Results

Acceptable/Guideline

870.4300
MRID
00139552

Carcinogenicity - Mice
(2 years)

0, 2.31, 9.61, or 44.65 mg/kg/day males
0, 2.63, 10.77 or 50.13 mg/kg/day females

Acceptable/Guideline

NOAEL = < 2.31/2.63 (M/F) mg/kg/day
LOAEL = 2.31/2.63 (M/F) mg/kg/day based on a dose-related increase in the incidence of hyperplastic nodules, basophilic and telangiectatic foci in the liver of females, accompanied by an increased incidence of stomach hyperkeratosis and spleen hematopoiesis in males.
Evidence of carcinogenicity: hepatocellular adenomas, carcinomas and combined; and lung adenomas, probably at dose levels above MTD.
                                Neurotoxicity

870.6200a
NA

Acute Neurotoxicity - Rat

Waived by HASPOC (J. Van Alstine, TXR# 0056451, 2/5/2013)

870.6200b
NA

Sub-chronic Neurotoxicity - Rat

Waived by HASPOC (J. Van Alstine, TXR# 0056451,
2/5/2013)

870.6300
NA
Developmental
Neurotoxicity - Rat
 A component of the EOGRT study
                                 Genotoxicity

870.5100
MRID
00161009

Reverse Gene Mutation in
Salmonella typhimurium

Negative up to 1 mg/plate, with and without metabolic activation.

870.5300
MRID
00161008
Forward Gene Mutation in mouse lymphoma cells

Negative at 0.06-20 ug/ml with and without metabolic activation.  HDT is highest non-cytotoxic dose.

870.5375
MRID
41795101
In Vitro Cytogenetics (Human
Lymphocytes)

Negative up to cytotoxic and/or insoluble concentrations.
870.5550
MRID
00161011
UDS Assay
(Human Embryonic Lung
Fibroblast)

Negative up to cytotoxic concentrations, with and without metabolic activation.
NonGuideline In Vitro Study
MRID
00161010
Cell Transformation

Negative up to cytotoxic concentrations, with and without metabolic activation.
                          Metabolism (Non-guideline)

N/A
MRID
0016096 and
MRID
46249601

Metabolism  -  Rat

1, 10, or 100 mg/kg

Acceptable/Non-guideline

No sex differences in proportion of various metabolites recovered in 24-hour urine samples.
Metabolic process saturated at the 100 mg/kg level.
No unchanged parent material found in the urine. Major metabolites: N-(2,4-dimethylphenyl)-N-methyl formamidine, 4-formamido-3-methyl benzoic acid, 4-

Table A.2.2    Toxicity Profiles for Amitraz

                              Guideline  Number

                                     MRID
                                     No.

                                  Study Type

                                   Results

acetamido-3-methyl benzoic acid and a polar fraction.  The polar fraction was labile to acid hydrolysis, yielding conjugates of 4-amino-3-methylbenzoic acid, N-(2,4-dimethylphenyl)-N-methyl formamidine, 4formamido-3-methyl benzoic acid and 4-acetamido-3methyl benzoic acid.

Peak levels of amitraz reached in urine within 8 hours: 78% of the dose in the urine and 9% in the feces by 98 hours.  Peak levels of metabolite BTS 27271 (chemical structure not identified in study) reached in urine within 24 hours: 89% of the dose in the urine and 4% in the feces by 96 hours.  Highest residues of amitraz and BTS 27271 reported in the liver.  Blood residue levels were 17.9 ppb for amitraz and not detectable for BTS 27271.  Kidney residue levels were comparable with 18.0 and 24 ppb for amitraz and BTS 27271, respectively.  Degradation products of amitraz and its metabolite, BTS 27271 were similar
N/A
MRID
00160964
MRID
46249601
Metabolism  -  Mouse

