31520 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Rules and Regulations 

12.2 Calculate the difference between the 

measured HCl concentration with and 

without interferents for each interference gas 

(or mixture) for your CEMS as: 

Calculate the total percent interference as: 

12.2.1 Calculate the equivalent 

concentration Ci,eff using Equation 4: 

* * * * * 12.4.4 Calculate the zero CD as a percent 

of span for an IP–CEMS as: 

* * * * * 

PS–18 Appendix A Standard Addition 

Procedures 

* * * * * 

11.0 Calculations and Data Analysis. * * * 

* * * * * 

11.2.3 If you determine your spike 

dilution factor using an independent stable 

tracer that is present in the native source 

emissions, calculate the dilution factor for 

dynamic spiking using equation A3: 

* * * * * 

■ 3. In appendix F to part 60, revise 

Sections 4.1.5, 4.1.5.1, 4.1.5.3, and 

5.2.4.2 in Procedure 6 to read as follows: 

Appendix F to Part 60—Quality 

Assurance Procedures 

* * * * * 

Procedure 6. Quality Assurance 

Requirements for Gaseous Hydrogen Chloride 

(HCl) Continuous Emission Monitoring 

Systems Used for Compliance Determination 

at Stationary Sources 

* * * * * 

4.0 Daily Data Quality Requirements and 

Measurement Standardization 

Procedures 

* * * * * 

4.1.5 Additional Quality Assurance for 

Data above Span. Unless otherwise specified 

in an applicable rule or permit, this 

procedure must be used to assure data 

quality and may be used when significant 

data above span is being collected. 

4.1.5.1 Any time the average measured 

concentration of HCl exceeds 150 percent of 

the span value for two consecutive 1-hour 

averages, conduct the following ‘above span’ 

CEMS response check. 

* * * * * 

4.1.5.3 Unless otherwise specified in an 

applicable rule or permit, if the ‘above span’ 

response check is conducted during the 

period when measured emissions are above 

span and there is a failure to collect at least 

one data point in an hour due to the response 

check duration, then determine the emissions 

average for that missed hour as the average 

of hourly averages for the hour preceding the 

missed hour and the hour following the 

missed hour 

* * * * * 

5.0 Data Accuracy Assessment 

* * * * * 

5.2.4.2 Calculate results as described in 

section 6.4. To determine CEMS accuracy 

you must calculate the dynamic spiking error 

(DSE) for each of the two upscale audit gases 

using equation A5 in appendix A to PS–18 

and Equation 6–3 in section 6.4 of Procedure 

6 in appendix B to this part. 

* * * * * 

[FR Doc. 2016–10989 Filed 5–18–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0853; FRL–9945–82] 

Maleic Anhydride; 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 maleic 

anhydride (CAS Reg. No. 108–31–6) 

when used as an inert ingredient 

(stabilizer) in pesticide formulations 

applied to growing crops at a maximum 

concentration not to exceed 3.5% by 

weight in the pesticide formulation. 

Exponent, on behalf of Cheminova A/S, 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an amendment to 

an existing requirement of a tolerance. 

This regulation eliminates the need to 


asabaliauskas on DSK3SPTVN1PROD with RULESER19MY16.024</GPH> ER19MY16.025</GPH> ER19MY16.026</GPH> ER19MY16.027</GPH> ER19MY16.028</GPH>
Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Rules and Regulations 31521 

establish a maximum permissible level 

for residues of maleic anhydride. 

DATES: This regulation is effective May 

19, 2016. Objections and requests for 

hearings must be received on or before 

July 18, 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–2014–0853, 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. 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–2014–0853 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 July 18, 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– 

2014–0853, 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–10771 by Exponent on 

behalf of Cheminova A/S, 1600 Wilson 

Boulevard, Suite 700, Arlington, VA 

22209. The petition requested that 40 

CFR 180.920 be amended by modifying 

an exemption from the requirement of a 

tolerance for residues of maleic 

anhydride (CAS Reg. No. 108–31–6) 

when used as an inert ingredient 

(stabilizer) in pesticide formulations 

applied to growing crops to allow for 

use at a maximum concentration not to 

exceed 5% 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 pesticide 

formulation from 5% to 3.5%. This 

limitation is based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov in 

document, Maleic Anhydride; 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 Products under 

40 CFR 180.920, in docket ID number 

EPA–HQ–OPP–2014–0853. 

