Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules 32221 

District Office, as appropriate. If sending 

information directly to the manager of the 

Boston ACO Branch, send it to the attention 

of the person identified in paragraph (j)(1) of 

this AD. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(j) Related Information 

(1) For more information about this AD, 

contact Maureen Maisttison, Aerospace 

Engineer, AIR–7B1, FAA, 1200 District Ave, 

Massachusetts, 01803; phone: 781–238–7076; 

fax: 781–238–7151; email: 

maureen.maisttison@faa.gov. 

(2) Refer to European Aviation Safety 

Agency AD 2017–0220, dated November 10, 

2017, for more information. You may 

examine the EASA AD in the AD docket on 

the internet at http://www.regulations.gov by 

searching for and locating it in Docket No. 

FAA–2018–0281. 

(3) For service information identified in 

this proposed AD, contact Hoffmann 

Propeller GmbH & Co. KG, Sales and Service, 

Ku ̈pferlingstrasse 9, 83022 Rosenheim, 

Germany; phone: +49 (0) 8031 1878 0; fax: 

+49 (0) 8031 1878 78; email: info@hoffmannprop.com. You may view this referenced 

service information at the FAA, Engine & 

Propeller Standards Branch, 1200 District 

Avenue, Burlington, MA. For information on 

the availability of this material at the FAA, 

call 781–238–7759. 

Issued in Burlington, Massachusetts, on 

July 6, 2018. 

Karen M. Grant, 

Acting Manager, Engine and Propeller 

Standards Branch, Aircraft Certification 

Service. 

[FR Doc. 2018–14862 Filed 7–11–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2011–F–0171] 

RIN 0910–AH83 

Food Labeling: Calorie Labeling of 

Articles of Food Sold From Certain 

Vending Machines; Front of Package 

Type Size 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) proposes to revise the type size 

labeling requirements for front of 

package (FOP) calorie declarations for 

packaged food sold from glass front 

vending machines. We are taking this 

action in response to requests from the 

vending and packaged foods industries 

to reduce the regulatory burden and 

increase flexibility, while continuing to 

provide calorie declarations for certain 

articles of food sold from vending 

machines. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by September 25, 2018. Please note that 

late, untimely filed comments will not 

be considered. 

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– 

2011–F–0171 for ‘‘Food Labeling: 

Calorie Labeling of Articles of Food 

Sold From Certain Vending Machines; 

Front of Package Type Size.’’ Received 

comments, those filed in a timely 

manner (see DATES), 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: http://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: 

Marjan Morravej, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

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

2371, Marjan.Morravej@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of This Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 


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C. Legal Authority 

D. Costs and Benefits 

II. Background 

A. Requirements for Calorie Labeling of 

Articles of Food in Vending Machines 

and Our Consideration of Front of 

Package Labeling Issues 

B. Challenges of Existing Type Size 

Requirement, and Proposed Change to 

‘‘150 Percent of the Size of the Net 

Quantity of Contents Declaration’’ 

C. Other Approaches 

III. Legal Authority 

IV. Description of the Proposed Rule 

(Proposed § 101.8(b)(2)) 

V. Proposed Effective and Compliance Dates 

VI. Economic Analysis of Impacts 

A. Introduction 

B. Summary of Benefits and Costs of the 

Proposed Rule 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. References 

I. Executive Summary 

A. Purpose of This Proposed Rule 

We are proposing to amend our 

vending machine labeling regulations in 

21 CFR part 101 by revising § 101.8(b)(2) 

(21 CFR 101.8(b)(2)), in order to revise 

the type size requirement when FOP 

labeling is used to meet the calorie 

declaration requirements for articles of 

food sold from certain vending 

machines. When using FOP labeling, 

our existing regulations at § 101.8(b)(2) 

require that the type size of the calorie 

declaration for articles of food sold from 

certain vending machines be at least 50 

percent of the size of the largest printed 

matter on the label. We propose, 

instead, to require that the type size of 

the calorie declaration on the front of 

the package be at least 150 percent (one 

and one-half times) the size of the net 

quantity of contents (i.e., net weight) 

declaration on the package of the 

vended food. We are proposing this 

change to reduce regulatory burdens 

that the vending and packaged foods 

industries shared with us after the final 

rule implementing the vending machine 

labeling requirements (79 FR 71259, 

December 1, 2014) was issued, while 

continuing to provide calorie 

declarations for certain articles of food 

sold from vending machines. Electronic 

comments must be submitted on or 

before September 25, 2018. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

September 25, 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. 

B. Summary of the Major Provisions of 

the Proposed Rule 

This proposed rule would revise the 

type size requirement for calories 

labeled on the front of the package of 

vended foods in § 101.8(b)(2). We are 

proposing that the type size be anchored 

to the net quantity of contents 

statement, such that the minimum type 

size is 150 percent (one and one-half 

times) the size of the net quantity of 

contents, instead of being based on the 

largest printed matter on the label. The 

proposed rule would only apply when 

calories are displayed on the front of the 

package of foods sold in glass front 

vending machines. 

