Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Proposed Rules 42963 

assessment bodies for testing ATVs 

designed or intended primarily for 

children 12 years of age or younger. 75 

FR 52616. Because the revisions to the 

2010 edition of the ANSI/SVIA standard 

would not substantially alter third-party 

conformance testing requirements for 

ATVs designed or intended primarily 

for children 12 years of age or younger, 

the current NOR for third-party testing 

of youth ATVs will remain unchanged. 

Thus, the Commission considers the 

existing accreditations that the 

Commission has accepted for testing to 

the ATV standard also cover testing to 

the revised ATV standard. 

XI. Request for Comments 

This NPR begins a rulemaking 

proceeding under section 232 of the 

CPSIA to amend the Commission’s 

mandatory ATV standard to reference 

the 2017 edition of the ANSI/SVIA 

standard. We invite all interested 

persons to submit comments on any 

aspect of this proposal. During the 

comment period, ANSI/SVIA 1–2017, 

American National Standard for FourWheel All-Terrain Vehicles Equipment 

Configuration, and Performance 

Requirements, is available for 

inspection at the CPSC’s Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814, telephone 301–504–7923. 

Comments should be submitted in 

accordance with the instructions in the 

ADDRESSES section at the beginning of 

this notice. 

List of Subjects in 16 CFR Part 1420 

Consumer protection, Imports, 

Incorporation by reference, Infants and 

children, Information, Labeling, Law 

enforcement, Recreation and recreation 

areas, Reporting and recordkeeping 

requirements, Safety. 

For the reasons stated in the 

preamble, the Commission proposes to 

amend Title 16 of the Code of Federal 

Regulations, as follows: 

PART 1420—REQUIREMENTS FOR 

ALL-TERRAIN VEHICLES 

■ 1. The authority citation for part 1420 

continues to read as follows: 

Authority: The Consumer Product Safety 

Improvement Act of 2008, Pub. Law 110–314, 

§ 232, 122 Stat. 3016 (August 14, 2008). 

■ 2. In the second sentence of § 1420.1, 

remove the words, ‘‘April 30, 2012,’’ 

and add in their place ‘‘(date 60 days 

after publication of a final rule in the 

Federal Register).’’ 

■ 3. Revise § 1420.3 to read as follows: 

§ 1420.3 Requirements for four-wheel 

ATVs. 

Each ATV shall comply with all 

applicable provisions of the American 

National Standard for Four-Wheel AllTerrain Vehicles (American National 

Standards Institute, Inc. ANSI/SVIA 1– 

2017), approved on June 8, 2017. The 

Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You may obtain a copy 

from Specialty Vehicle Institute of 

America, 2 Jenner, Suite 150, Irvine, CA 

92618–3806; telephone: 949–727–3727 

ext.3023; www.svia.org. You may 

inspect a copy at the Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814, telephone: 301–504–7923, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

Alberta E. Mills, 

Acting Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2017–19341 Filed 9–12–17; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 112 

[Docket No. FDA–2011–N–0921] 

RIN 0910–ZA50 

Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption; Extension of 

Compliance Dates for Subpart E 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to extend, for covered 

produce other than sprouts, the dates for 

compliance with the agricultural water 

provisions in the Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption rule. We are proposing to 

extend the compliance dates to address 

questions about the practical 

implementation of compliance with 

certain provisions and to consider how 

we might further reduce the regulatory 

burden or increase flexibility while 

continuing to achieve our regulatory 

objectives, in keeping with the 

Administration’s policies. 

DATES: Submit either electronic or 

written comments on this proposed rule 

by November 13, 2017. 

ADDRESSES: You may submit comments 

on the extension of the compliance 

period as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 13, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 


jstallworth on DSKBBY8HB2PROD with PROPOSALS
42964 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Proposed Rules 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2011–N–0921 for ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption; Extension of Compliance 

Dates for Subpart E.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Samir Assar, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1636. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This proposed extension of 

compliance dates concerns one of the 

seven foundational rules that we have 

established in Title 21 of the Code of 

Federal Regulations (21 CFR) as part of 

our implementation of the FDA Food 

Safety Modernization Act (FSMA; Pub. 

