[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57050-57054]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2011-23753]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0400]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2011-0014]


Approaches to Reducing Sodium Consumption; Establishment of 
Dockets; Request for Comments, Data, and Information

AGENCY: Food and Drug Administration, HHS; Food Safety and Inspection 
Service, USDA.

ACTION: Notice; establishment of dockets; request for comments, data, 
and information.

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SUMMARY: The Food and Drug Administration (FDA) and the Food Safety and 
Inspection Service (FSIS) are announcing the establishment of dockets 
to obtain comments, data, and evidence relevant to the dietary intake 
of sodium as well as current and emerging approaches designed to 
promote sodium reduction. FDA and FSIS are particularly interested in 
research that will help both organizations understand current and 
emerging practices by industry in sodium reduction in foods; current 
consumer understanding of the role of sodium in hypertension and other 
chronic illnesses, sodium consumption practices; motivation and 
barriers in reducing sodium in their food intakes; and issues 
associated with the development of targets for sodium reduction in 
foods to promote reduction of excess sodium intake. Excess sodium 
intake is linked to increased risk of heart disease and stroke. FDA and 
FSIS recognize ongoing efforts by a number of members of the restaurant 
and packaged food industries to reduce sodium and appreciate the 
complexities of reducing sodium in foods. Continued input and support 
from industry and other stakeholders are important to support further 
progress on this significant public health issue.

DATES: Submit either electronic or written comments and data and 
information by November 29, 2011.

ADDRESSES: FDA: Submit electronic comments and data and information to 
http://www.regulations.gov. Submit written comments and data and 
information to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
All submissions must include the Agency name and docket number FDA-
2011-N-0400.
    FSIS: Submit electronic comments and data and information to http://www.regulations.gov. Submit written comments and data and information 
to the Docket Clerk, U.S. Department of Agriculture, Food Safety and 
Inspection Service, FSIS Docket Room, 1400 Independence Avenue, SW., 
Patriots Plaza 3, Mailstop 3782, Room 163A, Washington, DC 20250-3700. 
All submissions must include the Agency name and docket number FSIS-
2011-0014.

FOR FURTHER INFORMATION CONTACT: FDA: Richard E. Bonnette, Center for 
Food Safety and Applied Nutrition (HFS-255), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 
240-402-1235.
    FSIS: Rosalyn Murphy-Jenkins, Director, Labeling and Program 
Delivery Division, Office of Policy and Program Development, Food 
Safety and Inspection Service, U.S. Department of Agriculture, USDA, 
FSIS, OPPD, LPDD Stop Code 3784, Patriots Plaza III, 8-161A, 1400 
Independence Avenue, SW., Washington, DC 20250-3700.

SUPPLEMENTARY INFORMATION:

I. Background

    Research shows that excess sodium consumption is a contributory 
factor in the development of hypertension, which is a leading cause of 
heart disease and stroke (Ref. 1), the first and fourth leading causes 
of death in the United States, respectively (Ref. 2). Research also 
shows that the increase in blood pressure seen with aging, common to 
most Western countries, is not observed in populations that consume low 
sodium diets (Refs. 3 and 4) and that the U.S. population consumes far 
more sodium than recommended (Ref. 5 and 7). Moreover, dietary 
reduction of sodium can lower blood pressure as has been demonstrated 
in the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial 
(Ref. 6). Because over three-quarters of sodium in the diet of the U.S. 
population is added during manufacturing of foods and preparation of 
restaurant foods, reduction in sodium consumption in the United States 
involves reduction in the sodium content of food in the U.S. 
marketplace (Refs. 5 and 7).
    In this document, we refer primarily to ``sodium,'' a component of 
sodium chloride, commonly known as ``salt.'' Most but not all sodium is 
added to food in the form of salt and we are interested in all sources 
of sodium added to foods. The comments, data, and evidence regarding 
sodium reduction obtained by the establishment of these dockets will 
provide important information about current and emerging practices and 
approaches designed to reduce excess sodium intake, primarily coming 
from salt.