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 


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31522 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Rules and Regulations 

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 maleic anhydride 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with maleic anhydride 

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 maleic anhydride 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. 

Maleic anhydride exhibits relatively 

low toxicity via oral and dermal routes 

of exposure. Maleic anhydride has been 

reported to be severely irritating to the 

skin and eyes of rabbits, dermally 

sensitizing to guinea pigs, and is a 

possible respiratory sensitizer. 

In a six-month repeat dose inhalation 

study, CD rats, Engle hamsters, and 

Rhesus monkeys were exposed by 

inhalation (whole body) to 0, 1.1, 3.3 

and 9.8 mg/m3 (0, 0.3, 0.8, and 2.4 ppm) 

maleic anhydride for six months. Body 

weights were decreased in rats at 3.3 

and 9.8 mg/m3 (0.8, and 2.4 ppm) in the 

mid- and high-exposure groups at 

intervals during the study (<10%). 

However, at study termination, body 

weights were decreased only at the 9.8 

mg/m3 exposure group (6–8%). These 

decreases in the body weights are not 

considered as an adverse effect. All 

other effects were limited to the 

respiratory tract and eye. All of these 

effects were considered indicative of 

irritation and judged to be reversible. 

The NOAEL for irritation in this study 

was 3.3 mg/m3 or 0.93 mg/kg/day based 

on localized eye/nasal irritation effects 

seen at the LOAEL of 9.8 mg/m3. The 

NOAEL for systemic toxicity in rats, 

hamsters and monkeys is 9.8 mg/m3, the 

highest dose tested. 

In a 28-day inhalation study with 

maleic anhydride in Sprague-Dawley 

rats, evidence of nasal and ocular 

irritation (concentration-dependent) 

occurred at 12, 32 and 86 mg/m3. 

Reduced body weight gain and food 

consumption as well as increased 

incidence of hemorrhagic lung foci 

occurred at 32 and 86 mg/m3. The 

NOAEL for the systemic toxicity is 12 

mg/m3 (3 ppm) based on the reduced 

body weights and food consumption 

seen at the LOAEL of 32 mg/m3. 

In a 90-day oral (dietary) study in rats 

were fed in the diet 0, 100, 250, or 600 

mg/kg/day maleic anhydride for 90 

days. At 600 mg/kg/day, there was slight 

proteinuria in both sexes, increased 

relative liver weight in males, increased 

relative/absolute kidney weights in both 

sexes. Macroscopic and microscopic 

kidney changes, including nephrosis 

were seen in male rats at 100, 250, and 

600 mg/kg/day. The LOAEL for this 

study is 100 mg/kg/day. In a separate 

study, rats were fed in the diet 0, 20, or 

40 mg/kg/day maleic anhydride, seven 

days a week for 90 days. There were no 

treatment-related effects. The NOAEL 

for this study is 40 mg/kg/day. 

In a 183-day oral (dietary) study in 

rats there were renal lesions and an 

increase in the absolute and relative 

liver and kidney weights at 250 mg/kg/ 

day and 600 mg/kg/day. The LOAEL for 

this study is 250 mg/kg/day. A NOAEL 

was not established. 

In a 2-year oral (dietary) study in rats 

only marginal toxicity was observed 

which was evidenced by small (<6%), 

but dose-related, decrease in body 

weights of rats. The LOAEL for this 

study is 32 mg/kg/day and the NOAEL 

for this study is 10 mg/kg/day. 

In a 90-day dietary study in dogs, 

there were no treatment related effects 

observed at doses up to 60 mg/kg/day, 

the highest dose tested. 

In an oral (gavage) developmental 

toxicity study in CD rats, no treatment 

related adverse effects were observed. 

The NOAEL for both maternal and 

developmental toxicity was 140 mg/kg/ 

day, the highest dose tested. 

