February 14, 2006

MEMORANDUM

SUBJECT:	Propylene/Dipropylene Glycol Revised Ecological Hazard and Environmental Risk Characterization Chapter for the Reregistration Eligibility Decision (RED) Document, Case 3126

TO:		Sanyvette Williams-Foy, Science Coordinator

Immediate Office

Antimicrobials Division (7510C)

And

Ben Chambliss, Team Leader

Connie Welch, Branch Chief

Regulatory Management Branch II

Antimicrobials Division (7510C)

FROM:	Kathryn Montague, M.S., Biologist

Risk Assessment and Science Support Branch

Antimicrobials Division (7510C)

THRU:	Siroos Mostaghimi, Team Leader

Norm Cook, Branch Chief

Risk Assessment and Science Support Branch

Antimicrobials Division (7510C)

Attached is the revised Propylene/Dipropylene Glycol ecological hazard and environmental risk characterization for incorporation into the RED document.

ECOLOGICAL HAZARD AND ENVIRONMENTAL RISK ASSESSMENT

Propylene and Dipropylene Glycol

Case No. 3126

(PC CODE 068603 and 068604)

February 14, 2006

Table of Contents

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1

1.  Ecological Toxicity Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

a.  Toxicity to Terrestrial Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

1.  Birds, Acute and Subacute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. Mammals, Acute and Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

b.  Toxicity to Aquatic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.  Freshwater Fish, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

2.  Freshwater Invertebrates, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

3.  Estuarine and Marine Organisms, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

4.  Aquatic Organisms, Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

c.  Toxicity to Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.  Risk Assessment and Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

a.  Environmental Fate Assessment Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

b.  Environmental Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

c.  Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

d.  Endangered Species Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

3.  References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  . . . . . . . . . . . . . .. . . .  12

	Ecological Effects Hazard and Environmental Risk Assessment

	Propylene and Dipropylene Glycol

Executive Summary:

Propylene glycol is used as an active pesticidal ingredient for the following use patterns:  air sanitizer, insecticide, fungicide, acaricide, antibacterial cleaner, and tuberculocide in residential areas and hospitals.  Dipropylene glycol is used as a fungicide, medical disinfectant, sanitizer and virucide in residential areas and hospitals.  All registered pesticidal uses of these two chemicals are indoor.  There are also non-pesticidal uses of both propylene and dipropylene glycol, e.g., solvents and de-icing fluids, and propylene glycol is also used as an inert ingredient in certain pesticide formulations (Quintec, for fungicidal application on cherry, grapes and hops, preharvest).

Both propylene glycol and dipropylene glycol show very low acute toxicity to terrestrial and aquatic animals.  No data were available to address the chronic toxicity of either chemical to animals or acute or chronic toxicity to plants.

Environmental exposure from the registered uses of propylene and dipropylene glycol should be minimal. No environmental modeling was performed, as these uses are all indoors. The lack of exposure coupled with the very low toxicity of these compounds indicates that acute risk to terrestrial and aquatic animals should not occur from the registered uses of these chemicals.  No data were available to address the risk to plants, but exposure to plants is not expected from the registered uses of propylene and dipropylene glycol.  Environmental modeling was conducted for the inert use of propylene glycol in pesticide formulations (see memo from A. Najm Shamim), and the estimated exposure was compared to the available acute toxicity information for birds, mammals, fish, and aquatic invertebrates.  The resulting risk quotients (RQs) were all below acute Agency levels of concern (LOCs) for birds, mammals, fish and aquatic invertebrates. Chronic risk and risk to plants could not be assessed due to a lack of chronic toxicity and phytotoxicity information.

For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, pg.81).  Chemicals in these categories therefore do not undergo a full screening-level risk assessment, and are considered to fall under a (no effect(  (NE) determination.  The active ingredient uses of  propylene and dipropylene glycol fall into this category.

Exposure to nontarget organisms from the inert use of propylene glycol in pesticide formulations was assessed.  Resulting RQs were well below acute LOCs for endangered birds, mammals, fish and aquatic invertebrates.  Therefore, the inert uses of propylene glycol are also considered to have no effect (NE) on listed species in those taxa.  Risk to plants cannot be addressed at this time due to a lack of phytotoxicity data.

A.	Ecological Toxicity Data

  The toxicity endpoints presented below are based on the results of toxicity studies submitted by registrants to meet the Agency(s ecological effects data requirements for the uses of propylene glycol and dipropylene glycol. Additional information was located in EPA/ORD’s ECOTOX database, which provides summary endpoints from the open scientific literature as well as studies submitted to the Agency.

1.	Toxicity to Terrestrial Animals

(a)  Birds, Acute and Subacute

In order to establish the toxicity of propylene glycol and dipropylene glycol to birds, the Agency required an acute oral toxicity study using the technical grade of the active ingredient (TGAI).  The preferred test species is either mallard duck (a waterfowl) or bobwhite quail (an upland game bird).  The results of submitted studies are provided in the following tables (Table 1 and 2).

Table 1.  Acute Oral Toxicity of Propylene Glycol to Birds

Species

% Active Ingredient (ai)

Endpoint

(mg/kg)

Toxicity Category (TGAI)

Satisfies Guidelines/

Comments

Reference

Northern bobwhite

(Colinus virginianus)

100

LD50 > 2000

NOEL = 2000

Practically non- toxic

Yes

Campbell and Beavers, 1995

MRID#43762301

Northern bobwhite

(Colinus virginianus)

99.88

LD50 > 2150

NOEL = 2150

Practically non-toxic

Yes

Pedersen, 1995

MRID #43888002

The results indicate that propylene glycol is practically non-toxic to birds on an acute oral basis. The studies are acceptable and fulfill guideline requirements (71-1/OPPTS 850.2100).

Table 1.  Acute Oral Toxicity of Dipropylene Glycol to Birds

Species

% Active Ingredient (ai)

Endpoint

(mg/kg)

Toxicity Category (TGAI)

Satisfies Guidelines/

Comments

Reference

Northern bobwhite

(Colinus virginianus)

100

LD50 > 2000

NOEL = 2000

Practically non- toxic

Yes

(  core study

(  14-day test duration

Campbell and Beavers, 1995

MRID#43760807

The results indicate that dipropylene glycol is practically non-toxic to birds on an acute oral basis. The study is acceptable and fulfills guideline requirements (71-1/OPPTS 850.2100).

A subacute dietary study using the TGAI may be required on a case-by-case basis depending on the results of lower tier ecological studies and pertinent environmental characteristics to establish the toxicity of a chemical to avian species.  This testing was not required for propylene or dipropylene glycol.

(b) Mammals

Table 3. Toxicity of Propylene Glycol to Mammals (excerpted from Toxicology chapter)

Species

Test Type

Results

Rat

Acute oral

LD50  8000 - 46000 mg/kg (toxicity category IV)

Rat

15-week feeding

NOAEC = 2500 mg/kg/day

Mouse

Developmental

maternal, reproductive, developmental NOAEL = 10400 mg/kg/day (oral)

Table 4. Toxicity of Dipropylene Glycol to Mammals (excerpted from Toxicology chapter)

Species

Test Type

Results

Rat

Acute oral

LD50 >5010 mg/kg (Toxicity category IV)

Mouse

90-day - drinking water

NOAEC = 4790mg/kg/day  male, 7430 mg/kg/day female

Rat

Developmental

reproductive, developmental NOAEL = 5000 mg/kg/day

Both propylene and dipropylene glycol show low acute toxicity to mammals in laboratory studies, and do not produce developmental or reproductive effects at fairly high doses.

2.	Toxicity to Aquatic Animals

(a)	Freshwater Fish, Acute

In order to establish the acute toxicity of an indoor use antimicrobial pesticide to freshwater fish, the Agency requires a freshwater fish toxicity study using the TGAI.  Data are generally required on only one species for indoor use antimicrobial pesticides.  The preferred test species are rainbow trout (a coldwater fish) or bluegill sunfish (a warmwater fish). Fish acute testing was required for propylene glycol, and was reserved for dipropylene glycol, depending upon the results of the propylene glycol fish test.  No fish acute toxicity testing has been submitted to the Agency. A survey of the EPA/ORD database ECOTOX provided multiple freshwater fish acute toxicity endpoints for propylene glycol, which are summarized in the table, below.

Table 5.  Acute Toxicity of Propylene Glycol to Freshwater Fish

Species

Endpoints

Toxicity Category

Reference

Goldfish (Carassius auratus)

Static 24 hr. LC50 >5000 ppm ai

 Practically non-toxic

Bridie et al., 1979 (ECOTOX reference #623)

Rainbow trout (Oncorhynchus mykiss)

Static 24-hr LC50 = 50,000 ppm

Practically non-toxic

Majewski et al., 1978 (ECOTOX reference # 991)

Fathead minnow (Pimephales promelas)

48 hr LC50 = 790 ppm

Practically non-toxic

Pillard, 1995

(ECOTOX reference #13727)

Fathead minnow (Pimephales promelas)

96 hr LC50 = 710 ppm

Practically non-toxic

Pillard, 1995

(ECOTOX reference #13727)

Fathead minnow (Pimephales promelas)

96 hr LC50 = 62,000 ppm ai

Practically non-toxic

Pillard, 1995

(ECOTOX reference #13727)

Table 6.  Acute Toxicity of Dipropylene Glycol to Freshwater Fish

Species

Endpoints

Toxicity Category

Reference

Goldfish (Carassius auratus)

24 hr. LC50 >5000 ppm ai

 Practically non-toxic

Bridie et al., 1979 (ECOTOX reference #623)

The results indicate that propylene glycol and dipropylene glycol are practically non-toxic to freshwater fish on an acute basis.  Since these data are supplemental information, Guideline 72-1/850.1075 is not fulfilled; however, since multiple published studies demonstrate very low toxicity to freshwater fish, no further testing is required for propylene glycol or dipropylene glycol.