1, 10, or 100 mg/kg

Acceptable/Non-guideline
Urine accounted for 73% (male) and 66% (female) of the radiolabel excreted with 56-58% excreted in the first 24 hours. Determination of radiolabel in the feces, expired air and tissues was not done. Polar metabolites, likely representing conjugates (type not reported), were the predominant metabolites identified, contributing 59-64% of the total, and BTS 39 098/BTS 31 158 contributing 15-19%. When the dose was increased to 100 mg/kg, the percentage of polar metabolites decreased in mice and the metabolite BTS 27 271 increased.  This suggests metabolic saturation and shifting in the metabolic pathway.
N/A
MRID
00160964
MRID
46249601
Metabolism  -  Baboon

10 mg/kg

Acceptable/Non-guideline
Urine accounted for 65% (male) and 83% (female) of the radiolabel excreted with 55-75% excreted in the first 24 hours. Determination of radiolabel in the feces, expired air and tissues was not done. Polar metabolites were the predominant metabolites identified, contributing 52-55% of the total, and BTS 39 098/BTS 31 158 contributing 19-26%.
                                Dermal Studies

870.7600
MRID
42133501

Dermal Penetration  -  Rats

1.0 mg/kg

Unacceptable/Guideline

The mean percent of dose absorbed: treatment site (2.98% at 24 hours, 1.41% at 120 hours); total absorbed (3.69% at 24 hours, 6.56% at 120 hours); total (6.67% at 24 hours, 7.79% at 120 hours).
870.7600

OECD
428
MRID
49724601

MRID
49724602
Dermal Triple Pack: In vitro dermal penetration in rats and humans (Acceptable/Nonguideline) & in vivo dermal
penetration in rats
(Acceptable/Guideline)

The most conservative estimate of dermal absorption in the rat in vivo study was 38% for the 100 ug/cm[2] group evaluated 24 hours after dosing. This value represents the combined absorbed and potentially absorbable dose and was similar to other measurements in the different dose groups and sacrifice times. The maximal dermal absorption

Table A.2.2    Toxicity Profiles for Amitraz

                              Guideline  Number

                                     MRID
                                     No.

                                  Study Type

                                   Results

0, 20, 60, or 100 ug a.i./cm[2]
through rat skin in the in vitro study was only 7 +- 3%. Consequently, the in vitro study was not considered predictive of in vivo results; therefore, the dermal triple pack methodology could not be applied, and the Agency will use the in vivo dermal absorption without refinement for risk assessment.

                             Immunotoxicity Study
                                   870.7800
MRID
49611501
Immunotoxicity  -  Rats

0, 0.5, 2, or 8 mg/kg/day

Acceptable/Non-guideline

Systemic:
NOAEL = 8 mg/kg/day (HDT)
LOAEL = not established

Immunotoxicity:
NOAEL = 8 mg/kg/day (HDT)
LOAEL = not established
                        Non-Guideline Studies (Human)
Non-
Guideline
Human
Study

MRID
43283101

Acute Oral Toxicity

0, 0.0625, or 0.125 mg/kg

NOAEL = 0.125 mg/kg/day (HDT)
LOAEL = not established

Non-
Guideline
Human
Study

MRID
00160964
46249601
Metabolism Study

0.25 mg/kg
NOAEL = not established
LOAEL = 0.25 mg/kg based on dry mouth, drowsiness, disorientation, decreased temperature, bradycardia, and slightly pale appearance.

Humans appear to be most sensitive species. Above effects not seen in mouse, rat, or baboon, however, effects would be difficult to evaluate in these species.
Non-
Guideline
Human
Study

MRID
44639401
Acute Dermal Toxicity

0, 8, 16 or 24 mg/kg

NOAEL = 24 mg/kg (no LOAEL)

   Executive Summaries for Endpoint Selection Studies

              CITATION: Campbell, J.K. and D. Needham (l984). A comparison of the metabolism of [14]Camitraz in rat, mouse, baboon and human. FBC Limited, Chesterford Park Research Station, Saffron Walden, Essex CB10 1XL, January 17, 1984. MRID 00160964.  Unpublished. TXR# 0052737.

              Campbell, J.K. and D. Needham (l984). Urinary excretion of [14]C-amitraz by two male humans following a single oral dose of 0.25 mg/kg body weight. FBC Limited, Chesterford Park Research Station, Saffron Walden, Essex CB10 1XL, February 4, 1984.  MRID 46249601. Unpublished. TXR# 0052737.