L. 111–353): ‘‘Standards for the 

Growing, Harvesting, Packing, and 

Holding of Produce for Human 

Consumption’’ (the produce safety 

regulation, published in the Federal 

Register of November 27, 2015, 80 FR 

74354) (https://www.fda.gov/fsma). 

In the preamble of the final rule 

establishing the produce safety 

regulation, we stated that the produce 

safety regulation would be effective on 

January 26, 2016, and provided for 

compliance dates of 1 to 6 years from 

the effective date depending on farm 

size, commodity, and provision(s) (see 

table entitled ‘‘compliance dates’’ in the 

preamble of the final rule establishing 

the produce safety regulation, 80 FR 

74354 at 74357, as corrected in a 

technical amendment at 81 FR 26466, 

May 3, 2016). (Some of the compliance 

dates identified in the technical 

amendment fall on weekends (i.e., 

January 26, 2019, is a Saturday and 

January 26, 2020, is a Sunday) and 

should therefore be read as referring to 

the next business day (i.e., January 28, 

2019, and January 27, 2020, 

respectively). We use the latter dates 

throughout this document.) 

For the majority of agricultural water 

provisions at subpart E (and for most of 

the other provisions in the rule), with 

respect to covered produce other than 

sprouts, we provided compliance 

periods of 4 years from the effective date 

of the rule for very small businesses, 3 

years for small businesses, and 2 years 

for all other businesses. We provided an 

additional 2 years beyond those 

compliance periods for certain water 

quality requirements in § 112.44 and 

related provisions in §§ 112.45 and 

112.46. See table 1. 

In a final rule, ‘‘The Food and Drug 

Administration Food Safety 

Modernization Act: Extension and 

Clarification of Compliance Dates for 

Certain Provisions of Four 

Implementing Rules’’ (81 FR 57784, 

August 24, 2016) we also extended the 

compliance date for certain ‘‘customer 

provisions’’ in the produce safety 

regulation (§ 112.2(b)(3)) and clarified 

the compliance dates for certain 

agricultural water testing provisions as 

originally established in the produce 

safety regulation. 

TABLE 1—AS STATED IN PRODUCE SAFETY REGULATION, COMPLIANCE DATES FOR REQUIREMENTS IN SUBPART E (AGRICULTURAL WATER) FOR COVERED ACTIVITIES INVOLVING COVERED PRODUCE (EXCEPT SPROUTS SUBJECT TO SUBPART M) 

Compliance dates of 2–4 years applicable to the farm based on its size Extended compliance date of additional 2 years beyond the compliance 

date based on size of farm 

§ 112.41 .................................................................................................... § 112.44. 

§ 112.42 .................................................................................................... § 112.45(a) with respect to § 112.44(a) criterion. 

§ 112.43 .................................................................................................... § 112.45(b). 

§ 112.45(a) with respect to safe and adequate standard ........................ § 112.46(b)(1) with respect to untreated ground water. 

§ 112.46(a) ................................................................................................ § 112.46(b)(2) and (b)(3). 

§ 112.46(b)(1) with respect to untreated surface water ........................... 112.46(c). 

§ 112.47.

§ 112.48.

§ 112.49.

§ 112.50.


jstallworth on DSKBBY8HB2PROD with PROPOSALS
Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Proposed Rules 42965 

II. Proposed Extension of Subpart E 

Compliance Dates for Produce Other 

Than Sprouts 

FDA has received feedback from 

numerous stakeholders raising issues 

regarding the practicality of some of the 

agricultural water requirements in the 

produce safety regulation as applied to 

covered produce other than sprouts. 

Many of these concerns relate to the 

testing requirements for pre-harvest 

agricultural water, which are different 

for sprouts than they are for other types 

of covered produce. We are proposing 

this extension in light of the feedback 

we have received and under Executive 

Orders 13777, 13771, and 13563. 

