Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations 42783 

the Federal Government and Indian 

tribes, or otherwise have any unique 

impacts on local governments. 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 final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

Although this action does not 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), EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low-income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this rule in the Federal 

Register. This rule 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: August 16, 2018. 

Michael Goodis, 

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 § 180.960, the table is amended 

by adding alphabetically the following 

polymers to read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*******

Lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1), minimum number average molecular weight (in amu); 4,500 daltons ................................................................................................................................ 1905409–74–6 

* * * * * * * 

[FR Doc. 2018–18407 Filed 8–23–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0574; FRL–9978–36] 

Zinc Oxide; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

exemption from the requirement of a 

tolerance for residues of zinc oxide 

(CAS Reg. No. 1314–13–2) when used as 

an inert ingredient in pesticide 

formulations applied to growing crops 

or raw agricultural commodities after 

harvest, to include use as a stabilizer, at 

a concentration not to exceed 15% by 

weight of the pesticide formulation. 

Nutrenare-AG, Inc. submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

establishment of an amended new use 

for an exemption from the requirement 

of a tolerance. This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of zinc oxide when used in accordance 

with the limitations of the exemption. 

DATES: This regulation is effective 

August 24, 2018. Objections and 

requests for hearings must be received 

on or before October 23, 2018, 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–2017–0574, 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: 

Michael L. Goodis, 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 


sradovich on DSK3GMQ082PROD with RULES
42784 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations 

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/text-idx?&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–2017–0574 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 October 23, 2018. 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– 

2017–0574, 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 February 

27, 2018 (83 FR 8408) (FRL–9972–17), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–11059) by Nutri Ag, Inc. 

(now d/b/a Nutrenare-AG, Inc.), 4740 N 

Interstate 35 E, Waxahachie, TX 75165. 

The petition requested that the 

exemption from the requirement of a 

tolerance for residues of zinc oxide 

(CAS Reg. No. 1314–13–2) when used as 

an inert ingredient in pesticide 

formulations applied to growing crops 

or raw agricultural commodities after 

harvest under 40 CFR 180.910 be 

amended to include use as a stabilizer, 

at a concentration not to exceed 15% by 

weight of the pesticide formulation. 

That document referenced a summary of 

the petition prepared by OMC Ag 

Consulting on behalf of Nutrenare-AG, 

Inc., the petitioner, which is available in 

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

While comments were submitted to the 

docket, none raised any issues related to 

the Agency’s safety assessment of zinc 

oxide. 

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 zinc oxide 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with zinc oxide 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 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations 42785 

subgroups of consumers, including 

infants and children. 

Zinc (typically in the form of zinc 

salts and zinc oxide) is ubiquitous in the 

environment, is widely distributed in 

plants and animals, and occurs in the 

earth’s crust at an average concentration 

of approximately 70 milligrams per 

kilogram (mg/kg). Zinc is also an 

essential nutrient in the body and a 

normal part of metabolism in all living 

organisms. Zinc is recommended for 

nutritional use and exists naturally in 

food. The U.S. Food and Drug 

Administration considers zinc oxide as 

generally recognized as safe for use as 

a nutrient in foods. See 21 CFR 

182.8991. 

Zinc oxide is one of several zinc salts 

the Agency has evaluated in 

reregistration and in registration review. 

The Agency’s current risk assessment 

for zinc oxide relies heavily on the 

Agency’s previous analysis, including 

the 2009 risk assessment, which is 

entitled ‘‘Summary of Human Health 

Effects Data for Zinc, Zinc Salts, and 

Zeolites Registration Review Decision 

Document’’ and is included in the zinc 

salts registration review docket at http:// 

www.regulations.gov, using document 

number EPA–HQ–OPP–2009–0011– 

0002. 

The 2009 zinc salts risk assessment 

concluded that ‘‘The Agency has 

reviewed all toxicity studies submitted 

for the zinc salts and has determined 

that the toxicological database is 

sufficient. The Agency has not selected 

toxicological endpoints for zinc salts. 

