Amicarbazone exhibits systemic toxicity to plants, transport through run-off or leaching and subsequent uptake by plants is likely, and herbicides that are photosystem II inhibitors like amicarbazone have a tendency to be metabolized into non-phytotoxic chemicals by plants that are resistant to their adverse effects. In addition, confined rotational crop studies suggest that amicarbazone and its degradates can accumulate in plants.  Therefore, there is great uncertainty concerning the amount of this chemical and its degradates in plants and the magnitude of exposure to animals that forage on those plants.

No reliable data are available that adequately depict the toxicity of the transformation products of amicarbazone to terrestrial animals, and exposure modeling for terrestrial animals was only performed using the parent.  Based on the half-lives from the one aerobic soil metabolism study, the metabolites are highly persistent and there is the potential for exposure of terrestrial animals to these chemicals. Subsequently, there is uncertainty about the risk that these metabolites pose to terrestrial animals.

Table 8.  Input parameters used in T-REX v1.1 to determine terrestrial EECs for amicarbazone.

                                Input Variable

                                Parameter Value

                                    Source

Maximum application rates

                        0.45, 0.22, or  0.15 lb a.i./A

                                 Product Label

Maximum number of applications per year

                                       1

                                 Product Label

Frequency of application

                                      NA

                                      NA

Foliar dissipation half-life

                                    35 days

                             T-REX Default Value

The EECs on food items may be compared directly with dietary toxicity data or converted to an oral dose, as is done for small mammals.  For mammals, the residue concentration is converted to daily oral dose based on the fraction of body weight consumed daily as estimated through mammalian allometric relationships.  The screening-level risk assessment for amicarbazone uses upper bound predicted residues as the measure of exposure.  A summary of the predicted upper bound and mean residues of amicarbazone that may be expected to occur on selected avian or mammalian food items immediately following application is presented in Table 9 for each scenario.  More detailed summaries of the T-REX output are presented in Appendix D.  Amicarbazone residues ranged from 107.6 to 2.30 ppm for upper bound residues and 38.11 to 1.07 ppm for mean residues.  Amicarbazone residues were highest on the surfaces of short grass and lowest on the surfaces of fruits, pods, and large insects.

Table 9.  Upper bound (24-hour) terrestrial upper bound and mean EECs found on selected avian and mammalian food items as calculated using T-REX.[a]

                               Application Rate

                                  Forage Type

                               Upper Bound EECs
                                     (ppm)

                                Mean EECs (ppm)

                               0.45 lb a.i./A[b]

short grass

                                     107.6

                                     38.11

tall grass

                                     49.32

                                     16.14

broadleaf plants and small insects

                                     60.53

                                     20.18

fruits/pods/large insects

                                     6.73

                                     3.14

                               0.22 lb a.i./A[c]

short grass

                                     52.51

                                     18.60

tall grass

                                     24.07

                                     7.88

broadleaf plants and small insects

                                     29.54

                                     9.85

fruits/pods/large insects

                                     3.28

                                     1.53

                               0.15 lb a.i./A[d]

short grass

                                     36.74

                                     13.01

tall grass

                                     16.84

                                     5.51

broadleaf plants and small insects

                                     20.67

                                     6.89

fruits/pods/large insects

                                     2.30

                                     1.07

a EEC equivalent dose = Upper bound Kenega value * (%BW consumed/100). %BW consumed = 114%, 65%, and 29% for small, medium, and large birds, respectively.
[b] Maximum recommended label application rate for amicarbazone for the following:
(1) Early Pre-plant, Pre-plant, At planting, and Pre-emergence applications in the Eastern Corn Belt; (2) Early Pre-plant applications in Western Corn Belt; (3) Special Fall applications; and (4) Winter applications.
c Maximum recommended label application rate for amicarbazone for Pre-plant, At planting, and Pre-emergence applications in the Western Corn Belt[.]
 d Maximum recommended label application rate for amicarbazone for all Early Post-emergence applications.

a EEC equivalent dose = Upper bound Kenega value * (%BW consumed/100). %BW consumed = 114%, 65%, and 29% for small, medium, and large birds, respectively.

      b.  Exposure Modeling for Non-Target Terrestrial Plants

TERRPLANT (TERRPLANT, Version 1.0, dated August 8, 2001) was used to estimate exposures and risks to terrestrial plant species (see Appendix C for a more detailed discussion of the TERRPLANT Model and results).  Input parameters for the model included: (1) toxicity values for monocots and dicots (EC25 values and EC05 or NOAEC values); (2) application rate; (3) run-off, based on chemical solubility; and (4) soil incorporation depth.  The model provides estimates of  exposure concentrations and risk quotients (RQs) for plant species that are not federally endangered or threatened (non-listed), and for those that are federally endangered or threatened (listed).  Input values used for estimating terrestrial plant exposure risks to amicarbazone are summarized in Table 10.

Table 10. Input parameters used in TERRPLANT v1.0 to determine terrestrial EECs for plants exposed to amicarbazone.

                                Input Variable

                                Parameter Value

                                    Source

Maximum application rates

                        0.45, 0.22, or  0.15 lb a.i./A

                                 Product Label

Runoff Value (0.01, 0.02, or 0.05 if chemical solubility <10, 10-100,  or >100 ppm, respectively)

                                   0.05 [a]

                                TERRPLANT 2001

Minimum incorporation depth (inches)

                                       1

                                 Product Label

[a] Based on the water solubility of 4,600 mg a.i./L.

TERRPLANT was run for single applications of each of the three maximum proposed application rates (0.45, 0.22, and 0.15 lb a.i./A) of amicarbazone for the varying application scenarios.  Amicarbazone can be applied at early stages of crop development as a ground spray that is unincorporated, incorporated at a minimum depth of one inch or irrigated in. For pesticide applications with a minimum incorporation depth of one inch or less,  the total loading EECs derived for the incorporation method will be same as the unincorporated method.  Therefore, only one set of EECs are calculated for each maximum application rate in this assessment.  EECs are estimated for total loading to terrestrial areas of concern, total loading to semi aquatic areas,  and spray drift for each maximum application rate (Table 11).

Exposure modeling for terrestrial plants was only performed using the parent, amicarbazone, due in part to the limited available data on the toxicity of amicarbazone's degradates to terrestrial and semi-aquatic plants.  Based on the half-lives from the one aerobic soil metabolism study, the metabolites are highly persistent and there is the potential for exposure of plants to these chemicals. Subsequently, there is uncertainty about the risk that these metabolites pose to terrestrial plants.

Table 11.  Summary output EECS from TERRPLANT for amicarbazone.

                               Application Rate
                                  (lb a.i./A)

                 EECs for plants inhabiting areas adjacent to
                                treatment site
                                  (lb a.i./A)

   EECs for semi-aquatic plants  inhabiting areas adjacent to treatment site
                                  (lb a.i./A)

                                   Drift EEC
                                  (lb a.i./A)

0.45

                                    0.0269

                                    0.2287

                                    0.0045

0.22

                                    0.0131

                                    0.1116

                                    0.0022

0.15

                                    0.0092

                                    0.0781

                                    0.0015

            c.  Terrestrial Exposure Monitoring (Field Data)

No data were identified to provide information on terrestrial monitoring.

C.  Ecological Effects Characterization

In screening-level ecological risk assessments, effects characterization describes the types of effects a pesticide has on aquatic or terrestrial organisms.  This characterization is based on registrant-submitted studies that describe information regarding acute and chronic effects toxicity for various aquatic and terrestrial animals and plants, and not open literature, because this is a new active ingredient registration.  Appendix E summarizes the results of the registrant-submitted toxicity studies used to characterize effects for this risk assessment.  Toxicity testing reported in this section does not represent all species of birds, mammals, or aquatic organisms.  Only a few surrogate species for both freshwater fish and birds are used to represent all freshwater fish (2000+) and bird (680+) species in the United States.  For mammals, acute studies are usually limited to the Norway rat or the house mouse.  Estuarine/marine testing is usually limited to a crustacean, a mollusk, and a fish.  Also, testing for reptiles and amphibians is not required.  The risk assessment assumes that avian, reptilian, and terrestrial phase amphibian toxicities are similar.  The same assumption is used for fish and aquatic phase amphibians.