Additional time would allow us to 

consider approaches to address these 

issues, as well as opportunities there 

may be to reduce the cost and enhance 

the flexibility of these requirements 

beyond those reflected in the final rule. 

As part of this proposed extension, we 

also propose to simplify the subpart E 

compliance period structure such that 

all the compliance dates for subpart E 

provisions as applied to non-sprout 

produce would occur at the same time, 

retaining date staggering based on farm 

size. Accordingly, covered farms would 

have 2 years beyond the previously 

published compliance dates for the 

water quality requirements in § 112.44 

and related provisions in §§ 112.45 and 

112.46, to comply with all of subpart E. 

Put another way, we propose to extend 

the compliance dates for provisions in 

the first column of table 1 by 4 years, 

and propose to extend the compliance 

dates for provisions in the second 

column of table 1 by 2 years, so that the 

compliance dates for non-sprout 

covered produce for all provisions of 

subpart E would be those in table 2. 

TABLE 2—PROPOSED COMPLIANCE DATES FOR REQUIREMENTS IN SUBPART E FOR COVERED ACTIVITIES INVOLVING

COVERED PRODUCE (EXCEPT SPROUTS SUBJECT TO SUBPART M) 

Size of covered farm 

Proposed time periods starting from the effective date of the November 27, 2015, 

produce safety final rule (January 26, 2016) 

Compliance period Compliance date 

Very Small Business ......................................................... 8 years ............................... January 26, 2024. 

Small Business ................................................................. 7 years ............................... January 26, 2023. 

All Other Businesses ........................................................ 6 years ............................... January 26, 2022. 

We believe the simpler compliance 

date structure would alleviate 

confusion, and because we are 

proposing it as part of a proposal to 

provide additional time for compliance 

with all of the provisions, we expect it 

to alleviate burden. We do not 

anticipate that the change would result 

in any practical or logistical compliance 

challenges. We request comment on 

whether this change to the compliance 

date structure would be helpful. 

This proposed rule is limited in scope 

to extending the compliance dates for 

covered produce other than sprouts. The 

proposed rule does not address the 

underlying requirements in subpart E, 

but only the compliance dates for those 

requirements (for covered produce other 

than sprouts). We will continue to work 

with stakeholders on the issues raised 

regarding the agricultural water 

requirements. 

Our goal is to complete this 

rulemaking as quickly as possible. 

However, we are aware that many farms 

have been working well in advance of 

their compliance dates to come into 

compliance. As we continue to work 

with stakeholders on issues raised 

regarding the agricultural water 

requirements, we intend to exercise 

enforcement discretion for covered 

produce other than sprouts relative to 

the agricultural water provisions in 

subpart E of the produce safety 

regulation. This means that while we 

are considering these issues, we do not 

intend to enforce the requirements in 

subpart E of the regulation for covered 

produce other than sprouts. Thus, by 

announcing we intend to exercise 

enforcement discretion for covered 

produce other than sprouts relative to 

the agricultural water provisions in 

subpart E, farms may choose to continue 

with their current water testing 

programs or allocate their resources 

differently to avoid incurring additional 

costs based on our proposal to extend 

the agricultural water compliance dates. 

And, as explained above, when we 

finalize compliance dates, we intend to 

continue to work with stakeholders to 

address agricultural water questions and 

with farms to prepare for compliance. 

This proposed rule also would not 

change the compliance dates for 

sprouts. In the final produce safety 

regulation, we provided staggered 

compliance periods based on farm size 

for covered activities involving sprouts. 

