determine compliance have decreased. Therefore, because we do not have
a basis to change the level of variance permitted for the label
declaration of nutrients, we decline to revise the rule as suggested by
the comment.
2. Methods Used To Determine Compliance
    Under our preexisting regulations, at Sec.  101.9(g)(2), a
composite of 12 subsamples, each taken from 12 different randomly
chosen shipping cases are analyzed by appropriate methods as given in
the ``Official Methods of Analysis of the AOAC International,'' 15th
Ed. (1990) to determine compliance with the requirements in Sec.
101.9, unless a particular method of analysis is specified in Sec.
101.9(c). If no AOAC method is available or appropriate, we use other
reliable and appropriate analytical procedures (see Sec.  101.9(g)(2)).
    The proposed rule would amend Sec.  101.9(g)(2) to update the
reference to the 19th Edition of the ``Official Methods of Analysis of
the AOAC International.'' The preamble to the proposed rule (79 FR
11879 at 11913) explained that the 19th edition published in 2012 and
that if a newer edition were published before we issued a final rule,
we intended to finalize the rule to refer to the newer edition provided
there are no substantive changes in the newer edition requiring
additional comment. The Official Methods of Analysis of AOAC
International, 20th Edition was

published in 2016. The 20th Edition includes a number of new methods of
analysis as well as changes to current methods. We need additional time
to consider the additions and changes, and to determine if additional
public comment is necessary on the 20th Edition of the AOAC Methods of
Analysis. Therefore, the final rule, at Sec.  101.9(g)(2), incorporates
by reference the 19th Edition of the Official Methods of Analysis of
the AOAC International.
    (Comment 522) Some comments supported incorporating the 19th
Edition of the AOAC Methods by reference in the final rule. Other
comments suggested other alternatives. Some comments suggested that a
specific edition of the AOAC Methods should not be incorporated by
reference to allow companies to use future editions of the reference to
meet compliance requirements. One comment stated that, given the
potential limitations of the two AOAC methods for fiber identified in
the proposed rule (AOAC 2009.01 and AOAC 2011.25) and the inevitable
delays between adoption by AOAC of the most relevant, updated, and
appropriate methods, we should incorporate all appropriate, equivalent,
and validated methods into the final rule.
    (Response) We decline to revise the rule to adopt the alternative
approaches suggested by the comments. We note that, under the
incorporation by reference regulations issued by the Office of the
Federal Register, incorporation by reference of publication is limited
to a specific edition and ``future amendments or revisions of the
publication are not included'' (1 CFR 51.1(f)). Thus, under Federal
regulations, we cannot incorporate by reference a specific AOAC method
and all future editions of that method.
    (Comment 523) Some comments questioned what we mean by ``equivalent
AOAC method,'' and whether the terms mean that any other AOAC method is
acceptable for determining fiber content.
    (Response) We used the terminology ``equivalent AOAC method'' to
mean a reliable and appropriate method which can be used for measuring
dietary fiber, soluble fiber, and insoluble fiber. For example, the
definition of dietary fiber requires that the fiber must contain 3 or
more monomeric units. We would consider a reliable and appropriate
method for dietary fiber to be one that can measure fibers with 3 or
more monomeric units.
    (Comment 524) Several comments suggested that AOAC 2009.01 and AOAC
2011.25 do not capture all dietary fibers. Many comments recommended
that we allow for the use of all validated AOAC methods for the
determination of dietary fiber. (We discuss issues related to AOAC
methods in greater detail in our response to comment 299.)
    (Response) In proposed Sec.  101.9(c)(6)(i), we stated that dietary
fiber content may be determined by subtracting the amount of non-
digestible carbohydrates added during processing that do not meet the
definition of dietary fiber from the value obtained using AOAC 2009.01,
AOAC 2011.25, or an equivalent method of analysis given in the 19th
edition of the AOAC methods. We stated, in proposed Sec.
101.9(c)(6)(i)(A), that soluble fiber may be determined using AOAC
2011.25 or an equivalent method of analysis as given in the 19th
edition of the AOAC Methods and stated, in proposed Sec.
101.9(c)(6)(i)(B), that insoluble fiber may be determined using AOAC
2011.25 or an equivalent method of analysis given in the 19th edition
of the AOAC Methods. Although we intended that the terms ``other
equivalent methods'' refer to other AOAC methods and their AACCI
counterparts, to provide clarification, the final rule omits the
incorporation by reference of the specific AOAC methods in Sec.
101.9(c)(6)(i), (c)(6)(i)(A), and (c)(6)(i)(B). Any dietary fiber
declared on the label would have to meet the new definition of dietary
fiber and manufacturers can measure the amount of dietary fibers in
their product accurately by using a method that can measure lower
molecular weight nondigestible oligosaccharides with DP 3-9. We would
determine compliance by using appropriate methods, as given in the
``Official Methods of Analysis of the AOAC International,'' 19th Ed.
(2012). We consider AOAC 2009.01 and AOAC 2011.25 to be reliable and
appropriate methods to measure the amount of dietary fiber in a serving
of a product. We consider AOAC 2011.25, as given in the ``Official
Methods of Analysis of the AOAC International,'' 19th Ed. (2012), to be
a reliable and appropriate method to measure the amount of soluble and
insoluble fiber in a serving of a product, if separately declared.
There may be other methods which manufacturers may use to measure
certain fibers which can provide an accurate and consistent result. We
will consider the method to use for purposes of determining compliance
consistent with Sec.  101.9(g).
3. Records Requirements
    Our preexisting regulations, at Sec.  101.9(g)(2), set forth
requirements for composite sampling and analysis to determine
compliance with labeling declarations. Specifically, unless a specific
analytical method is identified by regulation, composites are analyzed
by the appropriate AOAC method or, if no AOAC method is available or
appropriate, by other reliable and appropriate analytical procedures.
    In the preamble to the proposed rule (79 FR 11879 at 11956), we
noted that, for certain nutrients subject to the proposed rule, there
is no AOAC official method of analysis or other reliable or appropriate
analytical procedure that is available for us to verify the amount of
the declared nutrient on the Nutrition Facts label and ensure that the
declared nutrient amount is truthful, accurate and complies with all
applicable labeling requirements. The preamble to the proposed rule (79
FR 11879 at 11956) stated that there is no suitable analytical
procedure available to measure the quantity of: (1) 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 non-enzymatic browning and/or fermentation); (2) dietary
fiber (when a food product contains both non-digestible carbohydrate(s)
that meets the proposed definition of dietary fiber and non-digestible
carbohydrate(s) that does not meet the definition of dietary fiber);
(3) soluble fiber (when a mixture of soluble fiber and added
nondigestible carbohydrate(s) that does not meet the definition of
dietary fiber are present in a food); (4) insoluble fiber (when a
mixture of insoluble fiber and non-digestible carbohydrate(s) that does
not meet the definition of dietary fiber are present in a food); (5)
vitamin E (when a food product contains both RRR- [alpha]-tocopherol
and all rac-[alpha]-tocopherol acetate); and (6) folate (when a food
product contains both folate and folic acid).
    Under our preexisting regulations, at Sec.  101.9(g)(9), we may
permit the use of an alternative means of compliance or additional
exemptions when it is not technologically feasible, or some other
circumstance makes it impracticable, for firms to comply with the
requirements of Sec.  101.9. Under Sec.  101.9(g)(9), firms must submit
a written request to us for the use of an alternative means of
compliance or for a labeling exemption.
    The proposed rule would establish an alternative approach for
assessing compliance of the declared amount of certain nutrients when
there is no suitable analytical method available to measure the
nutrient's quantity as