In a 2-generation oral (gavage) 

reproductive toxicity study in rats, 

significant mortality occurred in the F0

and F1 parental animals and maleic 

anhydride was toxic to parental animals 

in all dose groups (20, 55 and 150 mg/ 

kg/day of maleic anhydride). There was 

no significant reduction in the 

percentage of pregnant females or the 

percentage of fertile males. Adverse 

effects on litter size and on pup survival 

were observed at the dose of 55 mg/kg/ 

day and above in the F2 litters. Maleic 

anhydride was toxic to parental animals 

in all dose groups. For parental toxicity 

the LOAEL was 20 mg/kg/day. Although 

a NOAEL for parental toxicity was not 

established, the selected NOAEL (which 

is from the 2-year toxicity study in the 

rat) will be protective of the kidney and 

bladder effects seen at the lowest dose 

tested in this study, since the 2-year 

toxicity study examined those organs 

and found no effects. The NOAEL for 

offspring toxicity was 55 mg/kg/day 

based on decreased pup survival 

observed at 150 mg/kg/day. 

Maleic anhydride was negative for 

mutagenicity or chromosomal 

aberrations in a battery of tests of 

genotoxicity including a bacterial gene 

mutation test, an in vivo mammalian 

chromosomal aberration test using rat 

bone marrow and an in vitro 

chromosomal test. 

In the previously described 2-year 

dietary study, male and female rats were 

exposed to 0, 10, 32, or 100 mg/kg/day 

maleic anhydride in feed for two years. 

There were no increases in tumor 

incidence that were considered related 


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Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Rules and Regulations 31523 

to maleic anhydride exposure. 

Additionally in a two-year chronic 

feeding study on Osborne-Mendel rats 

fed 0, 0.5, 1.0 or 1.5% maleic acid in 

their diets for two years resulted in no 

treatment-related increases in tumors. 

A 1-hour neurotoxicity inhalation 

study exposed rats to 0.72 mg/L of 

maleic acid which produced generalized 

inactivity, hyperpnea and sedation 

within 15 minutes of exposure. Gross 

necropsy revealed no significant 

findings. No neurotoxic effects have 

been reported in the other available 

studies. 

No immunotoxicity studies on maleic 

anhydride or maleic acid were available 

in the database. 

In a metabolism study, dogs were fed 

60 mg/kg/day maleic anhydride for 90 

days. Using a one compartment model, 

uptake rate and elimination rate 

constants were calculated as 3.49 × 10¥3

per day and 8.32 × 10¥2 per day, 

respectively. Based on this model, 99% 

of steady state was reached by day 55 

of the study. 

Maleic anhydride is readily 

hydrolyzed to maleic acid under 

aqueous conditions and is then 

hydroxylated to malic acid, which 

participates in the Krebs cycle or may be 

excreted unchanged or in conjugated 

form. 

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. 

An acute effect was not found in the 

database for maleic anhdyride. 

The 2-year oral toxicity study in rats 

was selected for dietary and dermal 

exposure scenarios (all non-acute 

durations) for this risk assessment. The 

NOAEL in this study was 10 mg/kg/day. 

The LOAEL was 32 mg/kg/day based on 

slight to marginal decreases in body 

weight. The rationale for selecting this 

study for the dietary is based on the fact 

that this study provided the lowest and 

most conservative toxicity endpoint in 

the most sensitive species for oral after 

a long-term exposure. No repeat dose 

dermal toxicity studies are available for 

maleic anhydride; the dermal risk 

assessment was conducted using the 

most sensitive conservative oral 

endpoint. An uncertainty factor of 100x 

was applied, 10x for interspecies 

variability and 10x for intraspecies 

variability; the FQPA safety factor was 

reduced to 1x. No dermal absorption 

studies were available for maleic 

anhydride or maleic acid, therefore, a 

dermal absorption value was estimated 

using the ratio of an oral LD50 and a 

dermal LD50. The two studies used were 

the oral rabbit LD50 of 875 mg/kg and 

the dermal rabbit LD50 of 2,620 mg/kg. 

The resulting estimated dermal 

absorption was 33%. Therefore, a 

dermal absorption factor of 33% will be 

used for dermal exposure scenarios. 

The 6-month inhalation toxicity study 

in rats was selected for inhalation 

exposure scenarios (all durations) for 

this risk assessment. The NOAEL in this 

study was 3.3 mg/m3 or 0.93 mg/kg/day 

based on localized eye/nasal irritation 

effects seen at the LOAEL of 9.8 mg/m3. 