   EXECUTIVE SUMMARY: In a metabolism study (MRIDs 00160964 and 46249601) radiolabeled Amitraz (1,5-di([14]C-2,4-dimethylphenyl)-3-methyl-1,3,5-triazapenta-1,4-diene) purity >95%, Batch #s REM-XLVI-85 and VA) was orally administered to rats, mice, baboons and humans.  Rats and mice were given 1, 10, or 100 mg/kg [[14]C]-Amitraz at 1, 10 or 100 mg/kg body weight in corn oil by gavage.  In addition, another group of mice were pretreated with 100 ppm and 400 ppm Amitraz in the diet for six weeks before being given a single gavage dose of 10 mg/kg of [[14]C]-Amitraz.  Baboons were given 10 mg/kg [[14]C]-Amitraz by gavage while human volunteers received a single 0.25 mg/kg dose of [[14]C]-Amitraz by capsule.

   Humans appear to be the most sensitive species to the neurological effects of Amitraz as shown by dry mouth, drowsiness, disorientation, decreased temperature, bradycardia, and slightly pale appearance after treatment with 0.25 mg/kg.  These effects were not found in rats, mice, or baboons, but, subjective effects would be difficult to evaluate in animal species.  Following treatment, the majority of the radiolabel was excreted in the urine, with 54.9-73.7%, excreted within 24 hours of treatment.  In further studies on human urine samples, ~43.5% of the dose was excreted within 12 hours, with 62.9% excreted within 24 hours.  No major differences in the amount of radiolabel excreted between sexes or species were noted.  The overall metabolic profile was similar across sex and species.  Polar metabolites, likely representing conjugates (type not reported), were the predominant metabolites identified, contributing 52-64% of the total with BTS 39 098/BTS 31 158 contributing 15-27%.

   The average proportion of metabolites identified in the urine following a single 1, 10, or 100 mg/kg oral dose of radiolabeled Amitraz was similar in rats and mice at doses of 1 mg/kg and 10 mg/kg.  When the dose was increased to 100 mg/kg, the percentage of polar metabolites decreased for both rats and mice and the metabolite BTS 27 271 increased.  This suggests metabolic saturation and shifting in the metabolic pathway.  In rats and mice pretreated with 100 ppm Amitraz in the diet for three weeks followed by three weeks of 400 ppm Amitraz in the diet, no effect on the relative concentrations of the metabolites were found.

   These urine metabolism studies in the rat, mouse, baboon and human and the human metabolism study are classified Acceptable/Nonguideline and satisfy the intent of the studies.

              CITATION: Cass, L (1992). T-344, Amitraz: Report of a double-blind tolerance study of amitraz in six adult healthy volunteers. Simbec Research Ltd., Merthyr Tydfil, Mid Glamorgan CF48 4DR, South Wales, United Kingdom. Laboratory Project RD 197/20170. June 8, 1992. MRID 43283101. Unpublished. TXR# 0052737.

   EXECUTIVE SUMMARY: In a double-blind sequential dosing oral human tolerance study of
   Amitraz, (Lot No. not reported, purity 98.2%), 7 adult male volunteers were given encapsulated 0, 0.0625, or 0.125 mg/kg in lactose over three 14-day periods. One volunteer was withdrawn from the study following development of a rash unrelated to treatment. The study subjects were 28.17 +- 3.54 years in age and weighed 67.15 +- 3.15 kg. The study was approved by the Simbec
   Independent Ethics Committee and done according to the Helsinki and Hong Kong revisions (l989). Each dose was administered 30 minutes after breakfast with 150 ml water. Vital signs including: pulse, respiration rate, blood, pressure and temperature were taken at  - 1, -0.5, 1, 3, 6, 12, 24, and 36 hours after dosing. ECGs were performed at  - 1, 1, 3, 6, 12, 24, and 36 hours after dosing and pupil responsiveness and psychomotor performance were evaluated pre-dose and at 2.5 and 8 hours after dosing. Urine was collected at 0-36 hours and 36-60 hours after treatment and blood for clinical chemistry and hematology was collected prior to the start of the study and 36 hours after each phase of the study.