A. Sodium: Current and Recommended Intake

    According to national food survey data from the ``What We Eat in 
America, National Health and Nutrition Examination Survey (NHANES) 
2007-2008,'' estimated average sodium intake from foods among persons 
in the United States aged 2 years or older is approximately 3,300 
milligrams per day (mg/d) (excluding salt added at the table) (Ref. 8). 
Most of this sodium comes from salt used in the manufacture or 
preparation of foods (Ref. 9). In 2005, the IOM set a Tolerable Upper 
Intake Level (UL) for sodium at 2,300 mg/d and an Adequate Intake (AI) 
at 1,500 mg/d for those 9 to 50 years of age, including pregnant and 
lactating women (AIs are lower for those 0-8 years of age and for those 
over 50 years of age) (Ref. 1). The 2010 Dietary Guidelines for 
Americans recommendations are to ``reduce daily sodium intake to less 
than 2,300 milligrams (mg) and further reduce intake to 1,500 mg among 
persons who are 51 and older and those of any age who are African 
American or have hypertension, diabetes, or chronic kidney disease.'' 
The 1,500 mg recommendation applies to about half of the U.S. 
population (Ref. 7). Current sodium intake is substantially higher

[[Page 57051]]

than what has been recommended by scientific and public health agencies 
and organizations in recent years. The Centers for Disease Control and 
Prevention (CDC) reported in 2010 that over 80 percent of adults (>=20 
years) recommended to consume less than 2,300 mg/d of sodium in fact 
consumed more than 2,300 mg/d (Ref. 10).
    The 2010 Dietary Guidelines for Americans also stated that ``Given 
the current U.S. marketplace and the resulting excessive high sodium 
intake, it is challenging to meet even the less than 2,300 mg 
recommendation'' and that a concerted effort is needed to reduce sodium 
in foods to help consumers meet the levels recommended (Ref. 7).
    An analysis of the potential savings from reduced sodium 
consumption in the U.S. adult population found that reducing average 
dietary sodium intake to 2,300 mg/d among adults 18 years or older 
could have substantial health and financial benefits. Estimates showed 
potential reduction of 11 million hypertension cases and an annual 
savings of $18 billion health care costs (Ref. 11). Another assessment 
on the cost-effectiveness of reducing sodium intake found that an 
intervention achieving a reduction of 1,200 mg/d would save $10 to $24 
billion in health care costs annually, comparable to benefits of 
population-wide reductions in tobacco use, obesity, and cholesterol 
levels (Ref. 12). Furthermore, this analysis found that a modest 
reduction over 10 years of about 400 mg sodium/d would be more cost-
effective than using medications to lower blood pressure in all persons 
with hypertension (Ref. 12).