(b)	Freshwater Invertebrates, Acute

The Agency requires a freshwater aquatic invertebrate toxicity study using the TGAI to establish the acute toxicity of an antimicrobial pesticide to freshwater invertebrates.  The preferred test species is Daphnia magna.  Results of submitted studies for proylene glycol and dipropylene glycol are provided in the following tables:

Table 7.  Acute Toxicity of Propylene glycol to Freshwater Invertebrates

Species

% Active Ingredient (ai)

Endpoints

(ppm)

Toxicity Category (TGAI)

Satisfies Guidelines/

Comments

Reference

Waterflea

(Daphnia magna)

100

48-hr. EC50> 110 ppm ai

NOEC = 110 ppm ai

Practically non-toxic

Yes

Graves and Swigert, 1995.  MRID #437623-02

Waterflea

(Daphnia magna)

99.76

48-hr. EC50 >1000 ppm ai

NOEC = 1000 ppm ai

Practically non-toxic

Yes

Collins, 1995

MRID #438880-03

The results of these studies indicate that propylene glycol is practically non-toxic to freshwater invertebrates.  The Guideline requirement has been fulfilled (850.1010/72-2). Additional data on the acute toxicity of propylene glycol to freshwater invertebrates was retrieved from the ECOTOX database.  This information is provided below:

Table 8.  Additional Data on the Acute Toxicity of Propylene Glycol to Freshwater Invertebrates

Species

Endpoints

Toxicity Category

Reference

Waterflea (Ceriodaphnia dubia)

48 hr. LC50 = 1020 ppm ; NOEC = 660 ppm

 Practically non-toxic

Pillard, 1995

(ECOTOX reference #13727)

Waterflea (Ceriodaphnia dubia)

48 hr LC50= 18340 ppm ai; NOEC = 13020 ppm ai

Practically non-toxic

Pillard, 1995

(ECOTOX reference #13727)

Waterflea (Ceriodaphnia dubia)

48 hr LC50 = 4919 ppm ai

Practically non-toxic

Cornell et al., 2000

(ECOTOX reference #48385)

Waterflea (Daphnia magna)

48 hr EC50 > 10000 ppm

Practically non-toxic

Kuhn et al., 1989

(ECOTOX reference #846)

These results further indicate that propylene glycol demonstrates very low toxicity to freshwater invertebrates.

Table 9.  Acute Toxicity of Dipropylene glycol to Freshwater Invertebrates

Species

% Active Ingredient (ai)

Endpoints

(ppm)

Toxicity Category (TGAI)

Satisfies Guidelines/

Comments

Reference

Waterflea

(Daphnia magna)

100

48-hr. EC50> 109 ppm ai

NOEC = 109 ppm ai

Practically non-toxic

Yes

Graves and Swigert, 1995.  MRID #437608-08

The results of this study indicate that dipropylene glycol is practically non-toxic to freshwater invertebrates.  The Guideline requirement has been fulfilled (850.1010/72-2).

(c)	Estuarine and Marine Organisms, Acute

Acute toxicity testing with estuarine and marine organisms using the TGAI is required when the end-use product is intended for direct application to the marine/estuarine environment or effluent containing the active ingredient is expected to reach this environment. Neither propylene glycol nor dipropylene glycol have such uses on their labels, so testing with marine/estuarine organisms is not required.  Some information on the acute toxicity of propylene glycol to marine/estuarine invertebrates was found in ECOTOX, and the results are provided below:

Table 10. Acute Toxicity of Propylene Glycol to Marine/Estuarine Organisms

Species

Endpoints

Toxicity Category

Reference

Brine Shrimp (Artemia salina)

static 24 hr. LC50 > 10000 ppm

 Practically non-toxic

Price et al., 1974

(ECOTOX reference #2408)

The results of this study indicate that propylene glycol is practically non-toxic to brine shrimp on an acute basis.

(d)  Aquatic Organisms, Chronic

Chronic toxicity testing (Fish early life stage, 850.1300/72-4a and aquatic invertebrate life cycle, 850.1400/72-4b) is not required for the currently registered uses of propylene glycol or dipropylene glycol. No comparable endpoints were found in the ECOTOX database.

3.  Toxicity to Plants

Plant toxicity testing is not required for the currently registered uses of propylene glycol or dipropylene glycol.  No phytotoxicity data were found in the ECOTOX database.

B.  Risk Assessment and Characterization

Risk assessment integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. One method of integrating the results of exposure and ecotoxicity data is called the quotient method.  For this method, risk quotients (RQs) are calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic:

           RQ = EXPOSURE/TOXICITY

RQs are then compared to AD's levels of concern (LOCs).  These LOCs are criteria used by OPP to indicate potential risk to nontarget organisms and the need to consider regulatory action.  The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms.  LOCs currently address the following risk presumption categories: (1) acute high - potential for acute risk is high regulatory action may be warranted in addition to restricted use classification; (2) acute restricted use - the potential for acute risk is high, but this may be mitigated through restricted use classification; (3) acute endangered species - the potential for acute risk to endangered species is high, and regulatory action may be warranted, and (4) chronic risk - the potential for chronic risk is high, and regulatory action may be warranted.   Currently, AD does not perform assessments for chronic risk to plants, acute or chronic risks to nontarget insects, or chronic risk from granular/bait formulations to mammalian or avian species.

The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk quotients are derived from the results of required studies.  Examples of ecotoxicity values derived from the results of short-term laboratory studies that assess acute effects are: (1) LC50 (fish and birds) (2) LD50 (birds and mammals (3) EC50 (aquatic plants and aquatic invertebrates) and (4) EC25 (terrestrial plants).  Examples of toxicity test effect levels derived from the results of long-term laboratory studies that assess chronic effects are: (1) LOEC (birds, fish, and aquatic invertebrates) (2) NOEC (birds, fish and aquatic invertebrates) and (3) MATC (fish and aquatic invertebrates).  For birds and mammals, the NOEC value is used as the ecotoxicity test value in assessing chronic effects.  Other values may be used when justified.  Generally, the MATC (defined as the geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in assessing chronic effects to fish and aquatic invertebrates.  However, the NOEC is used if the measurement endpoint is production of offspring or survival.

Risk presumptions, along with the corresponding RQs and LOCs are tabulated below.

Risk Presumptions for Terrestrial Animals

Risk Presumption

RQ

LOC

Birds and Wild Mammals

Acute High Risk

EEC1/LC50 or LD50/sqft2 or LD50/day3

0.5

Acute Restricted Use

EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)

0.2

Acute Endangered Species

EEC/LC50 or LD50/sqft or LD50/day

0.1

Chronic Risk

EEC/NOEC

1

 1  abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items

 2    mg/ft2             	3  mg of toxicant consumed/day

   LD50 * wt. of bird             	LD50 * wt. of bird

Risk Presumptions for Aquatic Animals

Risk Presumption

RQ

LOC

Acute High Risk

EEC1/LC50 or EC50

0.5

Acute Restricted Use

EEC/LC50 or EC50

0.1

Acute Endangered Species

EEC/LC50 or EC50

0.05

Chronic Risk

EEC/MATC or NOEC

1

 1  EEC = (ppm or ppb) in water

Risk Presumptions for Plants

Risk Presumption

RQ

LOC

Terrestrial and Semi-Aquatic Plants

 tc \l2 "Terrestrial and Semi-Aquatic Plants

Acute High Risk

EEC1/EC25

1

Acute Endangered Species

EEC/EC05 or NOEC

1

Aquatic Plants

 tc \l2 "Aquatic Plants

Acute High Risk

EEC2/EC50

1

Acute Endangered Species

EEC/EC05 or NOEC

1

1  EEC = lbs ai/A

2  EEC = (ppb/ppm) in water

1.  Environmental Fate Assessment Summary (excerpted from the Environmental Fate Science Chapter of  this RED document)

Propylene Glycol is not bioaccumlative ( log KOW is -0.92).   It does not hydrolyze and is very mobile in soils, but it  biodegrades in 4 days in aerobic soils, and the registered pesticidal uses are not likely to contaminate surface or ground water.  Its half life in air is about 32 hours (estimated) due to induced photochemical reaction with hydroxy radical in the atmosphere and its presence in the atmosphere is not likely a concern.

Dipropylene Glycol is not bioaccumlative ( log KOW is -1.07).  It does not hydrolyze. It is highly miscible in water and has low binding constant with soils and it is shown to be very mobile in soils.. Therefore, there is a potential for ground water and surface water contamination if outdoor use occurs, but this is not likely from the registered pesticidal uses.  Biodegradation of dipropylene glycol is slow, according to aerobic biological screening tests.  Its half life in air is about 13 hours (estimated) due to induced photochemical reaction with hydroxy radical in the atmosphere and hence its presence in the atmosphere is not likely to pose any problem.