The toxicological database for the zinc 

salts case is currently comprised of 

published and unpublished studies 

either submitted to the Agency or 

obtained directly from published open 

literature.’’ That risk assessment also 

referenced the Agency’s Reregistration 

Eligibility Decision (RED) for Zinc Salts 

of August, 1992. 

With regard to acute toxicity, the 

Agency’s database includes information 

indicating that zinc oxide presents low 

to no acute toxicity. With regard to 

subchronic and chronic toxicity, the 

Agency has reviewed the scientific 

literature about zinc, which has been 

extensively researched as a natural 

component of the earth’s crust and 

being widely distributed in plants and 

animals, an essential nutrient in the 

body and part of the metabolism of 

living things, and naturally occurring in 

foods. 

For toxicological concerns, there are 

adequate toxicology studies in the zinc 

database to evaluate incidental oral 

exposures. As noted in the 2009 risk 

assessment, at high levels, oral exposure 

to zinc in animal studies may result in 

toxic effects such as pancreatic and 

renal lesions as well as histological 

alterations in the pituitary and adrenal 

glands. In general, the levels of zinc 

causing these toxicological effects occur 

at much higher dose levels than the 

level recommended for nutritional use 

and that is naturally available in food. 

The 2009 risk assessment noted that 

zinc compounds have not been 

classified as cancerous compounds. 

B. Toxicological Points of Departure/ 

Levels of Concern 

As noted in the previous section, the 

2009 risk assessment did not identify 

any toxicological endpoints of concern 

because of the ubiquity of zinc in the 

environment and presence in food, its 

role as an essential element, and FDA’s 

consideration of zinc as GRAS for use as 

a nutrient in food. That assessment 

concluded that the toxicological effects 

seen in the database indicated effects at 

much higher levels than the level 

recommended for nutritional use and 

what is naturally found in food. To 

supplement those conclusions, the 

Agency considered the findings of the 

National Academy of Sciences’ (NAS) 

Institute of Medicine, Food and 

Nutrition Board; the European Food 

Safety Authority’s (EFSA) Panel on 

Dietetic Products, Nutrition and 

Allergies; and the European 

Commission’s Scientific Committee on 

Food (SCF). 

The NAS, EFSA, and SCF have 

considered zinc in its role as an 

essential nutrient. These organizations 

have established upper limit intake 

levels for zinc. The NAS upper limit 

intake level for zinc is referred to as the 

Tolerable Upper Intake Level (UL) and 

is defined as the highest level of daily 

nutrient intake that is likely to pose no 

risk of adverse health effects for almost 

all individuals. The NAS UL for zinc is 

40 mg/day for adults. The EFSA and 

SCF Tolerable Upper Intake Level for 

zinc is 25 mg/day for adults. Both of 

these values are based on adverse effects 

associated with chronic intake of 

supplemental zinc, particularly those 

attributable to copper deficiency, with 

these adverse effects observed at zinc 

exposure levels in humans above 60 mg/ 

day. 

The NAS Recommended Dietary 

Allowance (RDA) for zinc is based upon 

replacement of endogenous zinc loss in 

the body via normal metabolic processes 

and is established at 8 mg/day for 

women and 11 mg/day for men. (The 

EFSA Dietary Reference Values and the 

SCF Population Reference Intake are 

consistent with the NAS RDA, ranging 

from 7 mg/day to 12 mg/day for adults.) 

NAS also noted that the median intake 

of zinc from food in the United States 

was approximately 9 mg/day for women 

and 14 mg/day for men. The estimated 

worst-case dietary exposures to zinc 

from the use of zinc oxide as an inert 

ingredient in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest is 

2 mg/day, a value significantly less than 

both the RDA and UL for zinc. 

Because the Agency does not 

anticipate aggregate exposures to zinc 

oxide to approach the UL, it has not 

selected toxicological endpoints for zinc 

oxide for use in a quantitative risk 

assessment. 