Since the major effect of maleic 

anhydride is irritation via inhalation, 

this endpoint is protective of any 

systemic toxicity seen at concentrations 

of 32 mg/m3 and above seen in the 28- 

day inhalation toxicity study. An 

uncertainty factor of 100x was applied, 

10x for interspecies variability and 10x 

for intraspecies variability. The FQPA 

safety factor was reduced to 1x. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to maleic anhydride, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from maleic 

anhydride 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 maleic anhydride 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): 

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. In the case of maleic anhydride, 

EPA made specific adjustments to the 

dietary exposure assessment to account 

for the use limitation of maleic 

anhydride (as an inert ingredient in 

pesticide formulations applied to apples 

with a minimum preharvest interval of 

21 days and at maximum concentration 

of 3.5% by weight in all other 

preharvest uses). 

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 maleic 

anhydride, a conservative drinking 

water concentration value of 100 ppb 

based on screening level modeling was 

used to assess the contribution to 


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31524 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Rules and Regulations 

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). 

Maleic anhydride may be used as 

inert ingredient in pesticide products 

that are registered for specific uses that 

may result in indoor or outdoor 

residential inhalation and dermal 

exposures. A screening-level residential 

exposure and risk assessment was 

completed utilizing conservative 

residential exposure assumptions. The 

Agency assessed short- and 

intermediate-term dermal and 

inhalation exposures for residential 

handlers that would result from low 

pressure handwand, hose end sprayer 

and trigger sprayer for outdoor scenarios 

of each pesticide type, herbicide, 

insecticide and fungicide and mopping, 

wiping and aerosol sprays for indoor 

scenarios. The Agency assessed postapplication short-term dermal exposure 

for children and adults as well as shortterm hand-to-mouth exposure for 

children from contact with treated 

lawns. 

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 maleic anhydride 

to share a common mechanism of 

toxicity with any other substances, and 

maleic anhydride does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that maleic anhydride 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 

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 no evidence of increased 

quantitative or qualitative susceptibility 

of rat fetuses to the effects of maleic 

anhydride. In the 2-generation 

reproduction study, the LOAEL for 

parental toxicity was 20 mg/kg/day. No 

adverse effects on litter size or pup 

survival were noted at doses up to 55 

mg/kg/day. 

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 maleic 

anhydride is adequate for characterizing 

the toxicity and assessing the risk from 

dietary exposure. 

ii. There is no indication that maleic 

anhydride is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no indication that maleic 

anhydride is an immunotoxic chemical 

and there is no need for an 

immunotoxicity study or additional UFs 

to account for immunotoxicity. 

iv. There is no evidence that maleic 

anhydride results in increased 

susceptibility in in utero in rats in the 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening studies and prenatal 

developmental studies. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 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 maleic anhydride 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 maleic anhydride. 

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 

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, maleic anhydride 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 maleic 

anhydride from food and water will 

utilize 72.4% 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 maleic anhydride 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). 

Maleic anhydride may be used as an 

inert ingredient in pesticide products 

that are registered for uses 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 maleic anhydride. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 112 for adults and 105 for 

children. Because EPA’s level of 

concern for maleic anhydride is a MOE 

of 100 or below, these MOEs are not of 

concern. 


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Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Rules and Regulations 31525 

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). 

Maleic anhydride is currently used as 

an inert ingredient in pesticide products 

that are registered for uses that could 

result in intermediate-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 maleic anhydride. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded the 

combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 178 for adults and 

119 for children. Because EPA’s level of 

concern for maleic anhydride is a MOE 

of 100 or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit IV.A., maleic anhydride is not 

expected to pose a cancer risk. 

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 maleic 

anhydride residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Although EPA is establishing a 

limitation on the amount of maleic 

anhydride that may be used in pesticide 

formulations, an analytical enforcement 

methodology is not necessary for this 

exemption. 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 maleic anhydride 

exceeding 3.5% 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 maleic anhydride when used in 

pesticide formulations as an inert 

ingredient (stabilizer), not to exceed 

3.5% by weight of the formulation, 

instead of the 5% limit requested. The 

basis for this revision can be found at 

http://www.regulations.gov in document 

Maleic Anhydride; 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– 

0853. 