C. Legal Authority 

This action is consistent with our 

authority in section 403(q)(5)(H) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 343(q)(5)(H)). 

The FD&C Act, at section 403(q)(5)(H), 

requires certain vending machine 

operators to provide calorie declarations 

for certain articles of food sold from 

vending machines. In addition, we are 

issuing this proposed rule consistent 

with our authority in sections 201(n), 

403(a)(1), and 403(f), of the FD&C Act 

(21 U.S.C. 321(n), 343(a)(1), and 343(f)). 

Further, we are issuing this proposed 

rule under section 701(a) of the FD&C 

Act (21 U.S.C. 371(a)), which gives us 

the authority to issue regulations for the 

efficient enforcement of the FD&C Act. 

We discuss our legal authority in greater 

detail in Section III, ‘‘Legal Authority.’’ 

D. Costs and Benefits 

In response to requests from the 

vending and packaged foods industries 

to reduce the regulatory burden and 

increase flexibility, FDA is proposing to 

revise the existing type size 

requirements when calories are 

displayed on the front of the package of 

foods sold in glass front vending 

machines. Because this rule only 

proposes minor revisions to FOP calorie 

labeling type size requirements, we 

estimate there are no costs to vending 

machine operators and potential costs 

savings to vending machine operators 

and packaged food manufacturers. We 

welcome data that would help us to 

better estimate these impacts. 

II. Background 

A. Requirements for Calorie Labeling of 

Articles of Food in Vending Machines 

and Our Consideration of Front of 

Package Labeling Issues 

Section 403(q)(5)(H) of the FD&C Act 

requires certain vending machine 

operators to provide calorie declarations 

for certain articles of food sold from 

vending machines. Under section 

403(q)(5)(H)(viii) of the FD&C Act, if an 

article of food is sold from a vending 

machine that does not permit a 

prospective purchaser to examine the 

Nutrition Facts label before purchasing 

the article, or does not otherwise 

provide visible nutrition information at 

the point of purchase; and is operated 

by a person who is engaged in the 

business of owning or operating 20 or 

more vending machines, the vending 

machine operator must ‘‘provide a sign 

in close proximity to each article of food 

or the selection button that includes a 

clear and conspicuous statement 

disclosing the number of calories 

contained in the article.’’ 

In the Federal Register of December 1, 

2014 (79 FR 71259), we issued a final 

rule to implement the vending machine 

labeling requirements in section 

403(q)(5)(H) of the FD&C Act. The final 

rule, which became effective on 

December 1, 2016, requires vending 

machine operators that own or operate 

20 or more vending machines (or that 

voluntarily register with us to be subject 

to the final rule) to provide calorie 

declarations for certain articles of food 

sold from vending machines. The final 

rule describes which foods are subject to 

the calorie declaration requirement. The 

final rule also establishes type size, 

color, and contrast requirements for 

calorie declarations in, or on, the 

vending machines and for calorie 

declarations on signs adjacent to the 

vending machines. The final rule also 

clarifies that vending machine operators 

do not have to provide calorie 

information for a food if a prospective 

purchaser can view certain calorie 

information on the front of the package, 

in the Nutrition Facts label on the food, 

or in a reproduction of the Nutrition 

Facts label for the food, subject to 

certain requirements. The calorie 

declaration requirements covered in the 

final rule are codified at § 101.8. 

In the Federal Register of August 1, 

2016 (81 FR 50303), we issued a final 

rule that extended the compliance date 

for final calorie declaration 

requirements for certain food products 

sold from glass-front vending machines 

to July 26, 2018. The extended 

compliance date applies only to those 

products in glass front vending 

machines that provide FOP calorie 

disclosures and that comply with all 

aspects of the final vending machine 

labeling rule except that the disclosure 

is not 50 percent of the size of the 

largest print on the label. 

In the preamble of the proposed rule 

(published in the Federal Register of 

April 6, 2011 (76 FR 19237 at 19244)), 

we stated that FOP labeling could be a 


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way to provide ‘‘visible nutrition 

information,’’ as long as the criteria for 

color, font, and type size are met, and 

total calories contained in the vended 

food are included. We also tentatively 

concluded that the visible nutrition 

information must be in a type size 

reasonably related to the most 

prominent printed matter on the 

labeling, among other things, such that 

a purchaser is able to notice and read 

the information. The preamble to the 

proposed rule (76 FR 19237 at 19244) 

explained that we considered 

‘‘reasonably related’’ to mean a type size 

at least 50 percent of the size of the 

largest print on the label. This type size 

as specified in the preamble to the 

proposed rule is consistent with 

interpretations we have used in food 

labeling guidance when determining the 

type size of the statement of identity on 

packaged foods (Ref. 1). 

