Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Rules and Regulations 37815 

times established in advance by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Pacific Chart Supplement. 

Paragraph 6004 Class E Airspace Areas 

Designated as an Extension to a Class D or 

Class E Surface Area. 

* * * * * 

AWP HI E4 Hilo, HI [Corrected] 

Hilo International Airport, HI 

(Lat. 19°43′13′′ N., long. 155°02′55′′ W.) 

Hilo VORTAC 

(Lat. 19°43′17′′ N., long. 155°00′39′′ W.) 

That airspace extending upward from the 

surface within 3 miles each side of the Hilo 

VORTAC 090° radial, extending from the 4.3- 

mile radius of Hilo International Airport to 

8.7 miles east of the Hilo VORTAC. 

Paragraph 6005 Class E Airspace Extending 

Upward From 700 Feet or More Above the 

Surface of the Earth. 

* * * * * 

AWP HI E5 Hilo, HI [Amended] 

Hilo International Airport, HI 

(Lat. 19°43′13′′ N., long. 155°02′55′′ W.) 

Hilo VORTAC 

(Lat. 19°43′17′′ N., long. 155°00′39′′ W.) 

That airspace extending upward from 700 

feet above the surface within a 4.3-mile 

radius of Hilo International Airport and 

within 3 miles each side of the Hilo VORTAC 

090° radial, extending from the 4.3-mile 

radius to 8.7 miles east of the VORTAC and 

that airspace extending from the 4.3-mile 

radius to the 7.4-mile radius of the Hilo 

International Airport extending clockwise 

from a line 1.8 miles southwest of and 

parallel to the Hilo VORTAC 321° radial to 

a line 3 miles north of and parallel to the 

Hilo VORTAC 090° radial. 

Issued in Seattle, Washington, on August 3, 

2017. 

Byron Chew, 

Acting Group Manager, Operations Support 

Group, Western Service Center. 

[FR Doc. 2017–17004 Filed 8–11–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 133 

[Docket No. FDA–2017–D–4713] 

Ultrafiltered Milk in the Production of 

Standardized Cheeses and Related 

Cheese Products: Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a 

guidance for industry entitled 

‘‘Ultrafiltered Milk in the Production of 

Standardized Cheeses and Related 

Cheese Products: Guidance for 

Industry.’’ The guidance advises 

manufacturers who wish to use 

ultrafiltered milk (UF milk) or 

ultrafiltered nonfat milk (UF nonfat 

milk) in the production of standardized 

cheeses and related cheese products 

that, pending completion of a 

rulemaking regarding the use of UF milk 

in the production of these products, we 

intend to exercise enforcement 

discretion regarding the use of fluid UF 

milk and fluid UF nonfat milk in the 

production of standardized cheeses and 

related cheese products. We also intend 

to exercise enforcement discretion 

regarding the declaration of ingredients 

in the labeling of standardized cheeses 

and related cheese products when fluid 

UF milk and fluid UF nonfat milk are 

used as ingredients. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 14, 2017. Submit 

either electronic or written comments 

on FDA guidance at any time. 

ADDRESSES: You may submit comments 

as follows: 

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 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–4713 for ‘‘Ultrafiltered Milk in 

the Production of Standardized Cheeses 

and Related Cheese Products: Guidance 

for Industry.’’ Received comments 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 


sradovich on DSK3GMQ082PROD with RULES
37816 Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Rules and Regulations 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

Submit written requests for single 

copies of the guidance to the Office of 

Nutrition and Food Labeling, Center for 

Food Safety and Applied Nutrition 

(HFS–830), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Terri Wenger, Center for Food Safety 

and Applied Nutrition (HFS–800), Food 

and Drug Administration, 5001 Campus 

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

2373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Ultrafiltered Milk in the Production of 

Standardized Cheeses and Related 

Cheese Products: Guidance for 

Industry.’’ We are issuing this guidance 

consistent with our good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

Our regulations specify the standards 

of identity for cheeses and related 

cheese products in part 133 (21 CFR 

part 133). The general provisions within 

part 133, in part, define ‘‘milk’’ and 

‘‘nonfat milk’’ that may be used in the 

manufacture of cheeses and related 

cheese products. The definitions for 

‘‘milk’’ and ‘‘nonfat milk’’ in § 133.3(a) 

and (b), respectively, list different forms 

of milk and nonfat milk, including 

concentrated, reconstituted, and dried 

forms, that may be used in the making 

of cheeses and related cheese products. 

