21472 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Rules and Regulations 

TABLE 9—ADDITIONAL REGULATIONS APPROVED FOR THE SPOKANE REGIONAL CLEAN AIR AGENCY (SRCAA) 

JURISDICTION

[Applicable in Spokane County, excluding facilities subject to Energy Facilities Site Evaluation Council (EFSEC) jurisdiction, Indian reservations 

and any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and facilities subject to the applicability 

sections of WAC 173–400–700, 173–405–012, 173–410–012, and 173–415–012] 

State/local citation Title/subject State/local 

effective date EPA approval date Explanations 

Spokane Regional Clean Air Agency Regulations 

Regulation I—Article VI—Emissions Prohibited 

6.05 ............................ Particulate Matter and Preventing Particulate Matter from Becoming 

Airborne.

04/10/04 04/12/16 [Insert Federal 

Register citation].

Except 6.05(A). 

6.14 ............................ Standards for Control of Particulate Matter 

on Paved Surfaces.

06/03/07 04/12/16 [Insert Federal 

Register citation].

6.15 ............................ Standards for Control of Particulate Matter 

on Unpaved Roads.

06/03/07 04/12/16 [Insert Federal 

Register citation].

* * * * * * * 

* * * * * (e) * * * 

TABLE 2—ATTAINMENT, MAINTENANCE, AND OTHER PLANS

Name of SIP Provision Applicable geographic 

or nonattainment area 

State submittal 

date EPA approval date Explanations 

*******

Particulate Matter (PM10) 2nd 10-Year Limited Maintenance Plan.Spokane .................... 1/4/16 4/12/16 [Insert Federal 

Register citation].

[FR Doc. 2016–08272 Filed 4–11–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0449; FRL–9944–11] 

1,2-Propanediol, 3-[3-[1, 3, 3, 3-

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxanyl] propoxy]-; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- (CAS Reg. No. 70280–68–1) 

when used as an inert ingredient 

(antifoaming agent) in pesticide 

formulations applied to growing crops 

at a maximum concentration not to 

exceed 5% by weight. Exponent, on 

behalf of ISK Biosciences submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]-. 

DATES: This regulation is effective April 

12, 2016. Objections and requests for 

hearings must be received on or before 

June 13, 2016, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0449, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 


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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Rules and Regulations 21473 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0449 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 13, 2016. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0449, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Petition for Exemption 

In the Federal Register of April 6, 

2015 (80 FR 18327) (FRL–9924–00), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP IN–10699) by Exponent, on 

behalf of ISK Biosciences, 7470 Auburn 

Road, Suite A, Concord, OH 44077. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- (CAS Reg. No. 70280–68–1) 

when used as an inert ingredient 

(antifoaming agent) in pesticide 

formulations applied to growing crops 

at a maximum concentration not to 

exceed 10% in formulation. That 

document referenced a summary of the 

petition prepared by Exponent, the 

petitioner, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the limitation on the 

maximum concentration in the pesticide 

formulation from 10% to 5%. This 

limitation is based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov in 

document, ‘‘1,2-Propanediol, 3-[3- 

[1,3,3,3,3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-; Human health 

Risk Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pre-harvest Pesticide 

Products Under 40 CFR 180.920’’ in 

docket ID number EPA–HQ–OPP–2014– 

0449. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 1,2-propanediol, 

3-[3-[1, 3, 3, 3-tetramethyl-1- 


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21474 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Rules and Regulations 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by 1,2-propanediol, 3-[3-[1, 3, 3, 3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxyanyl] propoxy]- as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. 

There is currently limited data 

available for 1,2-propanediol, 3-[3- 

[1,3,3,3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-. The Agency 

received three studies specifically 

testing 1,2-propanediol, 3-[3-[1,3,3,3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-: acute oral 

toxicity, acute dermal toxicity, and an 

Ames assay. Those studies showed that 

1,2-propanediol, 3-[3-[1,3,3,3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]- was non-toxic via 

acute oral and acute dermal exposures 

and was negative for mutagenicity. To 

assess the remaining potential toxicity 

of 1,2-propanediol, 3-[3-[1,3,3,3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-, the Agency relied 

on data for a suitable cluster of 

structurally related linear short chain 

siloxane (Si-2 to Si-5) compounds. 

Based on the similar structures and 

physicochemical properties of these 

compounds to 1,2-propanediol, 3-[3- 

[1,3,3,3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-, which primarily 

differ only in the number of siloxane 

units, the Agency has determined that 

the toxicological properties of these 

compounds is representative of the 

toxicity of 3-[3-[1,3,3,3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-. The Agency has 

also determined that these data 

adequately address the 

physicochemical, mammalian 

metabolism, mammalian toxicological, 

and environmental fate endpoints of 

1,2-propanediol,3-[3-[1,3,3,3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-. 