   Two subjects reported tiredness, pre-dose (0.125 mg/kg) for 9 and 8h respectively, but this was determined to be unrelated to treatment. Vital signs and ECG parameters were within normal limits. No clinically significant changes were seen in pupil response. Psychomotor performance results showed no significant differences between pre- and post-treatment. One subject had a slightly elevated total bilirubin at the post-study screen but it returned to normal limits within three weeks completion of the study. No treatment-related effects were found on hematology or urinalysis parameters.

   This oral toxicity study in humans is Acceptable/Nonguideline and satisfies the intent of the study.

CITATION: 	Hoberman, A.M. (2016). Oral (Gavage) Extended One-Generation Reproduction
              Toxicity Study of Amitraz in Rats. Charles River Laboratories, Inc., Horsham, PA.  Laboratory Project ID.:  20001081, August 12, 2016. MRID 49994401.  Unpublished. TXR# 0057767.

EXECUTIVE SUMMARY:  In an extended one-generation reproduction toxicity study (MRID 49994401), Amitraz (98.8% a.i.; Batch # X080769/R5) in corn oil was administered daily via oral gavage in a dose volume of 5 mL/kg to 25 Sprague Dawley [Crl:CD(SD)] rats/sex/dose at dose levels of 0, 0.5, 1.5, or 7.5 mg/kg/day during premating, mating, littering, and post-partum.  The P generation males were dosed for 28 days prior to mating; P generation females were dosed for 15 days prior to mating. Following the birth of the F1 litters, the pups were randomly culled on postnatal day (PND) 4 to 12 pups/litter where possible (equal numbers of males and females if possible). The remaining F1 pups were administered the test substance beginning on PND 7 at the same dose level as their dam. On PND 21, the F1 pups were weaned and randomly assigned to one of four cohorts: Cohorts 1A and 1B to examine reproductive toxicity (Cohort 1B was not evaluated); Cohort 2A for evaluation of auditory startle (PND 24+-1), a functional observational battery (FOB; lactation day [LD] 17+-3 for females or PND 66+-3 for males), motor activity (FOB; LD 17+-3 for females or PND 66+-3 for males), and neurohistopathology (PND 90-92); and Cohort 2B for evaluation of neurohistopathology (PND 21).

Parental animals:  In females, there were no effects of treatment observed on body weights, body weight gains, or food consumption during pre-mating, gestation, or lactation. In both sexes, no adverse effects were observed for mortality, hematology, clinical chemistry, urinalysis, T4 concentrations, organ weights, or macroscopic or microscopic examinations.

Treatment-related effects were observed in the 7.5 mg/kg/day P males. Slight to moderate excess salivation, urine-stained abdominal fur, and vocalization to touch were observed (p<=0.01) at increased frequencies and in increased numbers of rats. Premating body weights of males were decreased (p<=0.01) by 6-8% during Days 15-28, resulting in a 46% decrease (p<=0.01) in premating (Days 1-28) body weight gains. Food consumption was decreased (p<=0.01) for every weekly interval during premating, resulting in an 11% decrease in premating food consumption. Following cohabitation, body weights were decreased (p<=0.01) by 9-14% during Days 36-85, resulting in a 43% decrease (p<=0.01) in overall (Days 1-85) body weight gains; overall food consumption was decreased (p<=0.01) by 12%. During the FOB observations, the number of males that appeared unkempt and had fecal and/or urine staining was increased (p<0.05). Males and females of the high dose group experienced decreased motor activity (ambulation and fine movements), particularly during the first several intervals, that were found to be statistically significant at individual intervals and over the entire treatment*time interval (where tested). Given the known neurotoxic effects of amitraz, the statistical significance, and the magnitude of the changes, the decrease in motor activity was considered adverse in both males and females.

The LOAEL for parental toxicity is 7.5 mg/kg/day, based on clinical signs of toxicity (salivation, urine stain fur, vocalization; males only), decreased body weights (males only), and decreased motor activity (both sexes).  The NOAEL is 1.5 mg/kg/day.