C. Exposure Assessment 

1. Dietary exposure. In evaluating 

dietary exposure to zinc oxide, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

qualitatively assessed dietary exposures 

from zinc oxide in food as follows: 

Dietary exposure to zinc oxide can 

occur following ingestion of foods with 

residues from treated crops, animals or 

food contact surfaces. In addition, 

dietary exposure is expected from the 

presence of zinc oxide naturally 

occurring in foods and from use as a 

nutrient. Based on the insoluble nature 

of zinc oxide, use on food crops would 

not be expected to result in residues of 

zinc oxide in drinking water, although 

zinc may be present naturally in water 

at low concentrations. 

2. Non-dietary exposure. The term 

‘‘residential exposure’’ is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., textiles 

(clothing and diapers), carpets, 

swimming pools, and hard surface 

disinfection on walls, floors, tables). 

Zinc oxide may be used in pesticide 

products and non-pesticide products 

that may be used in and around the 

home. Based on the discussion above, a 

quantitative residential exposure 

assessment for zinc oxide was not 

conducted. 

3. 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 zinc oxide to share 

a common mechanism of toxicity with 

any other substances, and zinc oxide 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 


sradovich on DSK3GMQ082PROD with RULES
42786 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations 

tolerance action, therefore, EPA has 

assumed that zinc oxide 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 website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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. 

As part of its qualitative assessment, 

the Agency did not use safety factors for 

assessing risk, and no additional safety 

factor is needed for assessing risk to 

infants and children. 

E. Aggregate Risks and Determination of 

Safety 

Exposures resulting from the use of 

zinc oxide as an inert ingredient in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest and the 

dietary exposure (expressed as median 

intake) of zinc from food, would be 

significantly less than the Tolerable 

Upper Intake Levels for zinc. Therefore, 

EPA concludes that aggregate exposure 

to residues of zinc oxide will not pose 

a risk to the U.S. population, including 

infants and children, and that there is a 

reasonable certainty that no harm will 

result to the general population, or to 

infants and children from aggregate 

exposure to zinc oxide residues. 

V. Other Considerations 

A. 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 limitations on the 

amount of zinc oxide that may be used 

as a stabilizer in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest. 

These limitations 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 or raw 

agricultural commodities after harvest 

for sale or distribution containing zinc 

oxide as a stabilizer that exceeds 15% 

by weight of zinc oxide. 

VI. Conclusions 

Therefore, the exemption from the 

requirement of a tolerance for residues 

of zinc oxide when used as an inert 

ingredient in pesticide formulations 

applied to growing crops or raw 

agricultural commodities after harvest 

under 40 CFR 180.910 is amended to 

include use as a stabilizer, at a 

concentration not to exceed 15% by 

weight of the pesticide formulation. 

VII. Statutory and Executive Order 

Reviews 

This action amends 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); Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997); or Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ ((82 

FR 9339, February 3, 2017). 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: August 16, 2018. 

Michael Goodis, 

Director, Registration Division. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations 42787 

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

■ 2. In § 180.910, revise the zinc oxide 

entry in 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 

*******

Zinc oxide (CAS Reg. No. 

1314–13–2).

Not more than 15% by weight in pesticide formulations when used as stabilizer ....... Coating agent, stabilizer. 

*******

[FR Doc. 2018–18402 Filed 8–23–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Part 231 

[Docket DARS–2017–0013] 

RIN 0750–AJ51 

Defense Federal Acquisition 

Regulation Supplement: Repeal of 

Independent Research and 

Development Technical Interchange 

(DFARS Case 2017–D041) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD is issuing a final rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to remove a requirement for 

major contractors to have a technical 

interchange with the Government prior 

to generating independent research and 

development costs. 

DATES: Effective August 24, 2018. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Carrie Moore, telephone 571–372–6093. 

SUPPLEMENTARY INFORMATION: 

I. Background 

DoD is amending the DFARS to 

remove the text at DFARS 231.205– 

18(c)(iii)(C)(4), which requires major 

contractors to engage in and document 

a technical interchange with the 

Government, prior to generating 

independent research and development 

(IR&D) costs for IR&D projects initiated 

in fiscal year 2017 and later, in order for 

those costs to be determined allowable. 

