Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations 17611 

Review Under Executive Order 13132, 

Federalism, 64 FR 43255 (August 4, 

1999) 

Review under Executive Order 13132 

requires that agencies review 

regulations for federalism effects on the 

institutional interest of states and local 

governments, and, if the effects are 

sufficiently substantial, prepare a 

Federal assessment to assist senior 

policy makers. This proposed rule will 

not have any direct effects on State and 

local governments within the meaning 

of the Executive Order. Therefore, the 

regulation requires no federalism 

assessment. 

List of Subjects in 36 CFR Part 1258 

Archives and records. 

For the reasons stated in the 

preamble, NARA amends 36 CFR part 

1258 as follows: 

PART 1258—FEES 

■ 1. The authority citation for part 1258 

remains as follows: 

Authority: 44 U.S.C. 2116(c) and 2307. 

■ 2. Revise § 1258.16 to read as follows: 

§ 1258.16 What is NARA’s refund policy? 

Due to various factors, it is 

occasionally difficult for NARA to make 

a legible reproduction. NARA will 

notify customers and ask for approval to 

proceed if we anticipate a reproduction 

of questionable legibility. As a result, 

NARA does not provide refunds except 

in special cases. If a customer requests 

a refund, we review the order to 

determine if we properly notified the 

customer of the questionable nature of 

the original and if the product is a true 

representation of the original. If the 

product is a true representation of the 

original, we will not issue a refund. If 

you feel we processed your order 

incorrectly or it contains errors, please 

contact us within 120 days of your order 

date to have your issue verified. Once 

we verify the issue, we will correct the 

error and resend the documents. If we 

cannot correct the error, you will 

receive a refund. 

Dated: March 20, 2016. 

David S. Ferriero, 

Archivist of the United States. 

[FR Doc. 2016–07149 Filed 3–29–16; 8:45 am] 

BILLING CODE 7515–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0019; FRL–9944–12] 

Salicylaldehyde; 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 salicylaldehyde 

(2-hydroxybenzaldehyde, CAS Reg. No. 

90–02–8) when used as an inert 

ingredient (penetration aid) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities under 

40 CFR 180.910 at a concentration not 

to exceed 14% by weight of the 

pesticide formulation. Ag-Chem 

Consulting LLC, on behalf of Omex 

Agrifluids 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 salicylaldehyde. 

DATES: This regulation is effective 

March 30, 2016. Objections and requests 

for hearings must be received on or 

before May 31, 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–2015–0019, 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). 

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. 

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–2015–0019 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 May 31, 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– 


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17612 Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations 

2015–0019, 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–10777) by Ag-Chem 

Consulting LLC, 12208 Quinque Lane, 

Clifton, VA 20124 on behalf of Omex 

Agrifluids, 24730 Avenue 13, Madera, 

CA 93637. The petition requested that 

40 CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of salicylaldehyde (CAS Reg. No. 90– 

02–8) when used as an inert ingredient 

(penetration aid) in pesticide 

formulations applied to growing crops 

or to raw agricultural commodities after 

harvest at a concentration not to exceed 

14% by weight of the pesticide 

formulation. That document referenced 

a summary of the petition prepared by 

Ag-Chem Consulting LLC, on behalf of 

Omex Agrifluids, the petitioner, which 

is available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 exemption is ‘‘safe.’’ 

Section 408(c)(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 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 salicylaldehyde 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with salicylaldehyde 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 salicylaldehyde as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

The acute oral toxicity of 

salicylaldehyde was examined in male 

rats and mice. The general oral lethal 

amount of salicylaldehyde is estimated 

to be 500 mg/kg in mice. The dermal 

LD50 for salicylaldehyde was 

determined to be greater than 23,000 

mg/kg. Dermal irritation studies found 

salicylaldehyde to be irritating, with 

eschar formation and scarring 14 days 

after administration. 

No adverse effects attributable to a 

single exposure to salicylaldehyde were 

seen in the toxicity databases. In a 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test, toxicity was not 

observed in parental animals nor in 

reproductive parameters at doses up to 

160 mg/kg/day, the highest dose tested. 