In general, categories of acute toxicity ranging from "practically nontoxic" to "very highly toxic" have been established for aquatic organisms (based on LD50, LC50, and EC50 values), terrestrial mammals (based on LD50 values), avian species (based on LC50 and LD50 values), and non-target insects (based on LD50 values for honey bees) (U.S. EPA 2001).  These categories are presented in Appendix E.

Presently, there is a dearth of reliable data that adequately depict the toxicity of all of the transformation products of amicarbazone to aquatic and terrestrial plants and animals.  Subsequently, there is uncertainty surrounding the toxicity of these chemicals to the taxonomic groups under consideration. Only limited data on the toxicity of Des-amino to aquatic algae and terrestrial plants are available. These data are discussed further in Sections 1b and 2b of the Ecological Effects Characterization.

Results of toxicity studies indicate that technical grade amicarbazone is practically non-toxic to honey bees, slightly toxic to practically non-toxic to birds, and slightly toxic to mammals on an acute basis.  However, results of chronic toxicity studies show that longer-term exposure to amicarbazone TGAI results in adverse effects on reproductive parameters in birds, and toxicity to parents and offspring in mammals.  Toxicity studies demonstrate that amicarbazone is practically non-toxic on an acute basis to estuarine/marine and freshwater fish, slightly toxic to freshwater invertebrates, and slightly toxic to practically non-toxic to estuarine/marine invertebrates.  Chronic exposure of aquatic animals to amicarbazone produces adverse effects on growth parameters in freshwater fish and on growth and reproductive parameters in freshwater and estuarine/marine invertebrates.  Data are not available to characterize the effects of chronic exposure of estuarine/marine fish to amicarbazone.  In aquatic plants, amicarbazone produces adverse effects in both algae and vascular plants. In a single test with Des-amino, the degradate was less toxic to algae than the parent.  Results of Tier 2 terrestrial plant studies with the amicarbazone formulated product MKH 3586 70 WG show that both monocots and dicots are sensitive to exposure in both seedling emergence and vegetative vigor studies.  In both studies, dicots appear more sensitive than monocots. Tier 2 seedling emergence and vegetative vigor studies with the amicarbazone metabolite MKH 3594 (Des-amino) indicate that the metabolite is less toxic than the parent compound for the four species tested, except onion.

      1.  Aquatic Effects

The acute and chronic toxicity reference values associated with freshwater and estuarine/marine species exposure to amicarbazone are summarized in Table 12.  All toxicity reference values used to assess the potential risks of amicarbazone exposure are obtained from studies using technical amicarbazone.  A more detailed summary of the aquatic toxicity data available to characterize risks associated with amicarbazone applications is given in Appendix E, Tables E-1 through E-7 and Table E-13.

Table 12. Amicarbazone toxicity reference values (TRVs) (mg of active ingredient/L) for aquatic organisms.

                               Exposure Scenario

                                   Species

                               Exposure Duration

                           Toxicity Reference Value
                                  (mg a.i./L)

                                   Endpoint

                                   Reference
                               (Classification)

Freshwater Fish

                                                                          Acute

                                 Rainbow Trout
                              Oncorhynchus mykiss

                                   96 hours

LC50 > 120.4 mg a.i./L

No endpoints affected

                                 MRID 45121807
                                (Supplemental)

                                                                        Chronic

                                Fathead minnow
                              Pimephales promelas

                                    33 days

NOAEC = 7.3
LOAEC = 13.0

Dry weight

                                 MRID 45121602
                                 (Acceptable)

Freshwater Invertebrates

                                                                          Acute

                                  Water flea
                                 Daphnia magna

                                   48 hours

EC50 = 40.8

Mortality & sub-lethal effects [a]  effectaa

                                 MRID45121808
                                 (Acceptable)

                                                                        Chronic

                                  Water flea
                                 Daphnia magna

                                    21 days

NOAEC  0.252
LOAEC = 0.252

Terminal length

                                 MRID45121822
                                (Supplemental)

Estuarine/Marine Fish

                                                                          Acute

                               Sheepshead minnow
                             Cyprinodon variegatus

                                   96 hours

LC50 >118.0

No endpoints affected

                                 MRID 45121806
                                 (Acceptable)

                                                                        Chronic

                               No data submitted

Estuarine/Marine Invertebrates

                                                                          Acute

Saltwater mysid
Mysidopsis bahia

                                   96 hours

LC50 = 109.7

Mortality

                                 MRID 45121810
                                 (Acceptable)

                                                                        Chronic

Saltwater mysid
Mysidopsis bahia

                                    28 days

NOAEC = 5.0
LOAEC = 10.0

Terminal dry weight

                                 MRID 45121601
                                (Supplemental)

Aquatic Plants

                                                                    Algae Acute

                                 Marine diatom
                             Skeletonema costatum

                                   96 hours

EC50 = 0.017
NOAEC = 0.0057

Cell density

                                 MRID 45121818
                                 (Acceptable)

                                                                    Macrophytes
                                                                          Acute

                                   Duckweed
                                  Lemna gibba

                                    14 days

EC50 = 0.210
NOAEC = 0.0406

Frond dry weight

                                 MRID 45121805
                                 (Acceptable)

[a] Sub-lethal effects include erratic movements, floating at surface, and abnormal position on tank bottom.

            a.  Aquatic Animals

Freshwater Fish
The acute toxicity of amicarbazone (TGAI) was evaluated in rainbow trout (Oncorhynchus mykiss; MRID 45121807) and bluegill sunfish (Lepomis macrochirus; MRID 45121804).    Details of these studies are provided in Table E-1.  Results of acute exposure studies yield 96-hour LC50 values in bluegill sunfish and rainbow trout of >128.5 and >120.4 mg a.i./L, respectively, indicating that amicarbazone is practically non-toxic to freshwater fish on an acute basis.    Only one fish displayed sub-lethal effects (abnormal position at bottom of test chamber in 66.4 mg a.i./L treatment group) in the testing with bluegill sunfish, and no sub-lethal effects were found in the study on rainbow trout. These studies do not fulfill guideline requirements for an acute toxicity study with the rainbow trout [§72-1(c)] or bluegill sunfish [§72-1(a)] and are classified as supplemental because the mean fish weight determined from control fish at test termination was less than the required initial weight range of 0.5 to 5g (0.36g and 0.43g, respectively for each study). This ecological risk assessment uses the lowest acute toxicity value (LC50 >120.4 mg a.i./L in rainbow trout) to evaluate risk of acute exposure of freshwater fish to amicarbazone.

The effects of chronic exposure of freshwater fish to amicarbazone (TGAI) were evaluated in an  early life-stage study in fathead minnow (Pimephales promelas; MRID 45121602).  Study details are provided in Table E-2.  No treatment-related adverse effects were observed for reproductive parameters.  Treatment-related effects were observed on terminal dry weight in the 13, 26, and 48 mg a.i./L treatment groups (33-day LOAEC = 13 mg a.i./L, NOAEC = 7.3 mg a.i./L), and terminal wet weight in the 48 mg a.i./L treatment group (33-day LOAEC = 48 mg a.i./L, NOAEC = 26 mg a.i./L).  This study fulfills the guideline requirements for an early life-stage toxicity study with freshwater fish [§72-4(a)] and is classified as acceptable.  The NOAEC of 7.3 mg a.i./L was used to assess the risk of chronic exposure of freshwater fish to amicarbazone.

