comply with the
regulations; therefore, FDA estimates the time burden of developing
these records as a joint task between the two facilities. Thus, FDA
estimates that this recordkeeping burden will be about 15 minutes per
week or 13 hours per year, and FDA assumes that the recordkeeping
burden will be shared between 2 entities (i.e. the ingredient supplier
and the manufacturer of finished products). Therefore, the total
recordkeeping burden for domestic facilities is estimated to be 9,061
hours (13 hours multiplied by 697), and the total recordkeeping burden
for foreign facilities is estimated to be 11,908 hours (13 hours
multiplied by 916), as shown in table 1 of this document.

    Dated: September 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22982 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 215 (Tuesday, November 6, 2012)]
[Rules and Regulations]
[Pages 66547-66548]
[FR Doc No: 2012-26962]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2008-0520; FRL 9748-9]

Approval and Promulgation of Implementation Plans; Michigan;
Detroit-Ann Arbor Nonattainment Area; Fine Particulate Matter 2005 Base
Year Emissions Inventory

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving the fine particulate matter
(PM2.5) 2005 base year emissions inventory, a portion of the
State Implementation Plan (SIP) revision submitted by the Michigan
Department of Environmental Quality (MDEQ) on June 13, 2008. The
emissions inventory is part of Michigan's SIP revision that was
submitted to meet the nonattainment requirements related to the state's
Detroit-Ann Arbor (Livingston, Macomb, Monroe, Oakland, St. Clair,
Washtenaw, and Wayne Counties) nonattainment area for the 1997 annual
PM2.5 national ambient air quality standards (NAAQS). This
action is being taken pursuant to sections 110 and 172 of the Clean Air
Act (CAA).

DATES: This final rule is effective on December 6, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R05-OAR-2008-0520. All documents in these dockets are listed
on the www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. We recommend that you telephone Carolyn Persoon at (312) 353-
8290 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Carolyn Persoon, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What action is EPA taking?
II. Final Action
III. Statutory and Executive Order Reviews

I. What action is EPA taking?

    On August 1, 2012 (77 FR 45532), EPA published a proposed
rulemaking to approve Michigan's PM2.5 2005 base year
emissions inventory for the Detroit-Ann Arbor area. EPA did not receive
any comments, adverse or otherwise, on the August 1, 2012, proposed
rulemaking. Pursuant to section 110 and 172 of the CAA, EPA is now
taking final action to approve the Detroit-Ann Arbor area
PM2.5 2005 base year emissions inventory as provided in
EPA's August 1, 2012, proposed rulemaking. A summary of the background
for today's final action is provided below. For more detail, please
refer to EPA's proposed rulemaking at 77 FR 45532.
    Section 172(c)(3) of the CAA requires areas to submit a
comprehensive, accurate, and current inventory from all sources of
actual emissions of the relevant pollutant or pollutants in such area.
Michigan selected 2005 as the base year for the emissions inventory per
40 CFR 51.1008(b). Emissions contained in Michigan's SIP revision
covered the general source categories of point sources, non-road mobile
sources, area sources, marine, aircraft and rail, and on-road mobile
sources. A detailed discussion of the emissions inventory and its
development can be found in the August 1, 2012, proposal. EPA has
reviewed Michigan's Detroit-Ann Arbor PM2.5 2005 base year
emissions inventory and has determined that it is adequate for the
purposes of meeting the section 172(c)(3) emissions inventory
requirement. Further, EPA has made the determination that the emissions
were developed consistent with the CAA, implementing regulations, and
EPA guidance for emission inventories.

II. Final Action

    EPA is taking final action to approve the PM2.5 2005
base year emissions inventory portion of the SIP revision submitted by
MDEQ on June 13, 2008, consistent with sections 110 and 172 of the CAA.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
final action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this final action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities

under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by January 7, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Reporting and recordkeeping
requirements.

    Dated: October 19, 2012.
Susan Hedman,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. In Sec.  52.1170 the table in paragraph (e) is amended by adding a
new entry for ``1997 Annual Fine Particulate Matter 2005 Base Year
Emissions Inventory'' at the end of the table to read as follows:

Sec.  52.1170  Identification of plan.

* * * * *
    (e) * * *

                       EPA-Approved Michigan Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                        Applicable          State
    Name of nonregulatory SIP          geographic or      submittal     EPA approval date         Comments
            provision               nonattainment area       date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
1997 Annual Fine Particulate       Detroit-Ann Arbor         6/13/08  11/6/12 [INSERT       ....................
 Matter 2005 Base Year Emissions    area (Livingston,                  CITATION OF
 Inventory.                         Macomb, Monroe,                    PUBLICATION].
                                    Oakland, St. Clair,
                                    Washtenaw, and
                                    Wayne Counties).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-26962 Filed 11-5-12; 8:45 am]
BILLING CODE 6560-50-P