
[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59129-59131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 100, 101, and 104

[Docket No. FDA-2016-N-0011]


Food Labeling; Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
food labeling regulations by redesignating a provision, updating any 
references to that provision to reflect the redesignation, and revising 
the section heading. The rule does not alter the content or application 
of the redesignated provision in any substantive manner. This action is 
editorial in nature and is intended to provide clarity and consistency 
to our regulations.

[[Page 59130]]


DATES: This rule is effective August 29, 2016.

FOR FURTHER INFORMATION CONTACT: Carole Adler, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1451 et seq.) 
requires certain consumer commodities sold in interstate commerce to be 
honestly and informatively labeled to facilitate value comparisons and 
enable consumers to make informed choices. FDA administers and enforces 
the FPLA with respect to drugs, cosmetics, medical devices, and certain 
foods. Pursuant to our authority under FPLA, FDA issued certain food 
labeling regulations, including specifications regarding the statement 
of identity and the net quantity of contents statement, which must be 
present on the labels of most packaged foods. Our regulations affecting 
the declaration of a food product's net quantity of contents are 
currently located in Sec.  101.105 (21 CFR 101.105). Section 101.105 
specifies how the net quantity of contents must be expressed on the 
package, including the required units of measurement, wording, 
typeface, and size to be used in the declaration, as well as the 
location of the declaration on the label or package. Currently, Sec.  
101.105 requires that the units of measurement be expressed using the 
most appropriate units of the customary inch/pound (avoirdupois) system 
carried out to not more than two decimal places, as applicable.
    In the Federal Register of May 21, 1993 (58 FR 29716), we proposed 
to amend our food labeling regulations to require that the net quantity 
of contents declaration be expressed using the most appropriate units 
of both imperial units (inches/pounds) and the metric system 
(International System of Units (SI)). The rule also proposed to provide 
examples of the quantity of contents declaration, include the SI 
equivalents to the avoirdupois terms used in the regulation, provide a 
specific conversion chart for use in calculating the conversion between 
the two systems of measurement, include SI terminology, provide 
exemptions from SI labeling requirements, permit the expression of the 
net quantity of contents to be carried out up to three decimal places, 
and make the SI declaration of the net quantity of contents on random 
weight packages optional. Additionally, the rule proposed certain 
technical amendments, including redesignating Sec.  101.105 as new 
Sec.  101.7, revising the section heading to correct the title of the 
section, and making other editorial changes to the net quantity of 
contents regulations. In the Federal Register of April 22, 2003 (68 FR 
19766), we announced our intent to withdraw the proposed rule, along 
with several other unrelated proposed actions that had been published 
more than 5 years before the withdrawal, but never finalized. The 
withdrawal was part of an overall regulatory reform initiative to 
reduce our regulatory backlog and focus our resources on higher 
priority regulations.
    Through this final rule, we are making some of the same technical 
amendments to the declaration of net contents provision that were 
proposed in 1993. However, we are not proposing at this time to 
reinstitute rulemaking proceedings concerning the remaining amendments 
proposed in 1993, such as those pertaining to the declaration of net 
quantity in SI units or those modifying the expression of net quantity 
in decimal fractions.

II. Provisions of Technical Amendments

    We are making technical amendments in our regulations at parts 1, 
100, 101, and 104 (21 CFR parts 1, 100, 101, and 104) to redesignate 
Sec.  101.105 as new Sec.  101.7, update references in other provisions 
to reflect this redesignation, and revise the section heading of the 
redesignated provision. Nothing in these technical amendments is to be 
construed as modifying the applicability of the current regulations 
affecting the declaration of net quantity of contents.

A. Redesignation

    FDA is amending the food labeling provisions in Sec.  101.105 by 
redesignating Sec.  101.105 as new Sec.  101.7. Section 101.105 is 
currently located in part 101, subpart G, which is entitled 
``Exemptions From Food Labeling Requirements.'' However, Sec.  101.105 
contains no information pertaining to when a food is exempt from a 
declaration of the net quantity of contents. Instead, Sec.  101.105 
establishes general provisions for the declaration of the statement of 
net quantity of contents on the labels of most packaged foods. By 
redesignating Sec.  101.105 as new Sec.  101.7, we are moving the 
provision to subpart A, entitled ``General Provisions.'' Subpart A 
provides general food labeling regulations and is a more appropriate 
location for a provision regulating the declaration of net quantity of 
contents.