However, fluid or dried filtered forms of 

milk obtained through mechanical 

filtration of milk or nonfat milk are not 

included within these definitions. 

Therefore, while current regulations 

permit the use of concentrated, 

reconstituted, and dried forms of milk 

and nonfat milk as basic dairy 

ingredients (i.e., the only difference in 

these ingredients is the amount of 

water), they do not provide for the use 

of fluid or dried filtered milk or fluid or 

dried filtered nonfat milk as basic dairy 

ingredients in standardized cheeses and 

related cheese products. 

Mechanical filtration technologies 

available for milk processing include 

ultrafiltration. For purposes of this 

guidance, we consider filtration to be a 

process whereby milk is passed over a 

series of semipermeable membranes 

with varying pore sizes. Ultrafiltration 

retains macromolecules and particles 

larger than about 0.001–0.02 

micrometers. In dairy processing, 

ultrafiltration is typically used to retain 

all protein components of milk, 

including casein and whey proteins, 

while some of the lactose, minerals, and 

water soluble vitamins present in milk 

are lost along with water. 

For purposes of the guidance, UF milk 

means raw or pasteurized milk that is 

passed over one or more semipermeable 

membranes to partially remove water, 

lactose, minerals, and water-soluble 

vitamins without altering the 

casein::whey protein ratio of the milk 

and resulting in a liquid product. UF 

nonfat milk is defined similarly, except 

that raw or pasteurized nonfat milk is 

used. 

In the Federal Register of October 19, 

2005 (70 FR 60751), we issued a 

proposed rule that would amend our 

regulations to provide for the use of 

fluid UF milk in the manufacture of 

standardized cheeses and related cheese 

products. We tentatively concluded that 

the proposed rule, if finalized, would 

promote honesty and fair dealing in the 

interest of consumers and, to the extent 

practicable, achieve consistency with 

existing international standards of 

identity for cheeses and related cheese 

products. 

While we have not completed the 

rulemaking as of August 2017, we are 

aware of issues regarding UF milk in the 

United States. In brief, due to recent 

developments in the export market, the 

United States dairy industry is 

experiencing an oversupply of and 

pricing challenges with domestically 

produced UF milk (Refs. 1 and 2). 

Additionally, we have received requests 

to exercise enforcement discretion while 

the rulemaking is pending, in part to 

mitigate the impact on U.S. companies 

producing UF milk (Ref. 3). 

FDA believes that food standards 

should provide for flexibility in 

manufacturing procedures and 

ingredients, provided that the basic 

nature and essential characteristics of 

the food are preserved. Given the 

oversupply of UF milk and the pending 

rulemaking, through this guidance we 

are announcing our intent to exercise 

enforcement discretion regarding the 

use of fluid UF milk and fluid UF nonfat 

milk in the production of standardized 

cheeses and related cheese products 

under part 133, in addition to the other 

required dairy ingredients, provided 

that the physical, chemical, and 

organoleptic properties of the cheese or 

cheese product are not affected. FDA is 

also announcing its intent to exercise 

enforcement discretion with respect to 

the labeling of standardized cheeses and 

related cheese products, when, in 

addition to milk or nonfat milk, fluid 

UF milk or fluid UF nonfat milk is used 

as an ingredient, but is not declared in 

the ingredient statement, provided that 

milk or nonfat milk is declared in the 

ingredient statement. We are exercising 

enforcement discretion with respect to 

the labeling of fluid UF milk and fluid 

UF nonfat milk in recognition of the 

costs and logistics involved in label 

changes; however, we encourage 

industry to identify these ingredients as 

‘‘ultrafiltered milk’’ and ‘‘ultrafiltered 

nonfat milk’’ to the extent feasible and 

appropriate. We intend to exercise 

enforcement discretion until we have 

completed a rulemaking process 

amending our regulations with respect 

to the issues covered by this guidance, 

or announce in the Federal Register our 

determination not to proceed with such 

a rulemaking. 

We are issuing this guidance without 

prior public comment under 21 CFR 

10.115(g)(2) because we have 

determined that prior public 

participation is not feasible or 

appropriate, as this guidance 

implements a temporary enforcement 

policy to address an oversupply of UF 

pending the completion of rulemaking 

regarding the use of UF milk in the 

production of standardized cheeses and 

related cheese products. The oversupply 

of UF milk would be worsened if we 

deferred exercising of enforcement 

discretion regarding the matters in the 

guidance while providing an 

opportunity for prior public comment. 