Oral repeat dose toxicity studies are 

available for structurally similar linear 

short chain siloxane chemicals, for 

durations ranging from 28 days up to 

one year in rats, rabbits, and dogs. The 

lowest NOAELs were in the 25 

milligram/kilogram/day (mg/kg/day) 

range for two 28-day oral repeat dose rat 

studies and a 90-day dog study. LOAELs 

for these studies were based mainly on 

liver effects which were present in all of 

these studies. 

Dermal repeated dose toxicity studies 

are available for two of the structurally 

similar linear short chain siloxane 

compounds. A 28-day dermal toxicity 

study in rats and rabbits showed no 

adverse effects up to limit dose of 1,000 

mg/kg/day. The NOAEL was 1,000 mg/ 

kg/day; the highest dose tested in both 

studies. 

Inhalation repeated dose toxicity 

studies are available for three of the 

structurally similar linear short chain 

siloxane compounds. Both 28-day and 

90-day rat inhalation studies are 

available as well as a one-year chronic 

inhalation study. The lowest inhalation 

NOAEL was 3.9 milligrams per Liter 

(mg/L) in a 90-day study, equivalent to 

a dose of greater than 1,000 mg/kg/day, 

a limit dose value. 

A carcinogenicity study is available 

on one structurally-related short chain 

siloxane compound. An increase 

incidence of Leydig cell tumors (LCTs) 

in males was observed at all doses. 

However, due to the high background 

incidence of LCTs in Fischer 344 rats, 

this effect has been determined to not be 

treatment-related. Renal tubular 

adenomas and carcinomas were also 

observed in the study but are 

attributable to male rat specific alpha2m-globulin mediated nephrotoxicity 

and therefore not relevant to cancer risk 

concerns in humans. Genotoxicity 

studies on 1,2-propanediol,3-[3-[1,3,3,3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]- and structurallyrelated compounds were negative for 

genotoxic effects. A DEREK (structureactivity modeling) analysis was 

conducted and identified no structural 

alerts for possible carcinogenicity 

among the linear short chain siloxane 

compounds. Therefore, based on the 

lack of human-relevant carcinogenicity 

in the available study, and the results of 

the genotoxicity studies and DEREK 

analysis, 1,2-propanediol,3-[3-[1,3,3,3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]- is not expected to 

be carcinogenic. 

Reproductive and developmental 

toxicity studies with linear short chain 

siloxane compounds demonstrated no 

adverse effects at doses at or below limit 

dose levels. No evidence of 

immunotoxicity or neuro toxicity at 

doses below the limit dose was observed 

in the available studies for the 

structurally related linear short chain 

siloxane (Si-2 to Si-5) compounds at up 

to limit dose levels. 

There are currently no publicallyavailable metabolism studies for 1,2- 

propanediol,3-[3-[1,3,3,3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-, however, the 

expected mammalian metabolic 

pathways which may be involved in the 

degradation of 1,2-propanediol,3-[3- 

[1,3,3,3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]- include a 

combination of ether hydrolysis 

followed by +-oxidation of the carbon 

chain followed by methyl oxidation of 

the silyl methyl groups. Methyl 

oxidation would result in the formation 

of a mixture of primary and alcohol 

metabolites. The more polar primary 

alcohol functionalities can both be 

conjugated and excreted directly or 

further oxidized to form a mixture of 

more polar carboxylic acid metabolites 

that are readily conjugated and excreted. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by 1,2-propanediol,3-[3- 

[1,3,3,3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]- as well as the 

NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, ‘‘1,2- 

Propanediol,3-[3-[1,3,3,3-tetraamethyl1-[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-; Human Health 

Risk Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pre-harvest Pesticide 

Products Under 40 CFR 180.920’’ in 

docket ID number EPA–HQ–OPP–2014– 

0449. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 


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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Rules and Regulations 21475 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for 1,2-propanediol, 3-[3-[1, 

3, 3, 3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- used for human risk 

assessment is shown in Table 1 of this 

unit. 