Fetal susceptibility was observed. 

Reduced bodyweight and offspring 

mortality after 4 days of nursing were 

observed at 160 mg/kg/day. The NOAEL 

was 40 mg/kg/day. There was no 

evidence of neurotoxicity or 

immunotoxicity in the combined 

repeated dose toxicity with the 

reproduction/developmental toxicity 

screening test. 

Salicylaldehyde was negative for 

mutagenicity in the Ames test and gave 

a positive response in the chromosome 

aberrations test using Chinese hamster 

cells (in vitro). An in vivo micronucleus 

assay was negative. Since the in vivo 

study is more reliable than the in vitro 

assays, the weight of evidence suggests 

that salicylaldehyde is unlikely to be 

mutagenic. 

There are no cancer studies available 

for salicylaldehyde. According to a 

DEREK (Nexus) (structural activity 

relationship) report, there are no 

structural alerts for carcinogenicity. 


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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations 17613 

Based on predicted rapid metabolism 

and excretion, lack of specific target 

organ toxicity in the repeat dose toxicity 

study, lack of mutagenicity concerns, 

and lack of any structural alerts for 

carcinogenicity, salicylaldehyde is not 

expected to be carcinogenic to humans 

at anticipated dietary concentrations. 

The metabolism of salicylaldehyde in 

rabbits demonstrated that 75% of single 

dose of salicylaldehyde was excreted in 

the urine as glucuronic acid and sulfate 

conjugates of vanillic acid. 

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 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). 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. 

No acute toxicological endpoint of 

concern has been identified for 

salicylaldehyde. On the basis of the 

repeated dose and reproductive/

developmental toxicity screening study, 

a no observed adverse effect level 

(NOAEL) for offspring toxicity for 

salicylaldehyde was 40 mg/kg bw/day 

based on reduced body weight and 

increased mortality in pups at 160 mg/ 

kg/day. The standard 10X factors for 

intra- and inter-species were applied in 

establishing he chronic reference dose 

(cRfD) of 0.4 mg/kg/day (40 mg/kg/day/ 

100). Based on the reduced FQPA Safety 

Factor for salicylaldehyde of 1X, the 

chronic population adjusted dose 

(cPAD) is equivalent to the chronic 

reference dose (cRfD) at 0.4 mg/kg//day. 

The chronic oral NOAEL is also 

applicable to the short- and 

intermediate-term dermal and 

inhalation exposure routes. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to salicylaldehyde, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

salicylaldehyde in food as follows: 

Acute dietary assessments take into 

account exposure estimates from dietary 

consumption of food and drinking 

water. Chronic dietary assessments take 

into account dietary food and drinking 

water. The Agency assessed the dietary 

exposures to salicylaldehyde as an inert 

ingredient used in pesticide 

formulations applied to growing crops 

and livestock. 

No adverse effects attributable to a 

single exposure to salicylaldehyde were 

seen in the toxicity databases; therefore, 

an acute dietary risk assessment is not 

appropriate. 

In conducting the chronic dietary 

exposure assessment to salicylaldehyde 

an inert ingredient used in pesticide 

formulations applied to growing crops, 

raw agricultural commodities, and 

livestock, the Dietary Exposure 

Evaluation Model/Food Commodity 

Intake Database (DEEM–FCID) TM, 

Version 3.16 was used. EPA used food 

consumption information from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(USDA/NHANES/WWEIA). This dietary 

survey was conducted from 2003 to 

2008. As to residue levels in food, no 

residue data were submitted for 

salicylaldehyde. In the absence of 

specific residue data, EPA has 

developed an approach that uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. 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): 

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. 

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 

salicylaldehyde, a conservative drinking 

water concentration value of 100 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). 

There are no current or proposed 

residential uses for salicylaldehyde; 

however, it is possible that 

salicylaldehyde may be used as an inert 

ingredient in pesticide products. A 

highly conservative residential exposure 

assessment was performed in which it 

was assumed that all residential use 

pesticide products would contain 

salicylaldehyde as an inert ingredient. A 

complete description of the approach 

used to assess possible residential 

exposures from salicylaldehyde can be 

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

document ‘‘Salicylaldehyde; 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 Pesticide Formulations,’’ 

pp. 15 in docket ID number EPA–HQ– 

OPP–2015–0019. 