declared on the label or in labeling. Specifically, the proposed rule,
at proposed Sec.  101.9(g)(10) and (g)(11), would require the
manufacturer to make and keep records that are necessary to verify the
declaration of: (1) The amount of added sugars when both naturally
occurring and added sugars are present in a food (in Sec.
101.9(c)(6)(iii)); (2) the amount of added non-digestible
carbohydrate(s) that does not meet the proposed definition of dietary
fiber when the dietary fiber present in a food is a mixture of non-
digestible carbohydrates that do and that do not meet the definition of
dietary fiber (in Sec.  101.9(c)(6)(i)); (3) the amount of added
soluble non-digestible carbohydrate(s) that does not meet the proposed
definition of dietary fiber when the soluble dietary fiber present in a
food is a mixture of soluble non-digestible carbohydrates that do and
that do not meet the definition of dietary fiber (in Sec.
101.9(c)(6)(i)(A)); (4) the amount of added insoluble non-digestible
carbohydrate(s) that does not meet the proposed definition of dietary
fiber when the insoluble dietary fiber present in a food is a mixture
of insoluble non-digestible carbohydrates that do and that do not meet
the definition of dietary fiber (in Sec.  101.9(c)(6)(i)(B)); (5) the
amount of all rac-[alpha]-tocopherol acetate added to the food and RRR-
[alpha]-tocopherol in the finished food when a mixture of both forms of
vitamin E are present in a food (in Sec.  101.9(g)(10)(i)); and (6) and
the amount of folic acid added to the food and the amount of folate in
the finished food when a mixture of both forms are present in a food
(in Sec.  101.9(g)(10)(ii)). In the preamble to the proposed rule (79
FR 11879 at 11956), we explained that the manufacturer is in the best
position to know which of its records provide the documentation
required under the circumstances described for us to determine
compliance. These records could include one or more of the following:
Analyses of databases, recipes or formulations, or batch records. We
stated that most manufacturers should already have the type of records
needed to validate the declared amount of these nutrients and that the
proposed records requirements provide flexibility in what records the
manufacturer makes available to us to verify the declared amount of
these nutrients for a particular marketed product (id.).
    The proposed rule, at proposed Sec.  101.9(g)(11), also would
require that records be kept for a period of 2 years after introduction
or delivery for introduction of the food into interstate commerce and
that such records be provided to us upon request during an inspection
for official review and copying or other means of reproduction. The
proposed rule also stated that records could be kept 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 in accordance with 21 CFR part 11.
    (Comment 525) Many comments agreed with the proposed recordkeeping
requirements. However, other comments objected to the proposed
recordkeeping requirements. Some comments said that our compliance
program for nutrition labeling should be based on the validation of
nutrient declarations through analytical methods and not through
recordkeeping. Other comments said that compliance should be based on
objective, analytical measures to yield consistent labeling practices
across the food industry. Others comments said that the proposed
recordkeeping requirements could invite unethical manufacturers to
provide inaccurate information about the quantity of nutrients in a
serving of their product.
    (Response) As discussed in the preamble to the proposed rule (79 FR
11879 at 11956), for certain nutrients, there are no official methods
of analysis or other reliable or appropriate analytical procedures that
are available to verify the amount of the declared nutrient on the
Nutrition Facts label. In the absence of such methods, there needs to
be some means for determining compliance, and so we proposed
recordkeeping as an alternative approach for assessing compliance of
the declared amount of certain nutrients. While the amount of most
other nutrients in Nutrition Facts can be verified analytically, for
those nutrients whose amounts cannot be determined analytically,
recordkeeping enables FDA to determine compliance with Sec.  101.9(g).
Regarding the potential for encouraging manufacturers to provide
inaccurate information to FDA, we note that all nutrient declarations
must be truthful and not misleading under sections 403(a)(1) and 201(n)
of the FD&C Act. Thus, whether determined analytically or through
calculations documented in appropriate records, manufacturers are
obligated to provide nutrient information that is not false or
misleading.
    (Comment 526) Several comments said that it would be very difficult
to obtain and retain the information required by FDA. Some comments
noted that the number of product formulations can be greater than
20,000 for certain manufacturers and that they would need to create
systems and dedicate additional resources to create and maintain
appropriate records on a large scale. Other comments said that
manufacturers typically get ingredients from suppliers in an extensive
supply chain and that many ingredients also contain multiple
ingredients themselves. Suppliers may not have the information
themselves, or the information for the formulations could be
proprietary. Additionally, nutrient information could be provided in
ranges, and manufacturers would be unable to determine or verify the
specific amounts of certain nutrients analytically.
    (Response) Although some manufacturers could have a large number of
foods that contain nutrients that would necessitate recordkeeping to
verify amounts, we do not agree that determining the nutrient
composition of a food and recording that information would present
undue difficulty for manufacturers. On the contrary, knowledge of what
ingredients and nutrients are in a food and providing that information
truthfully to consumers is a basic requirement for food producers.
Manufacturers, even those who produce large amounts of food products,
have experience with determining nutrient content of the food they
produce, and the maintenance of records of nutrient content, either
written or electronic. Regarding obtaining information from ingredient
suppliers, manufacturers are well suited to work with suppliers to
ensure that proper information is communicated throughout the supply
chain. Ingredient suppliers are obliged to have knowledge of the
contents of ingredients they provide to food manufacturers and this
information will need to be properly communicated. Manufacturers may be
able to choose suppliers that provide appropriate information as to the
contents of their ingredients or be able to ask their ingredient
suppliers for nutrient information.
    (Comment 527) Some comments suggested that the required approach
should be flexible and not mandate a specific type of record. The
comments indicated that manufacturers should be able to substantiate
using the records they believe best accomplish the validity of nutrient
information. The comments stated that we did not need access to
manufacturing records and that other methods, such as database
information or an explanation from a manufacturer, would suffice.
    (Response) Manufacturers will be responsible for the type of
records they maintain and are not required to