2.  Environmental Exposure Assessment

Environmental exposure modeling was not conducted for the registered pesticidal uses of propylene glycol or dipropylene glycol, as these uses are all indoors and are not expected to result in any appreciable environmental exposure. Environmental exposure will occur from the use of propylene glycol as an inert ingredient in certain pesticide formulations (inert in Quintec for fungicidal application on cherry, grapes and hops, preharvest). Environmental exposure for the inert use of propylene glycol was assessed (see attached memo from A. Najm Shamim). Estimated peak surface water concentrations were 887.54 ppb, and estimated annualized average concentrations were 11.07 ppb. Detailed environmental modeling was not performed for the terrestrial exposure from these uses; however, using a high exposure scenario of a 1 lb/A application rate applied via broadcast spray to short grasses with no environmental breakdown, an EEC of 240 ppm is obtained.

3.  Environmental Risk Assessment

The pesticidal uses of propylene glycol and dipropylene glycol considered in this RED make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur. The lack of exposure, coupled with the very low toxicity of these compounds to birds, mammals, and aquatic organisms, indicate very low ecological risk from their use. Toxicity and risk to plants cannot be addressed at this time due to the lack of phytotoxicity information; however, exposure to plants should not occur from the registered, indoor uses of these chemicals.

The high terrestrial acute estimated exposure value of 240 ppm, described above, is well below the levels causing acute toxic effects in birds and mammals (avian acute oral LD50s > 2000 mg/kg; rat acute oral >5010 mg/kg).  Acute RQs for birds and mammals of varying body size are reported in the table, below:

Table 11: Acute RQs for Terrestrial Organisms Based on High Exposure Estimate for the Inert Use of Propylene Glycol

Species

Body weight (kg)

Food Consumption (g/day)

LD50

(mg/kg bw)

EEC

(240 mg/kg x 1kg/1000g x Food Cons)

RQ

[EEC/(LD50 x bw)]

Bobwhite quail

0.170

15.20

2000

3.648

0.011

Field sparrow

0.0139

4.656

2000

1.116

0.040

Mouse/shrew

0.015

14.25

5010

3.42

0.046

Vole

0.035

5.25

5010

1.26

0.007

Rat

1.000

30.0

5010

7.2

0.001

No adverse acute effects to birds and mammals is anticipated from the use of propylene glycol as an inert ingredient in Quintec applied preharvest to hops, grapes, and cherries.

Estimated surface water concentrations from the inert use of propylene glycol are well below levels of concern for nontarget aquatic organisms, with RQs as follows:

Table 12: Acute RQs for Aquatic Organisms Based on Estimated Surface Water Concentrations from the Inert Use of Propylene Glycol

Species

Endpoint

Estimated Surface Water Concentration

Risk Quotient

Fathead minnow

96-hour LC50 = 710 ppm

Acute EEC = 887.54 ppb (0.9005 ppm)

0.0013

Daphnid

48-hr EC50 = 4919 ppm

Acute EEC = 887.54 ppb (0.9005 ppm)

0.00018

Brine Shrimp

24-hour EC50 = 1000 ppm

Acute EEC = 887.54 ppb (0.9005 ppm)

0.0009

4.  Endangered Species Considerations

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated habitat. Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.  To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 C.F.R. ( 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection (a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004).  After the Agency(s screening-level risk assessment is performed, if any of the Agency(s Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co-occur in the area of the proposed pesticide use.  If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is undertaken.  The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, pg.81).  Chemicals in these categories therefore do not undergo a full screening-level risk assessment, and are considered to fall under a (no effect(  (NE) determination.  The active ingredient uses of  propylene and dipropylene glycol fall into this category.

Exposure to nontarget organisms from the inert use of propylene glycol in pesticide formulations was assessed.  Resulting RQs were well below acute LOCs for endangered birds, mammals, fish and aquatic invertebrates.  Therefore, the inert uses of propylene glycol are also considered to have no effect (NE) on listed species in those taxa.  Risk to plants cannot be addressed at this time due to a lack of phytotoxicity data.

REFERENCES

Submitted Data:

MRID#43760807.  Campbell and Beavers, 1995.  Acute oral toxicity of dipropylene glycol to Northern bobwhite.  Unpublished data.

MRID #43760808.  Graves and Swigert, 1995.  Acute toxicity of dipropylene glycol to the waterflea (Daphnia magna).

MRID#43762301. Campbell and Beavers, 1995.  Acute oral toxicity of propylene glycol to Northern bobwhite.  Unpublished data.

MRID #43762302.  Graves and Swigert, 1995.  Acute toxicity of propylene glycol to the waterflea (Daphnia magna).  Unpublished data.

MRID #43888002.  Pedersen, 1995.  Acute oral toxicity of propylene glycol to Northern bobwhite.  Unpublished data.

MRID #43888003. Collins, 1995. Acute toxicity of propylene glycol to the waterflea (Daphnia magna).  Unpublished data.

Published Data:

Bridie, A.L., C.J.M. Wolff, and M. Winter.  1979.  The Acute Toxicity of Some Petrochemicals to Goldfish.  Water Res. 13(7):623-626. (ECOTOX reference #623).

Cornell, J.S., D.A. Pillard, and M.T. Hernandez. 2000.  Comparative Measures of the Toxicity of Component Chemicals in Aircraft Deicing Fluid.  Environ. Toxicol. Chem. 19(6):1465-1472. (ECOTOX reference #48385).

Kuhn, R., M. Pattard, K. Pernak, and A. Winter. 1989.  Results of the Harmful Effects of Selected Water Pollutants (Anilines, Phenols, Aliphatic Compounds) to Daphnia magna.  Water Res. 23(4):495-499. (ECOTOX reference #846).

Majewski, H.S., J.F. Klaverkamp, and D. P. Scott. 1978.  Acute Lethality and Sub-Lethal Effects of Acetone, Ethanol, and Propylene Glycol on the Cardiovascular and Respiratory Systems of Rainbow Trout. Water Res. 12(4):217-221. (ECOTOX reference # 991).

Pillard, D.A. 1995.  Comparative Toxicity of Formulated Glycol Deicers and Pure Ethylene and Propylene Glycol to Ceriodaphnia dubia and Pimephales promelas.  Environ. Toxicol. Chem. 14(2):311-315. (ECOTOX reference #13727).

Price, K.S., G.T. Waggy, and R. A. Conway. 1974.  Brine Shrimp Bioassay and Seawater BOD of Petrochemicals.  J. Water Pollut. Control Fed. 46(1):63-77.(ECOTOX reference #2408).

U.S. EPA.  2004.  Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and Threatened Species Effects Determinations, 1/23/04.

 PAGE  4


[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4043-4044]
[FR Doc No: 2018-01586]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2507-014.
    Applicants: Westar Energy, Inc.
    Description: Notice of Non-Material Change in Status of Westar
Energy, Inc.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5105.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER15-1579-009.
    Applicants: 67RK 8me LLC.
    Description: Compliance filing: 67RK 8me LLC Notice of Change in
Category Status to be effective 1/18/2018.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5066.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER15-1582-010.
    Applicants: 65HK 8me LLC.
    Description: Compliance filing: 65HK 8me LLC Notice of Change in
Category Status to be effective 1/18/2018.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5065.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER15-1914-011.
    Applicants: 87RL 8me LLC.
    Description: Compliance filing: 87RL 8me LLC Notice of Change in
Category Status to be effective 1/18/2018.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5067.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER16-1955-005.
    Applicants: Antelope DSR 2, LLC.
    Description: Compliance filing: Antelope DSR 2 Notice of Change in
Category Status to be effective 1/18/2018.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5069.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER17-512-004.
    Applicants: Virginia Electric and Power Company.
    Description: Compliance filing: VEPCO Informational Filing on
Deactivation of Certain Generation Units to be effective N/A.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5066.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER17-2470-002.
    Applicants: Red Dirt Wind Project, LLC.
    Description: Notice of Non-Material Change in Status of Red Dirt
Wind Project, LLC.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5157.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER18-27-001.
    Applicants: Thunder Ranch Wind Project, LLC.
    Description: Compliance filing: Thunder Ranch Wind Project, LLC MBR
Tariff to be effective 11/1/2017.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5143.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER18-670-000.
    Applicants: Ohio River Partners Shareholder LLC.
    Description: Petition for Limited Waiver of Ohio River Partners
Shareholder LLC.
    Filed Date: 1/17/18.
    Accession Number: 20180117-5134.
    Comments Due: 5 p.m. ET 1/25/18.

    Docket Numbers: ER18-676-000.
    Applicants: North American Energy Markets Association.
    Description: Baseline eTariff Filing: North American Energy Markets
Association Submits its 2018 Power and Gas Tariff to be effective 1/19/
2018.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5142.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER18-677-000.
    Applicants: SWITCH, LTD.
    Description: Baseline eTariff Filing: Switched On Request for MBR
Authority to be effective 3/20/2018.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5144.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER18-678-000.
    Applicants: Consolidated Edison Company of New York, Inc.
    Description: Sec.  205(d) Rate Filing: Cancellation 18-a 1/18/2018
to be effective 1/19/2018.
    Filed Date: 1/18/18.
    Accession Number: 20180118-5154.
    Comments Due: 5 p.m. ET 2/8/18.