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 or exemption from 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 salicylaldehyde to 

share a common mechanism of toxicity 

with any other substances, and 

salicylaldehyde does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that salicylaldehyde 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 


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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 

FQPA Safety Factor (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. 

There is evidence of increased 

susceptibility of infants and children 

due to exposure to salicylaldehyde. In a 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test, offspring toxicity 

was manifested as decreased body 

weights and increased mortality in the 

absence of maternal toxicity at doses up 

to 160 mg/kg/day. The offspring toxicity 

NOAEL was 40 mg/kg/day. However, 

there are no to low concerns for this 

susceptibility since there is a clear, well 

defined offspring toxicity NOAEL and 

this study is being used to establish the 

cRfD. 

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 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

salicylaldehyde includes the battery of 

acute studies, mutagenicity studies and 

a combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test. 

ii. There is no evidence of 

neurotoxicity in the available studies, 

therefore there is no need for a 

developmental neurotoxicity study. 

iii. There is no evidence of 

immunotoxicity in the available 

database, therefore there is no need for 

an immunotoxicity study. 

iv. There are low to no concerns for 

the increased susceptibility seen in the 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 14% by 

weight in the formulation (the 

maximum allowable use rate) and 

tolerance-level residues. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to salicylaldehyde 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 salicylaldehyde. 

E. Aggregate Risks and Determination of 

Safety 

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, salicylaldehyde 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 salicylaldehyde 

from food and water will utilize 13% of 

the cPAD for the U.S. population and 

49% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Salicylaldehyde may be used as inert 

ingredients in pesticide products that 

could result in short-term residential 

exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to salicylaldehyde. Using the 

exposure assumptions described in this 

unit, EPA has concluded the combined 

short- and intermediate-term food, 

water, and residential exposures result 

in short- and intermediate-term 

aggregate MOEs of 430 for adults and 

170 for children (1–2 years old). 

Because EPA’s level of concern for 

salicylaldehyde is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on a DEREK 

structural alert analysis and the lack of 

mutagenicity, salicylaldehyde not 

expected to pose a cancer risk to 

humans. 

5. Determination of safety section. 

Based on these risk assessments, EPA 

concludes that there is reasonable 

certainty that no harm will result to the 

general population, or to infants and 

children from aggregate exposure to 

salicylaldehyde residues. 

V. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. EPA 

is establishing a limitation on the 

amount of salicylaldehyde that may be 

used in pesticide formulations applied 

to growing crops. That 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 

formulation for use on growing crops for 

sale or distribution that exceed 14% of 

salicylaldehyde. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for residues 

salicylaldehyde (CAS Reg. No. 90–02–8) 

when used as an inert ingredient 

(penetration aid) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest at a concentration not to exceed 

crops at no more than 14% by weight 

of the pesticide 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 

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 


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Federal Register / Vol. 81, No. 61 / Wednesday, March 30, 2016 / Rules and Regulations 17615 

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 22, 2016. 

Susan Lewis, 

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 § 180.910, add alphabetically the 

inert ingredient ‘‘Salicylaldehyde’’ to 

the table to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Salicylaldehyde (CAS Reg. No. 90– 

02–8).

Not to exceed 14% by weight of pesticide formulation .................................... Penetration aid.

*******

[FR Doc. 2016–07085 Filed 3–29–16; 8:45 a.m.] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2016–0002; Internal 

Agency Docket No. FEMA–8429] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http:// 

www.fema.gov/fema/csb.shtm. 

DATES: The effective date of each 

community’s scheduled suspension is 

the third date (‘‘Susp.’’) listed in the 

third column of the following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact Patricia Suber, 

Federal Insurance and Mitigation 

Administration, Federal Emergency 

Management Agency, 500 C Street SW., 

Washington, DC 20472, (202) 646–4149. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 


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