This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

46119 

Vol. 83, No. 177 

Wednesday, September 12, 2018 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 927 

[Doc. No. AMS–SC–18–0049; SC18–927–2 

PR] 

Pears Grown in Oregon and 

Washington; Decreased Assessment 

Rate for Processed Pears 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

implement a recommendation from the 

Processed Pear Committee (Committee) 

to decrease the assessment rate 

established for ‘‘summer/fall’’ varieties 

of pears for canning for the 2018–2019 

and subsequent fiscal periods. The 

assessment rate would remain in effect 

indefinitely unless modified, 

suspended, or terminated. 

DATES: Comments must be received by 

October 12, 2018. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this proposed rule. 

Comments must be sent to the Docket 

Clerk, Marketing Order and Agreement 

Division, Specialty Crops Program, 

AMS, USDA, 1400 Independence 

Avenue SW, STOP 0237, Washington, 

DC 20250–0237; Fax: (202) 720–8938; or 

internet: http://www.regulations.gov. 

Comments should reference the 

document number and the date and 

page number of this issue of the Federal 

Register and will be available for public 

inspection in the Office of the Docket 

Clerk during regular business hours, or 

can be viewed at: http://

www.regulations.gov. All comments 

submitted in response to this rule will 

be included in the record and will be 

made available to the public. Please be 

advised that the identity of the 

individuals or entities submitting the 

comments will be made public on the 

internet at the address provided above. 

FOR FURTHER INFORMATION CONTACT: Dale 

Novotny, Marketing Specialist, or Gary 

Olson, Regional Director, Northwest 

Marketing Field Office, Marketing Order 

and Agreement Division, Specialty 

Crops Program, AMS, USDA; 

Telephone: (503) 326–2724, Fax: (503) 

326–7440, or Email: DaleJ.Novotny@

ams.usda.gov or GaryD.Olson@

ams.usda.gov. Small businesses may 

request information on complying with 

this regulation by contacting Richard 

Lower, Marketing Order and Agreement 

Division, Specialty Crops Program, 

AMS, USDA, 1400 Independence 

Avenue SW, STOP 0237, Washington, 

DC 20250–0237; Telephone: (202) 720– 

2491, Fax: (202) 720–8938, or Email: 

Richard.Lower@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: This 

action, pursuant to 5 U.S.C. 553, 

proposes an amendment to regulations 

issued to carry out a marketing order as 

defined in 7 CFR 900.2(j). This proposed 

rule is issued under Marketing Order 

No. 927, as amended (7 CFR part 927), 

regulating the handling of pears grown 

in Oregon and Washington. Part 927, 

(referred to as ‘‘the Order’’) is effective 

under the Agricultural Marketing 

Agreement Act of 1937, as amended (7 

U.S.C. 601–674), hereinafter referred to 

as the ‘‘Act.’’ The Committee locally 

administers the Order and is comprised 

of growers, handlers, and processors 

operating within the area of production, 

and a public member. 

The Department of Agriculture 

(USDA) is issuing this proposed rule in 

conformance with Executive Orders 

13563 and 13175. This proposed rule 

falls within a category of regulatory 

actions that the Office of Management 

and Budget (OMB) exempted from 

Executive Order 12866 review. 

Additionally, because this proposed 

rule does not meet the definition of a 

significant regulatory action, it does not 

trigger the requirements contained in 

Executive Order 13771. See OMB’s 

Memorandum titled ‘‘Interim Guidance 

Implementing Section 2 of the Executive 

Order of January 30, 2017, titled 

‘Reducing Regulation and Controlling 

Regulatory Costs’ ’’ (February 2, 2017). 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. Under the Order now in 

effect, Oregon and Washington pear 

handlers are subject to assessments. 

Funds to administer the Order are 

derived from such assessments. It is 

intended that the assessment rate would 

be applicable to all assessable ‘‘summer/ 

fall’’ varieties of pears specifically used 

for canning for the 2018–2019 fiscal 

period, and continue until amended, 

suspended, or terminated. 

The Act provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 608c(15)(A) of the Act, any 

handler subject to an order may file 

with USDA a petition stating that the 

order, any provision of the order, or any 

obligation imposed in connection with 

the order is not in accordance with law 

and request a modification of the order 

or to be exempted therefrom. Such 

handler is afforded the opportunity for 

a hearing on the petition. After the 

hearing, USDA would rule on the 

petition. The Act provides that the 

district court of the United States in any 

district in which the handler is an 

inhabitant, or has his or her principal 

place of business, has jurisdiction to 

review USDA’s ruling on the petition, 

provided an action is filed not later than 

20 days after the date of the entry of the 

ruling. 