    Docket Numbers: ER18-679-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Queue Position #AA2-017,
Original Service Agreement No. 4881 to be effective 12/20/2017.

    Filed Date: 1/19/18.
    Accession Number: 20180119-5029.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER18-680-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Revisions to OATT Sch. 12-Appx and
Appx A re: Linden/HTP's cost responsibility to be effective 1/1/2018.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5069.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER18-681-000.
    Applicants: NorthWestern Corporation.
    Description: Tariff Cancellation: Notice of Cancellation: SA 793,
Utilities Agreement with MDT (West Laurel) to be effective 1/20/2018.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5071.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER18-682-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: 3 Phases Renewables (OR
D.A.) to be effective 1/1/2018.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5079.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER18-683-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: GIA and Distrib Serv Agmt,
Difwind Farms Limited V Project SA 991 992 WDT1130QFC to be effective
1/17/2018.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5097.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER18-684-000.
    Applicants: Nevada Power Company.
    Description: Initial rate filing: Rate Schedule No. 158 NPC/
Desertlink O & M Agree to be effective 3/21/2018.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5135.
    Comments Due: 5 p.m. ET 2/9/18.

    Docket Numbers: ER18-685-000.
    Applicants: Nevada Power Company.
    Description: Initial rate filing: Rate Schedule No. 159 NPC/
Desertlink License & Sale Agr to be effective 3/21/2018.
    Filed Date: 1/19/18.
    Accession Number: 20180119-5144.
    Comments Due: 5 p.m. ET 2/9/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 19, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-01586 Filed 1-26-18; 8:45 am]
 BILLING CODE 6717-01-P


10Total MOE = [ 1/ ( 1/ dermal Moe + 1/ inhalation MOE)] 50 Provisional cancer risk estimates for occupational exposures to ametryn range from 5 x 10 8 to 6 x 10 6. The cancer risk estimates presented here are based on the provisional Q 1* that was described earlier in this document. In this sense the cancer risk estimates should be considered provisional until adequate data are available to reconsider these risk estimates. The carcinogenic risks presented here should be considered high end as they are based on conservative assumptions for maximum acreage and application rates used for 30 days/ year and for 35 years over a 70 year lifetime. Table 9.1d summarizes the provisional occupational cancer risks determined for likely ametryn exposure scenarios. 51 Table 9.1d. Cancer( Q*) Risk Table Exposure Scenario ( Scenario #) Crop1 Baseline Total Daily Dose2, 3 Baseline Daily LADD2, 4 Baseline Risk2, 5 Maximum PPE Total Daily Dose2, 6 Maximum PPE LADD3, 6 Maximum PPE Risk4, 6 Eng Cont Total Daily Dose2, 7 Eng Cont LADD3, 7 Eng Cont Risk4, 7 Mixer/ Loader Mixing/ Loading Liquids for Groundboom application ( 1) corn 1 4.11E 2 2.72E 4 0.0065 2.68E 4 1.77E 6 0.0034 1.41E 4 9.31E 7 Mixing/ Loading Liquids for Groundboom application ( 2) pineapple 0.72 2.96E 2 1.96E 4 0.0047 1.93E 4 1.28E 6 0.0025 1.01E 4 6.71E 7 Mixing/ Loading Liquids for Groundboom application ( 3) sugarcane 1.6 6.58E 2 4.36E 4 0.010 4.28E 4 2.84E 6 0.0055 2.25E 4 1.49E 6 Mixing/ Loading Liquids for Aerial application ( 4) sugarcane 6.3 2.59E 1 1.72E 3 0.041 1.69E 3 1.12E 5 0.022 8.86E 4 5.87E 6 Mixing/ Loading Liquids for Groundboom application ( 5) sugarcane 0.20 8.23E 3 5.45E 5 0.0013 5.35E 5 3.54E 7 0.00068 2.81E 5 1.86E 7 Mixing/ Loading Liquids for Aerial application ( 6) sugarcane 1.8 7.20E 2 4.77E 4 0.011 4.68E 4 3.10E 6 0.0060 2.46E 4 1.63E 6 Applicator Sprays for Groundboom application ( 7) corn 0.0090 3.71E 4 2.46E 6 0.0042 1.72E 4 1.14E 6 0.0020 8.05E 5 5.33E 7 Sprays for Groundboom application ( 8) pineapple 0.013 5.34E 4 3.54E 6 0.0060 2.48E 4 1.64E 6 0.0028 1.16E 4 7.68E 7 Table 9.1d. Cancer( Q*) Risk Table Exposure Scenario ( Scenario #) Crop1 Baseline Total Daily Dose2, 3 Baseline Daily LADD2, 4 Baseline Risk2, 5 Maximum PPE Total Daily Dose2, 6 Maximum PPE LADD3, 6 Maximum PPE Risk4, 6 Eng Cont Total Daily Dose2, 7 Eng Cont LADD3, 7 Eng Cont Risk4, 7 52 Sprays for Groundboom application ( 9) sugarcane 0.014 5.94E 4 3.93E 6 0.0067 2.76E 4 1.83E 6 0.0031 1.29E 4 8.53E 7 Sprays for Aerial application ( 10) sugarcane No Data No Data No Data No Data No Data No Data 0.015 6.05E 4 4.00E 6 Sprays for Groundboom application ( 11) sugarcane 0.0036 1.48E 4 9.83E 7 0.0017 6.89E 5 4.56E 7 0.00078 3.22E 5 2.13E 7 Sprays for Aerial application ( 12) sugarcane No Data No Data No Data No Data No Data No Data 0.0037 1.51E 4 1.00E 6 Flagger Flagging for Sprays application ( 13) sugarcane 0.040 1.66E 3 1.10E 5 0.025 1.04E 3 6.91E 6 0.00081 3.32E 5 2.20E 7 Flagging for Sprays application ( 14) sugarcane 0.010 4.15E 4 2.75E 6 0.0064 2.61E 4 1.73E 6 0.00020 8.30E 6 5.50E 8 1Crops and use patterns are from product labeling.

2Baseline represents the use of long pants and long sleeved shirt ( no respirator), while using equipment and systems that are not engineering controls.

3Total daily absorbed dose ( mg/ kg/ day) = [(( dermal unit exposure ( mg/ lb ai) * 6.0 % dermal absorption) + ( inhalation unit exposure ( ug/ lb ai) * 0.001 mg/ ug unit conversion * 100%

inhalation absorption)) * Application rate ( lb ai/ acre or lb ai/ gallon) * Area treated ( acres or gallons)] / Body weight ( 70 kg).

4LADD ( Lifetime average daily dose) mg/ kg/ day = Total daily absorbed dose ( mg/ kg/ day) * ( 30 days worked per year days worked per year/ 365 days per year) * ( 35 years worked years worked/ 70 year lifetime). Days worked per year are estimates.

5Cancer Risk = LADD ( mg/ kg/ day) * Q1* = 0.00662 ( mg/ kg/ day) 1.

6Maximum PPE represents the use of coveralls worn over long sleeved shirt and long pants, plus chemical resistant gloves and an organic vapor removing respirator or equivalent ( 10

fold PF), while using equipment and systems that are not engineering controls.

7Engineering controls represents the use of long pants and long sleeved shirt ( no respirator), plus   when mixing/ loading   chemical resistant gloves, while using equipment and systems that are engineering controls ( e. g., closed mixing/ loading, enclosed cockpits, and/ or enclosed cabs). Note that data for airblast applicators includes the use of chemical resistant gloves, because data are not available for the " no glove" scenario.

9.2 Short/ Intermediate/ Long Term Postapplication Risk 53 Ametryn product labeling specifies application as either a directed spray at weeds or as a preemergent broadcast spray, and includes instructions to avoid application to the crop foliage. Additionally, for corn and pineapples, the label specifies last ametryn application be made 30 and 160 days prior to harvesting respectively. For sugarcane, the label specifies " Avoid wetting sugarcane foliage, or injury may occur" and also recommends against application after " close in"  when the sugarcane grows over the planting beds prior to harvesting. For these reasons, HED does not anticipate any foliar residues on the ametryn treated crops. Therefore, HED does not expect there to be any postapplication foliar exposures to occur and postapplication occupational exposures were not assessed.

10.0 Data Needs and Label Requirements 10.1 Toxicology New rat cancer study ( Guideline # 870.4200). Forward gene mutation assay in mammalian cell cultures ( Guideline # 870.5300).

10.2 Residue Chemistry The following label amendments for uses on corn and sugarcane should be submitted: Corn  remove sweet corn or provide residue data. Corn  rotational crop restrictions  minimum plantback intervals ( PBIs) of 3 months for small grains, 10 months for spinach and potatoes, and 11 months for all other crops following application of ametryn to corn. Sugarcane  change the maximum application rate to 12 lb ai/ A/ crop cycle from 16 lb ai/ A/ crop cycle, or provide additional crop field trial data to support the 16 lb use rate. Sugarcane  rotational crop restriction  restrict rotation to soybean, sorghum, or cotton with a PBI of 11 months following application of ametryn to sugarcane. No rotational crop restriction is needed for corn since it is labeled as a primary crop for ametryn use.