B. Public and Industry Initiatives to Reduce Sodium Intake

    Since 1980, the U.S. Department of Agriculture (USDA) and the U.S. 
Department of Health and Human Services (HHS) have made recommendations 
in the Dietary Guidelines for Americans, including ``avoid too much 
sodium,'' ``use salt and sodium only in moderation,'' and ``choose and 
prepare foods with less salt'' (Refs. 7 and 13 through 17).
    FDA has supported these recommendations with a variety of 
initiatives designed to promote informed choices on the part of 
consumers. In 1984, FDA required that information on sodium be included 
on the label whenever nutrition information appeared on food labels (49 
FR 15510, April 18, 1984). In 1990, Congress enacted the Nutrition 
Labeling and Education Act (NLEA), which mandated nutrition labeling of 
food. In response to the NLEA, in 1993 FDA issued regulations requiring 
the declaration of sodium in absolute amounts and as a percentage of 
the Daily Value (58 FR 2206, January 6, 1993). FDA has also established 
standards for sodium-related nutrient content and health claims (e.g., 
21 CFR 101.13; 21 CFR 101.14; 21 CFR 101.61; 21 CFR 101.74). 
Furthermore, under section 403(q)(5)(H)(ii)(III) of the Federal Food, 
Drug, and Cosmetic Act, as amended by the Patient Protection and 
Affordable Care Act of 2010, certain restaurants and similar retail 
food establishments must provide, upon request, written nutrition 
information, which includes sodium content, for standard menu items. 
Additional efforts by FDA have included consumer education initiatives 
such as a joint sodium education initiative in 1981 with the National 
Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of 
Health (NIH) as part of the National High Blood Pressure Education 
Program (Ref. 18), and a November 29, 2007, public hearing concerning 
policies regarding salt and sodium in food (72 FR 59973, October 23, 
2007). At the hearing, there was general agreement that the levels of 
sodium in food are too high, but there was no consensus regarding 
approaches for reducing the levels of sodium in food (Ref. 19).
    FSIS, the agency responsible for nutrition labeling requirements 
for meat and poultry products, also coordinates and collaborates with 
FDA on nutrition labeling issues. In 1993, FSIS issued regulations 
establishing nutrition labeling requirements for meat and poultry 
products (9 CFR 317, part 381, subpart Y). These regulations, similar 
to FDA's nutrition labeling regulations, required the declaration of 
sodium in absolute amounts and as a percentage of the Daily Value on 
the labeling of nonexempted meat and poultry products. In December 
2010, FSIS issued regulations to ensure nutrition labeling of the major 
cuts of single-ingredient, raw meat and poultry products on labels or 
at point-of-purchase, unless an exemption applies (75 FR 82148, 
December 29, 2010). These regulations also require nutrition labels on 
all ground or chopped meat and poultry products, with or without added 
seasonings, unless an exemption applies. Thus, these regulations 
increase the type of meat and poultry products that must declare sodium 
in absolute amounts and as a percentage of the Daily Value in their 
labeling.
    Other U.S. public health agencies and organizations have also 
sought to inform consumers and encourage reduced sodium intake. In 
addition to conveying the benefits of reducing sodium related to 
hypertension through professional and consumer education activities, 
the NHLBI published guidelines recommending a sodium intake of no more 
than 2,400 mg/d dating back to 1993 (Refs. 20 through 26). More 
recently, the CDC has provided funding to various states and 
communities across the country in support of sodium reduction efforts 
to help create healthier food environments and reduce sodium intake by 
the population (Ref. 27). In addition, USDA, through the nutrition 
programs of the Center for Nutrition Policy and Promotion, promotes 
consumer messages related to sodium reductions via the interactive, 
web-based dietary assessment and weight management resources at 
ChooseMyPlate.gov, as well as through its MyPlate 2010 Dietary 
Guidelines for Americans consumer communications initiative and 
Consumer Brochure.
    In 2008, the New York City Department of Health and Mental Hygiene 
initiated the National Sodium Reduction Initiative (NSRI), a 
partnership of 70 local and state health departments and health 
organizations, which has set targets to reduce sodium in restaurant and 
processed foods (Ref. 28). The goal of NSRI is to decrease average 
sodium intake by 20 percent over 5 years (2009 through 2014) by 
developing stepwise reductions from 2009 base levels to those desired 
by 2014. To-date, 28 companies have responded to NSRI, committing to 
reductions in the sodium content of some of their products.
    These initiatives have been accompanied by efforts by industry, 
where a number of companies have played, and continue to play, a 
leadership role. Many food companies recognize that reduction of sodium 
in the American diet is an important public health issue. Some major 
food manufacturers have publicly committed to reducing the sodium 
content of their products over time. Certain companies have voluntarily 
identified specific product goals for sodium reduction. Many have 
demonstrated that substantial reductions in sodium can be achieved in 
certain food products and have established research programs to address 
key issues such as taste preference, technological advances, safety, 
and consumer acceptance in working through challenges and gaps in 
knowledge.
    Other countries are also engaged in sodium reduction activities 
(Refs. 29 and 30).