The removal of this DFARS text 

supports a recommendation from the 

DoD Regulatory Reform Task Force. On 

February 24, 2017, the President signed 

Executive Order (E.O.) 13777, 

‘‘Enforcing the Regulatory Reform 

Agenda,’’ which established a Federal 

policy ‘‘to alleviate unnecessary 

regulatory burdens’’ on the American 

people. In accordance with E.O. 13777, 

DoD established a Regulatory Reform 

Task Force to review and validate DoD 

regulations, including the DFARS. A 

public notice of the establishment of the 

DFARS Subgroup to the DoD Regulatory 

Reform Task Force, for the purpose of 

reviewing DFARS provisions and 

clauses, was published in the Federal 

Register at 82 FR 35741 on August 1, 

2017. No public comments were 

received on this DFARS requirement in 

response to the notice. Subsequently, 

the DoD Task Force reviewed the 

requirements of DFARS 231.205– 

18(c)(iii)(C)(4) and determined that the 

DFARS coverage was outmoded and 

recommended removal, since requiring 

a technical interchange between the 

Government and major contractors is 

unnecessary. The objective of the 

interchange can be met through other 

means. 

II. Applicability to Contracts At or 

Below the Simplified Acquisition 

Threshold and for Commercial Items, 

Including Commercially Available Offthe-Shelf Items 

This rule only removes an unneeded 

requirement in the DFARS that required 

a technical interchange between the 

Government and certain contractors. 

Therefore, the rule does not impose any 

new requirements on contracts at or 

below the simplified acquisition 

threshold and for commercial items, 

including commercially available offthe-shelf items. 

III. Expected Cost Savings 

Effective November 4, 2016, DFARS 

231.205–18(c)(iii)(C)(4) was revised to 

require contractors to engage in a 

technical interchange with the 

Government, prior to the generation of 

IR&D costs for IR&D projects initiated in 

fiscal year 2017 and later, in order for 

those costs to be allowable. This 

requirement causes the contractor to 

expend time preparing for a discussion, 

contacting appropriate Government 

personnel, and discussing the IR&D 

project. Since contractors commonly 

pool all of their IR&D project costs to 

develop a single billing rate, this 

requirement would necessitate 

contractors having to discuss all of the 

IR&D projects contained in their billing 

rate. While some contractors may have 

a single project, many have close to 100 

or more, which could be significantly 

burdensome. 

This requirement applies to major 

contractors seeking to include IR&D 

costs as part of their reimbursable costs 

under a contract. Major contractors are 

defined as those whose covered 

segments allocated a total of more than 

$11 million in IR&D and bid and 

proposal costs to covered contracts 

during the preceding fiscal year; 

therefore, small entities are not expected 

to meet the definition of a major 

contractor or to be impacted. IR&D costs 

are most commonly included in 

noncommercial, cost-type contracts that 

are subject to certified cost and pricing 

data and cost accounting standards. 

This rule removes the requirement for 

major contractors to have a technical 

interchange with the Government prior 

to generating IR&D costs. Removal of 

this requirement will result in freeing 

contractors to pursue IR&D projects 

without including the Government in 

those preliminary decisions. 

DoD has performed a regulatory cost 

analysis on this rule. The following is a 

summary of the estimated public 

annualized cost savings, calculated in 

2016 dollars at a 7-percent discount rate 

in perpetuity: 

Annualized 7% ¥$1.7 million 

Present Value 7% ¥$24.0 million 

To access the full Regulatory Cost 

Analysis for this rule, go to the Federal 

eRulemaking Portal at 

www.regulations.gov, search for 

‘‘DFARS Case 2017–D041,’’ click ‘‘Open 

Docket,’’ and view ‘‘Supporting 

Documents.’’ 


sradovich on DSK3GMQ082PROD with RULES