Freshwater Invertebrates

The acute toxicity of amicarbazone TGAI was evaluated in Daphnia magna under static conditions (MRID 45121808).  Study details are provided in Table E-3.  After 48 hours, mortality was 0% in the control, 15.0, and 25.2 mg a.i./L test groups, 10% in the 40.8 and 69.5 mg a.i./L test groups, and 15% in the 119 mg a.i./L test group. The 48-hour LC50 value was >119 mg a.i./L. Treatment-related sub-lethal effects included erratic movements, floating at the surface, and abnormal positions on the tank bottom. The 48-hour NOAEC value is 25.2 mg a.i./L. After 48 hours, sublethal effects were seen in 0% of the control, 15.0, and 25.2 mg a.i./L test groups, 50% of the 40.8 mg a.i./L test group, 100% of the 69.5 mg a.i./L test group, and 75% of the 119 mg a.i./L test group. Based on the 48-hour EC50 value of 40.8 mg a.i./L, amicarbazone is classified as slightly toxic to freshwater invertebrates.  This study satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates (§72-2) and is classified as acceptable. This ecological risk assessment uses the EC50 value of 40.8 mg a.i./L to evaluate the risk of acute exposure of freshwater invertebrates to amicarbazone.

The chronic toxicity of amicarbazone TGAI to freshwater invertebrates has been assessed  in a 21-day life-cycle toxicity test using Daphnia magna (MRID 45121822).  Study details are summarized in Table E-4.  No treatment-related effects on adult survival, time to first brood release, or terminal dry weights were observed. Treatment-related effects observed in this study included a decrease in the number of young/adult/reproductive day in the two highest treatment groups of 4.72 and 9.51 mg a.i./L (21-day LOAEC = 4.72, NOAEC = 2.31 mg a.i./L), and decreased terminal length in all treatment groups (21-day LOAEC = 0.252, NOAEC <0.252 mg a.i./L).  Since this life-cycle chronic toxicity study did not experimentally determine a NOAEC, it does not satisfy the guideline requirements for a chronic toxicity study with freshwater invertebrates [§72-4(b)] and is classified as supplemental.  However, the animals in the lowest test concentration (0.252 mg a.i./L) had an average terminal length of 5.05mm, only about a two percent reduction in length as compared to the control organisms (average length = 5.17 mm).  The LOAEC of 0.252 mg a.i./L was used in this risk assessment for the most sensitive effect (terminal length) to assess the risk of chronic exposure of freshwater invertebrates to amicarbazone. Thus, there is some uncertainty regarding the characterization of chronic risk.

Estuarine/Marine Fish
The acute toxicity of amicarbazone TGAI was evaluated in sheepshead minnow (Cyprinodon variegatus; MRID 45121806).  Study details are summarized in Table E-5.  No mortalities or signs of toxicity were observed, yielding a 96-hour LC50 value of >118 mg a.i./L, indicating that amicarbazone is practically non-toxic to estuarine/marine fish on an acute basis. This study satisfies the guideline requirements for a 96-hour acute toxicity study for estuarine/marine fish [§72-3(a)] and is classified as acceptable.  This ecological risk assessment uses the LC50 value of >118 mg a.i./L to evaluate the risk of acute exposure of estuarine/marine fish to amicarbazone.

Chronic toxicity studies in estuarine/marine fish were not submitted, and therefore, the chronic effects of amicarbazone on estuarine/marine fish could not be assessed.

Estuarine/Marine Invertebrates

The acute toxicity of amicarbazone TGAI to estuarine/marine invertebrates was evaluated in Eastern oyster (Crassostrea virginica; MRID 45121809) and saltwater mysid (Mysidopsis bahia; MRID 45121810).  In Eastern oyster, no mortalities or statistically significant reductions in shell growth were observed at the highest concentration of amicarbazone tested (63 mg a.i./L).   Based on the LC50 of >63 mg a.i./L, amicarbazone is classified as slightly toxic to practically non-toxic to the Eastern oyster.  Since this study was conducted at one concentration that was significantly less than the required limit concentration, it does not satisfy the requirements of an acute toxicity test with an estuarine/marine mollusk [§72-3(b)] and is classified as supplemental. Based on a calculated 96-hour LC50 value of 109.7 mg a.i./L, amicarbazone TGAI is classified as practically non-toxic to mysid shrimp on an acute basis.  At 96 hours, mortality was 0% in the control and 47 mg a.i./L test groups, 5% in the 82 mg a.i./L test group, and 90% in the 140 mg a.i./L test group. Treatment-related sub-lethal effects (erratic swimming and lethargy) were also observed, with a 96-hour NOAEC value of 47 mg a.i./L based on mortality and sublethal effects.  This study fulfills the requirements of an acute LC50 test with an estuarine/marine organism [§72-3(c)] and is classified as acceptable.  Study details are provided in Table E-6.  The calculated LC50 value of 109.7 mg a.i./L in mysid shrimp was used to evaluate risk of acute exposure of estuarine/marine invertebrates to amicarbazone.

The chronic toxicity of amicarbazone TGAI to estuarine/marine invertebrates was determined in a 28-day life-cycle test with mysid shrimp (Mysidopsis bahia; MRID 45121601).  Study details are provided in Table E-7.  Treatment-related adverse effects were observed for terminal dry weight in the 10 and 20  mg a.i./L treatment groups (LOAEC = 10 mg a.i./L, NOAEC=5.0 mg a.i./L), and this was the most sensitive endpoint. Terminal length (LOAEC = 20 mg a.i./L, NOAEC=10 mg a.i./L) and number of young/reproductive day (LOAEC = 20 mg a.i./L, NOAEC=10 mg a.i./L) were also decreased in the 20 mg a.i./L treatment group, while juvenile survival (LOAEC = 20 mg a.i./L, NOAEC = 10 mg a.i./L) was decreased in the 20 and 41 mg a.i./L treatment groups.  The 41 mg a.i./L treatment group was excluded from all statistical analyses other than for juvenile survival because there was only one replicate. This study does not fulfill the guideline requirements for an aquatic invertebrate life-cycle toxicity test using Mysidopsis bahia [§72-4(c)] and is classified as supplemental due to the following: survival data were not reported daily or in terms of each gender (following pairing); the number of reproductive females and the number of offspring produced per female were not provided; second-generation mysids were not monitored daily for at least 4 days for survival, development, and behavior; and terminal growth measurements were not provided in terms of each gender. This study could be upgraded to acceptable if the required raw data were submitted.  To assess chronic risk in estuarine/marine invertebrates, the 28-day NOAEC value of 5.0 mg a.i./L for decreased terminal dry weight was used.

            b.  Aquatic Plants

Acute toxicity studies on technical grade amicarbazone were conducted with duckweed (Lemna gibba; MRID 45121805), green algae (Selenastrum capricornutum; MRID 45121820), a marine diatom (Skeletonema costatum; MRID 45121818), blue-green alga (Anabaena flos-aquae; MRID 45121825), and a freshwater diatom (Navicula pelliculosa) (MRID 45121812).  Study details are provided in Table E-13.  Exposure of duckweed to amicarbazone resulted in decreased number of fronds (14-day EC50 value of 220 μg a.i./L) and decreased frond dry weight (most sensitive effect, 14-day EC50 value of 210 μg a.i./L).  The NOAEC reported for decreased frond dry weight is 40.6 ug a.i./L, while the LOAEC is 80.5 ug a.i./L.  This toxicity study satisfies the guideline requirements for an aquatic vascular plant study with Lemna gibba [§123-2] and is classified as acceptable. For macrophytes, the L. gibba 14-day EC50 value of 210 μg a.i./L for decreased frond dry weight was used to assess risk to non-listed aquatic macrophytes, while the NOAEC of 40.6 ug a.i./L for decreased frond dry weight was used to assess risk to listed aquatic macrophytes.