° Unless uses on sweet corn are deleted from all end use products ( EPs), data are required depicting residues of ametryn and its three thiomethyl metabolites in/ on sweet corn ears ( kernels plus cob with husks removed) following treatment at the maximum labeled rate.

° A new sugarcane processing study is required using sugarcane bearing detectable residues or sugarcane from plants treated at 5x the maximum label rate.

Additional data are required concerning product composition, preliminary analysis ( analysis for HCB/ PCB), certified limits, enforcement analytical method, dissociation constant, and solvent solubility for the Syngenta 90% ametryn T ( EPA Reg. No. 100 579).

10.3 Occupational and Residential Exposure 54 None 55 References:

Ametryn. HED Occupational and Residential Exposure Chapter of the Reregistration Eligibility Decision Document ( Revised), DP Barcode: D311600, Robert Travaglini, 21 DEC 2004 Ametryn. Chronic and Cancer Dietary Exposure Assessment for the Reregistration Eligibility Decision, DP Barcode: D307103, William Donovan, 06 OCT 2004.

Ametryn. Residue Chemistry Considerations for Reregistration Eligibility Decision, DP Barcode: D307104, William Donovan, 03 NOV 2004.

Drinking Water Exposure Assessment for Proposed Reregistration of Ametryn Use on Corn, Pineapple and Sugarcane ( Revised), DP Barcode: D307105, Kevin Costello, 16 NOV 2004. 56 Appendices 1.0 TOXICOLOGY DATA REQUIREMENTS The requirements ( 40 CFR 158.340) for food uses for ametryn are in Table 1. Use of the new guideline numbers does not imply that the new ( 1998) guideline protocols were used.

Test Technical Required Satisfied 870.1100 Acute Oral Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . 870.1200 Acute Dermal Toxicity . . . . . . . . . . . . . . . . . . . . . . 870.1300 Acute Inhalation Toxicity . . . . . . . . . . . . . . . . . . . . 870.2400 Primary Eye Irritation . . . . . . . . . . . . . . . . . . . . . . . 870.2500 Primary Dermal Irritation . . . . . . . . . . . . . . . . . . . . 870.2600 Dermal Sensitization . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes yes yes yes yes yes yes 870.3100 Oral Subchronic ( rodent) . . . . . . . . . . . . . . . . . . . . . 870.3150 Oral Subchronic ( nonrodent) . . . . . . . . . . . . . . . . . . 870.3200 21 Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3250 90 Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3465 90 Day Inhalation . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes no no see 870.4100a see 870.4100b yes     870.3700a Developmental Toxicity ( rodent) . . . . . . . . . . . . . . . 870.3700b Developmental Toxicity ( nonrodent) . . . . . . . . . . . . 870.3800 Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes 870.4100a Chronic Toxicity ( rodent) . . . . . . . . . . . . . . . . . . . . 870.4100b Chronic Toxicity ( nonrodent) . . . . . . . . . . . . . . . . . 870.4200a Oncogenicity ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . 870.4200b Oncogenicity ( mouse) . . . . . . . . . . . . . . . . . . . . . . . 870.4300 Chronic/ Oncogenicity . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes no yes yes no yes

870.5100 Mutagenicity   Gene Mutation  bacterial . . . . . . . . 870.5300 Mutagenicity   Gene Mutation  mammalian . . . . . . 870.5xxx Mutagenicity   Structural Chromosomal Aberrations 870.5xxx Mutagenicity   Other Genotoxic Effects . . . . . . . . . . yes no yes yes yes   yes yes 870.6100a Acute Delayed Neurotox. ( hen) . . . . . . . . . . . . . . . . 870.6100b 90 Day Neurotoxicity ( hen) . . . . . . . . . . . . . . . . . . . 870.6200a Acute Neurotox. Screening Battery ( rat) . . . . . . . . . 870.6200b 90 Day Neuro. Screening Battery ( rat) . . . . . . . . . . . 870.6300 Develop. Neuro . . . . . . . . . . . . . . . . . . . . . . . . . . . . no no no no no         870.7485 General Metabolism . . . . . . . . . . . . . . . . . . . . . . . . 870.7600 Dermal Penetration . . . . . . . . . . . . . . . . . . . . . . . . . yes no yes  Test Technical Required Satisfied 57 Special Studies for Ocular Effects Acute Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Subchronic Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . Six month Oral ( dog) . . . . . . . . . . . . . . . . . . . . . . . no no no       2.0 NON CRITICAL TOXICOLOGY STUDIES 870.4300. Combined Chronic Feeding/ Carcinogenicity  rats. In a combined chronic toxicity/ carcinogenicity study ( 1987, MRID 40349906), Ametryn ( 98.6% a. i., FL 840991) was administered to groups of 70 Sprague Dawley [ Crl: COBS ® CD ® ( SD) BR] rats/ sex at concentrations of 0, 50, or 500 ppm for 104 weeks. Groups of 70 rats per sex received a 5000 ppm diet that was reduced to 4000 ppm after 141 days and further reduced to 2000 ppm after 239 days because of reductions in weight gain at the higher doses. Ten rats/ sex/ group were dosed for 52 weeks for interim evaluation, and ten rats/ sex/ group control and the high dose groups were dosed for 56 weeks followed by control diet for 4 weeks to assess recovery. Treatment related effects were noted in the high dose ( 5000/ 4000/ 2000 ppm) group. 80% of males and 69% of females in the high dose group survived to study termination compared with only 43% and 44% of controls. The only treatment related clinical sign was loose feces observed in high dose males during the time they were fed the 5000 ppm diet. High dose males weighed 29 48% less than controls when fed the 5000 ppm diet and 18 26% less when fed the 4000 ppm diet followed by the 2000 ppm diet. High dose females weighed 20 34% less than controls regardless of the concentration of test material in the diet. High dose males and females lost weight during the first week of treatment and gained 38% and 40% less weight, respectively, when fed the 5000 ppm diet, 20% and 57% less weight, respectively, when fed the 4000 ppm diet, and 29% and 15% more weight, respectively, when fed the 2000 ppm diet for the remainder of the first year. During the second year, high dose males gained two times more weight than controls and high dose females gained 51% less weight than. High dose males and females consumed 18 41% and 30 45% less food when fed the 5000 ppm diet, 12 17% and 18 22% less when fed the 4000 ppm diet, and 6 14% and 7 12% less when fed the 2000 ppm diet up to day 560 and 532, respectively. Food efficiency for the first 91 days was reduced by 22% and 17% for high dose males and females, respectively. Body weight and gain in the 500 ppm males ( from about 3% to 6.3%, p < 0.05) and females ( from about 3% to 6.9%, p < 0.05) were statistically significantly lower ( from about 3% to 6.3%) for most of the two year study especially for males. The 50 ppm dose groups did not show statistical differences from the control. No toxicologically significant effects were observed on hematology or clinical chemistry parameters except for elevated alkaline phosphatase ( 68 94% increase) in high dose females. Males had significantly increased incidences of mineralization/ concretions in the renal pelvis ( 25/ 70 vs 10/ 70 for controls), pituitary hyperplasia ( 26/ 70 vs 13/ 70 for controls), and interstitial cell hyperplasia in the testes ( 12/ 70 vs 2/ 70 for controls). Males and females had a significant increase in the incidence of hepatocellular hyperplasia ( males: 34/ 70 vs 22/ 70; females: 36/ 70 vs 18/ 70) and a nonsignificant increase in the incidence of acinar cell metaplasia ( hepatocyte like cells) in the pancreas ( 3/ 70 for males, 4/ 69 for females vs 0/ 70 for controls in both sexes). Females had a significantly increased 58 incidence of " hepatocellular alterations" ( 49/ 70 vs 19/ 70 for controls). Acinar metaplasia in both sexes, interstitial cell hyperplasia in the testes, and hepatocellular alterations in females were observed in the high dose groups after only 1 year of treatment. The incidences of lesions after 1 year were reduced after the 4 week recovery period. The LOAEL is 5000/ 4000/ 2000 ppm ( 145.3 and 176.1 mg/ kg/ day for males and females, respectively) based on decreased body weight and weight gain in both sexes and histopathologic lesions in the kidney, testes, and pituitary in male rats and in the liver and pancreas in male and female rats. The NOAEL is 500 ppm ( 20.9 and 26.2 mg/ kg/ day, for males and females, respectively). The decreased weight effects were not considered by the CARC to be sufficient to meet criteria for adequate dosing for carcinogenicity assessment. The incidences of interstitial cell tumors in the testes and epididymal mesothelioma were 9/ 70 ( 12.9%, p= 0.06) and 3/ 70 ( 4.3%, N. S.) in high dose male rats compared with 3/ 70 ( 4.3%) and 0/ 70, respectively, for controls. The incidence of both lesions exceeded that of historical controls reported in the concurrent study ( 8.8% and 0%, respectively) and the incidence of interstitial cell tumors in the testes exceeded that reported in 2001 by Charles River Laboratories ( CRL) for Sprague Dawley rats. The incidences of other neoplasms were 4/ 70 ( 5.7%, p= 0.06) for thyroid follicular cell adenocarcinoma in high dose males compared with 0/ 70 for controls, 4/ 70 ( 5.7%, N. S.) for hepatocellular adenoma in highdose females compared with 1/ 70 ( 1.4%) for controls, and 24/ 70 ( 34.3%, p

0.01) for mammary adenocarcinoma in high dose females compared with 11/ 70 ( 15.7%) for controls; these incidences in the treated rats were above the historical control incidences reported in the current study but were less than the range for spontaneous incidences reported by CRL. The increased incidences of neoplasms in the testes and epididymides and thyroid in males and in the liver and mammary gland in females was evaluated by the HED CARC and it was determined that dosing was excessive based on reduced body weight and weight gain in both sexes and the interpretation of the neoplastic findings compromised at the high dose. The next lower dose level of 500 ppm was determined by the CARC to be insufficiently high to adequately challenge the animals for carcinogenicity evaluation. This chronic toxicity aspects of this study classified as Acceptable/ Guideline and satisfies the guideline requirement for a chronic toxicity study [ OPPTS 870.4100a]. The carcinogenicity assessment aspect of this study is classified as Unacceptable/ Guideline and does not satisfy the requirement for a carcinogenicity study ( OPPTS 870.4200) in rats.