The compliance date for activities 

involving sprouts for very small 

businesses is January 28, 2019. The 

compliance date for activities involving 

sprouts for small businesses is January 

26, 2018. The compliance date for 

activities involving sprouts for all other 

businesses is January 26, 2017. Because 

sprouts present a unique safety risk, the 

final produce safety regulation 

established sprout-specific requirements 

on multiple topics, including 

agricultural water. The agricultural 

water requirements for sprouts are 

different from the agricultural water 

requirements for other produce 

commodities (compare §§ 112.44(a)(1) 

and 112.44(b)). Moreover, based on the 

information available to us, many sprout 

farms use municipal water for growing 

activities; and under the produce safety 

regulation, covered farms are not 

required to test water from a public 

supply when certain conditions are met 

(see 21 CFR 112.46(a)(1) and (2)). We 

also established earlier compliance 

dates for sprouts than for other covered 

produce, and the first compliance date 

for covered sprout farms (January 26, 

2017) has already passed. We have not 

received any significant feedback from 

sprout farms that subpart E has posed 

particular challenges. Accordingly, we 

are proposing to take no action with 

regard to compliance dates for activities 

involving sprouts and thus the 

compliance dates for covered farms with 

respect to sprouts are the original 

compliance dates, including for the 

agricultural water provisions in Subpart 

E. 

Table 3 summarizes the compliance 

dates for the produce safety regulation 

as they would be if this proposed rule 

is finalized. Time periods start from 

effective date of the produce safety rule 

(January 26, 2016) except as otherwise 

specified. 


jstallworth on DSKBBY8HB2PROD with PROPOSALS
42966 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Proposed Rules 

III. Economic Analysis of Impacts 

We have examined the impacts of this 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4), and 

Executive Order 13771 on Reducing 

Regulation and Controlling Regulatory 

Costs (January 30, 2017). Executive 

Orders 12866 and 13563 direct us to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). 

Executive Order 13563 states the 

importance of quantifying costs and 

benefits, reducing costs and burdens, 

and harmonizing rules. We conclude 

that this proposed rule would not 

increase compliance costs and would 

instead reduce compliance costs by 

delaying certain compliance dates. 

Moreover, it would serve an important 

purpose of providing us an opportunity 

to consider how to reduce burdens on 

the public. We conclude that this 

proposed rule is an economically 


jstallworth on DSKBBY8HB2PROD with PROPOSALSEP13SE17.001</GPH>
Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Proposed Rules 42967 

significant regulatory action as defined 

by Executive Order 12866. 

This rule would extend, for nonsprout covered produce, the compliance 

date for all of the provisions of subpart 

E to 4 years after the relevant farm’s 

compliance date for all other provisions 

of the produce safety regulation (which 

varies based on establishment size). The 

estimated costs and benefits accrued in 

any given year of compliance with the 

produce safety regulation, relative to the 

first year of compliance, would not 

change. However, because the 

compliance dates for certain provisions 

would be extended, the discounted 

value of both total costs and total 

benefits would decrease. 

There would be a reduction in costs 

(i.e., cost savings) associated with 

extending, for non-sprout covered 

produce, the compliance date for all of 

the provisions of subpart E to 4 years 

after the relevant farm’s compliance 

date for the rest of the produce safety 

regulation. With respect to their nonsprout covered produce, covered farms 

would have 4 years from the compliance 

date for the other provisions of produce 

safety regulation to comply with the 

provisions in subpart E. Thus, while all 

initial start-up costs and recurring costs 

would remain the same as estimated in 

the final regulatory impact analysis for 

the produce safety regulation (Ref. 1), 

the annualized total costs, discounted at 

3 percent over 10 years, would decrease 

by about 3 percent from $404 million to 

$392 million, resulting in a savings of 

$12 million. No additional costs would 

be incurred by state, local, and tribal 

governments or the private sector as a 

result of this proposed rule. 

There would be a reduction in 

benefits associated with extending the 

compliance dates as described 

previously. Consumers eating nonsprout covered produce would not enjoy 

the potential health benefits (i.e., 

reduced risk of illness) provided by the 

provisions of subpart E until 2 to 4 years 

(depending on the specific provision) 

later than originally established in the 

produce safety regulation. Thus, the 

annualized total benefits to consumers, 

discounted at 3 percent over 10 years, 

would decrease by $108 million from 

$1.033 billion to $925 million. 

Estimated changes in benefits and costs 

as a result of this proposed extension 

are summarized in the following table. 