The Order provides authority for the 

Committee, with the approval of USDA, 

to formulate an annual budget of 

expenses and collect assessments from 

handlers to administer the program. The 

Committee members are familiar with 

the Committee’s needs and with the 

costs of goods and services in their local 

area and are in a position to formulate 

an appropriate budget and assessment 

rate. The assessment rate is formulated 

and discussed in a public meeting 

where all directly affected persons have 

an opportunity to participate and 

provide input. 

This proposed rule would decrease 

the assessment rate from $8.00, the rate 

that was established for the 2017–2018 

and subsequent fiscal periods, to $7.15 

per ton of ‘‘summer/fall’’ varieties of 

pears for canning handled for the 2018– 

2019 and subsequent fiscal periods. The 

assessment rate for ‘‘winter’’ and 

‘‘other’’ pears for processing would 

remain unchanged at $0.00. The 

Committee met on May 30, 2018, and 

unanimously recommended 2018–2019 

fiscal period expenditures of $693,472. 

In comparison, last year’s budgeted 

expenditures were $800,150. The 

Committee also unanimously 

recommended an assessment rate of 

$7.15 per ton of ‘‘summer/fall’’ varieties 


daltland on DSKBBV9HB2PROD with PROPOSALS
46120 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Proposed Rules 

of pears for canning handled. The 

proposed assessment rate of $7.15 per 

ton is $0.85 lower than the $8.00 per ton 

rate currently in effect. The Committee 

recommended the lower assessment rate 

to balance assessment revenue with its 

budgeted expenditures and to maintain 

its monetary reserve at levels authorized 

in the Order. 

The major expenditures 

recommended by the Committee for the 

2018–2019 fiscal period include 

$495,000 for promotion and paid 

advertising, $136,172 for research, 

$15,000 for market access programs, 

$25,000 for administrative and 

management services, and $22,300 for 

Committee expenses. In comparison, 

these major expense categories for the 

2017–2018 fiscal period were budgeted 

at $591,030, $147,694, $14,576, $25,000, 

and $21,850; respectively. 

The assessment rate recommended by 

the Committee was derived by 

considering anticipated expenses, 

expected shipments, and the amount of 

funds available in the authorized 

reserve. The quantity of assessable 

‘‘summer/fall’’ pears for canning for the 

2018–2019 fiscal period is estimated at 

100,000 tons. Thus, the proposed $7.15 

per ton should provide handler 

assessments of $715,000. This amount 

would be adequate to cover budgeted 

expenses of $693,472, with any excess 

funds used to make a small contribution 

to the Committee’s monetary reserve. 

Funds in the reserve (currently 

$497,565) would be kept within the 

maximum permitted by § 927.42(a) of 

approximately one fiscal period’s 

expenses. 

The assessment rate proposed in this 

rule would continue in effect 

indefinitely unless modified, 

suspended, or terminated by USDA 

upon recommendation and information 

submitted by the Committee, or other 

available information. 

Although this assessment rate would 

be in effect for an indefinite period, the 

Committee would continue to meet 

prior to or during each fiscal period to 

recommend a budget of expenses and 

consider recommendations for 

modification of the assessment rate. The 

dates and times of Committee meetings 

are available from the Committee or 

USDA. Committee meetings are open to 

the public and interested persons may 

express their views at these meetings. 

USDA would evaluate Committee 

recommendations and other available 

information to determine whether 

modification of the assessment rate is 

needed. Further rulemaking would be 

undertaken as necessary. The 

Committee’s budget for subsequent 

fiscal periods would be reviewed and, 

as appropriate, approved by USDA. 

Initial Regulatory Flexibility Analysis 

Pursuant to requirements set forth in 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601–612), the Agricultural 

Marketing Service (AMS) has 

considered the economic impact of this 

proposed rule on small entities. 

Accordingly, AMS has prepared this 

initial regulatory flexibility analysis. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

businesses subject to such actions in 

order that small businesses will not be 

unduly or disproportionately burdened. 

Marketing orders issued pursuant to the 

Act, and the rules issued thereunder, are 

unique in that they are brought about 

through group action of essentially 

small entities acting on their own 

behalf. 