produce any specific form or document for verification purposes.
Records used to verify nutrient content could include various types of
batch records providing data on the weight of certain nutrient
contributions to the total batch, records of test results conducted by
the manufacturer or an ingredient supplier, certificates of analysis
from suppliers subject to initial and periodic qualification of the
supplier by the manufacturer, or other appropriate verification
documentation that provide the needed assurance that a manufacturer has
adequately ensured the food or ingredients comply with labeling
requirements. The records submitted for inspection by FDA would only
need to provide information on the nutrient(s) in question. Information
about other nutrients can be redacted if necessary to ensure
confidentiality of a food product formulation.
    (Comment 528) Several comments addressed our legal authority to
require recordkeeping as described in the proposed rule.
    (Response) We address these comments in part II.C.4.
    (Comment 529) Some comments expressed concern that proprietary
information in recipes and formulations could be divulged and said that
the ability to retain and claim the proprietary nature of product
formulations is essential to staying competitive in the marketplace.
Other comments suggested that we clarify that the recordkeeping
requirements will not require access to proprietary information, such
as recipes and formulations. In addition, the comments recommended that
we specify what level of information and types of documents are
required to meet the recordkeeping requirements. Several comments
requested that manufacturers be permitted to develop a stand-alone
document that articulates the basis for the declaration of added sugars
in a product. Other comments recommended that, if we finalize the
recordkeeping requirements and require the copying of records, we
address the security of the information coming from inspections and the
protection of confidential information.
    (Response) The final rule does not require a specific document to
be retained nor does it require information on proprietary recipes or
overall formulations. Instead, the recordkeeping requirements seek
specific content information for certain nutrients, and this
information can be provided in various forms. For example, information
in some batch records could include data on the total batch weight of
the production of a particular food and also provide data on the weight
of certain nutrient contributions to the total batch. With these types
of data, calculations can be made to determine nutrient content for
individual foods or servings of a food. Documentation of this type
would not reveal any proprietary recipes or formulations and would be
limited to specific nutrient information. Information about the
nutrient content of the ingredients of a food product could be acquired
from ingredient suppliers subject to initial qualification and periodic
requalification by the manufacturer, and this type of information on
quantitative source amounts can be included in the batch records.
    Furthermore, even if a manufacturer's records contained
confidential commercial information or trade secret information or a
manufacturer believes that certain information should be protected from
public disclosure, we note that there are safeguards to protect against
public disclosure of that information and mechanisms that a
manufacturer can use to assert that certain information should be
protected from disclosure. As we stated in the preamble to the proposed
rule (79 FR 11879 at 11957), we would protect confidential information
from disclosure, consistent with applicable statutes and regulations,
including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and part 20 (21 CFR part
20). For example, our regulations pertaining to disclosure of public
information, at part 20, include provisions that protect trade secrets
and commercial or financial information which is privileged or
confidential. If a manufacturer keeps proprietary recipe information in
its records, it should mark the information as such before providing
the records to us upon request.
    (Comment 530) One comment expressed concerns that allowing for
recordkeeping as a way to verify the amount of nutrients such as added
sugar in some products would encourage those manufacturers to provide
false reporting of the added sugar content of their products.
    (Response) We note that having a false declaration on the label is
a violation of section 403(a)(1) of the FD&C Act. Providing false
information in records to the Agency may also be a potential criminal
violation under 18 U.S.C. 1001. Under 18 U.S.C. 1001, whoever, in any
matter within the jurisdiction of the executive, legislative, or
judicial branch of the Government of the United States, knowingly and
willfully: (1) Falsifies, conceals, or covers up by any trick, scheme,
or device a material fact; (2) makes any materially false, fictitious,
or fraudulent statement or representation; or (3) makes or uses any
false writing or document knowing the same to contain any materially
false, fictitious, or fraudulent statement or entry may be subject to a
fine or imprisonment.
    (Comment 531) Some comments disagreed with the proposed requirement
to keep records for at least 2 years after a food's introduction into
interstate commerce. The comments said manufacturers would have to keep
track of an additional data point (the date on which the food is
actually shipped) as opposed to the date on which it is manufactured.
The comments said that shipping dates can vary, even for foods from the
same batches, and could occur months after manufacture, and this could
result in extremely divergent record maintenance timeframes for foods.
    Furthermore, some comments said that is unclear whether the term
``food'' is intended to refer to a particular batch of food or to an
individual food.
    Other comments suggested that 2 years is a long time for foods with
very short shelf lives. Some comments noted that the Seafood Hazard
Analysis and Critical Control Points (HACCP) regulations allow for a 1-
year record retention period for refrigerated products and a 2 year
period for frozen, preserved, or shelf-stable products. The comments
suggested that, similarly, the 2 year requirement for recordkeeping
related to nutrition labeling should be limited to frozen, preserved,
or shelf-stable products and that a shorter period of 1 year should be
allowed for maintenance of records for refrigerated and perishable
foods.
    (Response) We recognize that there can be a wide variation of
manufacturing practices, shipping practices, and shelf lives among
packaged foods. We believe, however, that it is more practical to
establish a single recordkeeping period rather than establish different
recordkeeping periods for different products or for different
manufacturing or shipping practices. It would be more difficult for FDA
to establish a compliance program for one segment of the regulated
industry that starts the recordkeeping process when the food is made
and a different compliance program for another segment of the industry
that starts the recordkeeping process when the food is shipped.
Likewise, for manufacturers who make several food products, it may be
easier for them to use the same recordkeeping period for all products
rather than use different recordkeeping periods for different products.
Therefore, we have designed a

compliance program or strategy that involves a single recordkeeping
period.
    As for the comment asking whether ``food'' referred to a particular
batch or to an individual food, the term food refers to an individual
food item, but there are not specific requirements on what type of
documentation is required. If the same documentation addresses the
declarations on an entire batch of food or an even greater quantity of
food, those records may be sufficient.
    (Comment 532) Some comments suggested that manufacturers should be
allowed to keep records at locations separate from factories (e.g.,
corporate headquarters) and that we allow a reasonable timeframe (e.g.,
72 hours or 15 days) to obtain the records and make them available.
    (Response) Records must be made available to us for examination or
copying during an inspection upon request; this is consistent with our
other recordkeeping regulations (see, e.g., 21 CFR 111.605 and
111.610). The records would need to be reasonably accessible (access to
records within 24 hours can be considered reasonable) to FDA during an
inspection at each manufacturing facility (even if not stored onsite)
to determine whether the food has been manufactured and labeled in
compliance with labeling requirements. Records that can be immediately
retrieved from another location by electronic means are considered
reasonably accessible.
    (Comment 533) Some comments said that the recordkeeping
requirements could present a barrier to trade. They stated that access
to records of manufacturers of imported foods may not be possible
unless reciprocal agreements are in place and that such agreements
could pose a challenge to trade with certain countries.
    (Response) We disagree with the comments. As in the case of
domestic manufacturers, foreign manufacturers of food produced for sale
in the United States must follow all applicable laws and regulations
related to nutrition labeling. The final rule establishes the same
recordkeeping requirements for foreign and domestic firms. To the
extent records are not available during a foreign facility inspection
for imported products, that would certainly inform a determination
about the admissibility of the food.
    (Comment 534) Several comments addressed recordkeeping as it
pertained to added sugars. The comments said the proposed recordkeeping
requirements were overreaching, especially when, according to the
comments, we acknowledged that added sugars do not pose a safety issue
and are not uniquely or directly related to a risk of chronic disease,
a health-related condition, or a physiological endpoint. Some comments
noted that previous FDA recordkeeping requirements involved
pharmaceutical safety or potentially adulterated foods that pose safety
hazards. Some comments stated that we have never required recordkeeping
to support a mandatory disclosure on the Nutrition Facts label that
does not involve risk of disease. A few comments explained that
obtaining added sugar information, in particular, from ingredient
suppliers is difficult because ingredients do not distinguish between
naturally occurring and added sugars and manufacturers are unable to
distinguish them analytically.
    (Response) We recognize that it may be difficult to determine the
quantity of added sugars and intrinsically occurring sugars in a
particular ingredient or food, and we stated this several times in the
preamble to the proposed rule (see 79 FR 11879 at 11905, 11906, and
11956). The recordkeeping requirement, in the absence of an analytical
method that would distinguish between added and intrinsically occurring
sugars in a food, is an alternative means of verifying compliance;
contrary to the comments' statements regarding added sugars and safety
hazards or chronic disease, the recordkeeping requirement was not based
on or otherwise dependent on an independent relationship between added
sugars and chronic disease. Instead, as we stated in the preamble to
the proposed rule (79 FR 11879 at 11956), the information contained in
manufacturers' records is an accurate and practical method for assuring
that the nutrient declarations comply with section 403(q) of the FD&C
Act.
    (Comment 535) Some comments suggested that we extend the
requirement in proposed Sec.  101.9(g)(10)(v) to all foods declaring
added sugar to allow food manufacturers to keep records to demonstrate
the amount of added sugars remaining in the finished food when that
amount is less than the initial amount of added sugars.
    (Response) We decline to revise the rule as suggested by the
comment. Section 101.9(g)(10)(v) states that when the amount of added
sugars is reduced through non-enzymatic browning and/or fermentation,
the manufacturer must make and keep certain data, information, and
records to document the differences in added sugar content between the
unfinished and finished products. Not all foods undergo non-enzymatic
browning and/or fermentation, so extending Sec.  101.9(g)(10)(v) to all
foods is unnecessary.
    (Comment 536) One comment noted that we have described the new
recordkeeping requirement for certain nutrients as analogous. The
comment said that the recordkeeping for added sugars is different than
those for other nutrients, such as fiber, folate, or vitamin E in that
the recordkeeping requirement for added sugars is unavoidable due to
the mandatory nature of the added sugars declaration.
    (Response) The new recordkeeping requirements are analogous based
on the fact that inspection of records is the only method to evaluate
compliance with the nutrition labeling regulations for a certain number
of nutrients. For certain nutrients there are no AOAC official methods
of analysis or other reliable or appropriate analytical procedures that
are available for us to verify the amount of the declared nutrient on
the Nutrition Facts label and ensure that the declared nutrient amounts
are truthful, accurate and complies with all applicable labeling
requirements. However, we agree that there are difference as to which
manufacturers will need to keep records for nutrient content and which
products will necessitate recordkeeping. Some manufacturers who
voluntarily declare vitamin E content, for example, will have to keep
records for vitamin E content but manufacturers who do not declare
vitamin E will not need to maintain any records for vitamin E content.
Conversely, most manufacturers will need to maintain records on added
sugar content. As discussed in part II.H.3, however, we have concluded
that the declaration of added sugars is necessary to assist consumers
in maintaining healthy dietary practices. Thus, the added sugars
declaration is required and, as is the case for any nutrient that does
not have any analytical method available to assess compliance, the
records described here will have to be maintained and made available
for inspection.
    (Comment 537) One comment stated that we have said that requiring
recordkeeping could spur reformulation, but also stated that we have
not provided any evidence of this.
    (Response) We do not cite potential reformulation of food products
as a reason for or a benefit resulting from recordkeeping requirements.
The recordkeeping requirements are only being created to establish an
alternative approach for assessing compliance of the declared amount of
certain nutrients when there is no suitable analytical method available
to measure the