TABLE 4—SUMMARY OF THE CHANGES IN BENEFITS AND COSTS AS A RESULT OF THIS PROPOSED RULE, ANNUALIZED

OVER 10 YEARS, IN MILLIONS OF 2016 DOLLARS

Costs to 

industry under 

2015 final rule 

Costs to 

industry with 

the proposed 

compliance 

extension 

Benefits of 

reduced risk of 

illness under 

2015 final rule 

Benefits of 

reduced risk of 

illness with the 

proposed 

compliance 

extension 

Annualized 3% ................................................................................................. $404 $392 $1,033 $925 

Annualized 7% ................................................................................................. 382 370 983 874 

Net Present Value 3% ..................................................................................... 3,443 3,340 8,811 7,886 

Net Present Value 7% ..................................................................................... 2,681 2,598 6,901 6,143 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities when 

‘‘the agency publishes a general notice 

of proposed rulemaking.’’ (5 U.S.C. 

601(2)). We have analyzed this proposed 

rule under the Regulatory Flexibility 

Act and determined that, because it 

would only extend certain compliance 

dates for agricultural water provisions 

in the produce safety regulation, it 

would not have a significant economic 

impact on a substantial number of small 

entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before issuing ‘‘any 

rule that includes any Federal mandate 

that may result in the expenditure by 

State, local, and tribal governments, in 

the aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any one year.’’ 

The current threshold after adjustment 

for inflation is $148 million, using the 

most current (2016) Implicit Price 

Deflator for the Gross Domestic Product. 

We have determined that this proposed 

rule would not result in an expenditure 

in any year that meets or exceeds this 

amount. 

Executive Order 13771, entitled 

Reducing Regulation and Controlling 

Regulatory Costs, was issued on January 

30, 2017. Section 2(a) of Executive 

Order 13771 requires an agency, unless 

prohibited by law, to identify at least 

two existing regulations to be repealed 

when the agency publicly proposes for 

notice and comment or otherwise 

promulgates a new regulation. In 

furtherance of this requirement, section 

2(c) of Executive Order 13771 requires 

that the new incremental costs 

associated with new regulations shall, to 

the extent permitted by law, be offset by 

the elimination of existing costs 

associated with at least two prior 

regulations. This proposed rule is 

expected to be an Executive Order 

13771 deregulatory action. Details on 

the estimated cost savings of this 

proposed rule can be found in the rule’s 

economic analysis. 

For interested persons, the detailed 

preliminary regulatory impact analysis 

is available in the docket for this rule 

(Ref. 2) at https://www.regulations.gov, 

and at https://www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm. 

IV. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(j) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

V. Paperwork Reduction Act of 1995 

This proposed rule contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

VI. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

conclude that the proposed rule does 

not contain policies that have 

federalism implications as defined in 


jstallworth on DSKBBY8HB2PROD with PROPOSALS
42968 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Proposed Rules 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. Executive Order 13175 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have determined that the proposed rule 

does not contain policies that have 

substantial direct effects on one or more 

Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Accordingly, we conclude that the 

proposed rule does not contain policies 

that have tribal implications as defined 

in the Executive order and, 

consequently, a tribal summary impact 

statement is not required. 

VIII. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and is available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the Web site address, as of the date this 

document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. FDA, ‘‘Final Regulatory Impact Analysis, 

Standards for the Growing, Harvesting, 

Packing and Holding of Produce for 

Human Consumption.’’ November 2015. 

Available at: https://www.fda.gov/ 

AboutFDA/ReportsManualsForms/ 

Reports/EconomicAnalyses/ 

ucm472310.htm. 

2. FDA, ‘‘Preliminary Regulatory Impact 

Analysis, Preliminary Regulatory 

Flexibility Analysis, and Unfunded 

Mandates Reform Act Analysis for the 

Standards for the Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption; Extension of 

Compliance Dates for Subpart E; 

Proposed Rule,’’ 2017. Available at: 

https://www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/. 

Dated: September 8, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19434 Filed 9–12–17; 8:45 am] 

BILLING CODE 4164–01–P 


jstallworth on DSKBBY8HB2PROD with PROPOSALS