[[Page 57052]]

C. Institute of Medicine of the National Academies--Report on 
Strategies To Reduce Sodium

    In April 2010, the IOM released a report entitled ``Strategies to 
Reduce Sodium Intake in the United States.'' The report concluded that 
sodium intake, with the greatest contribution from salt, remains well 
above recommended levels despite several decades of education, 
labeling, and outreach efforts to reduce sodium consumption in the 
United States (Ref. 5). In the report, the committee considered past 
and current sodium reduction initiatives, consumer preference, the 
functional roles of sodium in food, research needs, regulatory options, 
and nutrition labeling in developing its recommendations. The IOM 
report acknowledged a number of complicating factors in reducing sodium 
in food. Although sodium primarily plays a role in altering taste, the 
IOM report noted that sodium chloride and other sodium-containing 
ingredients play a critical role in food safety by reducing the growth 
of pathogens thereby improving safety and shelf-life. In addition, 
these compounds provide functional and physical properties such as 
improving texture, controlling stickiness, and improving meltability. 
Among other things, the IOM report noted that more research is needed 
to develop and implement new technologies for sodium reduction and 
discussed the role of voluntary action by industry.

D. Sources and Function of Sodium in the Typical Diet

    According to data presented to the IOM committee during the March 
2009 public information gathering workshop (see Appendix L of the IOM 
Sodium Report), approximately 75 percent of the total sodium intake for 
most individuals is attributed to salt added as an ingredient or 
processing aid to processed and restaurant foods (Ref. 5). Sodium in 
the form of salt is added to food for many reasons. For example, salt 
functions as a seasoning agent and flavor-enhancer, a preservative and 
curing agent, a formulating and processing aid, and a dough conditioner 
(Ref. 5). Salt added at the table and in cooking provides only a small 
proportion of the total sodium that Americans consume (Ref. 9). A 
number of other sodium-containing ingredients contribute to sodium 
intake in lesser amounts (<1 percent) (Ref. 31). Some examples include 
sodium alginate, which alters viscosity; sodium phosphates, which bind 
liquid to reduce purge, in particular for solution-enhanced meat and 
poultry products; sodium sulfite, sodium nitrite, and sodium benzoate, 
which preserve food and inhibit microbial growth; and sodium lactate, 
diacetate, and acetate, which are dual purpose for flavoring and 
antimicrobial (pathogen reduction) purposes (Ref. 32). Non-sodium forms 
of these ingredients, which replace sodium with compounds such as 
potassium, calcium, and magnesium, are also available for some of these 
applications (Ref. 31).
    According to the National Cancer Institute (NCI), individual and 
mixed foods contributing the highest proportion of sodium to the U.S. 
diet include yeast breads (250 mg/d), chicken and chicken mixed dishes 
(233 mg/d), pizza (217 mg/d), pasta and pasta dishes (174 mg/d), and 
cold cuts (155 mg/d) (Ref. 33). The CDC reported that close to 40 
percent of daily sodium intake comes from grain-based products, such as 
breads, cakes, cookies, and crackers, and that almost 30 percent comes 
from processed meat products, such as bacon, sausage, lunch meat, 
poultry, and fish mixtures (Ref. 10). Sodium occurs naturally in nearly 
all foods; however this intrinsic sodium is not a significant dietary 
contributor for most Americans. Essentially, any single-ingredient food 
is low in sodium.