nutrient's quantity as declared on the label or in labeling.
4. Inclusion of Potassium as a Mineral
    Potassium is specified as a Class I and Class II nutrient in our
preexisting regulations at Sec.  101.9(g)(4)(i) and (g)(4)(ii),
respectively and is the only vitamin or mineral that is specifically
listed under the description of both Class I and Class II nutrients.
Because the proposed rule (at Sec.  101.9(c)(8)(iv)) would establish an
RDI for potassium and require declaration of the absolute amount along
with a percent DV on the Nutrition Facts label, we also proposed to not
list potassium separately under the description of Class I and Class II
nutrients and to remove the term ``potassium'' from Sec.  101.9(g)(4),
(g)(4)(i), (g)(4)(ii), and (g)(6). Instead, potassium would be covered
under the term ``mineral'' that appears in each section, and any
listing of potassium on the Nutrition Facts label would have to meet
the specific compliance requirements for minerals under Sec.
101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6).
    We did not receive any comments regarding potassium and Sec.
101.9(g)(4) or (g)(6). Therefore, we have finalized those provisions
without change.
5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber,
Added Sugars, and Sugar Alcohols
    Our preexisting labeling requirements for Class I and Class II
nutrients are at Sec.  101.9(g)(4). Because the proposed rule would
revise Sec.  101.9(c)(6)(iv) to remove the provision for voluntary
declaration of ``Other carbohydrate,'' we proposed to remove the
compliance requirements related to ``Other carbohydrate'' in Sec.
101.9(g)(4) and (g)(6).
    We also proposed, when all of dietary fiber in a food product meets
the proposed definition of dietary fiber, to include soluble and
insoluble fiber as both Class I and Class II nutrients under Sec.
101.9(g)(4); include added sugars within Sec.  101.9(g)(5) such that
the label declaration of added sugars will be deemed misbranded under
section 403(a) of the FD&C Act if the nutrient composite is greater
than 20 percent in excess of the added sugars value declared on the
label, and within Sec.  101.9(g)(6) such that reasonable deficiencies
of added sugars would be permitted; and include soluble and insoluble
fiber and sugar alcohols within Sec.  101.9(g)(6) such that reasonable
excesses of these nutrients would be permitted.
    We did not receive comments with respect to the removal of other
carbohydrate from Sec.  101.9(g)(4) and (6) or on the addition of
soluble and insoluble fiber to Sec.  101.(g)(4) and (6), and so we have
finalized those provisions without change. We address comments on the
compliance requirements for added sugars in part II.H.3; however, we
are finalizing the addition of added sugars to the compliance
requirements of Sec.  101.9(g)(5) and (g)(6) as proposed.
6. Miscellaneous Comments
    Although we did not receive any comments on our proposed revisions
to the compliance requirements in Sec.  101.9(g)(4), (g)(5), and
(g)(6), we did receive a number of comments related to Class I and
Class II nutrients.
    (Comment 538) We proposed to amend Sec.  101.9(g)(4)(i) to say
that, when a vitamin, mineral, protein, or non-digestible
carbohydrate(s) (when the food contains only non-digestible
carbohydrates (soluble or insoluble) that meet the definition of
dietary fiber) meets the definition of a Class I nutrient, the nutrient
content of the composite must be formulated to be at least equal to the
value for that nutrient declared on the label. Currently, our
preexisting regulations, at Sec.  101.36(f)(1), state that compliance
for dietary supplements will be determined in accordance with Sec.
101.9(g)(1) through (g)(8) and that the criteria on Class I and Class
II nutrients given in Sec.  101.9(g)(3) and (g)(4) also are applicable
to other dietary ingredients.
    Two comments would revise the requirements for Class I nutrients in
Sec.  101.9(g)(4)(i) and Sec.  101.36(f)(1) such that added nutrients
in fortified or fabricated foods must contain at least 90 percent of
the declared amount rather than the current requirement of 100 percent
of the declared amount. The comments recommended that we allow for
fortified and fabricated foods to contain less than the declared amount
of a Class I nutrients because degradation of dietary ingredients is
anticipated and can occur during the shelf life of the product. The
comments said that degradation can occur faster in some nutrients than
others with certain matrices. The comments expressed concern that firms
may include large excesses (greater than 120 percent of the declared
amount) to remain in compliance with requirements for Class I nutrients
and other dietary ingredients over the shelf life of the product. One
comment stated that a lower limit of 90 percent potency as in the U.S.
Pharmacopeia (USP) should be permitted because DSHEA made it clear that
Congress' intent was that the compendial standards should be the
guiding influence where compendial standards exist and products are
represented as complying with those standards (21 U.S.C. 343(s)(2)(D)).
    One comment also would revise Sec.  101.36(f)(1) to state that the
food is also in compliance if it conforms to the specifications of an
official compendium. The comment suggested that reasonable excesses of
dietary ingredients over labeled amounts would still be acceptable
within current good manufacturing practices.
    Another comment noted that jurisdictions outside of the United
States, such as Denmark, Korea, and the United Kingdom, recognize a
minimum value of 80 to 90 percent of the declared amount for added
vitamins and minerals at the end of shelf life. The comment suggested
that allowing for a minimum of 90 percent of the declared amount of an
added vitamin or mineral in the Class I requirements would promote
harmonization with other jurisdictions.
    One comment suggested that allowing for a minor loss of strength
during the product shelf life for Class I nutrients and other dietary
ingredients would be similar to what is allowed in drug monographs.
    (Response) We acknowledge the comments' arguments for revising our
compliance requirements for Class I nutrients, but decline to revise
the rule to allow for less than 100 percent of the amount declared on
the label. We note that the USP compendial standards for label claims
deviations vary from nutrient to nutrient and even vary with different
dietary supplement formulations (e.g., high potency products). This is
a complex issue that warrants further consideration. We need to further
consider and review the available information and to make a
determination whether to propose changes with respect the requirements
for Class I nutrients and/or other requirements that may be affected.
    (Comment 539) One comment referred to a statement made in the
preamble to the proposed rule (79 FR 11879 at 11958) that we expect
that, when a food product contains added sugars, added dietary fiber,
vitamin E as all rac-[alpha]-tocopherol acetate, and added folic acid,
the declared amount must be at least equal to the amount of the
nutrient added to the food. The comment noted that there are instances
when the declared amount of vitamin E, fiber, or folic acid could be
less than the amount added to the recipe as a result of process losses
or losses over shelf life. The comment said it is incorrect to assume
that the declared amount would be equal to at least the amount added to
the recipe.

