0813 SS Part A for NFL SS Final Rules 2016

Food Labeling: Nutrition Facts and Supplement Facts Label and
Reference Amounts Customarily Consumed Per Eating Occasion
RIN 0910-AF22 and RIN 0910-AF23
OMB Control No. 0910-NEW
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 403(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA) specifies certain nutrients
to be declared in nutrition labeling, and authorizes the Secretary of Health and Human Services
to require other nutrients to be declared if the Secretary determines that a nutrient will provide
information regarding the nutritional value of such food that will assist consumers in maintaining
healthy dietary practices. The Secretary also has discretion under section 403(q) of the FFDCA
to remove, by regulation and under certain circumstances, nutrient information that is otherwise
explicitly required in food labeling under this section. To provide updated nutrition information
on food labels and improve how nutrition information is presented to consumers, the Food and
Drug Administration (FDA, we, or us) has undertaken rulemaking to revise the Nutrition Facts
and Supplement Facts labels. We have also promulgated regulations that establish standards to
define serving size and requires that certain products provide additional information within the
Nutrition Facts label that conveys that information to consumers. We have issued these final
rules based on current scientific evidence, dietary recommendations of most recent consensus
reports, and public comments received in response to proposed rulemaking. We have also taken
these actions consistent with current data on the associations between nutrients and chronic
diseases, health-related conditions, physiological endpoints, and/or maintaining a healthy dietary
pattern that reflects current public health conditions in the United States.
Specifically, we have amended the regulations at 21 CFR 101.9, 101.12, and 101.36 where
revision to 21 CFR 101.9 and 101.36 updates the list of nutrients that are required or permitted to
be declared; provides updated Daily Reference Values and Reference Daily Intake values that
are based on current dietary recommendations from consensus reports; amends requirements for
foods represented or purported to be specifically for children under the age of 4 years and
pregnant and lactating women and establishes nutrient reference values specifically for these
population subgroups; and revises the format and appearance of the Nutrition Facts label.
Revisions to 21 CFR 101.12 define a single-serving container; require dual-column labeling for
certain containers; update, modify, and establish several reference amounts customarily
consumed (RACCs); amend the label serving size for breath mints; and make technical
amendments to various aspects of the serving size regulations.
We therefore request approval of the information collection provisions set forth in the final rules
entitled: “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” and “Food
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion;
Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts
Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments”

2. Purpose and Use of the Information Collection
FDA believes that the information collection provisions associated with the revisions to the
Nutrition and Supplement Facts labels are necessary because analytical methods are not available
that would allow us to verify labeling declarations and consumers rely on this information to
make healthy dietary choices. Because of the increased prevalence of obesity and diabetes and
high rates of chronic diseases such as heart disease and stroke in the United States, treatment and
prevention of these diseases has become a major public health concern and a national priority.
FDA believes that the information collection provisions associated with the rulemaking better
aligns the information provided in the Nutrition Facts label with new data on consumption,
dietary recommendations, and scientific evidence on the relationship between nutrition and
chronic disease; improves the design and content of the Nutrition Facts label to make relevant
label information more salient and easy to understand so that consumers may make more
informed decisions; and potentially prompts industry to reformulate products to maintain health
and nutrient content claims. We believe also that the information collection provisions
associated with reference amounts customarily consumed per eating occasion, breath mints, and
other technical amendments of the applicable regulations will better inform consumers who
purchase these food products.
3. Use of Improved Information Technology and Burden Reduction
While the rulemaking does not require the use of electronic reporting or recordkeeping, we
encourage this approach and believe respondents currently utilize information technology to
satisfy information collection provisions required under other Federal regulations regarding the
labeling and manufacture of food and its delivery or introduction for delivery into interstate
commerce. Similarly, we expect that third-party disclosure provisions imposed by the
rulemaking will be addressed through automated labeling processes currently employed by
respondents to the collection of information.
4. Efforts to Identify Duplication and Use of Similar Information
Information about the nutrient content of foods is mandated under the Nutrition Labeling and
Education Act (NLEA) of 1990 and the Dietary Supplement Health and Education Act of 1994
(DSHEA). We believe the information collection requirements under the rulemaking are
consistent with these statutory authorities in conjunction with authority under the FFDCA and
we are unaware of any duplicative collection requirements.
5. Impact on Small Businesses or Other Small Entities
We estimate approximately 98 percent of respondents are small businesses. Exemption
provisions that currently exists for some small businesses and specific products will continue to
apply under the rulemaking. Currently, we allow certain small businesses whose products do not
sell more than 100,000 units to apply for a labeling exemption for that particular product. Such
an exemption is granted for 12 months (on a per product basis) and the business has the option to
re-apply for a continuation of this exemption.