B. Revising Section Heading

    We also are revising the section heading of new Sec.  101.7 to 
read: ``Declaration of net quantity of contents'' instead of 
``Declaration of net quantity of contents when exempt.'' The revised 
heading, by removing any reference to exemptions, is more reflective of 
the section's general provisions for the declaration of the statement 
of net quantity of contents on all food labels. The revised heading 
does not alter the substance of the provision.

C. Revising References

    Several existing regulations refer to Sec.  101.105. Therefore, 
because we are redesignating Sec.  101.105 as a new Sec.  101.7, we are 
making corresponding editorial changes to reflect the redesignation in 
parts 1, 100, 101, and 104. These corresponding changes replace any 
mention of Sec.  101.105 with Sec.  101.7.

III. Notice and Public Comment

    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because these 
amendments are nonsubstantive and provide only technical changes to 
redesignate an existing regulation, make corresponding changes to other 
regulations to reflect the redesignated section number, and make an 
editorial change to the section heading. These technical amendments are 
being made to improve the accuracy of our regulations.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 100

    Administrative practice and procedure, Food labeling, Food 
packaging, Foods, Intergovernmental relations.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 104

    Food grades and standards, Frozen foods, Nutrition.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, the Food and 
Drug Administration amends 21 CFR parts 1, 100, 101, and 104 as 
follows:

[[Page 59131]]

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343, 
350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 
371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 
243, 262, 264.


Sec.  1.1 [Amended]  

0
2. Amend Sec.  1.1(c) as follows:
0
a. Remove ``101.105(f)'' and add in its place ``101.7(f)''.
0
b. Remove ``101.105(i)'' and add in its place ``101.7(i)''.
0
c. Remove ``101.105(j)'' and add in its place ``101.7(j)''.
0
d. Remove ``101.105(o)'' and add in its place ``101.7(o)''.


Sec.  1.20   [Amended]

0
3. In Sec.  1.20, by removing ``Sec.  101.105(f)'' and adding in its 
place ``Sec.  101.7(f)''.


Sec.  1.24   [Amended]

0
4. Amend Sec.  1.24 as follows:
0
a. Remove ``Sec.  101.105'' in paragraph (a)(2) and add in its place 
``Sec.  101.7''.
0
b. Remove ``Sec.  101.105(b)(2)'' wherever it appears and add in its 
place ``Sec.  101.7(b)(2)''.
0
c. Remove ``Sec.  101.105(f)'' wherever it appears and add in its place 
``Sec.  101.7(f)''.
0
d. Remove ``Sec.  101.105(j)'' wherever it appears and add in its place 
``Sec.  101.7(j)''.
0
e. Remove ``Sec.  101.105(j)(1)'' wherever it appears and add in its 
place ``Sec.  101.7(j)(1)''.

PART 100--GENERAL

0
5. The authority citation for part 100 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 337, 342, 343, 348, 371.


Sec.  100.155  [Amended]

0
6. Amend Sec.  100.155 in paragraphs (a) and (b) by removing ``Sec.  
101.105'' and adding in its place ``Sec.  101.7''.

PART 101--FOOD LABELING

0
7. 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.


Sec.  101.2 [Amended]  

0
8. Amend Sec.  101.2 in paragraph (c) introductory text by removing 
``Sec.  101.105(h)(1)'' and adding in its place ``Sec.  101.7(h)(1)''.


Sec.  101.105   [Redesignated as Sec.  101.7]

0
9. Redesignate Sec.  101.105 as Sec.  101.7.

0
10. Revise newly designated Sec.  101.7 section heading to read as 
follows:


Sec.  101.7  Declaration of net quantity of contents.

* * * * *


Sec.  101.13   [Amended]

0
11. Amend paragraphs (d)(2), (h)(4)(i), and (i)(2) by removing ``Sec.  
101.105(i)'' and adding in its place ``Sec.  101.7(i)''.


Sec.  101.30   [Amended]

0
12. Amend Sec.  101.30(g) by removing ``Sec.  101.105(i)'' and adding 
in its place ``Sec.  101.7(i)''.

PART 104--NUTRITIONAL QUALITY GUIDELINES FOR FOODS

0
13. The authority citation for part 104 continues to read as follows:

    Authority:  21 U.S.C. 321, 343, 371(a).


Sec.  104.5   [Amended]

0
14. Amend Sec.  104.5(b) by removing ``Sec.  101.105'' and adding in 
its place ``Sec.  101.7''.

    Dated: August 16, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19925 Filed 8-26-16; 8:45 am]
 BILLING CODE 4164-01-P