Offspring:  There were no effects of treatment on the number of pups delivered live or stillborn, birth or live birth indices, developmental landmarks, hematology, clinical chemistry, organ weights, or macroscopic examinations. At 7.5 mg/kg/day, an increase (p<=0.01) in pup deaths between PND 1-4 (3.9% treated vs. 0 control) resulted in a decreased (p<=0.01) viability index (95.1% treated vs. 99.7% control). Also at this dose, PND 21 body weights were decreased (p<=0.01) by 5% and 7% and PND 7-21 body weight gains were decreased (p<=0.01) by 8% and 10% in males and females, respectively.

T4 levels in PND 5 males could not be evaluated at the high dose because only one of two available sample was above the LLOQ. Overall there appears to be no effect of treatment on T4 levels on PND 5 males at the low and mid doses. Thyroid hormone levels for PND 5 females are unable to be interpreted because of the low number of pups in the concurrent control group (n = 3) very near the LLOQ. There was no effect of treatment on T4 levels on PND 22 males or females. TSH levels could not be evaluated because most samples were below the assay's LLOQ.

The LOAEL for offspring toxicity is 7.5 mg/kg/day, based on increased PND 1-4 pup deaths and decreased body weights in the pups (males and females).  The NOAEL is 1.5 mg/kg/day.

F1 adults  -  Cohorts 1A and 1B:  There were no treatment-related effects on mortality, clinical signs, sexual maturation, hematology, clinical chemistry, urinalysis, organ weights, or macroscopic or microscopic findings.

At 1.5 and 7.5 mg/kg/day there was a 24-25% decrease in female serum T4 levels. The changes were considered adverse due to the statistical significance and concerns for the number of animals near the LLOQ. At 7.5 mg/kg/day, body weights were decreased (p<=0.05) in the males by 4-13% during PND 42-98; body weights were decreased (p<=0.05) in the females by 4-6% during PND 28-77 and PND 91.  Adult body weight gains (PND 21-98) were decreased by 13% in the
7.5 mg/kg/day males; adult body weight gains were unaffected by treatment in the 7.5 mg/kg/day females.  Food consumption was decreased (p<=0.01) by 5-14% for every weekly interval during PND 42-98 in the 7.5 mg/kg/day males. Males and females of the high dose group experienced decreased motor activity (ambulation and fine movements) that were found to be statistically significant at individual intervals and over the entire treatment*time interval. Given the known neurotoxic effects of amitraz, the statistical significance, and the magnitude of the changes, the decrease in motor activity was considered adverse in both males and females.

The LOAEL for F1 adult toxicity is 1.5 mg/kg/day, based on decreased T4 levels (↓25%; females only). The NOAEL is 0.5 mg/kg/day.

Reproductive toxicity:  No treatment-related effects were observed on sperm motility or density, or reproductive performance in either the P males and females or in the F1 males.

Evaluation of estrous cyclicity found an increase incidence of females with persistent diestrus at the high dose (7/24 of the females; 29.1%). Evaluations of ovarian follicles in the F1 Cohort 1A females revealed the mean number of primordial follicles was increased (p<=0.05) in the 7.5 mg/kg/day females for both the left and right ovary and both ovaries combined.

The LOAEL for reproductive toxicity was 7.5 mg/kg/day based on increased incidence of persistent diestrus and increase number of primordial follicles.  The NOAEL for reproductive toxicity is 1.5 mg/kg/day.

Developmental neurotoxicity  -  Cohorts 2A and 2B:

There were no effects of treatment on brain weights in the Cohort 2A or 2B rats. The Cohort 2A
7.5 mg/kg/day males had an 11% decrease (p<=0.01) in terminal body weight that resulted in a 12% increase (p<=0.01) in relative brain weight; absolute brain weight was unaffected by treatment.

In the 7.5 mg/kg/day Cohort 2A males (PND 90), the area of the rostral (preoptic) hypothalamus was decreased (↓8%; p<=0.05) compared to control. In the 7.5 mg/kg/day Cohort 2B (PND 21) males, decreases in corpus callosum thickness (↓18%; p<=0.05) and distance across the hippocampal pyramidal layers (↓5%; p<=0.001) were observed. Given the statistical significance of the above-mentioned parameters, the magnitude of change, and the lack of data for both the low and mid dose, these effects are considered adverse.