In all species of algae tested, amicarbazone TGAI resulted in decreased cell density and biomass. Decreased growth rate was exhibited by all species of algae except Selenastrum capricornutum.  EC50 values range from 17 μg a.i./L for decreased cell density in Skeletonema costatum to >490  μg a.i./L for decreased growth rate in Anabaena flos-aquae.  For algae, the lowest 96-hour EC50 value of 17 μg a.i./L for decreased cell density in the marine diatom, Skeletonema costatum, was used to assess acute risk to non-listed algae, while the NOAEC of 5.67 μg a.i./L for decreased cell density was used to assess risk to listed aquatic algae.  This study satisfies the guideline requirements for an aquatic nonvascular plant study with Skeletonema costatum [§123-2] and is classified as acceptable.

The effects of acute exposure of the amicarbazone metabolite Des-amino were evaluated in the green algae S. capricornutum (MRID 45121827, Table E-13).  Results of this study show that the Des-amino metabolite is much less toxic than its parent compound, with no adverse effects on cell density, growth rate, or biomass at concentrations up to 1353 μg metabolite/L.

      2.  Terrestrial Effects

The toxicity measures of effect used to characterize risks of amicarbazone exposure to birds and mammals are summarized in Table 13.  Results of all studies in terrestrial animal species are summarized in Appendix E, Tables E-9 to E-11.

Table 13. Amicarbazone toxicity reference values (TRVs) for terrestrial organisms.

                               Exposure Scenario

                                   Species

                               Exposure Duration

                           Toxicity Reference Value

                                   Endpoint

                                   Reference
                               (Classification)

Mammals

                                                                         Acute

                                      rat
                              (Rattus norvegicus)

                               Single oral dose

LD50 = 1087 mg a.i./kg body wt

Mortality

                                 MRID 45121605
                                 (Acceptable)

                                                                        Chronic

                                      rat
                              (Rattus norvegicus)

              2-generation reproductive study (dietary exposure)

NOAEC = 100 ppm a.i.
LOAEC = 500 ppm  a.i [a]

[NOAEC in ppm equivalent to dose of 6.4 mg a.i./kg body wt/day in males and 7.3 mg a.i./kg body wt/day in females; LOAEC in ppm equivalent to dose of 33.9 mg a.i./kg body wt/day in males and 38.7 mg a.i./kg body wt/day in females]  [b]

Decreased body weight and weight gain for male and female pups and parents

                                 MRID 45121625
                                 (Acceptable)

Birds

                                                                         Acute

                     bobwhite quail (Colinus virginianus)

                               single oral dose

LD50 = 1965 mg a.i./kg body wt

NOAEL = 250 mg a.i./kg body wt
LOAEL = 500 mg a.i./kg body wt

Mortality

Decreased male food consumption and male body weight gain

                         MRID 45121811 (Supplemental)

                                                                         Acute

                                 mallard duck
                             (Anas platyrhynchos)

                                 5-day dietary

LC50 >10,536 ppm a.i.  [a]

NOAEC = 627 ppm a.i.
LOAEC = 1222 ppm a.i.

Mortality

Body weight and food consumption

                          MRID 45121815 (Acceptable)

                                                                       Chronic

                                 mallard duck
                           (Anas platyrhynchos) and
                                bobwhite quail
                             (Colinus virginiamus)

                  Avian reproduction study (dietary exposure)

                            Mallard Duck: 20 weeks

                           Bobwhite Quail: 21 weeks

NOAEC = 27.1 ppm a.i. [a]
(for both mallard duck and bobwhite quail)

LOAEC =149 ppm a.i.  [a]
(for both mallard duck and bobwhite quail)

Reduction in number of viable embryos and hatchlings per eggs set for bobwhite quail

Decreased eggshell thickness for mallard duck

                                 MRID 45121814
                              (Duck: Acceptable)

                       MRID 45121819 (Quail: Acceptable)

Terrestrial Insects

                                                                          Acute

                                   honeybee
                               (Apis mellifera)

                         48 hour acute contact  study

LD50 >200 μg a.i./bee

Mortality

                         MRID 45121816 (Supplemental)

                                                                          Acute

                                   honeybee
                               (Apis mellifera)

                           48 hour acute oral study

LD50 = 24.4 μg a.i./bee

NOAEL =9.9 μg a.i./bee
LOAEL =19.8 μg a.i./bee

Mortality

Mortality, uncoordinated movements, and lethargy

                         MRID 45121816 (Supplemental)

Plants - Tier II seedling emergence

                                                                        Monocot

                                     onion

                              single application

EC25 = 0.10 lb a.i./A
EC05 = 0.034 lb a.i./A  [c]

Dry weight

                                 MRID 45121821
                                 (Acceptable)

                                                                          Dicot

                                  sugar beet

                              single application

EC25 = 0.030 lb a.i./A
NOAEC = 0.016 lb a.i./A

Dry weight

                                 MRID 45121821
                                 (Acceptable)

Plants - Tier II vegetative vigor

                                                                        Monocot

                                     onion

                              single application

EC25 = 0.026 lb a.i./A
NOAEC = 0.016 lb a.i./A

Dry weight

                                 MRID 45121821
                                 (Acceptable)

                                                                          Dicot

                                   buckwheat

                              single application

EC25 = 0.0037 lb a.i./A
NOAEC = 0.002 lb a.i./A

Dry weight

                                 MRID 45121821
                                 (Acceptable)

 a  Results are expressed in terms of dietary concentration (ppm a.i. or mg a.i./kg diet)
 [b] Dose-based equivalent was calculated by study authors based on food consumption during the study.
 [c] In the absence of a valid NOAEC value, the EC05 value was used to characterize risk to listed monocots.

            a.  Terrestrial Animals

Mammals

Results of an acute oral toxicity study in rats (Rattus norvegicus) show that administered single doses of amicarbazone TGAI yield an LD50 value of 1087 mg a.i./kg body weight (MRID 45121605).  Based on these results, amicarbazone TGAI is classified as slightly toxic to mammals.  The oral LD50 of 1087 mg a.i./kg body weight will be used to assess acute risk in mammals.  Results of a 2-generation reproductive study in rats show that no treatment-related adverse effects on reproductive parameters resulted from long-term exposure to amicarbazone (MRID 45121625).  Due to the lack of reproductive toxicity, the NOAEC for reproductive effects was 1000 ppm a.i.  However, chronic amicarbazone exposure resulted in parental systemic toxicity (decreases in weight and weight gain) and toxicity to offspring (decreases in body weight and body weight gain) at the two highest test concentrations of 500 and 1000 ppm a.i..  The LOAEC and NOAEC for the affected endpoints for both pups and parents were 500 ppm a.i. and 100 ppm a.i., respectively.  To assess chronic exposure risk in mammals, the NOAEC value of 100 ppm a.i. for parental systemic toxicity and toxicity in offspring will be used.  Results of this study are expressed in terms of both dietary concentration (NOAEC = 100 ppm a.i.) and the equivalent daily dose (NOAEL = 6.4 mg a.i./kg body wt/day in males); both of these values will be used to assess the chronic risk of amicarbazone in mammals.  Additional details pertaining to acute and chronic toxicity studies in mammals are presented in Table E-11.