In the preamble to the final rule (79 

FR 71259 at 71269), we noted that many 

comments supported the idea that FOP 

labeling could provide visible nutrition 

information; these comments said that 

FOP labeling is the most efficient way 

to satisfy section 403(q)(5)(H)(viii) of the 

FD&C Act. Other comments stated that 

vending machine operators are likely to 

prefer food products with FOP labeling 

because operators selling such food 

products in their vending machines 

would not have to provide calorie 

declarations in compliance with section 

403(q)(5)(H)(viii)(I)(bb) of the FD&C Act. 

We also discussed several comments 

that said that interpreting ‘‘reasonably 

related’’ to mean a type size that is at 

least 50 percent of the size of the largest 

print on the label would require a type 

size that is too large. One comment 

suggested revising the rule to specify a 

ratio for the size of the FOP calorie 

disclosure relative to other printed 

material on the label. The comment 

stated that ‘‘reasonably related’’ would 

be hard to enforce, and we should 

require the FOP calorie disclosure to be 

at least two-thirds the size of the largest 

type size of any other writing on the 

package, with a minimum size of onehalf square inch. Other comments stated 

we should omit type size or prominence 

requirements for the FOP calorie 

disclosure. 

In response to comments to the 

proposed rule, we revised the rule by 

removing the words ‘‘reasonably 

related’’ at § 101.8(b)(2) and instead 

required the calorie labeling print to be 

‘‘at least 50 percent of the size of the 

largest printed matter on the label.’’ We 

also noted that vending machine 

operators had other options for 

satisfying section 403(q)(5)(H)(viii) of 

the FD&C Act, including using a 

vending machine that provides 

electronic reproductions of Nutrition 

Facts labels, as provided in 

§ 101.8(b)(1), or posting signs with 

calorie declarations, as provided in 

§ 101.8(c). 

B. Challenges of Existing Type Size 

Requirement, and Proposed Change to 

‘‘150 Percent of the Size of the Net 

Quantity of Contents Declaration’’ 

Since the publication of the final rule, 

several industry representatives 

indicated that the 50 percent type size 

requirement for FOP calorie labeling 

presents significant technical challenges 

to the packaged foods industry (Refs. 2 

and 3). They said it would make the 

calorie declaration very large on some 

products and would make label redesign 

difficult or not practical. They 

explained that, for glass front vending 

machines without electronic displays, 

FOP labeling assures that consumers 

will get accurate calorie information for 

vended foods. The industry 

representatives also said that many 

packaged food manufacturers who wish 

to help vending machine operators 

comply with the regulations by 

providing packaged foods with FOP 

labeling will have to redesign their 

labels at great expense. They noted the 

existence of several voluntary FOP 

labeling programs where calorie 

information is presented in a FOP type 

size that ranges from 100 to 150 percent 

of the size of the net quantity of 

contents statement on the principal 

display panel. They acknowledged these 

labeling programs do not meet our type 

size requirements, and said that 

complying with the type size 

requirement for calorie labeling would 

significantly disrupt their FOP nutrition 

labeling programs because there would 

no longer be enough room on the label 

to accommodate both the voluntary FOP 

information and our calorie labeling 

requirement. Thus, they said that the 

nutrition information beyond calorie 

labeling that is presently provided 

under industry FOP programs may no 

longer be included. Additionally, they 

said that, while the existing FOP 

labeling may not be at least 50 percent 

of the size of the largest printed matter 

on the label, as required by our rule, the 

calorie information is nonetheless 

visible to consumers. Finally, they 

stated that, in most cases, industry 

would be able to comply with a rule that 

linked the FOP type size for calorie 

labeling if it were no larger than 150 

percent of the type size of the net 

quantity of contents statement. Other 

industry representatives also have 

expressed support for using the 150 

percent standard for purposes of the 

FOP type size requirement (Refs. 4–7). 

Consequently, the proposed rule 

would remove the requirement 

specifying the FOP labeling be at least 

50 percent of the size of the largest 

printed matter on the label and instead 

link the type size to the size of the net 

quantity of contents statement. 

Specifically, the proposed rule would 

revise § 101.8(b)(2) pertaining to 

‘‘articles of food not covered’’ to state 

that the visible nutrition information 

must be in a type size at least 150 

percent of the size of the net quantity of 

contents declaration on the front of the 

package. 

This revision, if finalized, would 

allow for greater flexibility for the use 

of FOP calorie labeling in glass front 

vending machines, while still ensuring 

that a FOP calorie declaration would be 

visible for the consumer, regardless of 

the size of the package. It also would 

minimize the need for label changes for 

foods that currently have voluntary FOP 

calorie declarations that are 150 percent 

of the size of the net quantity of content 

statement provided the calorie 

declarations meet the other criteria in 

the final rule. It is our understanding 

that many packaged food products sold 

in glass front vending machines that 

currently bear FOP calorie labeling 

would meet the 150 percent 

requirement that we are proposing. 