The 28-day studies in rats the NOAEL 

was 25 mg/kg/day with a LOAEL of 250 

mg/kg/day based on based on increases 

in absolute liver weights, hepatocellular 

hypertrophy and protoporphyrin 

accumulation with associated bile duct 

proliferation and periportal chronic 

inflammation. A 90-day dog study had 

a NOAEL of 24 mg/kg/day with a 

LOAEL of 77 mg/kg/day based on 

increased relative liver weight in 

females and lower relative testes weight 

in males with slight testicular atrophy 

or hypoplasia in males. A NOAEL of 25 

mg/kg/day was selected for use as the 

endpoint for dietary exposure in this 

risk assessment. An additional 

uncertainty factor of 3X was applied for 

the use of shorter term study for a 

chronic risk assessment. 

Dermal and inhalation exposure 

endpoints were not selected as there 

were no adverse effects observed up to 

limit dose levels in both rat and rabbit 

dermal and inhalation toxicity studies. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR 1,2-PROPANEDIOL, 3-[3-[1, 3, 3, 3-TETRAMETHYL-1- 

[(TRIMETHYLSILYL)OXY]-1-DISILOXYANYL] PROPOXY]- FOR USE IN HUMAN RISK ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment 

Study and toxicological 

effects 

Acute dietary (All populations) ....... An acute effect was not found in the database therefore an acute dietary assessment is not necessary. 

Chronic dietary (All populations) .... NOAEL= 25 mg/kg/day .................

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

Chronic RfD = 0.08 mg/kg/day .....

cPAD = 0.08 mg/kg/day ...............

28-Day oral toxicity study-rat 

LOAEL = 250 mg/kg/day based 

on protoporphyrin accumulation 

in the liver. 

Incidental oral short-term (1 to 30 

days).

NOAEL= 25 mg/kg/day .................

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 ..................... 28-Day oral toxicity study-rat 

LOAEL = 250 mg/kg/day based 

on protoporphyrin accumulation 

in the liver. 

Incidental oral intermediate-term (1 

to 6 months).

NOAEL= 25 mg/kg/day .................

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 ..................... 28-Day oral toxicity study-rat 

LOAEL = 250 mg/kg/day based 

on protoporphyrin accumulation 

in the liver. 

Cancer (Oral, dermal, inhalation) .. Not likely to be carcinogenic to humans based on the lack of increased incidence of tumor formation compared to controls in the 1-year carcinogenicity study, lack of mutagenicity, and no structural alerts for 

genotoxicity or carcinogenicity identified in a qualitative structure activity relationship (SAR) database, 

DEREK. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFS = use of a short-term study for long-term risk assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 1,2-propanediol, 3-[3-[1, 3, 

3, 3-tetramethyl-1-[(trimethylsilyl)oxy]- 

1-disiloxyanyl] propoxy]-, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- in food as follows: 

i. Acute Exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide 

chemical, if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a 1-day 

or single exposure. No such effects were 

identified in the toxicological studies 

for 1,2-propanediol, 3-[3-[1, 3, 3, 3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxyanyl] propoxy]-; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. The chronic 

dietary exposure assessment for this 

inert ingredient utilizes the Dietary 

Exposure Evaluation Model Food 

Commodity Intake Database (DEEM– 

FCID), Version 3.16, EPA, which 

includes food consumption information 

from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat In America’’, (NHANES/

WWEIA). This dietary survey was 

conducted from 2003 to 2008. In the 

absence of actual residue data, the inert 

ingredient evaluation is based on a 

highly conservative model which 

assumes that the residue level of the 

inert ingredient would be no higher 

than the highest established tolerance 

for an active ingredient on a given 

commodity. Implicit in this assumption 

is that there would be similar rates of 

degradation between the active and 

inert ingredient (if any) and that the 

concentration of inert ingredient in the 

scenarios leading to these highest of 

tolerances would be no higher than the 

concentration of the active ingredient. 

The model assumes 100 percent crop 

treated (PCT) for all crops and that every 

food eaten by a person each day has 

tolerance-level residues. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 


jstallworth on DSK7TPTVN1PROD with RULES
21476 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Rules and Regulations 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts,’’ 

(D361707, S. Piper, 2/25/09) and can be 

found at http://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2008– 

0738. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that 1,2-propanediol, 3-[3-[1, 

3, 3, 3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- does not pose a cancer risk to 

humans. Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]-, a conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Residential use patterns are possible 

for pesticide products containing 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]-. Residential exposure could 

occur via the dermal and inhalation 

routes of exposure. However, there are 

no concerns for dermal or inhalation 

exposure because no effects were seen 

in dermal or inhalation toxicity studies 

up to the limit dose. Incidental oral 

exposure for children is possible either 

by hand-to-mouth or object-to-mouth 

ingestion resulting from contact with 

treated surfaces. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found 1,2-propanediol, 3- 