Birds
Acute toxicity studies on technical grade amicarbazone have been conducted with bobwhite quail (Colinus virginianus) and mallard ducks (Anas platyrhynchos); results are summarized in Tables E-8 and E-9.  For the acute single-dose toxicity study with bobwhite quail, 0% mortality occurred in the 0, 63, 125, 250, and 500 mg a.i./kg body weight test groups, while 40% mortality was observed in the 1000 and 2000 mg a.i./kg bw test groups.  Although 50% mortality was not observed in any test group, results of probit analysis yielded an LD50 value of 1965 mg a.i./kg body weight (95% C.I.: 1260 to 11254)(MRID 45121811), classifying amicarbazone as slightly toxic to birds on an acute oral basis.  An LD50 was calculated despite 50% mortality not actually being observed because statistically it cannot be stated with much certainty that the LD50 is above 2000 mg a.i./kg bw. Based on reductions in male body weight gain, the LOAEL and NOAEL for the study were 500 and 250 mg a.i./kg body weight, respectively. Reductions in female body weight gain were also evident in the 1000 and 2000 mg a.i./kg body weight  treatment groups.  Since this study fails to establish a precise LD50 value, or establish with certainty that the  LD50 is above 2000 mg a.i./kg body weight, it does not satisfy the guideline requirements for acute oral toxicity studies with the bobwhite quail (§71-1) and is classified as supplemental.  To assess acute oral risk of amicarbazone to birds, the acute oral LD50 value of 1965  mg a.i./kg body weight was  used.

Results of an acute dietary exposure study in mallard ducks (MRID 45121815) yielded an acute LC50 value of >10, 536 ppm a.i.  Based on these results, amicarbazone is classified as practically non-toxic to birds on an acute dietary basis.  Although no treatment-related mortality or signs of pathology were observed at the highest test concentration, sub-lethal effects were observed at 1222 ppm a.i.  Body weight and feed consumption were the endpoints affected. Based on reduced terminal body weight, a NOAEC of 627 ppm a.i. was reported.  This toxicity study satisfies the guideline requirements for avian dietary studies with mallards (§71-2(b)) and is classified as acceptable.  To assess acute dietary risk of amicarbazone to birds, the acute dietary LC50 value of >10,536 ppm a.i. was used.

Results of avian reproduction studies of bobwhite quail (MRID 45121819) and mallard ducks (MRID 45121814) exposed to amicarbazone are detailed in Table E-10.  In bobwhite quail, a reduction in the number of viable embryos per eggs set and a decrease in the number of hatchlings per eggs set were observed at 149 ppm a.i., with a dietary NOAEC value of 27.1 ppm a.i.  Similarly, in mallard ducks, LOAEC and NOAEC values of 149 and 27.1 ppm a.i., respectively, were reported for decreased egg shell thickness.  Male weight gain was also affected in the bobwhite quail (LOAEC = 722, NOAEC = 149 ppm a.i.), while the number of eggs laid, eggs cracked, eggs not cracked of eggs laid, eggs set, eggs set of eggs laid, viable embryos of eggs set, live embryos, hatchling weight, and survivor weight were all endpoints that were affected in mallard ducks (LOAEC = 722 and NOAEC = 149 ppm a.i. for all).  These studies satisfy the guideline requirements for avian reproduction studies with bobwhite quail and mallard ducks (§71-4) and are classified as acceptable.  To assess chronic risk in birds, the dietary NOAEC of 27.1 ppm a.i. was used.

Non-target Insects
Results of an acute contact study in honey bees (Apis mellifera L.) using technical grade amicarbazone yield an LD50 value of >200 μg a.i./bee (MRID 45121816), indicating that amicarbazone is practically non-toxic to honey bees.  This study is classified as supplemental because the solvent used is not an EPA-recommended solvent (Adhäsit(R)) and therefore, the study does not meet guideline requirements for a contact toxicity test with honey bees (§141-1). In an acute oral exposure study in honey bees, an LD50 value of 24.4 μg a.i./bee was reported (MRID 45121816).  In this same study, sub-lethal effects (uncoordinated movements and lethargy) were reported during the first 4 hours after oral exposure, with an NOAEL value of 9.9 μg a.i./bee.  At 24 and 48 hours, no sub-lethal effects were observed. The acute oral study is classified as supplemental because it is a non-guideline study.  The results of these tests are summarized in Table E-12

            b.  Terrestrial Plants
Terrestrial plant testing (seedling emergence and vegetative vigor) is required for herbicides that have terrestrial non-residential outdoor use patterns and that may move off the application site through either volatilization (vapor pressure > 1.0 x 10[-5] mm Hg at 25[o]C) or drift (aerial or irrigation), and/or that may have listed species associated with the application site. In addition, terrestrial Tier II studies are required for all low dose herbicides (those with the maximum use rate of 0.5 lbs ai/A or less) and any pesticide showing a negative response equal to or greater than 25% in Tier I tests.  Tier II terrestrial plant testing is required for amicarbazone because it is a low dose herbicide with the potential for widespread use. Tier II tests measure the responses of plants at five or more test chemical concentrations relative to a control.  For seedling emergence and vegetative vigor testing, the following plant species and groups should be tested: (1) six species of at least four dicotyledonous families, one species of which is soybean (Glycine max) and the second crop is a root crop; and (2) four species of at least two monocotyledonous families, one of which is corn (Zea mays).

Tier 2 studies were conducted using the amicarbazone formulated product MKH 3586 70 WG (MRID 45121821) and the amicarbazone metabolite MKH 3586 70 WG (MRID 45121826).  Seedling emergence and vegetative vigor were studied on a combination of eleven non-target crops (including soybean, buckwheat, sugarbeet, carrot, canola, lettuce, tomato, oat, ryegrass, corn, and onion) following application of amicarbazone formulated product MKH 3586 70 WG.  Details of these studies are summarized in Tables E-14 (for most sensitive species), Table E-15 (most sensitive parameter for all species tested for seedling emergence), and Table E-16 (most sensitive parameter for all species tested for vegetative vigor).  Based on the results of these tests, it appears that emerging seedlings are less sensitive to amicarbazone via soil/root uptake exposure than emerged plants via foliar routes of exposure.  All tested plants exhibited adverse effects in the vegetative vigor toxicity tests following exposure to amicarbazone, while four of the ten species tested (corn, oat, ryegrass, and soybean) were not adversely affected in the seedling emergence study. For both seedling emergence and vegetative vigor, dicots appear more sensitive than monocots.  These data also suggest that grasses (family Poaceae) are generally more tolerant than other plant families, and that amicarbazone appears to be a little more selective and not a broad spectrum herbicide based on the distribution of toxicity among the species tested.  For example, while the grasses (oat, corn, and ryegrass) and soybean (a legume) are basically resistant to amicarbazone and tomato appears to have some tolerance, the rest of the species appear to be sensitive to this chemical.

Overall, the results of studies using the amicarbazone formulated product MKH 3586 70 WG show that both monocots and dicots are sensitive to exposure for both seedling emergence and vegetative vigor parameters and that dry weight was the most sensitive parameter in both studies.  Results of seedling emergence studies identify onion as the most sensitive monocot (EC25 = 0.10 lb a.i./A; EC05 = 0.034 lb a.i./A, NOAEC = 0.126 lb a.i./A) and sugarbeet as the most sensitive dicot (EC25 = 0.030 lb a.i./A; NOAEC = 0.016 lb a.i./A).  Results of vegetative vigor studies show that onion is the most sensitive monocot (EC25 = 0.026 lb a.i./A; NOAEC = 0.016 lb a.i./A) and buckwheat is the most sensitive dicot (EC25 = 0.0037 lb a.i./A; NOAEC = 0.002 lb a.i./A). EC25 values were used to assess risk in non-listed species, while NOAEC values were used to assess risk in listed species.  However, since the seedling emergence NOAEC for onion is greater than the EC25 value, the NOAEC value may not represent a valid toxicity value for use in characterization of risk.  Therefore, in the absence of a valid seedling emergence NOAEC value in monocots, the EC05 value of 0.034 lb a.i./A for onion was used to assess risk to listed monocot species.