In the 7.5 mg/kg/day Cohort 2A females (PND 90), a slight increase (↑3%; p<=0.05) in the thickness of the parietal cortex was noted, but this minor change was not considered adverse. There were no other findings in the microscopic measurements.

The LOAEL for developmental neurotoxicity is 7.5 mg/kg/day based on brain morphometrics (↓ hypothalamus area, ↓ corpus callosum thickness, ↓ in distance across hippocampal pyramidal layers; males only). The NOAEL is not established since brain morphometrics were not reported for the mid or low dose groups.

Initially, a Cohort 3 was integrated into the EOGRTS protocol to determine potential immunotoxic effects. This Cohort was not tested within the EOGRTS; however, an immunotoxicity study was submitted in which 10 female SD rats/dose were administered the test compound via gavage at 0, 0.5, 2, or 8 mg/kg/day for 27 days (MRID 49611501). The systemic and immunotoxic NOAEL was set at the highest dose tested, 8 mg/kg/day, with positive controls (cyclophosphamide monohydrate) acting accordingly. Given the lack of immunotoxicity in the stand alone study up to the highest dose tested in the EOGRTS, the immunotoxicity study (MRID 49611501), satisfies the immunotoxic portion of the EOGRTS.

This study is classified as acceptable/non-guideline and does not satisfy the guideline requirements (OCSPP No guideline; OECD 443) for an extended one-generation reproduction toxicity study in the rat. Additional thyroid hormone data and brain morphometric data (discussed in deficiency section at the end of DER) is required to upgrade this study to guideline.

Appendix B.  Physical/Chemical Properties

 Table B.1.1  Physicochemical Properties of Amitraz.

 Parameter

                                    Value

                                  Reference

 Melting point/range

                                  86-87 C

 Amitraz RED, 3/1/1995

 pH of 1% aqueous suspension

 N/A (low solubility; decomposes in water)

 Amitraz RED, 3/1/1995

 Density or specific gravity

                            1.128 g/mL at 20 C

 Amitraz RED, 3/1/1995

 Water solubility

                           <1 ppm at 20-25 C

 Amitraz RED, 3/1/1995

 Solvent solubility

 At 20-25 C xylene  	 acetone  	 methanol
66.6 g/100 mL
50.0 g/100 mL
 2.38 g/100 mL

 Amitraz RED, 3/1/1995

 Vapor pressure

                          3.4 x 10[-4] Pa at 25 C

 Amitraz RED, 3/1/1995

 Octanol/water partition coefficient (Kow)

                       3.0 x 10[5] at 25 C (pH 5.8)

 CBRS No. 3975, H. Fonouni, 7/21/1988

Appendix C.  Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These data include an acute oral human study, a human metabolism study, and the Residential SOPs (Pet SOP), are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requirements.  For certain studies, the ethics review may have included review by the Human Studies Review Board (HSRB).  Descriptions of data sources, as well as guidance on their use, can be found at the Agency website[,].

Appendix D.  Summary of Amitraz US and International Tolerances and Maximum
Residue Limits (MRLs)

Table D.1.  Summary of Amitraz US and International Tolerances and Maximum Residue Limits (MRLs)
U.S.
Canada
Mexico
Codex
Residue Definition:
40 CFR 180.287
Amitraz (N'-[2,4-dimethylphenyl]N-[[(2,4dimethylphenyl)imino]methyl]]-Nmethylmethanimidamide) and its metabolites containing the 2,4dimethylaniline moiety calculated as the parent
N,N-bis(2,4xylyliminomethyl)methylamine, including the metabolite N-(2,4dimethylphenyl)-N'-methyl formamidine

Sum of amitraz and N-(2,4dimethylphenyl)-N'methylformamidine calculated as N-(2,4dimethylphenyl)-N'methylformamidine.
Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)
Commodity
U.S.
Canada
Mexico
Codex
Cattle, fat
0.1

Cattle, meat
0.02[1]