[3-[1, 3, 3, 3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- to share a common 

mechanism of toxicity with any other 

substances, and 1,2-propanediol, 3-[3-[1, 

3, 3, 3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that 1,2-propanediol, 3-[3-[1, 3, 

3, 3-tetramethyl-1-[(trimethylsilyl)oxy]- 

1-disiloxyanyl] propoxy]- does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Although some adverse reproductive 

effects were observed in the inhalation 

developmental/reproductive toxicity 

studies, these effects were at dose levels 

far in excess of the clear NOAEL 

established in the oral reproductive and 

developmental screening study and the 

regulatory doses used in the risk 

assessment were selected to be 

protective of these effects. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 3x to account for the 

use of a subchronic study to derive a 

chronic reference dose. That decision is 

also based on the following findings: 

i. Although only limited data on 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- is available, the Agency has 

reliable data based on the structurally 

related linear short chain siloxane (Si-2 

to Si-5) compounds to adequately 

characterize the toxicity and assess the 

risk from dietary exposure to 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]-. 

ii. There is no indication that 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- is a neurotoxic chemical at 

doses below the limit dose and there is 

no need for a developmental 

neurotoxicity study or additional 

uncertainty factors (UFs) to account for 

neurotoxicity. 

iii. There is no indication that 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- is a immunotoxic chemical 

and there is no need for a 

immunotoxicity study or additional UFs 

to account for immunotoxicity. 

iv. As discussed in Unit IV.D.2., there 

is no need to retain the FQPA 10x to 

address any concern for potential 

increased susceptibility in infants and 

children from prenatal or postnatal 

exposure to 1,2-propanediol, 3-[3-[1, 3, 

3, 3-tetramethyl-1-[(trimethylsilyl)oxy]- 

1-disiloxyanyl] propoxy]-. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on a highly 

conservative model that assumes 100 

percent crop treated (PCT) for all crops 

and that every food eaten by a person 

each day has residues of inert ingredient 

equivalent to the residue level of the 

highest established tolerance for an 

active ingredient on a given commodity. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to 1,2-propanediol, 3-[3-[1, 3, 3, 3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxyanyl] propoxy]- in drinking 

water. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by 1,2-propanediol, 3-[3-[1, 3, 3, 

3-tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxyanyl] propoxy]-. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 


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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Rules and Regulations 21477 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, 1,2-propanediol, 3- 

[3-[1, 3, 3, 3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- is not expected to pose an 

acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- from food and water will 

utilize 88.3% of the cPAD for children 

1–2 years old, the population group 

receiving the greatest exposure. Based 

on the explanation in this unit regarding 

residential use patterns, chronic 

residential exposure to residues of 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

1,2-Propanediol, 3-[3-[1, 3, 3, 3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxyanyl] propoxy]- may be used as 

an inert ingredient in pesticide products 

that would result in short-term 

residential exposure. Short-term risk is 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

Although short-term residential 

exposure is possible, there was no 

endpoint of concern identified in both 

dermal and inhalation toxicity studies. 

However the Agency has determined 

that it is appropriate to aggregate 

chronic exposure through food and 

water with short-term residential 

exposures for children. EPA has 

concluded the combined short-term 

aggregated food, water, and residential 

exposures results in an aggregate MOE 

of 334 for children. Children’s aggregate 

MOE combines average food and water 

exposure from the chronic dietary 

exposure with residential exposure 

associated with contact with treated 

lawns (hand-to-mouth + object-tomouth). As the level of concern is for 

MOEs that are lower than 300, these 

MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

1,2-Propanediol, 3-[3-[1, 3, 3, 3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxyanyl] propoxy]- may be used as 

an inert ingredient in pesticide products 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Although 

intermediate-term residential exposure 

is possible, there was no endpoint of 

concern identified in both dermal and 

inhalation toxicity. However the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures for children. EPA 

has concluded the combined 

intermediate-term aggregated food, 

water, and residential exposures results 

in an aggregate MOE of 342 for children. 

Children’s aggregate MOE combines 

average food and water exposure from 

the chronic dietary exposure with 

residential exposure associated with 

contact with treated lawns (hand-tomouth + object-to-mouth). As the level 

of concern is for MOEs that are lower 

than 300, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit IV.A., 

EPA does not expect 1,2-propanediol, 3- 

[3-[1, 3, 3, 3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- to pose a cancer risk to 

humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Although EPA is establishing a 

limitation on the amount of 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- that may be used in pesticide 

formulations, an analytical enforcement 

methodology is not necessary for this 

exemption from the requirement of 

tolerance. The limitation will be 

enforced through the pesticide 

registration process under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136 et seq. EPA 

will not register any pesticide for sale or 

distribution for use on growing crops 

with concentrations of 1,2-propanediol, 

3-[3-[1, 3, 3, 3-tetramethyl-1- 

[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- exceeding 5% by weight of 

the formulation. 