There are approximately 1,500 

growers of pears for processing in the 

production area and approximately 43 

handlers of processed pears subject to 

regulation under the Order. Small 

agricultural producers are defined by 

the Small Business Administration 

(SBA) as those having annual receipts 

less than $750,000, and small 

agricultural service firms are defined as 

those whose annual receipts are less 

than $7,500,000 (13 CFR 121.201). 

According to data from USDA 

National Agricultural Statistics Service 

(NASS), the Committee, and the 

industry for the 2016–2017 season (the 

most recent complete season of record) 

the average f.o.b. price for OregonWashington processed Bartlett pears 

(the only variety used for canning in the 

production area) was approximately 

$390.50 per ton. Total shipments for 

that period were approximately 103,020 

tons. Using the number of handlers, and 

assuming a normal distribution, the 

majority of handlers would have average 

annual receipts of less than $7,500,000 

($390.50 per ton times 103,020 tons 

equals $40,229,310 divided by 43 

handlers equals $935,565 per handler). 

In addition, based on data from the 

Committee, the industry produced 

103,020 tons of processed pears in the 

production area during the 2016–2017 

season, with an average grower price of 

$360 per ton. Based on the average 

grower price, production, and the total 

number of Oregon-Washington 

processed pear growers reported by the 

Committee (1,500), and assuming a 

normal distribution, the average annual 

grower revenue is below $750,000 ($360 

per ton times 103,020 tons equals 

$37,087,200 divided by 1,500 growers 

equals $24,725 per grower). Thus, the 

majority of Oregon and Washington 

processed pear handlers and growers 

may be classified as small entities. 

This proposal would decrease the 

assessment rate collected from handlers 

for the 2018–2019 and subsequent fiscal 

periods from $8.00 per ton to $7.15 per 

ton of Oregon and Washington 

‘‘summer/fall’’ pears for canning 

handled. The Committee unanimously 

recommended 2018–2019 fiscal period 

expenditures of $693,472 and the $7.15 

per ton assessment rate. The proposed 

assessment rate of $7.15 per ton is $0.85 

lower than the rate in effect for the 

2017–2018 fiscal period. The quantity of 

assessable ‘‘summer/fall’’ pears for 

canning for the 2018–2019 fiscal period 

is estimated at 100,000 tons. Thus, the 

proposed $7.15 per ton rate should 

provide $715,000 in assessment income. 

Income derived from handler 

assessments should be adequate to cover 

budgeted expenses, with any excess 

funds to be carried over in the 

Committee’s monetary reserve to be 

used in subsequent years. 

The major expenditures 

recommended by the Committee for the 

2018–2019 fiscal period include 

$495,000 for promotion and paid 

advertising, $136,172 for research, 

$15,000 for market access programs, 

$25,000 for administrative and 

management services, and $22,300 for 

Committee expenses. In comparison, 

these major expense categories for the 

2017–2018 fiscal period were budgeted 

at $591,030, $147,694, $14,576, $25,000, 

and $21,850, respectively. 

The proposed lower assessment rate is 

necessary to balance assessment 

revenue with the Committee’s 2018– 

2019 fiscal period budgeted 

expenditures and to maintain its 

monetary reserve at levels authorized in 

the Order. 

Prior to arriving at this budget and 

assessment rate, the Committee 

considered the benefits and costs related 

to maintaining the current assessment 

rate of $8.00 per ton and establishing 

other assessment rates. However, 

leaving the assessment rate unchanged 

would generate more revenue than 

required to meet the Committee’s 2018– 

2019 fiscal period budgeted expenses of 

$693,472, and would add a large 

amount of excess funds to the 

Committee’s already sufficient monetary 

reserve. Based on estimated shipments, 

the recommended assessment rate of 

$7.15 per ton should provide $715,000 

in assessment income. The Committee 

determined assessment revenue would 

be adequate to fully cover budgeted 

expenditures for the 2018–2019 fiscal 

period, with a small amount of excess 

funds to be added to the Committee’s 

monetary reserve. Reserve funds would 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Proposed Rules 46121 

be kept within the amount authorized in 

the Order. 

A review of historical information and 

preliminary information pertaining to 

the upcoming fiscal year indicates that 

the average grower price for the 2018– 

2019 season should be approximately 

$296 per ton of pears for processing. 