The seedling emergence study using amicarbazone is classified as acceptable and fulfills the guideline requirements for seedling emergence studies (Subdivision J, §123-1 (a; TIER II)).  The vegetative vigor study using amicarbazone is classified as acceptable for buckwheat, canola, lettuce, soybean, oat, onion, corn, and ryegrass, and fulfills the guidance requirements for vegetative vigor studies for these species (Subdivision J, §123-1(b; Tier II)).  However, vegetative vigor data collected for sugar beet and tomato are classified as invalid due to overcrowded conditions and heightened competition, and are not used in this assessment.  EPA protocol allows a maximum of 2 and 3 plants per six inch pot for tomato and sugar beet, respectively. The vegetative vigor study deviated from this acceptable protocol for these species by exceeding these recommendations and having 5 plants per 3.5 inch pot.

Results of Tier 2 seedling emergence and vegetative vigor studies with the amicarbazone  metabolite MKH 3594 (Des-amino) indicate that the metabolite is less toxic than the parent compound for three of the four species tested (sugarbeet, lettuce, buckwheat)(MRID 45121826). Only the seedling emergence study determined a NOAEC for any species; onion emergence and onion dry weight each had a NOAEC of 0.013 lb a.i./A.  A NOAEC could not be determined for any other species in either test; all other NOAECs were greater than the highest concentration tested (0.028 lb a.i./A).  These tests applied concentrations of Des-amino at levels found to be toxic for  the parent.  Thus, the tests were conducted  at concentrations less than the maximum application rate.  Although an EC25 could not be calculated for any endpoint because a 25% effect was not elicited, a NOAEC and an EC05 were determined to be 0.013 and 0.014 lb a.i./A, respectively, for onion emergence.  This NOAEC and  EC05 are less than the values determined for onion in the emergence study with the parent, suggesting that  Des-amino is more toxic than amicarbazone to onion.  These tests do not fulfill the US EPA guideline requirements for seedling emergence and vegetative vigor studies (§123-1, TIER II)) because they were conducted with MKH 3594 (Des-amino), a metabolite of MKH 3586.  Vegetative vigor data collected for sugar beet using Des-amino are classified as invalid due to overcrowded conditions and heightened competition, and are not used in this assessment.  Details of this study are provided in Table E-14.

IV.  Risk Characterization

Risk characterization is the integration of exposure and ecological effects characterization to determine the ecological risk from the use of amicarbazone, and the likelihood of effects on aquatic and terrestrial organisms based on varying pesticide-use scenarios.  The risk characterization provides an estimation and a description of the risk; articulates risk assessment assumptions, limitations, and uncertainties; synthesizes an overall conclusion; and provides the risk managers with information to make regulatory decisions.

The exposure and toxicity effects data were integrated in order to evaluate the risks of adverse ecological effects on non-target species.  For the assessment of amicarbazone risks, the risk quotient (RQ) method was used to compare exposure and measured toxicity values (see Appendix F).  Estimated environmental concentrations (EECs) were divided by acute and chronic toxicity values.  The resulting RQs were then compared to the Agency's levels of concern (LOCs).  These LOCs, which are summarized in Appendix F, are the Agency's interpretive policy used to analyze potential risk to non-target organisms and the need to consider regulatory action.  These criteria are used to indicate when a pesticide's use as directed on the label has the potential to cause adverse effects on non-target organisms.  Details of the RQs derived for all aquatic and terrestrial organisms are provided in Appendix G.

A.  Risk Estimation - Integration of Exposure and Effects Data

      1.  Non-target Aquatic Animals and Plants

To assess risk of amicarbazone to non-target aquatic animals (i.e., fish and invertebrates) and plants (i.e., macrophytes and algae), surface water EECs for amicarbazone (parent only) were obtained from the Tier 2 model PRZM/EXAMS based on the label-recommended usage scenarios (Table 6) and a 1% drift assumption for ground sprays. This risk assessment uses the highest peak 24-hour concentration (winter weed control on Texas corn) in surface water generated from the PRZM/EXAMS model to represent acute exposure to fish, aquatic invertebrates, algae, and macrophytes, and the highest 21-day concentration of all scenarios (winter weed control on Texas corn) to represent chronic exposure to aquatic invertebrates and fish. No RQs calculated using these concentrations exceeded any LOC for any aquatic animal or macrophyte. Therefore, further calculations of additional RQs based on lower EECs for other usage scenarios were not performed for any aquatic animal or aquatic vascular plant in this assessment. However, there were exceedances for aquatic algae, and multiple RQs were calculated for this organism based on the various label-recommended usage scenarios.

Toxicity reference values for aquatic organisms exposed to technical grade amicarbazone are summarized in Table 12. Toxicity data are either inadequate or unavailable to calculate RQs based on the following measures of effect (e.g., acute or chronic toxicity reference values) and receptors:

            ·	chronic NOAEC toxicity data for estuarine/marine fish

Acute RQs for fish and aquatic invertebrates are summarized in Table 14.  Chronic RQs for fish and aquatic invertebrates are summarized in Table 15.  Risk quotients for non-listed and listed aquatic plants are summarized in Table 16 and Table 17, respectively. Risk quotients for aquatic algae for the multiple scenarios generated by PRZM/EXAMS are listed in Table 18.

Table 14. Acute RQs for fish and invertebrates exposed to amicarbazone.

                               Species Category

                                   Organism

                               LC50 or EC50  [a]
                                  (mg a.i./L)

                             Peak 24-hour  EEC [b]
                                  (mg a.i./L)

                                 Acute RQ [c]
                                  (EEC/LC50)

                                freshwater fish

                                 rainbow trout

                                   >120.4

                                    0.03378

                                 No acute risk

                           freshwater invertebrates

                                  water flea

                                     40.8

                                    0.03378

                                    0.0008

                             estuarine/marine fish

                               sheepshead minnow

                                   >118.0

                                    0.03378

                                 No acute risk

                        estuarine/marine invertebrates

                                saltwater mysid

                                     109.7

                                    0.03378

                                    0.0003

[a]  RQs are based on the following toxicity data:  for freshwater fish, the rainbow trout (Oncorhynchus mykiss) 96 -hr LC50 >120.4 mg a.i./L; for freshwater invertebrates, the water flea (Daphnia magna) 48-hr EC50 =40.8 mg a.i./L; for estuarine/marine fish, the sheepshead minnow (Cyprinodon variegatus) 96-hr LC50 >118 mg a.i./L; and for estuarine/marine invertebrates, the saltwater mysid (Mysidopsis bahia) 96-hr LC50 = 109.7 mg a.i./L.
[b]  EEC value (mg/L) reported is the highest peak 24-hour concentration in surface water of all scenarios generated from PRZM/EXAMS 2.
[c]  RQs are below the LOC for acute risk (LOC 0.5), acute restricted use (LOC 0.1), and acute endangered species risk (LOC 0.05).

Table 15. Chronic RQs for fish and invertebrates exposed to amicarbazone.

                               Species Category

                                   Organism

                                   NOAEC [a]
                                  (mg a.i./L)

                                    EEC [b]
                                  (mg a.i./L)

                                Chronic RQ [c]
                                  (EEC/NOAEC)

                                freshwater fish

                                fathead minnow

                                      7.3

                                    0.03353

                                    0.005

                           freshwater invertebrates

                                  water flea

                                     0.252

                                    0.03353

                                    0.133

                             estuarine/marine fish

                               No data submitted

                        estuarine/marine invertebrates

                                saltwater mysid

                                      5.0

                                    0.03353

                                    0.007

[a]  RQ values are based on the following toxicity data: fathead minnow (Pimephales promelas) 33-day NOAEC = 7.3 mg a.i./L; water flea (Daphnia magna) 21-day LOAEC = 0.252 mg a.i./L; and saltwater mysid (Mysidopsis bahia) 28-day NOAEC = 5.0 mg a.i./L.
[b]  EEC values (mg a.i./L) used for fish and invertebrates are the highest 21-day average concentration in surface water of all scenarios generated from PRZM/EXAMS.
[c]  RQs are below the LOC for chronic risk (LOC 1).