However, to more fully understand the 

current marketplace, we specifically 

invite comment and data on the 

percentage of food products commonly 

sold in glass front vending machines 

bearing voluntary FOP calorie labeling, 

and for those products that currently 

bear voluntary FOP calorie labeling, the 

type size of the FOP calorie labeling 

used on the products. 

C. Other Approaches 

Data and information currently 

available to FDA indicate that the 

proposed rule is consistent with some 

existing voluntary FOP calorie 

declarations currently used on food 

product labels and it is feasible for other 

foods that may be sold in vending 

machines. We also evaluated two other 

approaches for providing visible 

nutrition information that would meet 

the criteria in section 403(q)(5)(H)(viii) 

of the FD&C Act, such that the food 

would not be subject to the vending 

machine calorie labeling requirements. 

We invite comment on these two 

alternative approaches, described more 

fully below. 


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1. Alternative Approach A—At Least 

100 Percent of the Size of the Net 

Quantity of Contents Declaration 

The first alternative approach would 

be to require the visible nutrition 

information to be in a type size that is 

at least 100 percent of the size of the net 

quantity of contents declaration. Our 

existing food labeling regulations for 

packaged foods, at 21 CFR 101.7(i), 

require that the declaration of net 

quantity be in letters and numerals in a 

type size that is established in relation 

to the area of the principal display panel 

of the package and that the declaration 

be uniform for all packages of 

substantially the same size. The 

regulation prescribes the following size 

specifications for net quantity 

declarations: 

• Not less than one-sixteenth inch in 

height on packages the principal display 

panel of which has an area of 5 square 

inches or less; 

• Not less than one-eighth inch in 

height on packages the principal display 

panel of which has an area of more than 

5 but not more than 25 square inches; 

• Not less than three-sixteenths inch 

in height on packages the principal 

display panel of which has an area of 

more than 25 but not more than 100 

square inches; and 

• Not less than one-fourth inch in 

height on packages the principal display 

panel of which has an area of more than 

100 square inches, except not less than 

1⁄2 inch in height if the area is more than 

400 square inches. 

If the declaration is blown, embossed, 

or molded on a glass or plastic surface 

rather than by printing, typing, or 

coloring, then the lettering sizes are to 

be increased by one-sixteenth of an 

inch. 

We considered requiring the visible 

nutrition information to be in a type size 

that is at least 100 percent of the size of 

the net quantity of contents declaration 

on the front of the package; in other 

words, the visible nutrition information 

would, at a minimum, be the same size 

as the net quantity of contents 

declaration. We invite comment on the 

impact of meeting the visible nutrition 

information criteria, required under 

section 403(q)(5)(H)(viii) of the FD&C 

Act, especially on food in smaller 

packages, such as small candy bars or 

single serve bags of nuts, that are sold 

in glass front vending machines under 

this alternative approach where the FOP 

calorie declaration is at least the same 

size as the net quantity of contents 

declaration. 

FDA invites comment on the 

advantages and disadvantages of this 

alternative. 

2. Alternative Approach B—Not 

Specifying Any Size 

The second alternative approach 

would be to not specify any size for the 

visible nutrition information. This 

option would give the packaged food 

industry considerable flexibility in 

deciding how large—or how small— 

voluntary FOP calorie labeling could be, 

and may reduce the need for packaging 

changes for some manufacturers. We 

note that in developing the final 

vending machine labeling rule, we 

considered, but disagreed with 

comments asking that we omit 

requirements for prominence or type 

size of FOP calorie disclosures. As we 

discussed in the preamble to that final 

rule, ‘‘When a vending machine food is 

in a vending machine, a prospective 

purchaser cannot handle the product to 

make it easier for the purchaser to read 

the nutrition information. Therefore, 

‘visible nutrition information’ on the 

front of package must be large enough, 

and prominent enough, for prospective 

purchasers to see and use the 

information’’ (79 FR 71259 at 71269). 

We invite comment on the advantages 

and disadvantages of this alternative. 

III. Legal Authority 

We are proposing to revise the 

labeling requirements for providing 

calorie declarations for food sold from 

certain vending machines, as set forth in 

this proposed rule, consistent with our 

authority in section 403(q)(5)(H) of the 

FD&C Act. Under section 403(q)(5)(H), 

certain vending machine operators must 

provide calorie declarations for certain 

articles of food sold from vending 

machines. Under section 403(a)(1) of the 

FD&C Act, such information must be 

truthful and non-misleading. Under 

section 403(f) of the FD&C Act, any 

word, statement, or other information 

required by or under the FD&C Act to 

appear on the label or labeling of an 

article of food must be prominently 

placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use. Under section 

403(a), (f), or (q) of the FD&C Act, food 

to which these requirements apply is 

deemed misbranded if these 

requirements are not met. In addition, 

under section 201(n) of the FD&C Act, 

the labeling of food is misleading if it 

fails to reveal facts that are material in 

light of representations made in the 

labeling or with respect to consequences 

that may result from use. Thus, we are 

issuing this proposed rule under 

sections 201(n), 403(a)(1), 403(f), and 

403(q)(5)(H) of the FD&C Act, as well as 

under section 701(a) of the FD&C Act, 

which gives us the authority to issue 

regulations for the efficient enforcement 

of the FD&C Act. 