    (Response) We agree that there could be process losses or losses
over shelf life for some nutrients added to a product. Product loss
over the shelf-life of a product is a complex issue that warrants
further review. We need additional time to review the available
information and to make a determination whether to propose changes with
respect the requirements for Class I nutrients and/or other
requirements that may be affected.
    (Comment 540) The proposed rule, at Sec.  101.9(g)(3)(ii), would
state that when a nutrient or nutrients are not naturally occurring in
an ingredient added to a food, the total amount of such nutrient in the
final food product is subject to Class I requirements. One comment
supported the rule, but two comments asked us to clarify that this
provision is referring to ingredients, such as vitamin premixes, that
contribute to, but do not account for, the total declared amount of the
nutrient. The comments expressed concern that the rule could be
construed to apply to the use of ingredients such as enriched flour or
vitamin A fortified milk which may not contribute substantially to the
nutrient composition of foods. An example might be a mixed dish
containing carrots and a small amount of milk with added vitamin A.
Because the naturally occurring vitamin A in the carrots would be the
primary source of vitamin A in the product rather than the added
vitamin A in the milk, the comment would have us consider vitamin A to
be a Class II nutrient.
    (Response) We decline to revise the rule to refer to ingredients
that contribute to, but do not account for, the total declared amount
of the nutrient. There are cases when fortified ingredients contribute
significantly to the amount of a nutrient when the same nutrient also
occurs naturally in the food. For example, enriched flour containing
thiamin could be added to bread containing oats where oats are also a
source of thiamin. Our intent in proposing to amend Sec.
101.9(g)(3)(ii) was to clarify, rather than alter, the requirement for
manufacturers so that, even if a small amount of a nutrient is added to
a food, where the final food product also contains an ingredient with
the same nutrient in a naturally occurring form, the final food product
is subject to the Class I requirements. Thus, contrary to the comments'
interpretation, we would not consider the vitamin A to be a Class II
nutrient in the example provided by the comment.
    We note that manufacturers can choose to use ingredients that are
not fortified when formulating their products. In the example provided
in the comment, the manufacturer could use milk that is not fortified
with vitamin A in formulating the product. In such case, the vitamin A
in the finished food would be from a naturally occurring source, and
the food would have to meet the requirements for Class II nutrients
rather than Class I nutrients.

S. Technical Amendments

    The proposed rule also would make certain technical amendments,
such as changing the name of the program office to reflect its current
name and making non-substantive edits for purposes of plain language.
1. Changing the Name of the Program Office
    The proposed rule would update the name of the program office that
is responsible for developing regulations and answering questions
related to nutrition labeling as well as for maintaining some
references discussed throughout Sec.  101.9. The program office's
former name was the Office of Nutritional Products, Labeling and
Dietary Supplements; at the time we issued the proposed rule, the
program office's name was the Office of Nutrition, Labeling and Dietary
Supplements. We proposed to update the name throughout Sec.  101.9.
    We did not receive any comments regarding the change in the program
office's name. However, since we issued the proposed rule, the program
office's name changed again, to be the Office of Nutrition and Food
Labeling, and so we have revised Sec.  101.9 accordingly.
2. Changing the Publication Date of Report Incorporated by Reference
    Our preexisting regulations, at Sec.  101.9(c)(7)(ii), provide that
the protein digestibility-corrected amino acid score must be determined
by methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein
Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on
Protein Quality Evaluation,'' Rome, 1990, except that when official
AOAC procedures described in Sec.  101.9(c)(7) require a specific food
factor other than 6.25 to be used. We incorporated the ``Report of the
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation'' by
reference in Sec.  101.9(c)(7)(ii), but Sec.  101.9(c)(7)(ii)
incorrectly uses 1990 as the publication date when the report actually
was published in 1991. Thus, the proposed rule would change the
publication date of the report that is incorporated by reference from
1990 to 1991.
    We received no comments regarding this change and have revised
Sec.  101.9(c)(7)(ii) by replacing ``1990'' with ``1991.'' However,
with respect to this and other references that we incorporated by
reference in the final rule, we have revised the incorporation-by-
reference language in the final rule to meet the current requirements
at 5 CFR part 51. Consequently, much of the incorporation by reference
language can be found at a new Sec.  101.9(l).
3. Plain Language Edits
    On October 13, 2010, the President signed the Plain Writing Act of
2010 requiring that Federal Agencies use ``clear Government
communication that the public can understand and use.'' On January 18,
2011, the President issued Executive Order (E.O.) 13563, ``Improving
Regulation and Regulatory Review'' (75 FR 3821 (January 21, 2011));
section 1 of E.O. 13563 sets forth ``General principles of
regulation,'' and these principles include ensuring that regulations
are ``accessible, consistent, written in plain language, and easy to
understand.'' To make the requirements of Sec.  101.9 easier to
understand, we proposed editorial changes that would not change the
meaning or intent of the language in Sec.  101.9(g)(3)(ii); (g)(4)(i);
(g)(4)(ii); (g)(5); and (g)(8). Specifically, the proposed rule would:
     Revise Sec.  101.9(g)(3)(ii) to clarify that when a
nutrient or nutrients are not naturally occurring (exogenous) in an
ingredient that is added to a food, the total amount of such
nutrient(s) in the final food product is subject to Class I
requirements rather than Class II requirements. We proposed this change
because the existing rule did not explicitly state that such a nutrient
would be subject to Class I requirements.
     Remove ``Class I'' and ``Class II'' from Sec.
101.9(g)(4)(i) and (g)(4)(ii), and to state instead that when the list
of nutrients provided in those sections meets the definition of a Class
I or Class II nutrient provided for in Sec.  101.9(g)(3)(i) and
(g)(3)(ii), the declaration of those nutrients must meet certain
requirements. We explained that this change was intended to prevent
confusion by having two different definitions of a ``Class I'' and
``Class II'' nutrient for compliance with nutrition labeling
requirements.
     Remove the words ``Provided, That'' from Sec. Sec.
101.9(g)(4)(ii) and (g)(5) because the words do not provide further
clarification and are unnecessary.
     Add the word ``Alternatively'' at the beginning of Sec.
101.9(g)(8) to indicate that use of an FDA approved database

is an alternative to the type of nutrient analysis described in Sec.
101.9(g)(1) and (g)(2).
    (Comment 541) One comment stated that the proposed rule does not
meet the requirements of the Plain Writing Act of 2010 (Pub. L. 111-
274) and said it should be rewritten at a much lower literacy level.
    (Response) Although we strive to use plain language and to draft
our regulations in a manner such that they are easy to understand, we
disagree with the comment. The comment did not provide any specific
examples or suggestions on how we should rewrite the rule, so we do not
have an adequate basis to determine which parts of the rule, in the
comment's view, should be rewritten or how they should be revised.
    We also note that, while we have made every effort to write the
rule in plain language and in easily understood terms, the rule imposes
requirements on firms who have Nutrition Facts or Supplement Facts
labels on their products rather than on laymen. The intended
``audience'' for the rule is an important consideration when it comes
to plain language. As the Federal Plain Language Guidelines state:

    One of the most popular plain language myths is that you have to
``dumb down'' your content so that everyone everywhere can read it.
That's not true. The first rule of plain language is: Write for your
audience. Use language your audience knows and feels comfortable
with. Take your audience's current level of knowledge into account.
Don't write for an 8th grade class if your audience is composed of
Ph.D. candidates, small business owners, working parents, or
immigrants. Only write for 8th graders if your audience is, in fact,
an 8th grade class.