Table 16. Acute RQs for non-listed aquatic plants exposed to amicarbazone.

                                   Organism

                                   EC50 [a]
                                  (mg a.i./L)

                            Peak 24-hour  EEC  [b]
                                  (mg a.i./L)

                                   Acute RQ
                                  (EEC/EC50)

                                  S. costatum

                                     0.017

                                    0.03378


[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Page 18529]
[FR Doc No: 2019-08835]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1656-000]

Wilkinson Solar LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Wilkinson
Solar LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is May 15, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
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intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
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    Dated: April 25, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-08835 Filed 4-30-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Proposed Rules]
[Pages 44048-44050]
[FR Doc No: 2013-17631]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0637; Directorate Identifier 2013-SW-030-AD]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
(Sikorsky) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede an existing airworthiness directive
(AD) for Sikorsky Model S-76A, B, and C helicopters. The existing AD
currently requires inspecting the main rotor lower bifilar arm assembly
(bifilar arm assembly) for a crack, and if there is a crack, replacing
the bifilar arm assembly. The AD also requires a one-time test for the
correct torque on the lug nuts, and if necessary, conducting torque
stabilization tests. Since we issued that AD, Sikorsky has developed a
terminating procedure for the inspections required by the existing AD.
This proposed AD would retain the requirements of that AD, and would
require replacing the main rotor hub (MRH) pilot with a different part-
numbered MRH pilot, which would be terminating action for the
requirements of the AD. The proposed actions are intended to prevent
failure of a bifilar lug, damage to the main rotor control system, and
subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by September 23,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, any comments received and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this proposed AD, contact
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT 06614;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>or at http://www.sikorsky.com. You may review service information at the FAA, Office
of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Nicholas Faust, Aviation Safety
Engineer, Boston Aircraft Certification Office, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, Massachusetts
01803; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    On October 26, 2005, we issued AD 2005-22-01, amendment 39-14345
(70 FR 61721) for Sikorsky Model S-76A, B, and C helicopters with an
MRH pilot part number (P/N) 76103-08003-101 with 1,500 or more hours
time-in-service (TIS) installed. The AD requires, every 50 hours TIS,
inspecting the main rotor lower bifilar arm assembly in the attachment
area around the lower bifilar lugs for a crack. If there is a crack,
the AD requires replacing the bifilar arm assembly. If there is not a
crack, the AD requires a one-time test for the correct torque on the
lug nuts, and if necessary, conducting torque stabilization tests. The
AD was prompted by four reports

of cracked bifilars. Those actions were intended to prevent failure of
a bifilar lug, damage to the main rotor control system, and subsequent
loss of control of the helicopter.

Actions Since Existing AD Was Issued

    Since we issued AD 2005-22-01, Sikorsky issued Alert Service
Bulletin 76-65-65, dated March 22, 2012 (ASB 76-65-65). ASB 76-65-65
specifies measuring the MRH diameter and, if the diameter is small,
replacing the MRH pilot with a newly-redesigned MRH pilot. The new MRH
pilot has a larger flange diameter that provides greater support for
the bifilar assembly and reduces stress on the bifilar assembly
attachment lugs. We propose to supersede AD 2005-22-01 to require
installation of the large diameter MRH pilot as terminating action for
the repetitive inspection requirements. These actions are intended to
prevent failure of a bifilar lug, damage to the main rotor control
system, and subsequent loss of control of the helicopter.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Related Service Information

    Sikorsky issued S-76 Alert Service Bulletin (ASB) 76-65-62, dated
December 14, 2004 (ASB 76-65-62), which describes procedures to inspect
the lower bifilar assembly for a crack. We have also reviewed ASB 76-
65-65, which specifies measuring the MRH diameter and, if the diameter
is small, replacing the MRH pilot with a newly-redesigned MRH pilot
with a larger flange diameter.

Proposed AD Requirements

    This proposed AD would retain the repetitive inspection
requirements of AD 2005-22-01, but would also require replacing the MRH
pilot, P/N 76103-08003-101, with MRH pilot, P/N 76103-08003-102, as
terminating action.

Costs of Compliance

    We estimate that this proposed AD would affect 181 helicopters of
U.S. Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD. Inspecting the bifilar arm assembly would
require about 4 work-hours, at an average labor rate of $85 per hour,
for a cost per helicopter of $340 and a total cost to U.S. operators of
$61,540.
    Replacing a cracked bifilar arm assembly would require about 4
work-hours, at an average labor rate of $85 per hour, and required
parts would cost about $19,727, for a cost per helicopter of $20,067.
    Replacing the MRH pilot, P/N 76103-08003-101, with an MRH pilot, P/
N 76103-08003-102, would require about 0.7 work-hour, at an average
labor rate of $85 per hour, and required parts would cost about $1,043,
for a cost per helicopter of $1,103 and a total cost to U.S. operators
of $199,643.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This proposed regulation is
within the scope of that authority because it addresses an unsafe
condition that is likely to exist or develop on products identified in
this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2005-22-01, Amendment 39-14345 (70 FR 61721, October 26, 2005), and
adding the following new AD:

Sikorsky Aircraft Corporation: Docket No. FAA-2013-0637; Directorate
Identifier 2013-SW-030-AD.

(a) Applicability

    This AD applies to Model S-76A, B, and C helicopters with a main
rotor hub (MRH) pilot, part number (P/N) 76103-08003-101, installed,
certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack on the MRH pilot
bifilar assembly lug, which could result in failure of a bifilar
lug, damage to the main rotor system, and subsequent loss of control
of the helicopter.

 (c) Affected ADs

    This AD supersedes AD 2005-22-01, Amendment 39-14345 (70 FR
61721, October 26, 2005).

(d) Comments Due Date

    We must receive comments by September 23, 2013.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    (1) For MRH pilots with 1,500 or more hours time-in-service
(TIS), within 50 hours TIS, and thereafter at intervals not to
exceed 50 hours TIS, inspect the lower bifilar arm assembly for a
crack in the lug attachment area. Conduct the inspection of the
lower bifilar arm assembly by following the Accomplishment
Instructions, paragraph 3.A.(1) through 3.A.(6), of Sikorsky Alert
Service Bulletin No. 76-65-62, dated December 14, 2004 (ASB 76-65-
62).

    (i) If there is a crack on any bifilar assembly arm lug, before
further flight, replace the bifilar arm assembly with an airworthy
bifilar arm assembly.
    (ii) If no crack is found at the initial inspection, perform a
one-time torque test. Perform the torque test and the additional
torque procedures as stated in the Accomplishment Instructions,
paragraph 3.B.(1) through 3.B.(3), of ASB 76-65-62. The torque test
is not required at the recurring inspection intervals of the lower
bifilar arm assembly.
    (iii) Within 600 hours TIS, replace the MRH pilot, P/N 76103-
08003-101, with an MRH pilot, P/N 76103-08003-102.
    (2) For MRH pilots with less than 900 hours TIS, prior to
accumulating 1,500 hours TIS, replace the MRH pilot, P/N 76103-
08003-101, with a MRH pilot, P/N 76103-08003-102.
    (3) After the effective date of this AD, do not install an MRH
pilot, P/N 76103-08003-101, on any helicopter.