IV. Description of the Proposed Rule 

(Proposed § 101.8(b)(2)) 

The proposed rule would make a 

change to the existing rule for calorie 

labeling of food sold from vending 

machines, in order to reduce the 

regulatory burden and increase 

flexibility while continuing to provide 

calorie declarations for certain articles 

of food sold from vending machines. We 

propose to revise § 101.8(b)(2) to remove 

the requirement that the type size of the 

visible calorie declaration for articles of 

food be at least 50 percent of the size of 

the largest printed matter on the label 

and, instead, to require the type size to 

be at least 150 percent (one and one-half 

times) the size of the net quantity of 

contents (i.e., net weight) declaration on 

the package of the vended food. We also 

would make a minor editorial correction 

to the same sentence in § 101.8(b)(2), 

substituting the word ‘‘prospective’’ in 

place of ‘‘perspective.’’ 

We also would revise the first 

sentence of § 101.8(b)(2) by inserting a 

comma after the word ‘‘minimum.’’ This 

change corrects a punctuation error. 

V. Proposed Effective and Compliance 

Dates 

We are proposing that any final rule 

resulting from this rulemaking have an 

effective date of 30 days after the date 

of its publication in the Federal 

Register. We also are proposing that 

covered vending machine operators 

comply with any final rule resulting 

from this rulemaking by January 1, 

2020. We are proposing this compliance 

date in order to provide sufficient time 

for the packaged food industry to revise 

their labels, as appropriate, consistent 

with any new requirements. 

As discussed in section II.A., by July 

26, 2018, vending machine operators 

with glass front vending machines will 

have to comply with all vending 

machine requirements of the final rule 

issued in 2014. However, it is unlikely 

that we will be able to complete the 

current rulemaking to revise the type 

size labeling requirements for FOP 

calorie declarations before the July 26, 

2018 compliance date. Therefore, 

pending completion of this rulemaking, 

FDA intends to exercise enforcement 

discretion with respect to the July 26, 

2018 compliance date for products sold 

in glass front vending machines that 

provide a FOP calorie disclosure and 


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the product complies with all aspects of 

the final vending machine labeling rule 

except that the disclosure is not 50 

percent of the size of the largest print on 

the label. 

Further, as previously noted, vending 

machine operators with glass front 

vending machines will have to comply 

by July 26, 2018, with all vending 

machine requirements, including 

complying with calorie disclosure 

requirements in 21 CFR 101.8(c)(2). 

Although these requirements cover 

gums, mints, and roll candy products 

sold in glass front machines, FDA 

intends to exercise enforcement 

discretion, at least until January 1, 2020, 

with respect to gums, mints, and roll 

candy products sold in glass front 

machines in packages that are too small 

to bear FOP labeling. FDA intends to 

consider this issue further. 

VI. Economic Analysis of Impacts 

A. Introduction 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 13771, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). 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 

13771 requires that the costs associated 

with significant 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 has 

been designated as a significant 

regulatory action as defined by 

Executive Order 12866. This proposed 

rule is expected to be an Executive 

Order 13771 deregulatory action. 

Additional details can be found in the 

proposed rule’s preliminary economic 

analysis. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. The vending machine final rule 

does not impose burdens to the 

suppliers of vending machine foods. 

While suppliers are not obliged to 

engage in FOP calorie labeling, this 

proposed rule, if finalized, would allow 

for greater flexibility for the use of FOP 

calorie labeling in glass front vending 

machines than the existing regulations, 

potentially reducing the burden on 

covered vending machine operators of 

providing additional calorie labeling. 

Thus, we propose to certify that the 

proposed rule will 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 proposing 

‘‘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 $150 million, 

using the most current (2017) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

B. Summary of Benefits and Costs of the 

Proposed Rule 

FDA proposes to revise the type size 

labeling requirements for providing FOP 

calorie declarations for packaged food 

sold from certain vending machines. We 

are taking this action in response to 

requests from the vending and packaged 

foods industries to reduce the regulatory 

burden and increase flexibility. The 

proposed rule would revise the type size 

requirements for FOP calorie labeling on 

packaged foods displayed for sale in 

glass front vending machines. 