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6. Consequences of Collecting the Information Less Frequently
The rulemaking requires that manufacturers make and keep records to verify the following
declarations: added sugars, when a food product contains both naturally-occurring sugars and
added sugars, and for specific foods containing added sugars, alone or in combination with
naturally-occurring sugars, where the added sugars are subject to fermentation; isolated or
synthetic non-digestible carbohydrates that do not meet the proposed definition of dietary fiber;
different forms of vitamin E; and, folate/folic acid. The rulemaking also requires manufacturers
to maintain the records to verify the label declaration of the aforementioned nutrients for a period
of two years after introduction or delivery for introduction of the food into interstate commerce.
Such records must be provided to FDA upon request, during an inspection, for official review
and photocopying or other means of reproduction, and that records required may be retained
either as original records, true copies (such as photocopies, pictures, scanned copies, microfilm,
microfiche, or other accurate reproductions of the original records) or electronic records. Where
reduction techniques such as microfilming are used, suitable reader and photocopying equipment
would need to be readily available. We believe these information collection requirements
impose minimum burden to respondents while consistent with statutory requirements under the
NLEA, DSHEA, and FFDCA. Finally, to ensure necessary third-party disclosures to consumers,
we believe the requirements of the rulemaking represent minimal burden to respondents.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In the Federal Register of March 3, 2014, we published the proposed rule entitled, “Food
Labeling: Revision of the Nutrition and Supplement Facts Labels” (79 FR 11879), and the
proposed rule entitled, “Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints;
and Technical Amendments” (79 FR 11989) to solicit public comment on revisions to FDA
regulations. At the same time, we also solicited public comment on the associated information
collection provisions in accordance with 5 CFR 1320.8(d). In the Federal Register of July 27,
2015, we again sought public comment regarding certain limited additional provisions of
revisions in a supplemental notice of proposed rulemaking (80 FR 44303), and again solicited
comment on the associated information collection.
Comments in response to the rulemaking may be found under docket nos. FDA-2012-N-1210
and FDA-2004-N-0258 and are discussed in the agency’s final rules published on May 27, 2016
in the Federal Register. As finalized, we believe the rulemaking imposes minimal burden on
respondents while ensuring that necessary nutrition information is conveyed to consumers.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
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10. Assurance of Confidentiality Provided to Respondents
Records that may be reviewed during FDA inspections are subject to FDA regulations in 21 CFR
Part 20. Confidential commercial information is protected from disclosure under FOIA in
accordance with section 552(a) and (b) (5 U.S.C. 552(a) and (b)) and by part 20. To the extent
that § 20.64 applies, we will honor the confidentiality of any data in investigation records
compiled for law enforcement purposes.
11. Justification for Sensitive Questions
The information collection does not contain questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: Respondents to the information collection are manufacturers of
retail food products marketed in the United States.
We estimate the burden associated with the information collection below. Upon reexamination
of data we have reduced the number of respondents identified in our proposed rulemaking but
retain our previous hourly burden estimates. Specific calculations are discussed more fully and
may be found in the agency’s Final Regulatory Impact Analysis (FRIA) under docket nos. FDA2012-N-1210 and FDA-2004-N-0258 and available on the internet at
http://www.fda.gov/aboutfda/reportsmanualsforms/reports/economicanalyses/default.htm
Recordkeeping
We require that firms make and keep certain records necessary to verify the amount of the
nutrients in the finished food product. The Nutrition Facts label rule does not specify what
records must be used to verify the amounts of these nutrients, but does specify the information
that the records must contain. The Nutrition Facts label rule requires manufacturers to, upon
request during an inspection, provide FDA with the records that contain the required information
for each of these nutrients to verify the amount of the nutrient declared on the product label.
These records may include analyses of nutrient databases, recipes or formulations, information
from recipes or formulations, batch records, or any other records that contain the required
information to verify the nutrient content in the final product.
Table 1 – Estimated Annual Recordkeeping Burden1
Type of Declaration;
21 CFR Section