Federal Plain Language Guidelines, ``Think About Your Audience,'' p. 1
(March 2011).
    Consequently, the final rule makes the plain language edits to
Sec.  101.9(g)(4)(i), (g)(4)(ii), and (g)(8). However, we have made
additional revisions to Sec.  101.9(g)(3)(ii) for clarification. In
addition, upon further consideration, we decided to retain the words
``Provided, That'' in Sec. Sec.  101.9(g)(4)(ii) and (g)(5). Removing
the clause would no longer signal to the reader that no regulatory
action will be taken based on a determination of a nutrient value that
falls above a certain level by a factor less than the variability
generally recognized for the analytical method used in that food at the
level involved.
4. Correcting Sec.  101.9(c)(8)(iii) To Provide Instructions for
Rounding Percent DVs
    (Comment 542) One comment noted that the first sentence in proposed
Sec.  101.9(c)(8)(iii) did not provide clear instructions for how to
declare the percent DVs for vitamins and minerals when the percent
daily is between 2 to 10 percent, between 10 to 50 percent, or above
50-percent.
    (Response) The text in first sentence in proposed Sec.
101.9(c)(8)(iii) was inadvertently changed, and we did not mean to
propose to amend this requirement. The text in the first sentence of
Sec.  101.9(c)(8)(iii) should read ``The percentages for vitamins and
minerals shall be expressed to the nearest 2-percent increment up to
and including the 10-percent level, the nearest 5-percent increment
above 10 percent and up to and including the 50-percent level, and the
nearest 10-percent increment above the 50-percent level.''
5. Miscellaneous Changes
    The final rule also makes several non-substantive changes.
    The proposed rule would amend Sec.  101.9(c) to state that the
requirements of Sec.  101.9(c) apply to the labeling of food ``for
adults and children over the age of 4 years, and on foods (other than
infant formula) purported to be specifically for infants through 12
months, children 1 through 3 years of age, and pregnant women and
lactating women.'' After further consideration, we have decided not to
amend Sec.  101.9(c) as we had proposed because the additional language
is not necessary. As discussed part II.O, we have the same requirements
for mandatory and voluntary labeling for products represented or
purported to be for pregnant women and lactating women because women of
reproductive age consume the same foods as the general population and,
in general, continue consuming similar foods during pregnancy.
Therefore, the requirements for mandatory and voluntary labeling for
children and adults 4 years of age and older also apply to products
represented or purported to be for pregnant women and lactating women,
and there is no reason to mention requirements for pregnant women and
lactating women in Sec.  101.9(c). In addition, the requirements for
mandatory and voluntary labeling for products purported to be for
infants through 12 months of age and children 1 through 3 years of age
are provided in Sec.  101.9(j)(5). Therefore, there is no reason to
mention requirements for mandatory and voluntary labeling of nutrients
on products represented or purported to be for infants through 12
months or children 1 through 3 years in Sec.  101.9(c).
    The proposed rule also would make minor conforming changes to Sec.
101.9(c)(1)(i)(D) and (E) by deleting the word ``or'' from the former
and adding the word ``or'' to the latter. This change reflected the
addition of a new subparagraph (F), such that we needed to move the
conjunction to its correct place between the last two subparagraphs in
Sec.  101.9(c)(1)(i). The final rule adopts these changes.

T. Miscellaneous Comments

    We also received comments on a variety of topics that were
unrelated to the proposed rule. In brief, we received comments asking
about:
     Declaring the presence of genetically modified organisms
(GMOs) or GMO-related issues;
     Ingredient listing, particularly with respect to specific
ingredients such as high-fructose corn syrup;
     Front-of-package labeling;
     Labeling of alcoholic beverages by another Federal Agency;
     Declaring whether a product contains caffeine, gluten,
allergens, ``toxins'' (particularly from pesticides and food
containers);
     Listing the glycemic index of foods and listing whole
grains in a food;
     Health claim or nutrient content claim regulations;
     Expiration dates on food labels;
     Whether we should define the term ``natural'' on food
labels;
     Issues related to our final rules on menu labeling and
vending machine labeling; and
     Listing artificial sweeteners in the Nutrition Facts
label.
    Generally speaking, these topics are distinct from the Nutrition
Facts and Supplement Facts label requirements, and so they are beyond
the scope of this rulemaking. We note, however, that we have issued
regulations regarding ``gluten-free'' labeling (see 78 FR 47154 (August
5, 2013) (now codified at 21 CFR 101.91), labeling of standard menu
items in restaurants and similar retail food establishments (known
informally as ``menu labeling'') (see 78 FR 71155 (December 1, 2014))
(now codified at 21 CFR 101.9), calorie labeling of articles of food in
vending machines (78 FR 71259 (December 1, 2014) (also codified at 21
CFR 101.9), and Small Entity Compliance Guides for the gluten-free
labeling rule and the menu labeling rules (see 79 FR 36322 (June 26,
2014) and 80 FR 13225 (March 13, 2015) respectively).
    We also have a longstanding policy for the use of the term
``natural'' on labels of human food (see 56 FR 60421 at 60466 (November
27, 1991) (proposed rule on food labeling, nutrient content claims, and
general principles)), and, in the Federal Register of November 12,

2015 (80 FR 69905), issued a notice to receive information and comments
on the use of the term ``natural'' in the labeling of human food
products, including foods that are genetically engineered or contain
ingredients produced through the use of genetic engineering and on
specific questions we posed in the notice.