There are currently several voluntary 

FOP labeling programs where calorie 

information is presented. If finalized, 

this proposal may provide an increased 

incentive for packaged food 

manufacturers to add new or amend 

current FOP calorie labeling to foods in 

order to comply with the updated 

standard. If so, glass front vending 

machine operators carrying exclusively 

those products will not have to provide 

signs with calorie information for the 

food, providing an opportunity to 

reduce operator costs. To the extent this 

occurs, some costs may shift from the 

vending machine operator to the 

manufacturer. Packaged food 

manufacturing firms may choose to 

incur additional costs associated with 

amending the FOP label in order to 

retain revenue streams from current 

customers, including vending machine 

operators. If total revenue is greater than 

total cost, this proposed rule will 

provide cost savings for packaged food 

manufacturing firms. We expect the 

potential cost savings to both vending 

machine operators and packaged food 

manufacturers to outweigh the costs to 

packaged food manufacturers and thus 

the net effect to be positive, but lack the 

data to quantify this effect. We welcome 

data that would help us to better 

estimate these impacts. 

We have developed a comprehensive 

Economic Analysis of Impacts that 

assesses the impacts of the proposed 

rule. The full analysis of economic 

impacts is available in the docket for 

this proposed rule (Ref. 8) and at 

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

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(k) 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. 

VIII. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed rule contains no new 

collection of information beyond what 

was described in the December 2014 

final rule and approved under OMB 

control number 0910–0782. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

IX. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. Section 

4(a) of the Executive Order requires 

Agencies to construe a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute. Federal law includes 

an express preemption provision that 

preempts any nutrition labeling 

requirement of food that is not identical 

to the requirement of section 403(q) of 

the FD&C Act, except that this provision 

does not apply to food that is offered for 

sale in a restaurant or similar retail food 

establishment that is not part of a chain 

with 20 or more locations doing 

business under the same name and 

offering for sale substantially the same 

menu items unless such restaurant or 

similar retail food establishment elects 

to comply voluntarily with the nutrition 

information requirements under section 

403(q)(5)(H)(ix) of the FD&C Act. The 

proposed rule would create 

requirements for nutrition labeling of 

food under section 403(q) of the FD&C 


amozie on DSK3GDR082PROD with PROPOSALS1
32226 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules 

Act that would preempt certain nonidentical State and local nutrition 

labeling requirements. 

Section 4205 of the Patient Protection 

and Affordable Care Act (ACA), which 

amended the FD&C Act to require 

certain vending machine operators to 

provide calorie declarations for certain 

articles of food sold from vending 

machines, also included a Rule of 

Construction providing that nothing in 

the amendments made by section 4205 

of the ACA shall be construed: (1) To 

preempt any provision of State or local 

law, unless such provision establishes 

or continues into effect nutrient content 

disclosures of the type required under 

section 403(q)(5)(H) of the FD&C Act 

and is expressly preempted under 

subsection (a)(4) of such section; (2) to 

apply to any State or local requirement 

respecting a statement in the labeling of 

food that provides for a warning 

concerning the safety of the food or 

component of the food; or (3) except as 

provided in section 403(q)(5)(H)(ix) of 

the FD&C Act, to apply to any restaurant 

or similar retail food establishment 

other than a restaurant or similar retail 

food establishment described in section 

403(q)(5)(H)(i) of the FD&C Act (see Pub. 

L. 111–148, section 4205(d) of the ACA, 

124 Stat. 119, 576 (2010)). 

We interpret the provisions of section 

4205 of the ACA related to preemption 

to mean that States and local 

governments may not impose nutrition 

labeling requirements for food sold from 

vending machines that must comply 

with the Federal requirements of section 

403(q)(5)(H) of the FD&C Act, unless the 

State or local requirements are identical 

to the Federal requirements. In other 

words, States and localities cannot have 

additional or different nutrition labeling 

requirements for food sold either: (1) 

From vending machines that are 

operated by a person engaged in the 

business of owning or operating 20 or 

more vending machines subject to the 

requirements of section 

403(q)(5)(H)(viii) of the FD&C Act; or (2) 

from vending machines operated by a 

person not subject to the requirements 

of section 403(q)(5)(H)(viii) of the FD&C 

Act who voluntarily elects to be subject 

to those requirements by registering 

biannually under section 

403(q)(5)(H)(ix) of the FD&C Act. 

Otherwise, for food sold from vending 

machines not subject to the nutrition 

labeling requirements of section 

403(q)(5)(H)(viii) of the FD&C Act, 

States and localities may impose 

nutrition labeling requirements. Under 

our interpretation of section 4205(d)(1) 

of the ACA, nutrition labeling for food 

sold from these vending machines 

would not be nutrient content 

disclosures of the type required under 

section 403(q)(5)(H)(viii) of the FD&C 

Act and, therefore, would not be 

preempted. Under this interpretation, 

States and localities would be able to 

continue to require nutrition labeling for 

food sold from vending machines that 

are exempt from nutrition labeling 

under section 403(q)(5) of the FD&C Act. 

This interpretation is consistent with 

the fact that Congress included vending 

machine operators in the voluntary 

registration provision of section 

403(q)(5)(H)(ix) of the FD&C Act. There 

would have been no need to include 

vending machine operators in the 

provision that allows opting into the 

Federal requirements if States and 

localities could not otherwise require 

non-identical nutrition labeling for food 

sold from any vending machines. 