(We also note that, as we stated in the 

preamble to the 2005 proposed rule, we 

tentatively conclude that fluid UF milk 

can be used in standardized cheeses 

while maintaining the essential 

characteristics of those cheeses 

specified in the individual standards of 

identity in part 133 (see 70 FR 60751 at 

60756 through 60757).) However, as 

with all Agency guidances, the public 

may comment on the guidance at any 

time. This guidance is not subject to 

Executive Order 12866. 

II. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/FoodGuidances or 

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

FDA Web site listed in the previous 

sentence to find the most current 

version of the guidance. 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Rules and Regulations 37817 

III. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are 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 addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. Letter from Senator Amy Klobuchar, 

Senator Al Franken, Representative 

Collin Peterson, and Representative Tim 

Walz, to President Donald J. Trump, 

accessed on the Web at https://

www.klobuchar.senate.gov/public/ 

index.cfm/2017/4/klobuchar-frankenpeterson-walz-urge-administration-tosupport-minnesota-dairy-farmersthrough-strong-enforcement-of-our-tradelaws-with-canada. 

2. Congressional Research Service, ‘‘New 

Canadian Dairy Pricing Regime Proves 

Disruptive for U.S. Milk Producers,’’ 

dated April 20, 2017, accessed on the 

Web at https://www.everycrsreport.com/ 

reports/IN10692.html. 

3. Letter from Michael D. Dykes, D.V.M., 

President and CEO, International Dairy 

Foods Association, to Stephen Ostroff, 

M.D., Deputy Commissioner for Foods 

and Veterinary Medicine, Food and Drug 

Administration, dated June 22, 2017. 

Dated: August 9, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–17118 Filed 8–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9777] 

RIN 1545–BG41; 1545–BH38 

Arbitrage Guidance for Tax-Exempt 

Bonds; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains a 

correction to final regulations (TD 9777) 

that were published in the Federal 

Register on Monday, July 18, 2016 (81 

FR 46582). The final regulations relate 

to the arbitrage restrictions under 

section 148 of the Internal Revenue 

Code applicable to tax-exempt bonds 

and other tax-advantaged bonds issued 

by State and local governments. 

DATES: This correction is effective 

August 14, 2017 and applicable July 18, 

2016. 

FOR FURTHER INFORMATION CONTACT: 

Spence Hanemann at (202) 317–6980 

(not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations (TD 9777) that 

are the subject of this correction are 

under section 148 of the Internal 

Revenue Code. 

Need for Correction 

As published, the final regulations 

(TD 9777) contain an error that may 

prove to be misleading and are in need 

of clarification. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Correction of Publication 

Accordingly, 26 CFR part 1 is 

amended by making the following 

correcting amendment: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

§ 1.148–11 [Amended] 

■ Par. 2. Amend § 1.148–11(k)(1) by 

adding ‘‘1.148–6(d)(3)(iii)(A);’’ before 

‘‘1.148–6(d)(4)’’. 

Martin V. Franks, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration) . 

[FR Doc. 2017–17135 Filed 8–11–17; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2017–0034; FRL–9965–26– 

Region 9] 

Approval of California Air Plan 

Revisions, San Joaquin Valley Unified 

Air Pollution Control District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking final action to 

approve a revision to the San Joaquin 

Valley Unified Air Pollution Control 

District (SJVUAPCD or ‘‘the District’’) 

portion of the California State 

Implementation Plan (SIP). This revised 

rule concerns emissions of oxides of 

nitrogen, carbon monoxide, oxides of 

sulfur, and particulate matter of 10 

microns or less from boilers, steam 

generators and process heaters. We are 

approving a local rule that regulates 

these emission sources under the Clean 

Air Act (CAA or the Act). 

DATES: This rule will be effective on 

September 13, 2017. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R09–OAR–2017–0034. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

or other information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available through http://

www.regulations.gov, or please contact 

the person identified in the FOR FURTHER

INFORMATION CONTACT section for 

additional availability information. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Levin, EPA Region IX, (415) 972– 

3848, levin.nancy@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us’’ 

and ‘‘our’’ refer to the EPA. 

Table of Contents 

I. Proposed Action 

II. Public Comments and EPA Responses 

III. EPA Action 

IV. Incorporation by Reference 

V. Statutory and Executive Order Reviews 

I. Proposed Action 

On March 21, 2017 (82 FR 14496), the 

EPA proposed to approve the following 

rule into the California SIP. 


sradovich on DSK3GMQ082PROD with RULES