Added Sugars;
101.9(c)(6)(iii)2
Dietary Fiber;
101.9(c)(6)(i)2
Soluble Fiber;
101.9(c)(6)(i)(A)2

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Avg. Burden per
Recordkeeping

Total
Hours

31,283

1

31,283

1

31,283

31,283

1

31,283

1

31,283

31,283

1

31,283

1

31,283

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Type of Declaration;
21 CFR Section

Insoluble Fiber;
101.9(c)(6)(i)(B)2
Vitamin E ;
101.9(c)(8)3
Folate/Folic
Acid/101.9(c)(8)3
New Products
TOTAL

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Avg. Burden per
Recordkeeping

Total
Hours

31,283

1

31,283

1

31,283

31,283

1

31,283

1

31,283

31,283

1

31,283

1

31,283

216

1

216

1

216
187,914

1

There are no capital costs or operating and maintenance costs associated with this collection of information. Hours are
annualized over 3 years.
2
These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars,
dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and
naturally occurring sugars, added sugars that undergo fermentation in certain fermented foods, and products with nondigestible carbohydrates (soluble or insoluble) that do and do not meet the definition of dietary fiber.
3
These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and
folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is
being made or these nutrients are directly added to the food for enrichment purposes.

Based on our experience with food labeling regulations, we believe that the new records that
would be required to be retained are records that a prudent and responsible manufacturer uses
and retains as a normal part of doing business, e.g., analyses of nutrient databases, recipes or
formulations, batch records, or other records. Thus, the recordkeeping burden of the rulemaking
consists of the time required to identify and assemble the records for copying and retention.
Based on our previous experience with similar information collection, we estimate the
recordkeeping burden of the Nutrition Facts Label rule to be 1 hour per product as estimated in
Table 1.
Under the Nutrition Facts label rule, the declarations for added sugars, dietary fiber, soluble
fiber, and insoluble fiber are mandatory, and we conservatively estimate that all roughly 31,283
food manufacturers would incur this recordkeeping burden and that the required recordkeeping
would be 1 hour per manufacturer. These calculations are reflected in Table 1, rows 1-4. The
declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content
claim is being made or these nutrients are directly added to the food for enrichment purposes.
However, we conservatively estimate that all 31,283 respondents food would incur this
recordkeeping burden and that the required recordkeeping would be 1 hour per manufacturer.
These calculations are reflected in Table 1, rows 5 and 6.
It is hard to predict with certainty the exact number of newly introduced products that would be
covered under the Nutrition Facts label rule each year, but based on the industry growth rate
using U.S. Census Bureau Business and Industry data, we estimate that number to be 216. Thus,
we estimate that 216 new products would be affected by the Nutrition Facts Label rule, and that
the required recordkeeping would be 1 hour per product, for an annual recurring recordkeeping
burden of 216 hours (216 × 1), as reflected in Table 1, row 7. Adding the burden from new
products to the burden for existing products results in a total of 187,914 burden hours and annual
records.

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Reporting
Table 2 – Estimated Annual Reporting Burden1
Filing of citizen petition Regarding
to a particular isolated or synthetic
non-digestible carbohydrate
Dietary Fiber; 101.9(c)(6)(i)
1

No. of
Respondents

No. of
Responses per
Respondent
1

28

Total
Annual
Responses
28

Avg.
Burden per
Response
1

Total
Hours
28

There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate that there are approximately 28 isolated or synthetic non-digestible carbohydrates
that do not meet the definition of dietary fiber. Once a citizen petition filed by a manufacturer
related to a particular isolated or synthetic non-digestible carbohydrate is granted or denied, or
the carbohydrate is the subject of an authorized health claim, and the dietary fiber is listed in the
definition of dietary fiber, the use of the dietary fiber as an ingredient in any food product must
be included in the total amount of dietary fiber declared in nutrition labeling for such product.
Thus, we estimate that 28 manufacturers would incur a recordkeeping burden associated with
filing a citizen petition to amend the listing of dietary fiber related to an isolated and synthetic
non-digestible carbohydrate that is not currently listed in the definition of dietary fiber and that
the required recordkeeping would be 1 hour per manufacturer. This calculation is reported in
Table 2.
Third-Party Disclosure
Table 2.--Estimated Annual Third-Party Disclosure Burden1
Labeling
Modifications
of …

No. of
Respondents

No. of
Disclosures
per
Respondent

Total Annual
Disclosures

Average
Burden per
Disclosure

Total
Hours

NFL/SSL
31,283
26
813,358
2 1,626,716
Serving Size
13,452
25
336,300
2
672,600
New Products
500
1
500
2
1,000
TOTAL
1,150,158
2,300,316
1
There are no operating and maintenance costs associated with this collection of information.