In addition, the express preemption 

provisions of 21 U.S.C. 343–1(a)(4) do 

not preempt any State or local 

requirement respecting a statement in 

the labeling of food that provides for a 

warning concerning the safety of the 

food or component of the food. This is 

clear from both the literal language of 21 

U.S.C. 343–1(a)(4) with respect to the 

scope of preemption and from the Rule 

of Construction at section 4205(d)(2) of 

the ACA. 

X. 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 website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, ‘‘Guidance for Industry: A Food 

Labeling Guide (4. Name of Food)’’, last 

updated January 2013. Retrieved from 

https://www.fda.gov/downloads/Food/ 

GuidanceRegulation/UCM265446.pdf. 

2. Letter from Karin F. R. Moore, Vice 

President and General Counsel, Grocery 

Manufacturers Association, and cosigned 

by the American Beverage Association, 

National Automated Merchandising 

Association, National Confectioners 

Association, and SNAC International, to 

Susan Mayne, Ph.D., Director, Center for 

Food Safety and Applied Nutrition, 

dated March 31, 2016. 

3. Letter from Karin F. R. Moore, Senior Vice 

President and General Counsel, Grocery 

Manufacturers Association, and cosigned 

by the American Beverage Association, 

National Automated Merchandising 

Association, National Confectioners 

Association, and SNAC International, to 

Susan Mayne, Ph.D., Director, Center for 

Food Safety and Applied Nutrition, 

dated June 28, 2016. 

4. Letter from Karin F. R. Moore, Senior Vice 

President and General Counsel, Grocery 

Manufacturers Association, and cosigned 

by the American Beverage Association, 

National Automated Merchandising 

Association, National Confectioners 

Association, and SNAC International, to 

Scott Gottlieb, M.D., Commissioner of 

Food and Drugs, FDA, dated July 19, 

2017. 

5. Letter from Jason Eberstein, Director, State 

& Federal Government Affairs, National 

Automatic Merchandising Association, 

to Scott Gottlieb, M.D., Commissioner of 

Food and Drugs, FDA, dated November 

21, 2017. 

6. Letter from Brad G. Figel, Vice President, 

North America Public Affairs, Mars, Inc., 

to Mick Mulvaney, Director, Office of 

Management and Budget, dated January 

30, 2018. 

7. Letter from Elizabeth Avery, President and 

CEO, SNAC International, to Dockets 

Management Staff, FDA, dated February 

12, 2018. 

8. FDA, ‘‘Food Labeling: Calorie Labeling of 

Articles of Food Sold From Certain 

Vending Machines; Front of Package 

Type Size, Preliminary Regulatory 

Impact Analysis, Initial Regulatory 

Flexibility Analysis, Preliminary Small 

Entity Analysis,’’ dated June 2018. Also 

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

AboutFDA/ReportsManualsForms/ 

Reports/EconomicAnalyses/default.htm. 

List of Subjects in 21 CFR Part 101 

Food labeling, Nutrition, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, we propose that 21 

CFR part 101 be amended as follows: 

PART 101—FOOD LABELING 

■ 1. The authority citation for part 101 

continues to read as follows: 

Authority: 15 U.S.C. 1453, 1454, 1455; 21 

U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 

243, 264, 271. 

■ 2. Section 101.8 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 101.8 Vending machines. 

* * * * * 

(b) * * * 

(2) The prospective purchaser can 

otherwise view visible nutrition 

information, including, at a minimum, 

the total number of calories for the 

article of food as sold at the point of 

purchase. This visible nutrition 

information must appear on the food 

label itself. The visible nutrition 

information must be clear and 

conspicuous and able to be easily read 

on the article of food while in the 


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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules 32227 

1While EPA administers most provisions in the 

CWA, the Department of the Army, Corps of 

Engineers (Corps) administers the permitting 

program under section 404. During the 1980s, both 

agencies adopted substantially similar definitions of 

‘‘waters of the United States.’’ See 51 FR 41206, 

Nov. 13, 1986, amending 33 CFR 328.3; 53 FR 

20764, June 6, 1988, amending 40 CFR 232.2. 

vending machine, in a type size at least 

150 percent of the size of the net 

quantity of contents declaration on the 

front of the package, and with sufficient 

color and contrasting background to 

other print on the label to permit the 

prospective purchaser to clearly 

distinguish the information. 

* * * * * 

Dated: July 6, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14906 Filed 7–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Department of the Army, Corps of 

Engineers 

33 CFR Part 328 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 110, 112, 116, 117, 122, 

230, 232, 300, 302, and 401 

[EPA–HQ–OW–2017–0203; FRL–9980–52– 

OW] 

RIN 2040–AF74 

Definition of ‘‘Waters of the United 

States’’—Recodification of Preexisting 

Rule 

AGENCY: Department of Defense, 

Department of the Army, Corps of 

Engineers; Environmental Protection 

Agency (EPA). 