870.4200. Carcinogenicity  mouse. In this carcinogenicity study ( 1981, MRID No.: 40349904), four groups of 60/ sex Charles River CD 1 strain mice were dosed as control, 10, 1000 or 2000 ppm of ametryn ( Batch # FL 761356, 98.9% purity) for 102 weeks. These doses convert to 0, 1.5, 150 or 300 mg/ kg/ day based on 1 ppm = 0.15mg/ kg/ day. These dose levels were based on range finding studies ( MRID # 92002041) that demonstrated that at 1000 and 3000 ppm there was significant body weight decrease and at 3000 ppm and above there were clinical signs ( hunched posture, labored breathing, thin appearance and deaths at 10000 ppm and above). There were no reactions to treatment noted. There were no treatment related increases in neoplasms. This carcinogenicity study in mice was classified as " Minimum" and satisfies the guideline requirement for a series 870.4100 carcinogenicity study in mice. The high dose, although there was no actual toxicity noted, was considered close enough to the dose levels that in the dose range finding study demonstrated toxicity. 59 870.7485. General Metabolism. There are three studies ( all 1990, MRID Nos.: 41463301, 41463302 and 41463303), that assess the general metabolism of ametryn in rats. In this series of studies, ametryn, either radiolabelled or otherwise was administered to young (< 8 weeks) Sprague Dawley strain rats ( 5/ sex) as either single oral low ( 0.5 mg/ kg), multiple low ( 0.5 mg/ kg/ day for 14 days or signal high ( 200 mg/ kg) or an intravenous dose ( 0.5 mg/ g). In general, this series of studies demonstrated that ametryn is readily absorbed by rats after a single dose or multiple oral dose( s). Ametryn was widely distributed with low (< 1% ) residues in all tissues and organs. The liver ( 0.312% of the total dose) had the highest concentration. Excretion was mainly through the urine ( 50 61%) within 48 hours with the remainder in the feces ( 30 42%). Thirty six mostly polar conjugated and unconjugated metabolic products were detected and 13 were identified in the urine. N dealkalation of the parent and glutathione conjugation were the major biotransformation products. No significant differences in pharmacokinetic parameters were noted among the dosing groups or between sexes. 60 3.0 TOLERANCE REASSESSMENT SUMMARY Tolerance Reassessments for Ametryn The tolerances listed in 40 CFR § 180.258( a and c) are currently expressed in terms of ametryn ( 2 ethylamino) 4( isopropylamino) 6( methylthio) s triazine per se. The ametryn risk assessment team has determined that the residues of concern for the tolerance expression consists of ametryn per se. A summary of ametryn tolerance reassessments is presented in Table A. 3.0.

Tolerances Listed Under 40 CFR § 180.258 ( a and c):

Adequate residue data are available to reassess the established tolerances on bananas, corn ( forage, grain, and stover), pineapples, and sugarcane. However, data are not available to support the tolerance on sweet corn, kernels plus cobs with husks removed. If no registrant intends to support the use on sweet corn, then this tolerance should be revoked once use directions for sweet corn are deleted from all EPs.

The available residue data indicate that tolerances can be lowered for all commodities ( see Table A. 3.0). Tolerances on corn grain, forage, and stover should be split to include field and pop corn ( e. g. Corn, field, grain and Corn, pop, grain)

Based on the available livestock metabolism and feeding studies, there is no reasonable expectation of finite residues occurring in livestock commodities. Therefore, tolerances for livestock commodities are not currently required.

The tolerances on forage and fodder of pineapples and sugarcane should be revoked as these commodities are no longer regulated, and the tolerances on banana, cassava, tanier, and yams should be revoked as uses on these crops are not being supported. 61 Table A. 3.0. Tolerance Reassessment Summary for Ametryn.

Commodity Current Tolerance ( ppm) Range of Residues 1 ( ppm) Tolerance Reassessment 1 ( ppm) Comment/[ Correct Commodity Definition]

Tolerances Listed Under 40 CFR § 180.258( a):

Banana 0.25 < 0.02 0.04 Revoke Use is not being supported.

Corn, forage 0.5 < 0.02 0.10 0.1 Tolerances for forage, grain and stover should each be split into separate tolerances for Corn, field and Corn, pop. Corn, grain 0.25 < 0.02 0.05 2 Corn, stover 0.5 < 0.02 0.05 2 Corn, sweet, kernel plus cob with husks removed 0.25 No data TBD 3 Residue data remain outstanding. If uses on sweet corn are deleted from EPs, then this tolerance should be revoked.

Pineapple 0.25 < 0.02 0.05 0.05 2 Pineapple, fodder 0.25 not applicable Revoke These commodities are no longer regulated livestock feed items Pineapple, forage 0.25 not applicable Sugarcane, cane 0.25 < 0.02 0.05 2 Sugarcane, fodder 0.25 not applicable Revoke These commodities are no longer regulated livestock feed items Sugarcane, forage 0.25 not applicable Tanier 0.25 no data Revoke Uses are not being support on these crops. Yam, true, tuber 0.25 no data Tolerances Listed under 40 CFR 180.258( c):

Cassava, root 0.1 no data Revoke Use is not being supported 1 The range of residues for ametryn per se. 2 The LOQ for the current enforcement method is 0.05 ppm for ametryn per se. 3 TBD = to be determined.


[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Proposed Rules]
[Pages 3061-3066]
[FR Doc No: 2016-00697]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-8463; Directorate Identifier 2014-NM-226-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2013-20-
11, for all Airbus Model A318, A319, A320, and A321 series airplanes.
AD

2013-20-11 currently requires modifying the passenger emergency oxygen
container assembly. Since we issued AD 2013-20-11, we have determined
that the unsafe condition also affects oxygen containers labeled ``DAe
Systems.'' This proposed AD would expand the affected group of oxygen
containers to include those labeled ``DAe Systems.'' We are proposing
this AD to prevent a high temperature oxygen generator and mask from
falling down and possibly resulting in an ignition source in the
passenger compartment, injury to passengers, and reduced availability
of supplemental oxygen.

DATES: We must receive comments on this proposed AD by March 7, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For Airbus service information identified in this proposed AD,
contact Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96;
fax: +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    For B/E Aerospace service information identified in this proposed
AD, contact Dieter Heins, Customer Support Manager, Oxygen & PSU
Systems, B/E Aerospace Systems, GmbH Revalstr. 1, D-23560 L[uuml]beck;
telephone: +49 (0)451 4093 2976; fax: +49 (0)451 4093 4488; email:
<EMAIL_ADDRESS>    You may view this referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8463; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory 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 FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-8463;
Directorate Identifier 2014-NM-226-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On September 17, 2013, we issued AD 2013-20-11, Amendment 39-17617
(78 FR 64162, October 28, 2013). AD 2013-20-11 requires modifying the
passenger emergency oxygen container assembly on all Model A318, A319,
A320, and A321 series airplanes.
    Since we issued AD 2013-20-11, Amendment 39-17617 (78 FR 64162,
October 28, 2013), we have determined that the unsafe condition also
affects oxygen containers labeled ``DAe Systems.''
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2014-0207, dated September 16, 2014 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition. The MCAI states:

    It was determined that oxygen generators, installed on a
specific batch of Type 1 (22 min) passenger emergency oxygen
container assemblies, may become detached by extreme pulling of the
mask tube at the end of oxygen supply. Investigations revealed that
such detachment can be caused by the increase in temperature towards
the end of the generator operation, which may weaken the plastic
housing in the attachment area of the bracket.
    This condition, if not corrected, could make the rivets slip
through the plastic housing, causing a `hot' oxygen generator and
mask to fall down, possibly resulting in injury to passengers.
    To address this potential unsafe condition, EASA issued AD 2012-
0055 (later revised) [http://ad.easa.europa.eu/blob/easa_ad_2012_0055_R1_superseded.pdf/AD_2012-0055R1_1] [which
corresponds to FAA AD 2013-20-11, Amendment 39-17617 (78 FR 64162,
October 28, 2013)] to require modification of the affected oxygen
container assemblies. That [EASA] AD also prohibited installation of
unmodified containers on any aeroplane as replacement parts.
    Since that [EASA] AD was issued, it was found that the affected
containers have not only been marked with company name B/E
Aerospace, as was specified, but also, for a brief period, with the
former company name DAe Systems.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2012-0055R1, which is superseded, and
expands the affected group of containers to include those that have
the name ``DAe Systems'' on the identification plate.
    This [EASA] AD also clearly separates the serial number (s/n)
groups of containers into those manufactured by B/E Aerospace and
those manufactured by DAe Systems, for which additional compliance
time is provided.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8463.

Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information. This service
information describes procedures for installation of a reinforcement
plate in the oxygen container assembly.
     Airbus Service Bulletin A320-35-1049, dated June 15, 2011.
     Airbus Service Bulletin A320-35-1053, dated June 15, 2011.
     Airbus Service Bulletin A320-35-1054, dated June 15, 2011.
     Airbus Service Bulletin A320-35-1055, dated June 15, 2011.
     Airbus Service Bulletin A320-35-1056, dated June 15, 2011.
     Airbus Service Bulletin A320-35-1057, dated June 15, 2011.
     Airbus Service Bulletin A320-35-1058, dated June 15, 2011.
    This service information is reasonably available because the
interested parties have access to it through their normal

course of business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 4 airplanes of U.S.
registry.
    The actions required by AD 2013-20-11, Amendment 39-17617 (78 FR
64162, October 28, 2013), and retained in this proposed AD take about 2
work-hours per product, at an average labor rate of $85 per work-hour.
Based on these figures, the estimated cost of the actions that are
required by AD 2013-20-11 is $170 per product.
    We also estimate that it would take about 2 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $680, or $170 per
product.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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 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 above, 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; 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.

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)
2013-20-11, Amendment 39-17617 (78 FR 64162, October 28, 2013), and
adding the following new AD:

Airbus: Docket No. FAA-2015-8463; Directorate Identifier 2014-NM-
226-AD.

(a) Comments Due Date

    We must receive comments by March 7, 2016.

(b) Affected ADs

    This AD replaces AD 2013-20-11, Amendment 39-17617 (78 FR 64162,
October 28, 2013).

(c) Applicability

    This AD applies to the Airbus airplanes, certificated in any
category, specified in paragraphs (c)(1) through (c)(4) of this AD,
all manufacturer serial numbers.
    (1) Airbus Model A318-111, -112, -121, and -122 airplanes.
    (2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (3) Airbus Model A320-211, -212, -214, -231, -232, and -233
airplanes.
    (4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Reason

    This AD was prompted by a determination that oxygen generators
installed on a certain batch of passenger emergency oxygen container
assemblies might become detached by extreme pulling of the mask tube
at the end of the oxygen supply causing a high temperature oxygen
generator and mask to fall down. This AD was also prompted by a
determination that the unsafe condition affects oxygen containers
labeled ``DAe Systems.'' We are issuing this AD to prevent a high
temperature oxygen generator and mask from falling down and possibly
resulting in an ignition source in the passenger compartment, injury
to passengers, and reduced availability of supplemental oxygen.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Oxygen Container Assembly Modification, With Service
Information Referenced in a New Paragraph

    This paragraph restates the requirements of paragraph (g) of AD
2013-20-11, Amendment 39-17617 (78 FR 64162, October 28, 2013), with
service information referenced in a new paragraph. Except as
specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD,
within 5,000 flight cycles, or 7,500 flight hours, or 24 months,
whichever occurs first, after December 2, 2013 (the effective date
of AD 2013-20-11): Modify each type 1 (22 minute) passenger
emergency oxygen container assembly installed on an airplane, having
a part number (P/N) listed in paragraph (g)(1)(i) of this AD and a
serial number (S/N) listed in paragraph (g)(1)(ii) of this AD, in
accordance with the Accomplishment Instructions of the applicable
Airbus service information specified in paragraphs (k)(1) through
(k)(7) of this AD.
    (1) An oxygen container that has a part number listed in
paragraph (g)(1)(i) of this AD and a serial number as listed in
paragraph (g)(1)(ii) of this AD, and that has been modified using
the instructions of B/E Aerospace Service Bulletin 1XC22-0100-35-
006, is compliant with the modification requirement of paragraph (g)
of this AD.
    (i) Oxygen container part numbers listed in paragraphs
(g)(1)(i)(A) through (g)(1)(i)(D) of this AD, where xxxxx stands for
an alphanumerical value.
    (A) 13C22Lxxxxx0100.
    (B) 13C22Rxxxxx0100.
    (C) 14C22Lxxxxx0100.

    (D) 14C22Rxxxxx0100.
    (ii) Oxygen container serial numbers listed in paragraphs
(g)(1)(ii)(A) through (g)(1)(ii)(H) of this AD.
    (A) ARBC-0182 to ARBC-9999, inclusive.
    (B) ARBD-0000 to ARBD-9999, inclusive.
    (C) ARBE-0000 to ARBE-9999, inclusive.
    (D) BEBF-0000 to BEBF-9999, inclusive.
    (E) BEBH-0000 to BEBH-9999, inclusive.
    (F) BEBK-0000 to BEBK-9999, inclusive.
    (G) BEBL-0000 to BEBL-9999, inclusive.
    (H) BEBM-0000 to BEBM-0454, inclusive.
    (2) Airplanes on which Airbus Modification 150704 has not been
embodied in production are excluded from the requirements of
paragraph (g) of this AD, unless an oxygen container with a part
number listed in paragraph (g)(1)(i) of this AD and a serial number
listed in paragraph (g)(1)(ii) of this AD is installed.
    (3) Airplanes on which Airbus Modification 150704 has been
embodied in production and that are not listed by model and
manufacturer serial number in the applicable Airbus service
information specified in paragraphs (k)(1) through (k)(7) of this
AD; are excluded from the requirements of paragraph (g) of this AD,
unless an oxygen container with a part number listed in paragraph
(g)(1)(i) of this AD and a serial number listed in paragraph
(g)(1)(ii) of this AD is installed.

    Note 1 to paragraph (g) of this AD: The oxygen container
assemblies listed in paragraph (g)(1)(i) of this AD and paragraph
(g)(1)(ii) of this AD are B/E Aerospace products with the mark ``B/E
AEROSPACE'' on the identification plate.

(h) Retained Parts Installation Limitation, With Service Information
Referenced in a New Paragraph

    This paragraph restates the requirements of paragraph (h) of AD
2013-20-11, Amendment 39-17617 (78 FR 64162, October 28, 2013), with
service information referenced in a new paragraph. As of December 2,
2013 (the effective date of AD 2013-20-11), no person may install,
on any airplane, an oxygen container with a part number listed in
paragraph (g)(1)(i) of this AD, and serial number listed in
paragraph (g)(1)(ii) of this AD, unless the oxygen container has
been modified according to the applicable Airbus service information
specified in paragraphs (k)(1) through (k)(7) of this AD.

(i) New Requirement of This AD: Modification of Additional Oxygen
Containers

    At the applicable times specified in paragraphs (i)(1) and
(i)(2) of this AD: Modify each type 1 (22 minute) passenger
emergency oxygen container assembly installed on an airplane, having
a part number and a serial number listed in paragraph (j) of this
AD, in accordance with the Accomplishment Instructions of the
applicable Airbus service information specified in paragraphs (k)(1)
through (k)(7) of this AD; except as specified in paragraph (l) of
this AD.
    (1) For units with ``B/E AEROSPACE'' on the identification plate
and having a part number and a serial number listed in paragraph
(j)(1) of this AD: Within 5,000 flight cycles, or 7,500 flight
hours, or 24 months, whichever occurs first after the effective date
of this AD.
    (2) For units with ``DAe Systems'' on the identification plate
and having a part number and a serial number listed in paragraph
(j)(2) of this AD: Within 2,500 flight cycles, or 3,750 flight
hours, or 12 months, whichever occurs first after the effective date
of this AD.

(j) New Part Numbers and Serial Numbers for the Parts Affected by
Paragraph (i) of This AD

    Affected parts for the actions required by paragraph (i) of this
AD are identified in paragraphs (j)(1) and (j)(2) of this AD.
    (1) For oxygen containers with ``B/E AEROSPACE'' on the
identification plate: Units having a part number identified in
paragraphs (j)(1)(i) through (j)(1)(iv) of this AD, where part
number ``xxxxx'' stands for any alphanumerical value, and a serial
number of BEBM-0455 to BEBM-9999, inclusive.
    (i) 13C22Lxxxxx0100.
    (ii) 13C22Rxxxxx0100.
    (iii) 14C22Lxxxxx0100.
    (iv) 14C22Rxxxxx0100.
    (2) For oxygen containers with ``DAe Systems'' on the
identification plate: Units having a part number identified in
paragraphs (j)(1)(i) through (j)(1)(iv) of this AD, where part
number ``xxxxx'' stands for any alphanumerical value, and a serial
number identified in paragraphs (j)(2)(i) through (j)(2)(iv) of this
AD.
    (i) ARBC-0000 to ARBC-9999 inclusive.
    (ii) ARBD-0000 to ARBD-9999 inclusive.
    (iii) ARBE-0000 to BEBE-9999 inclusive.
    (iv) BEBE-0000 to BEBE-9999 inclusive.