Total
Capital
Costs (in
billions of
2014$)
$2.47
$1.00
$0.01
$3.48

We calculate a third-party burden associated with the Nutrition Facts Label rule to account for
the need by food manufacturers to revise their nutrition labels. We estimate 2 hours per
disclosure for a total burden of 1,626,716 hours. The incremental time burden for reviewing
labels to assess how to bring them into compliance with the requirements of the Nutrition Facts
label is estimated to be 1 hour per label. These requirements reflect a one-time burden attributed
to revision of the label because establishments must already print packaging for food products as
part of normal business practices, and must disclose required nutrition information under food
labeling regulations. Upon implementation of the rule we expect this burden to have been
realized. We calculate each label redesign would require 1 additional hour, making the total 2
burden hours per UPC. We estimate 31,283 manufacturers representing 813,358 UPCs, with an
average disclosure of 26 labels annually (813,358/31,283), would be covered under the Nutrition
Facts label rule. Based on the RIA, we have estimated the capital cost to be $2.47 billion
(2014$). This information is reflected in Table 3, row 1.
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Under §§ 101.9 and 101.12, some manufacturers of retail food products will need to make
labeling changes to modify the serving sizes and other nutrition information based on changes to
what products may be or are required to be labeled as a single serving, or based on updated,
modified, or established RACCs. Additionally, some manufacturers will need to change product
labels to add a second column of nutrition information per package or per discrete unit as part of
the Nutrition Facts label. The third-party disclosure burden consists of the setup time required to
design a revised label and incorporate it into the manufacturing process. This burden is reflected
in Table 3, row 2. Based upon our knowledge of food labeling, we estimate that the affected
manufacturers would require 2 hours per product to modify the label’s Nutrition Facts panel. We
estimate that it will take an affected manufacturer 1 hour to review a label to assess how to bring
it into compliance with the new requirements. We estimate each label redesign will require 1
additional hour per UPC, for a total of 2 hours per UPC. We estimate 13,452 manufacturers will
initially be affected by the rulemaking and that 336,300 products will initially be required to be
relabeled, for an average of 25 (336,300/13,452) products annually per respondent. Based on the
RIA, we estimate the initial capital cost to be $1 billion (2014$). These calculations are reflected
in Table 3, row 2.
Finally, the rulemaking generates recurring burdens related to the requirement that some
manufacturers undertake an extensive label change due to the effect of the changed definition of
a single-serving container on the permissibility of certain health and nutrient content claims, and
also to the requirement that some manufacturers undertake a major redesign of their labels to
include a Nutrition Facts Panel that had not previously been required. We estimate that about
500 new products will be affected by these requirements each year, and that associated the
disclosure burden is 2 hours per product, for an annual burden of 1,000 hours. Based on the
RIA, we estimate the annual recurring capital cost to be approximately $0.01 billion (2014$).
These calculations are reflected in Table 3, row 3.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs associated with the information collection.
14. Annualized Cost to the Federal Government
FDA’s review of the retained records would generally occur as part of its routine inspection
activities. Based on internal data, we estimate the current cost of labeling enforcement efforts to
be roughly $1.3 million per year (2014$), and we do not expect a significant increase in such
efforts as a result of the rulemaking.
15. Explanation for Program Changes or Adjustments
While this is a new information collection, upon implementation of the rulemaking we expect to
consolidate the burden under OMB Control No. 0910-0381 (Food Labeling Regulations).
16. Plans for Tabulation and Publication and Project Time Schedule
These information collection requirements will not be published, tabulated or manipulated.
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17. Reason(s) Display of OMB Expiration Date Is Inappropriate
We are not seeking approval not to display the expiration date for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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