ACTION: Supplemental notice of 

proposed rulemaking. 

SUMMARY: The purpose of this 

supplemental notice is for the 

Environmental Protection Agency (EPA) 

and the Department of the Army 

(agencies) to clarify, supplement and 

seek additional comment on an earlier 

proposal, published on July 27, 2017, to 

repeal the 2015 Rule Defining Waters of 

the United States (‘‘2015 Rule’’), which 

amended portions of the Code of 

Federal Regulations (CFR). As stated in 

the agencies’ July 27, 2017 Notice of 

Proposed Rulemaking (NPRM), the 

agencies propose to repeal the 2015 

Rule and restore the regulatory text that 

existed prior to the 2015 Rule, as 

informed by guidance in effect at that 

time. If this proposal is finalized, the 

regulations defining the scope of federal 

Clean Water Act (CWA) jurisdiction 

would be those portions of the CFR as 

they existed before the amendments 

promulgated in the 2015 Rule. Those 

preexisting regulatory definitions are 

the ones that the agencies are currently 

implementing in light of the agencies’ 

final rule published on February 6, 

2018, adding a February 6, 2020 

applicability date to the 2015 Rule, as 

well as judicial decisions preliminarily 

enjoining and staying the 2015 Rule. 

DATES: Comments must be received on 

or before August 13, 2018. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OW–2017–0203, at http://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or removed from Regulations.gov. 

The agencies may publish any comment 

received to the public docket. Do not 

submit electronically any information 

you consider to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The agencies will generally not 

consider comments or comment content 

located outside of the primary 

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

other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/ 

dockets.commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Michael McDavit, Office of Water 

(4504–T), Environmental Protection 

Agency, 1200 Pennsylvania Avenue 

NW, Washington, DC 20460; telephone 

number: (202) 566–2428; email address: 

CWAwotus@epa.gov; or Stacey Jensen, 

Regulatory Community of Practice 

(CECW–CO–R), U.S. Army Corps of 

Engineers, 441 G Street NW, 

Washington, DC 201314; telephone 

number: (202) 761–6903; email address: 

USACE_CWA_Rule@usace.army.mil. 

SUPPLEMENTARY INFORMATION: The 

agencies propose to repeal the Clean 

Water Rule: Definition of ‘‘Waters of the 

United States,’’ 80 FR 37054, and 

recodify the regulatory definitions of 

‘‘waters of the United States’’ that 

existed prior to the August 28, 2015 

effective date of the 2015 Rule. Those 

preexisting regulatory definitions are 

the ones that the agencies are currently 

implementing in light of the agencies’ 

final rule (83 FR 5200, February 6, 

2018), which added a February 6, 2020 

applicability date to the 2015 Rule. 

Judicial decisions currently enjoin the 

2015 Rule in 24 States as well. If this 

proposal is finalized, the agencies 

would administer the regulations 

promulgated in 1986 and 1988 in 

portions of 33 CFR part 328 and 40 CFR 

parts 110, 112, 116, 117, 122, 230, 232, 

300, 302, and 401, and would continue 

to interpret the statutory term ‘‘waters of 

the United States’’ to mean the waters 

covered by those regulations, as the 

agencies are currently implementing 

those regulations consistent with 

Supreme Court decisions and 

longstanding practice, as informed by 

applicable guidance documents, 

training, and experience. 

State, tribal, and local governments 

have well-defined and established 

relationships with the federal 

government in implementing CWA 

programs. Those relationships are not 

affected by this proposed rule, which 

would not alter the jurisdiction of the 

CWA compared to the regulations and 

practice that the agencies are currently 

applying. The proposed rule would 

permanently repeal the 2015 Rule, 

which amended the longstanding 

definition of ‘‘waters of the United 

States’’ in portions of 33 CFR part 328 

and 40 CFR parts 110, 112, 116, 117, 

122, 230, 232, 300, 302, and 401, and 

restore the regulations as they existed 

prior to the amendments in the 2015 

Rule.1

The agencies are issuing this 

supplemental notice of proposed 

rulemaking (SNPRM) to clarify, 

supplement and give interested parties 

an opportunity to comment on certain 

important considerations and reasons 

for the agencies’ proposal. The agencies 

clarify herein the scope of the 

solicitation of comment and the actions 

proposed. In response to the July 27, 

2017 NPRM, (82 FR 34899), the agencies 

received numerous comments on the 

impacts of repealing the 2015 Rule in its 

entirety. Others commented in favor of 

retaining the 2015 Rule, either as 

written or with modifications. Some 

commenters interpreted the proposal as 

restricting their opportunity to provide 

such comments either supporting or 

opposing repeal of the 2015 Rule. In this 

SNPRM, the agencies reiterate that this 

regulatory action is intended to 

permanently repeal the 2015 Rule in its 

entirety, and we invite all interested 

persons to comment on whether the 

2015 Rule should be repealed. 


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