B. Revisions to Petitioned-For 

Tolerances 

Based upon an evaluation of the data 

included in the petition, EPA is 

establishing an exemption from the 

requirement of a tolerance for residues 

of 1,2-propanediol 3-[3-[1, 3, 3, 3- 

tetramethyl-1-[(trimethylsilyl)oxy]-1- 

disiloxyanyl] propoxy]- when used in 

pesticide formulations as an inert 

ingredient (antifoaming agent), not to 

exceed 5% by weight of the formulation, 

instead of the 10% limit requested. The 

basis for this revision can be found at 

http://www.regulations.gov in 

document, ‘‘1,2-Propanediol,3-[3- 

[1,3,3,3-tetraamethyl-1- 

[(trimethylsilyl)oxy]-1- 

disiloxanyl]propoxy]-; Human Health 

Risk Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pre-harvest Pesticide 

Products Under 40 CFR 180.920’’ in 

docket ID number EPA–HQ–OPP–2014– 

0449. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for 1,2- 

propanediol, 3-[3-[1, 3, 3, 3-tetramethyl1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- (CAS Reg. No. 70280–68–1) 

when used as an inert ingredient 

(antifoaming agent) in pesticide 

formulations applied to growing crops 

at a maximum concentration not to 

exceed 5% by weight in formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 


jstallworth on DSK7TPTVN1PROD with RULES
21478 Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Rules and Regulations 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 31, 2016. 

G. Jeffrey Herndon, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.920, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] 

propoxy]- (CAS Reg. No. 70280–68–1).

Not to exceed 5% by weight of pesticide formulation.Antifoaming agent. 

* * * * * * * 

[FR Doc. 2016–08282 Filed 4–11–16; 8:45 am] 

BILLING CODE 6560–50–P 

GULF COAST ECOSYSTEM 

RESTORATION COUNCIL 

40 CFR Part 1800 

[Docket Number: 104122016–1111–01] 

RESTORE Act Spill Impact Component 

Allocation 

AGENCY: Gulf Coast Ecosystem 

Restoration Council. 

ACTION: Notice of effective date of final 

rule. 

SUMMARY: This document confirms that 

on April 4, 2016, the United States 

District Court for the Eastern District of 

Louisiana entered a consent decree 

(Consent Decree) among the United 

States; the states of Alabama, Florida, 

Louisiana, Mississippi and Texas; and 

BP Exploration and Production Inc. 

with respect to the civil penalty and 

natural resource damages in case 

number MDL No. 2179. The Gulf Coast 

Ecosystem Restoration Council 

(Council) regulation (Spill Impact 

Regulation) that implements the Spill 

Impact Component Allocation of the 

Resources and Ecosystems 

Sustainability, Tourist Opportunities, 

and Revived Economies of the Gulf 

Coast States Act of 2012 (RESTORE Act) 

is effective as of the date of publication 

of this document. 

DATES: The Spill Impact Regulation is 

effective on April 12, 2016. 

FOR FURTHER INFORMATION CONTACT: Will 

Spoon at (504) 239–9814. 

SUPPLEMENTARY INFORMATION: 

Background 

On December 15, 2015, the Council 

published the Spill Impact Regulation 

in the Federal Register (80 FR 77580), 

to be effective on the date that the 

Council publishes this document in the 

Federal Register confirming that the 

United States District Court for the 

Eastern District of Louisiana has entered 

the Consent Decree. 

On April 4, 2016, the United States 

District Court for the Eastern District of 

Louisiana entered the Consent Decree. 

The Council confirms such entry by 

publication of this document, and the 

Spill Impact Regulation is therefore 

effective. 

For more information on the Spill 

Impact Regulation, please see the final 

rule (80 FR 77580, December 15, 2015). 

Procedural Requirements 

Regulatory Planning and Review 

(Executive Orders 12866 and 13563) 

As an independent Federal entity that 

is comprised, in part, of the Secretaries 

of the Departments of the Interior, 

Agriculture, Commerce and Homeland 

Security; the Secretary of the Army; and 

the Administrator of Environmental 

Protection Agency, the requirements of 

Executive Orders 12866 and 13563 do 

not apply to this document. 


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