0.052
Cattle, meat byproducts
0.2[1]
0.2 (kidney; liver)

0.2 (edible offal)2
Cotton, undelinted seed

0.5 (cotton seed)
0.05 (cotton seed oil)
Hog, fat
0.1[1]

Hog, kidney
0.1[1]
0.2

0.2 (edible offal)3
Hog, liver
0.1[1]
0.2

0.2 (edible offal)3
Hog, meat
0.05[1]

0.052
Hog, meat byproducts
0.3[1]

Honey
0.2
0.1

Honeycomb
9

Milk
0.03[1]

0.01 (*)2
Milk, fat
0.2[1]

Pear

1

0.5 (pome fruit)
Cherry

0.5
Cucumber

0.5
Orange

0.5
Peach

0.5
Sheep, meat

0.12
Sheep, meat byproducts

0.2 (edible offal)[2]
Tomato

0.5
Apple

0.5

0.5 (pome fruit)
Prepared 7/16/2018, D. Drew
Appendix E. Search Parameters for Amitraz Toxicology Literature Review

Date and Time of Amitraz Literature Search:
4/18/2018; 08:50 am

Search Details:
((Amitraz)) AND (rat OR mouse OR dog OR rabbit OR monkey OR mammal)

PubMed hits: 361
Number of Swift Articles:  330 for Animal
Number of Swift Articles:  165 for Human
Number of Swift Articles:   1 for No Tag


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26127-26128]
[FR Doc No: 2021-10052]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2021-0050]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on March 6, 2021, the Southern
California Railway Museum (SCRM) petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR 230.17,
One thousand four hundred seventy-two (1472) service day inspection.
FRA assigned the petition Docket Number FRA-2021-0050.
    For locomotive SCRM VC 2, SCRM requests to extend the period in
which the 1472 service day inspection must be completed until November
21, 2021, which is the date at which the locomotive's next annual
inspection is due. At the end of the proposed extension period, SCRM VC
2 will have a total of less than 320 service days, which is less than
22% of the 1472 service day allowance. SCRM states that the extension
would allow it to continue operating the locomotive for fundraising
purposes and aligning the 1472 service day inspection with the annual
inspection would potentially improve SCRM's financial challenges due to
less revenue in the previous year.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.

    Communications received by June 28, 2021 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
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individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
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privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2021-10052 Filed 5-11-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: November 6, 2007 (Volume 72, Number 214)]
[Notices]
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[DOCID:fr06no07-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 199-205]

Santee Cooper Hydroelectric Project; Notice of Availability of
the Final Environmental Impact Statement for the Santee Cooper
Hydroelectric Project

October 26, 2007.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission or FERC)
regulations contained in the Code of Federal Regulations (CFR)(18 CFR
part 380 [FERC Order No. 486, 52 FR 47897]), the Office of Energy
Projects staff (staff) reviewed the application for a New Major License
for the Santee Cooper Hydroelectric Project, and have prepared a final
environmental impact statement (FEIS) for the project which is located
on the Santee and Cooper Rivers in Berkeley, Calhoun, Clarendon,
Orangeburg, and Sumpter Counties, South Carolina.
    The FEIS contains staff's analysis of the applicant's proposal and
the alternatives for relicensing the Santee Cooper Hydroelectric
Project. The FEIS documents the views of governmental agencies, non-
governmental organizations, affected Indian tribes, the public, the
license applicant, and Commission staff.
    The FEIS will be part of the record from which the Commission will
make its decision.
    A copy of the FEIS is available for review at the Commission's
Public Reference Room (Room 2A, located at 888 First Street, NE.,
Washington, DC 20426) or may be viewed on the Commission's Web site at
http://www.ferc.gov, using the ``e-Library'' link. Enter the docket

number, excluding the last three digits, to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    CD versions of the FEIS have been mailed to everyone on the mailing
list for the project. Copies of the CD, as well as a limited number of
paper copies, are available from the Public Reference Room identified
above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.

    For further information, please contact Monte TerHaar at (202) 502-
6035 or at<EMAIL_ADDRESS>
 Kimberly D. Bose,
Secretary.
[FR Doc. E7-21733 Filed 11-5-07; 8:45 am]

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