VI. Conclusions 

Therefore, EPA is amending the 

existing exemption from the 

requirement of a tolerance under 40 CFR 

180.920 for maleic anhydride (CAS Reg. 

No. 108–31–6). In addition to the 

existing limitation for use as an inert 

ingredient (stabilizer) in pesticide 

formulations applied to growing crops 

for use in pesticide formulations 

applied to apples with a minimum 

preharvest interval of 21 days, the 

Agency is extending the exemption for 

use in all pesticide formulations at a 

maximum concentration not to exceed 

3.5% in the pesticide formulation. In 

order to clarify that this extension 

applies only to maleic anhydride, the 

Agency is separating the existing 

exemption for maleic anhydride from 

the existing maleic acid exemption. 

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 

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: May 6, 2016. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 


asabaliauskas on DSK3SPTVN1PROD with RULES
31526 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Rules and Regulations 

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: 

■ i. Remove the existing entry for 

‘‘Maleic acid and maleic anhydride’’ 

from the table. 

■ ii. Add alphabetically the following 

entries ‘‘Maleic acid,’’ and ‘‘Maleic 

anhydride’’ to the table to read as 

follows: 

§ 180.920 Inert ingredients used 

preharvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Maleic acid ................................................. For pesticide formulations applied to apples with a minimum preharvest interval of 

21 days.

Stabilizer. 

Maleic anhydride (CAS Reg. No. 108–31– 

6).

Not to exceed 3.5% in pesticide formulations; or for pesticide formulations applied 

to apples with a minimum preharvest interval of 21 days.

Stabilizer. 

* * * * * * * 

[FR Doc. 2016–11837 Filed 5–18–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

48 CFR Parts 1501, 1505, 1516, 1528, 

1529, 1532 and 1552 

[EPA–HQ–OARM–2015–0799; FRL 9945–66– 

OARM] 

Environmental Protection Agency 

Acquisition Regulation; General, 

Publicizing Contract Actions, Types of 

Contracts, Bonds and Insurance, 

Taxes, Contract Financing, Solicitation 

Provisions and Contract Clauses 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is issuing a final rule to 

make administrative changes to the 

Environmental Protection Agency 

Acquisition Regulation (EPAAR). EPA 

does not anticipate any adverse 

comments. 

DATES: This rule is effective on July 18, 

2016 without further action, unless EPA 

receives adverse comment by June 20, 

2016. If EPA receives adverse comment, 

we will publish a timely withdrawal in 

the Federal Register informing the 

public that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OARM–2015–0799, at http://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

The EPA may publish any comment 

received to its public docket. Do not 

submit electronically any information 

you consider to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e. on the web, cloud, or 

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Julianne Odend’hal, Policy, Training, 

and Oversight Division, Acquisition 

Policy and Training Service Center 

(3802R), Environmental Protection 

Agency, 1200 Pennsylvania Avenue 

NW., Washington DC 20460; telephone 

number: (202) 564–5218; email address: 

odend’hal.julianne@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why is EPA using a direct final rule? 

EPA is publishing this rule without a 

prior proposed rule because EPA views 

this as a noncontroversial action and 

anticipates no adverse comment. 

EPAAR Parts 1501, 1505, 1516, 1528, 

1529, 1532, and 1552 are being 

amended to make administrative 

changes to the EPAAR. If EPA receives 

adverse comment, a timely withdrawal 

will be published in the Federal 

Register informing the public that the 

rule will not take effect. Any parties 

interested in commenting must do so at 

this time. 

II. Does this action apply to me? 

The EPAAR applies to contractors 

who have a contract with the EPA. 

III. What should I consider as I prepare 

my comments for EPA? 

A. Submitting CBI. Do not submit this 

information to EPA through http://

www.regulations.gov or email. Clearly 

mark the part or all of the information 

that you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI, and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

B. Tips for Preparing Your Comments. 

When submitting comments, remember 

to: 

• Identify the rulemaking by docket 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

• Follow directions—The agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

• Explain why you agree or disagree, 

suggest alternatives, and substitute 

language for your requested changes. 

• Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

• If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

• Provide specific examples to 

illustrate your concerns, and suggest 

alternatives. 

• Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 


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