III. Effective and Compliance Dates

    In the preamble to the proposed rule (79 FR 11879 at 11959), we
indicated that a final rule, as well as any final rule resulting from
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,'' would become effective 60 days after the date
of the final rule's publication in the Federal Register (79 FR 11879 at
11959). We also suggested that a final rule have a compliance date that
would be 2 years after the effective date (id.). We explained that
industry might need some time to analyze products for which there may
be new mandatory nutrient declarations, make any required changes to
the Nutrition Facts label (which may be coordinated with other planned
label changes), review and update records of product labels, and print
new labels.
    (Comment 543) Several comments asked that we provide for a longer
compliance date. Some comments specifically requested more time for
small businesses. Some comments said that there are a limited number of
label printing facilities and that they anticipated that small firms
would have to wait longer to have new labels printed. The comments
indicated that printing facilities would work with larger companies
before working with small businesses or that the large companies would
be able to negotiate more quickly with printing facilities to fill
their labeling orders first. Other comments stated that small
businesses often order a 2-year supply of labels or packaging, so a 2-
year compliance date would force small businesses to discard inventory.
One comment said that some manufacturers would need to work with design
firms to revise or develop label designs.
    Another comment requested a longer compliance date because of other
label changes that we or other nations are requiring or anticipated new
labeling requirements. The comment mentioned our declaratory order
regarding partially hydrogenated oils (80 FR 34650 (June 17, 2015)), a
Vermont state law requiring labeling of genetically engineered foods
and similar legislation in other States, and a possible change to the
Nutrition Facts Table and ingredient statements in Canada. Some
comments said that synchronizing compliance dates would reduce the
economic impact of food manufacturers or that providing a longer
compliance date would reduce the economic impact on manufacturers.
    Several comments also said that manufacturers may decide to
reformulate products. One comment said that a longer compliance date
would make it possible for more manufacturers to reformulate products
to reduce added sugars, to qualify for nutrient content claims, or
``otherwise meet FDA's public health objectives.'' Another comment said
that a longer compliance period would give companies time to
reformulate ``where appropriate.''
    Some comments said there would be environmental consequences or
impacts if companies had to dispose of labels or could not use existing
label stock.
    In general, the comments suggested different compliance dates,
ranging from 3 to 5 years, and stressed the impact on small businesses.
    (Response) After considering the comments, we have maintained the
compliance date of 2 years after the effective date, except that
manufacturers with less than $10 million in annual food sales have a
compliance date of 3 years after the effective date. Because the
comments emphasized the rule's potential impact on small businesses, we
agree that the impacts to smaller businesses may be more substantial
than those on larger businesses, and so we have decided to provide a 3-
year compliance date for manufacturers with less than $10 million in
annual food sales. Thus, for manufacturers with less than $10 million
in annual food sales, the compliance date will be July 26, 2019.
    We take no position with respect to the comment's statements on
label printing facilities and their interaction with large companies,
but agree, generally, that small businesses may have fewer resources
(both in terms of personnel and financial resources) to deal with
regulatory changes and that an extended compliance date may mitigate
the rule's impact on small businesses and reduce the need to dispose of
potentially non-compliant labeling stock. Although the comments did not
suggest any criteria to decide what constitutes a ``small business,''
for purposes of this rulemaking, we consider a small business to be a
manufacturer with less than $10 million in annual sales, which we
estimate using Nielsen data that covers approximately 95 percent of all
food manufacturers and 48 percent of food UPCs.
    We also decline to extend the compliance date for small businesses
to 4 or 5 years. We note that the Nutrition Facts label's principal
purpose is to assist consumers in maintaining healthy dietary
practices. In establishing the compliance date for the rule, we have
tried to balance the label's principal purpose against the need for
industry to analyze products and to review, update, change, and print
labels (see 79 FR 11879 at 11959). If we were to extend the compliance
date for small businesses to 4 or 5 years, we may inadvertently create
consumer confusion because different versions of the Nutrition Facts
label would exist in the market for a longer period of time. The more
years that differences exist between label formats on different
products due to extended compliance periods, the more concern we would
have about these differences frustrating, rather than enhancing, the
consumer's ability to maintain healthy dietary practices and
potentially undermining public confidence in the Nutrition Facts label.

IV. Economic Analysis of Impacts

    We have examined the impacts of this final rule under Executive
Order 12866, Executive Order 13563, 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). We are
publishing two final rules on nutrition labeling in the Federal
Register. We have developed one final Regulatory Impact Analysis (RIA)
(Ref. 274) that assesses the impacts of the two final rules taken
together; the RIA is available at http://www.regulations.gov (Docket
No. FDA-2012-N-1210) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/. We believe that the
final rules, taken as a whole, are an economically significant
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any

significant impact of a rule on small entities. Additional costs per
entity from the final rules are small, but not negligible, and as a
result we find that the final rules, taken as a whole, will 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 issuing ``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 $144
million, using the most current (2014) Implicit Price Deflator for the
Gross Domestic Product. These final rules, taken as a whole, would
result in an expenditure that meets or exceeds this amount. The
analysis that we have performed to examine the impacts of the final
rules under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of
1995 are included in the RIA (Ref. 274) and is available at http://www.regulations.gov (Docket No. FDA-2012-N-1210).

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the OMB under the PRA. The title, description, and
respondent description of the information collection provisions are
shown in the following paragraphs with an estimate of the annual
reporting and recordkeeping burden. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    Title: Record Retention, Reporting, and Third-Party Disclosure
Requirements for the Declaration of Added Sugars, Dietary Fiber,
Soluble Fiber, Insoluble Fiber, Vitamin E and Folate/Folic Acid.

A. Recordkeeping Requirements

    Description of Respondents: The likely respondents to this
information collection are manufacturers of retail food products
marketed in the United States, whose products contain: (1) A mixture of
naturally occurring and added sugars; or (2) a mixture of non-
digestible carbohydrates that do and do not meet the definition of
dietary fiber. The likely respondents to this information collection
also include manufacturers of retail food products marketed in the
United States, whose products contain: (1) Mixtures of different forms
of vitamin E; or (2) both folate and folic acid.
    Description: The Nutrition Facts label rule requires that, under
certain circumstances, manufacturers make and keep certain records to
verify the amount of added sugars when a food product contains both
naturally occurring sugars and added sugars, isolated or synthetic non-
digestible carbohydrates that do not meet the definition of dietary
fiber, different forms of vitamin E, and folate/folic acid declared on
the Nutrition Facts or Supplement Facts label, which is the amount in
the finished food product. Manufacturers are required to provide such
records to an appropriate regulatory official upon request during
inspection. Manufacturers also are required to maintain the records to
verify the label declaration of the aforementioned nutrients for a
period of 2 years after introduction or delivery for introduction of
the food into interstate commerce. Manufacturers of food products that
contain an isolated or synthetic non-digestible carbohydrate that are
not listed in the definition of dietary fiber will have the option of
submitting a citizen petition to FDA asking us to amend the definition
of ``dietary fiber'' to include the carbohydrate as a listed dietary
fiber, by demonstrating the physiological benefits of the isolated or
synthetic non-digestible carbohydrate to human health. In addition, if
the isolated or synthetic non-digestible carbohydrate is the subject of
an authorized health claim, FDA would consider the carbohydrate to be a
dietary fiber with a beneficial physiological effect to human health
and would amend the definition of ``dietary fiber'' to include the
carbohydrate as a listed dietary fiber. If the citizen petition is
granted, or if the isolated or synthetic non-digestible carbohydrate is
the subject of an authorized health claim, then the non-digestible
carbohydrate is considered to meet the definition of dietary fiber and
the definition would be amended to include the dietary fiber in the
listing of dietary fibers that must be included in the total amount of
dietary fiber declared on the Nutrition or Supplement Facts label by
food manufacturers who manufacture food products that contain the
isolated or synthetic non-digestible carbohydrate. The record
requirements are necessary because analytical methods are not available
that would allow us to differentiate between naturally occurring and
added sugars, non-digestible carbohydrates (soluble or insoluble) that
do and do not meet the definition of dietary fiber, the various forms
of vitamin E, and folate or folic acid in order to quantify the amount
of added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin
E, or folate/folic acid in the final food product. For the nutrients
described in the preceding sentence for which there are no analytical
methods available to verify the label declaration, we must rely on
information known only to the manufacturer, e.g., analyses of nutrient
databases, the food's formulation or recipe, batch records, or other
records, to determine whether their product contains the declared
amount of the nutrient and is in compliance with the requirements of
Sec. Sec.  101.9(g) and 101.36(f).
    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 would require 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 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.
    We estimate the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Type of declaration/CFR section     Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Added Sugars/Sec.                         31,283               1          31,283               1          31,283
 101.9(c)(6)(iii) \2\...........

Dietary Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i) \2\.............
Soluble Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(A) \2\..........
Insoluble Fiber/Sec.                      31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(B) \2\..........
Dietary Fiber/Sec.                            28               1              28               1              28
 101.9(c)(6)(i).................
Vitamin E/Sec.   101.9(c)(8) \3\          31,283               1          31,283               1          31,283
Folate/Folic Acid/Sec.                    31,283               1          31,283               1          31,283
 101.9(c)(8) \3\................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         187,726
                                 -------------------------------------------------------------------------------
    Total Initial Hours.........  ..............  ..............  ..............  ..............         187,726
                                 -------------------------------------------------------------------------------
New Products....................             216               1             216               1             216
                                 -------------------------------------------------------------------------------
    Total Recurring Hours.......  ..............  ..............  ..............  ..............             216
                                 -------------------------------------------------------------------------------
        Total Burden Hours......  ..............  ..............  ..............  ..............         187,942
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\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 and products with non-digestible 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 by the final
rules 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 final rules consists of the time
required to identify and assemble the records for copying and
retention. Based on our previous experience with similar recordkeeping
requirements, 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. 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, it is estimated 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. 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
roughly 31,283 food manufacturers would incur this recordkeeping burden
and that the required recordkeeping would be 1 hour per manufacturer.
    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 estimated
using U.S. Census Bureau Business and Industry data, we estimate that
number to be about 216. Thus, we estimate that about 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 x 1). Adding the
burden from new products to the burden for existing products results in
a total of 187,942 recordkeeping burden hours for the covered
establishments under the Nutrition Facts Label rule, as reported in
table 1.