Therefore, the estimated assessment 

revenue for the 2018–2019 fiscal period 

as a percentage of total grower revenue 

would be about 2.4 percent ($7.15 per 

ton assessment divided by $296 per ton 

grower price). 

This proposed action would decrease 

the assessment obligation imposed on 

handlers for the 2018–2019 and 

subsequent fiscal periods. Assessments 

are applied uniformly on all handlers, 

and some of the costs may be passed on 

to producers. However, decreasing the 

assessment rate would reduce the 

burden on handlers, and may reduce the 

burden on producers. 

The Committee’s meetings were 

widely publicized throughout the 

Oregon and Washington processed pear 

industry. All interested persons were 

invited to attend the meetings and 

participate in Committee deliberations 

on all issues. Like all Committee 

meetings, the May 30, 2018, meeting 

was a public meeting and all entities, 

both large and small, were able to 

express views on this issue. Finally, 

interested persons are invited to submit 

comments on this proposed rule, 

including the regulatory and 

information collection impacts of this 

action on small businesses. 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

chapter 35), the Order’s information 

collection requirements have been 

previously approved by OMB and 

assigned OMB No. 0581–0189. No 

changes in those requirements would be 

necessary because of this action. Should 

any changes become necessary, they 

would be submitted to OMB for 

approval. 

This proposed rule would not impose 

any additional reporting or 

recordkeeping requirements on either 

small or large Oregon and Washington 

processed pear handlers. As with all 

Federal marketing order programs, 

reports and forms are periodically 

reviewed to reduce information 

requirements and duplication by 

industry and public sector agencies. 

AMS is committed to complying with 

the E-Government Act, to promote the 

use of the internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

USDA has not identified any relevant 

Federal rules that duplicate, overlap, or 

conflict with this proposed rule. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

rules-regulations/moa/small-businesses. 

Any questions about the compliance 

guide should be sent to Richard Lower 

at the previously mentioned address in 

the FOR FURTHER INFORMATION CONTACT

section. 

List of Subjects in 7 CFR Part 927 

Marketing agreements, Pears, 

Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, 7 CFR part 927 is proposed to 

be amended as follows: 

PART 927—PEARS GROWN IN 

OREGON AND WASHINGTON 

■ 1. The authority citation for 7 CFR 

part 927 continues to read as follows: 

Authority: 7 U.S.C. 601–674. 

■ 2. In § 927.237 revise the intro 

paragraph text and paragraph (a) to read 

as follows: 

§ 927.237 Assessment rate. 

On and after July 1, 2018, the 

following base rates of assessment for 

pears for processing are established for 

the Processed Pear Committee: 

(a) $7.15 per ton for any or all 

varieties or subvarieties of pears for 

canning classified as ‘‘summer/fall’’ 

excluding pears for other methods of 

processing; 

* * * * * 

Dated: September 6, 2018. 

Bruce Summers, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2018–19683 Filed 9–11–18; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 310 

[Docket No. FDA–2017–N–6924] 

RIN 0910–AH47 

Repeal of Regulation Requiring an 

Approved New Drug Application for 

Drugs Sterilized by Irradiation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to repeal a regulation 

that requires an FDA-approved new 

drug application (NDA) or abbreviated 

new drug application (ANDA) for any 

drug product that is sterilized by 

irradiation (the irradiation regulation). 

Repealing the irradiation regulation 

would mean that over-the-counter 

(OTC) drug products that are generally 

recognized as safe and effective, that are 

not misbranded, and that comply with 

all applicable regulatory requirements 

can be marketed legally without an NDA 

or ANDA, even if they are sterilized by 

irradiation. FDA is proposing to take 

this action because the irradiation 

regulation is out of date and 

unnecessary. The technology of 

controlled nuclear radiation for 

sterilization of drugs is now well 

understood, and our regulations require 

that OTC drugs be manufactured in 

compliance with current good 

manufacturing practices (CGMPs). 

Appropriate and effective sterilization 

of drugs, including by irradiation, is 

adequately addressed by the CGMP 

requirements. This action is part of 

FDA’s implementation of Executive 

Orders (EOs) 13771 and 13777. Under 

these EOs, FDA is comprehensively 

reviewing existing regulations to 

identify opportunities for repeal, 

replacement, or modification that will 

result in meaningful burden reduction 

while allowing the Agency to achieve 

our public health mission and fulfill 

statutory obligations. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by November 13, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 13, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2018. 

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 


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