(g) Special Flight Permit

    Special flight permits will not be issued.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston Aircraft Certification Office, FAA, may
approve AMOCs for this AD. Send your proposal to: Nicholas Faust,
Aviation Safety Engineer, Boston Aircraft Certification Office,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, Massachusetts 01803; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(i) Additional Information

    For service information identified in this AD, contact Sikorsky
Aircraft Corporation, Attn: Manager, Commercial Technical Support,
mailstop s581a, 6900 Main Street, Stratford, CT 06614; telephone
(800) 562-4409; email<EMAIL_ADDRESS>or at http://www.sikorsky.com. You may review the service information at the FAA,
Office of the Regional Counsel, Southwest Region, 2601 Meacham
Blvd., Room 663, Fort Worth, Texas 76137.

(j) Subject

    Joint Aircraft Service Component (JASC) Code: 6220: Main Rotor
Head.

    Issued in Fort Worth, Texas, on July 11, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-17631 Filed 7-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Rules and Regulations]
[Pages 29645-29647]
[FR Doc No: 2011-12378]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0184]
RIN 1625-AA00

Safety Zone, Newport River; Morehead City, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone on the waters of
the Newport River under the main span US 70/Morehead City--Newport
River high rise bridge in Carteret County, NC. This safety zone is
necessary to provide for safety of life on navigable waters during the
establishment of staging for bridge maintenance. This rule will enhance
the safety of the contractors performing maintenance as well as the
safety of vessels that plan to transit this area.

DATES: This rule is effective from 10 a.m. to 4 p.m. on June 30, 2011.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2011-0184 and are available online by going to
http://www.regulations.gov, inserting USCG-2011-0184 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail BOSN3 Joseph M. Edge, Coast Guard Sector
North Carolina, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On April 5, 2011, we published a notice of proposed rulemaking
(NPRM) entitled Safety Zone, Newport River; Morehead City, North
Carolina in the Federal Register (33 FR 165). We received no comments
on the proposed rule. No public meeting was requested, and none was
held.

Background and Purpose

    The State of North Carolina Department of Transportation awarded a
contract to Astron General Contracting Company of Jacksonville, NC to
perform bridge maintenance on the US Highway 70 Fixed bridge crossing
Newport River at Morehead City, North Carolina. The contract provides
for cleaning, painting, and steel repair to begin on June 1, 2011 and
will be completed by July 31, 2011. The contractor requires the main
channel in the vicinity of the bridge to remain closed during
mobilization on June 30, 2011 from 10 a.m. to 4 p.m. The Coast Guard
will temporarily restrict access to this section of Newport River
during the mobilization of the bridge maintenance equipment.

Discussion of Comments and Changes

    There were no comments; no changes were made.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although this regulation will restrict access to the area, the
effect of this rule will not be significant because: (i) The safety
zone will be in effect for a limited time, from 10 a.m. to 4 p.m., on
June 30, 2011, (ii) the Coast Guard will give advance notification via
maritime advisories so mariners can adjust their plans accordingly, and
(iii) although the safety zone will apply to the section of the Newport
River in the immediate vicinity of the US Highway 70 Fixed bridge,
vessel traffic may use alternate waterways to transit safely around the
safety zone. All Coast Guard vessels enforcing this regulated area can
be contacted on marine band radio VHF-FM channel 16 (156.8 MHz).

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a

substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of recreational and fishing
vessels intending to transit the specified portion of Newport River
from 10 a.m. to 4 p.m. on June 30, 2011.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will only be in effect for six hours from 10 a.m. to 4 p.m.
Although the safety zone will apply to the section of the Newport River
in the vicinity of the bridge, vessel traffic may use alternate
waterways to transit safely around the safety zone. Before the
effective period, the Coast Guard will issue maritime advisories widely
available to the users of the waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves the establishment of a
temporary safety zone to protect the public from bridge maintenance
operations.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping

requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add temporary Sec.  165.T05-0184 to read as follows:

Sec.  165.T05-0184  Safety Zone; Newport River, Morehead City, North
Carolina.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector North Carolina. Representative means
any Coast Guard commissioned, warrant, or petty officer who has been
authorized to act on the behalf of the Captain of the Port.
    (b) Location. The following area is a safety zone: This zone
includes the waters of Newport River directly under, latitude
34[deg]43'15'' North, longitude 076[deg]41'39'' West, and 100 yards on
either side of the U.S. Highway 70 Fixed bridge at Morehead City, North
Carolina.
    (c) Regulations. (1) The general regulations contained in Sec.
165.23 of this part apply to the area described in paragraph (b) of
this section.
    (2) Persons or vessels requiring entry into or passage through any
portion of the safety zone must first request authorization from the
Captain of the Port, or a designated representative, unless the Captain
of the Port previously announced via Marine Safety Radio Broadcast on
VHF Marine Band Radio channel 22 (157.1 MHz) that this regulation will
not be enforced in that portion of the safety zone. The Captain of the
Port can be contacted at telephone number<PHONE_NUMBER> or by radio on
VHF Marine Band Radio, channels 13 and 16.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 10 a.m.
to 4 p.m. on June 30, 2011 unless cancelled earlier by the Captain of
the Port.

    Dated: May 6, 2011.
A. Popiel,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2011-12378 Filed 5-20-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5894-5895]
[FR Doc No: 2023-01796]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1211]

Recommendations for Evaluating Donor Eligibility Using Individual
Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``Recommendations for
Evaluating Donor Eligibility Using Individual Risk-Based Questions to
Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood
and Blood Products; Draft Guidance for Industry.'' The draft guidance
document provides blood establishments that collect blood or blood
components, including Source Plasma, with FDA's revised donor deferral
recommendations for individuals with increased risk for transmitting
human immunodeficiency virus (HIV) infection. FDA is also recommending
that these blood establishments make corresponding revisions to donor
educational materials, donor history questionnaires and accompanying
materials, along with revisions to donor requalification and product
management procedures. This draft guidance, when finalized, will
supersede the guidance entitled, ``Revised Recommendations for Reducing
the Risk of Human Immunodeficiency Virus Transmission by Blood and
Blood Products; Guidance for Industry'' dated April 2020 and updated
August 2020.

DATES: Submit either electronic or written comments on the draft
guidance by March 31, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2015-D-1211 for ``Recommendations for Evaluating Donor Eligibility
Using Individual Risk-Based Questions to Reduce the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products; Draft
Guidance for Industry.'' 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 draft 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 draft 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 draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Andrew Harvan, 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Recommendations for Evaluating Donor Eligibility Using Individual
Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products; Draft Guidance for
Industry.'' This draft guidance document provides blood establishments
that collect blood or blood components, including Source Plasma, with
FDA's revised donor deferral recommendations for individuals with
increased risk for transmitting HIV infection. FDA is also recommending
that these blood establishments make corresponding revisions to donor
educational materials, donor history questionnaires and accompanying
materials, along with revisions to donor requalification and product
management procedures.
    In this draft guidance, based on FDA's review of the available
science, FDA recommends eliminating the time-based deferrals for men
who have sex with men (MSM) and women who have sex with MSM. Instead,
FDA recommends assessing donor eligibility using gender-inclusive,
individual risk-based questions relevant to HIV risk. In addition, FDA
recommends deferral of any individual taking medications to treat or
prevent HIV infection. FDA does not expect that implementation of these
recommendations will be associated with any adverse effect on the
safety of the blood supply.
    This draft guidance, when finalized, will supersede the guidance
entitled, ``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated April 2020 and updated August 2020.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on evaluating
donor eligibility using individual risk-based questions to reduce the
risk of HIV transmission by blood and blood products. 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

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections 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 for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 601.12 have been approved under OMB control
number 0910-0338; the collections of information in 21 CFR 606.121 and
parts 610 and 630 have been approved under OMB control number 0910-
0116; and the collections of information for consignee notification
have been approved under OMB control number 0910-0681.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01796 Filed 1-27-23; 8:45 am]
BILLING CODE 4164-01-P