B. Reporting Requirements

    Description of Respondents: The likely respondents to this
information collection are manufacturers of retail food products
marketed in the United States, whose products contain: (1) A
combination of both naturally occurring and added sugars; or (2) a
mixture of non-digestible carbohydrates that do and do not meet the
definition of dietary fiber, soluble fiber, and insoluble fiber. The
likely respondents to this information collection also include
manufacturers of retail food products marketed in the United States,
whose products contain: (1) Mixtures of different forms of vitamin E;
or (2) both folate and folic acid if a health or nutrient content claim
is being made or these nutrients are directly added to the food for
enrichment purposes.
    Description: Under the Nutrition Facts label rule, we require that
firms provide records upon request during an inspection that they use
to verify the declared amounts of added sugars, dietary fiber, soluble
fiber, insoluble fiber, vitamin E, and folate/folic acid on the
Nutrition Facts or Supplement Facts label.
    The reporting requirement is necessary because, at the present
time, analytical methods are not available that would allow us to
differentiate between naturally occurring and added sugars, non-
digestible carbohydrates that both do and do not meet the definition of
dietary fiber, soluble fiber, and insoluble fiber, the various forms of
vitamin E, and folate or folic acid in order to quantify the amount of
added sugars, dietary fiber, vitamin E, or

folate/folic acid in the final food product. For these foods, we must
rely on information known only to the manufacturer to assess compliance
with the qualifying amount of nutrient. The food manufacturer would
assemble and provide the records to FDA regulatory officials upon
request during an inspection. We would review the records to verify the
label declaration and assess compliance.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Type of declaration/CFR section     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Added Sugars/Sec.                         31,283               1          31,283               1          31,283
 101.9(c)(6)(iii) \2\...........
Dietary Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i) \2\.............
Soluble Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(A) \2\..........
Insoluble Fiber/Sec.                      31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(B) \2\..........
Vitamin E/Sec.   101.9(c)(8) \3\          31,283               1          31,283               1          31,283
Folate/Folic Acid/Sec.                    31,283               1          31,283               1          31,283
 101.9(c)(8) \3\................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         187,698
                                 -------------------------------------------------------------------------------
    Total Initial Hours.........  ..............  ..............  ..............  ..............         187,698
                                 -------------------------------------------------------------------------------
New Products....................             216               1             216               1             216
                                 -------------------------------------------------------------------------------
    Total Recurring Hours.......  ..............  ..............  ..............  ..............             216
                                 -------------------------------------------------------------------------------
        Total Burden Hours......  ..............  ..............  ..............  ..............         187,914
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\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 and products with non-digestible 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 records that would be required to be provided to FDA, upon
request, 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 reporting burden to the food manufacturer consists
of the time required to assemble and provide the records to appropriate
regulatory officials. Based on our previous experience with similar
reporting requirements, we estimate the reporting burden of the
Nutrition Facts Label rule to be 1 hour per response, as estimated in
table 2.
    We do not expect to request records from all covered manufacturers
to assess compliance, but for the purpose of this analysis the number
of respondents is conservatively estimated to be all covered
establishments. We estimate the number of responses per record keeper
to be 1 and the hourly burden per response to be 1 hour. Built into the
estimate of 1 hour is the range from 0 hours, for some covered
manufacturers that do not need to maintain records, to a larger number
of hours for some covered manufacturers, such as those who produce
fermented foods, which may require more time to gather or produce the
necessary records. As shown in table 2, the initial reporting burden
for covered establishments is 187,698 hours. Also, in accordance with
our previous estimate of the number of newly introduced products that
would be covered by the requirements to be 216, we estimate the
recurring reporting burden hours to be 216. Adding the burden from new
products to the initial hours results in a total of 187,914 reporting
burden hours for the covered establishments under the Nutrition Facts
Label rule, as estimated in table 2.

C. Third-Party Disclosure Requirements

    Description of Respondents: Respondents to this collection of
information include manufacturers of food products. We estimate the
burden of this collection of information as follows:

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of                                                          Total capital costs
              21 CFR section                   Number of      disclosures per     Total annual    Average burden    Total hours       (in billions of
                                              respondents        respondent       disclosures     per disclosure                           2014$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.9 and 101.36..........................          31,283                 26          813,358                2        1,626,716                  $2.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    We have estimated that the burden associated with the Nutrition
Facts Label rule would be a burden created by the need for food
manufacturers to revise their nutrition labels. We estimate that the
third party disclosure burden would be approximately 2 hours per
disclosure, for a total burden of 1,626,716 hours.

D. Third-Party Disclosure Burden for Manufacturers

    The incremental time burden for reviewing labels to assess how to
bring them into compliance with the requirements of the Nutrition Facts
label

rule has been estimated to be 1 hour per label. These requirements do
not generate any recurring burden per label because establishments must
already print packaging for food products as part of normal business
practices, and must disclose required nutrition information under the
NLEA.
    Each label redesign would require an estimated 1 additional hour,
making the total burden hours to be 2 hours in burden per UPC.
    We estimate that about 31,283 manufacturers representing about
813,358 UPCs, with an average disclosure of 26 (813,358/31,283), would
be covered under the Nutrition Facts label rule. The total number of
responses is equal to the total number of UPCs being changed.
Multiplying the total number of responses by the hours per response
gives the total burden hours (Table 3, Column 6). Based on the RIA, we
have estimated the capital cost to be $2.47 billion (2014$).
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995. Before the effective date of this
final rule, we will publish a notice in the Federal Register announcing
OMB's decision to approve, modify, or disapprove the information
collection provisions in this final rule.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.

VI. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of
this action. We have concluded that the action will not have a
significant impact on the human environment, and that an environmental
impact statement is not required (Refs. 275-276). Our finding of no
significant impact and the evidence supporting that finding, contained
in an environmental assessment, may be seen in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday.

VII. 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.''
    Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act provides that no
State or political subdivision of a State may directly or indirectly
establish under any authority or continue in effect as to any food in
interstate commerce with respect to any requirement for nutrition
labeling of food that is not identical to the requirement of section
403(q) of the FD&C Act.
    The express preemption provision of section 403A(a) of the FD&C Act
does 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 (section 6(c)(2) of the
Nutrition Labeling and Education Act of 1990, Public Law 101-535, 104
Stat. 2353, 2364 (1990)). If this proposed rule is made final, the
final rule would create requirements that fall within the scope of
section 403A(a) of the FD&C Act.
    (Comment 544) One comment argued that our federalism analysis in
the proposed rule should have included a discussion of the limits which
the First Amendment places on Federal law. The comment also said that
section 403A of the FD&C Act is limited to food in interstate commerce.
    (Response) It is correct that, as quoted in the proposed rule's
Federalism section, section 403A of the FD&C Act applies to food in
interstate commerce. We decline to change our Federalism section to
include a First Amendment analysis. The Federalism section discusses
the limitations on states or political subdivisions of a State with
regard to requirements for food labeling.
    We address First Amendment arguments in part II.C.1.

VIII. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 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 http://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.

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