(k) New Service Information Paragraph for the Requirements of
Paragraphs (g), (h), (i), and (m) of This AD

    Accomplish the requirements specified in paragraphs (g), (h),
(i), and (m) of this AD in accordance with the Accomplishment
Instructions of the applicable Airbus service information identified
in paragraphs (k)(1) through (k)(7) of this AD.
    (1) Airbus Service Bulletin A320-35-1049, dated June 15, 2011.
    (2) Airbus Service Bulletin A320-35-1053, dated June 15, 2011.
    (3) Airbus Service Bulletin A320-35-1054, dated June 15, 2011.
    (4) Airbus Service Bulletin A320-35-1055, dated June 15, 2011.
    (5) Airbus Service Bulletin A320-35-1056, dated June 15, 2011.
    (6) Airbus Service Bulletin A320-35-1057, dated June 15, 2011.
    (7) Airbus Service Bulletin A320-35-1058, dated June 15, 2011.

(l) New Exceptions to the Requirements of Paragraph (i) of This AD

    (1) An oxygen container that has a part number and a serial
number listed in paragraph (j) of this AD, and that has been
modified as specified in B/E Aerospace Service Bulletin 1XC22-0100-
35-006, is compliant with the modification requirement of paragraph
(i) of this AD.
    (2) Airplanes on which Airbus Modification 150704 has not been
embodied in production are excluded from the requirements of
paragraph (i) of this AD, unless an oxygen container with a part
number and a serial number listed in paragraph (j) of this AD is
installed.
    (3) Airplanes on which Airbus Modification 150704 has been
embodied in production and that are not listed by model and
manufacturer serial number in the Airbus service information
specified in paragraphs (k)(1) through (k)(7) of this AD, as
applicable, are excluded from the requirements of paragraph (i) of
this AD, unless an oxygen container with a part and a serial number
listed in paragraph (j) of this AD is installed.
    (4) Airplanes on which the design of the passenger oxygen
container is not Design A, as defined in figure 1 to paragraph
(l)(4) of this AD, are excluded from the requirements of paragraph
(i) of this AD for that passenger oxygen container.

    Note 2 to paragraph (l)(4) of this AD: For ``Design A,'' the
placard on the passenger oxygen container test button is as
described in ``Picture A'' in figure 1 to paragraph (l)(4) of this
AD. The mask configuration (``ZZ'' in ``Picture A'') is a number,
and the test button is as shown in ``Picture B.''

[GRAPHIC] [TIFF OMITTED] TP20JA16.001

(m) New Requirement of This AD: Parts Installation Limitation

    As of the effective date of this AD, no person may install, on
any airplane, an oxygen container with a part number and a serial
number listed in paragraph (j) of this AD, unless the oxygen
container has been modified in accordance with the Accomplishment
Instructions of the applicable Airbus service information specified
in paragraphs (k)(1) through (k)(7) of this AD.

(n) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office. The AMOC approval letter must specifically
reference this AD.
    (ii) AMOCs approved previously for AD 2013-20-11, Amendment 39-
17617 (78 FR 64162, October 28, 2013), are approved as AMOCs for the
corresponding provisions of paragraphs (g) and (h) of this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(o) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD

2014-0207, dated September 16, 2014, for related information. This
MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2015-8463.
    (2) For Airbus service information identified in this AD,
contact Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96;
fax: +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (3) For B/E Aerospace service information identified in this AD,
contact Dieter Heins, Customer Support Manager, Oxygen & PSU
Systems, B/E Aerospace Systems, GmbH Revalstr. 1, D-23560
L[uuml]beck; telephone: +49 (0)451 4093 2976; fax: +49 (0)451 4093
4488; email<EMAIL_ADDRESS>    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington, on January 5, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-00697 Filed 1-19-16; 8:45 am]
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[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11330-11331]
[FR Doc No: 2011-4546]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 558

[Docket No. FDA-2011-N-0003]

Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of a New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of
eight new animal drug applications (NADAs). In a notice published
elsewhere in this issue of the Federal Register, FDA is withdrawing
approval of these NADAs.

DATES: This rule is effective March 14, 2011.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The sponsors have requested that FDA
withdraw approval of the three NADAs listed in table 1 of this document
because the products are no longer manufactured or marketed:

                      Table 1--Voluntary Requests for Withdrawal of Approval of Three NADAs
----------------------------------------------------------------------------------------------------------------
                                              NADA No. product          21 CFR section affected (sponsor drug
                Sponsor                  (established name of drug)                 labeler code)
----------------------------------------------------------------------------------------------------------------
First Priority, Inc., 1590 Todd Farm     NADA 48-647;                Sec.   520.1720a (058829).
 Dr., Elgin, IL 60123.                    Phenylbutazone Boluses
                                          (phenylbutazone).
Yoder Feed, Division of Yoder, Inc.,     NADA 96-161; Hy-Con TYLAN   Sec.   558.625 (035369).
 Kalona, IA 52247.                        Premix (tylosin
                                          phosphate).
Triple ``F'', Inc., 10104 Douglas Ave.,  NADA 119-062; Cadco-BN-10   Sec.   558.485 (011490).
 Des Moines, IA 50322.                    BANMINTH Premix (pyrantel
                                          tartrate).
----------------------------------------------------------------------------------------------------------------

    Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin, IL 60123 (Truow)
has informed FDA that it is the owner of five feed premix NADAs
previously owned by milling companies which it has purchased. NADA 100-
352 was owned by NutriBasics Co., last doing business at P.O. Box 1014,
Wilmar, MN 56201. NADA 107-002 and NADA 123-000 were owned by Seeco,
Inc., also last doing business at P.O. Box 1014, Wilmar, MN 56201. NADA
133-833 and NADA 135-243 were owned by Southern Micro-Blenders, Inc.,
last doing business at 3801 N. Hawthorne St., Chattanooga, TN 37406.
Truow has requested that FDA withdraw approval of the five NADAs in
table 2 of this document because they are no longer manufactured or
marketed:

          Table 2--Voluntary Requests for Withdrawal of Approval of Five NADAs by Truow Nutrition, Inc.
----------------------------------------------------------------------------------------------------------------
                                              NADA No. product          21 CFR section affected (sponsor drug
            Previous sponsor             (established name of drug)                 labeler code)
----------------------------------------------------------------------------------------------------------------
NutriBasics Co., P.O. Box 1014, Wilmar,  NADA 100-352; Seeco T-10    Sec.   558.625 (053740).
 MN 56201.                                Premix (tylosin
                                          phosphate).
Seeco, Inc., P.O. Box 1014, Wilmar, MN   NADA 107-002; Seeco TYLAN-  Not codified.
 56201.                                   Sulfa 10 Premix (tylosin
                                          phosphate and
                                          sulfamethazine).
Seeco, Inc., P.O. Box 1014, Wilmar, MN   NADA 123-000; Super Swine   Sec.   558.485 (011749).
 56201.                                   Wormer B-9
                                          BANMINTH(pyrantel
                                          tartrate).
Southern Micro-Blenders, Inc., 3801 N.   NADA 133-833; TYLAN 10      Sec.   558.625 (049685).
 Hawthorne St., Chattanooga, TN 37406.    Premix (tylosin
                                          phosphate).
Southern Micro-Blenders, Inc., 3801 N.   NADA 135-243; Swine Guard-  Sec.   558.485 (049685).
 Hawthorne St., Chattanooga, TN 37406.    BN BANMINTH Premix
                                          (pyrantel tartrate).
----------------------------------------------------------------------------------------------------------------

    In a notice published elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADA 48-647, 96-161, 100-
352, 107-002, 119-062, 123-000, 133-833, and 135-243, and all
supplements and amendments thereto, is withdrawn, effective March 14,
2011. As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these withdrawals of approval.
    Following these changes of sponsorship, Yoder Feed, Division of
Yoder, Inc., Triple ``F'', Inc., NutriBasics Co., Seeco, Inc., and
Southern Micro-Blenders, Inc., are no longer the sponsor of an approved
application. Accordingly, 21 CFR 510.600(c) is being amended to remove
the entries for these firms.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 520

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the
entries for ``Triple ``F'', Inc.'' and ``Yoder Feed, Division of Yoder,
Inc.''; and in the table in paragraph (c)(2), remove the entries for
``011490'', ``011749'', ``035369'', ``049685'', and ``053740''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
4. In Sec.  520.1720a, revise paragraph (b)(6) to read as follows:

Sec.  520.1720a  Phenylbutazone tablets and boluses.

* * * * *
    (b) * * *
    (6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
5. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
6. In Sec.  558.485, revise the section heading and paragraph (b)(3) to
read as follows:

Sec.  558.485  Pyrantel.

* * * * *
    (b) * * *
    (3) Nos. 010439, 012286, 016968, and 017790: 9.6 and 19.2 grams per
pound for use as in paragraphs (e)(1)(i) through (e)(1)(iii) of this
section.
* * * * *

Sec.  558.625  [Amended]

0
7. In Sec.  558.625, remove and reserve paragraphs (b)(8), (b)(38), and
(b)(80).

    Dated: February 18, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-4546 Filed 3-1-11; 8:45 am]
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