E. Sodium Reduction Opportunities

    FDA and FSIS are considering potential ways to promote gradual, 
achievable and sustainable reduction of sodium intake over time. 
Research on a variety of issues, including the development of possible 
targets for the reduction of the sodium content of foods, is needed to 
assist FDA and FSIS in this effort. Sodium-containing food ingredients 
are used for multiple purposes at variable levels in diverse foods. The 
sodium intake of the U.S. population reflects both the sodium levels of 
individual foods and the amounts of foods consumed. As such, there are 
a variety of factors that may inform judgments about appropriate 
opportunities for sodium reduction. These factors include:
    1. The important role that sodium has in food safety with respect 
to limiting microbial growth and maintaining the shelf-life of some 
foods;
    2. The effect of sodium reduction on the physical attributes (e.g., 
consistency, texture, shape, form) of some foods in ways that may 
impact consumer acceptance or food processing and manufacturing 
practices;
    3. The feasibility, practicality, and cost of reducing sodium in 
various food categories;
    4. The magnitude (time and percent sodium reduction) of any gradual 
or stepwise reduction effort;
    5. The need to act gradually in a manner that is acceptable to 
consumers, while also achieving significant sodium reduction, because 
taste preference for sodium is acquired and can be modified (Refs. 34 
and 35).

II. Establishment of a Docket and Request for Specific Input on Certain 
Topics

    FDA and FSIS are establishing dockets to provide an opportunity for 
interested persons to submit comments, research, data, and other 
information that will better inform them about current and emerging 
practices by the private sector in sodium reduction; current consumer 
understanding of the role of sodium in hypertension and other chronic 
illnesses; sodium consumption practices; motivation and barriers in 
reducing sodium in their food intakes; and issues associated with the 
development of targets for sodium reduction in foods to promote 
reduction in excess sodium intake. In particular, both agencies welcome 
input on the following matters:
    1. Comments and research related to recent sodium reduction 
initiatives by industry and the effects of those initiatives;
    2. Comments and research related to consumer understanding of the 
role of sodium in hypertension and other chronic illnesses, sodium 
consumption practices, and motivation and barriers in reducing sodium 
in their food intakes;
    3. Comments and research related to effective strategies for 
sustainable and meaningful reduction of sodium in foods sold in 
packaged or prepared form across the food supply, including and in 
particular foods with a high sales volume;
    4. Comments and research related to existing or potential positive 
incentives for innovation in reformulating packaged and restaurant 
foods to reduce added sodium;
    5. Comments and research related to the recommendations from the 
April 2010 IOM Sodium report on ``Strategies to Reduce Sodium Intake in 
the United States,'' including research related to information gaps 
identified in the IOM report (taste preferences for sodium, 
technological role of sodium/salt, role of food matrix, food safety, 
etc.);
    6. Comments and research related to the following: (a) Methods for 
establishing sodium reduction targets, including information on general 
target design (e.g., setting sodium reduction targets based on food 
categories, serving size, or formulations), (b) step-wise

[[Page 57053]]

approaches to achieve sustainable sodium reductions and timeframes for 
achieving such reductions, and (c) methods for evaluating the impact of 
a sodium reduction strategy;
    7. Comments and research related to avoiding potential unintended 
consequences for food safety, nutrition (including effects on added 
sugars or solid fats), or food manufacturing technologies that could 
result from interventions to reduce sodium;
    8. Comments and research related to existing voluntary sodium 
reduction efforts, including the voluntary sodium reduction targets set 
by the New York City-initiated NSRI partnership, and their 
applicability to a potentential federal sodium reduction initiative;
    9. Comments and research related to food formulation, processing, 
production, and other technology that could lead to meaningful and 
sustainable reductions in the amount of sodium in food, including 
specific food categories, targets, and methods to monitor;
    10. Comments and research on the role that food standards of 
identity play in promoting or limiting the feasibility of sodium 
reduction of foods (among other things, standards of identity for 
certain foods define the nature of those foods, generally in terms of 
how those foods are prepared, the types of ingredients that they must 
contain (i.e., mandatory ingredients) and that they may contain (i.e., 
optional ingredients), and how those foods must be labeled (Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 341); the Federal Meat 
Inspection Act (21 U.S.C. 607(c)); and the Poultry Products Inspection 
Act (21 U.S.C. 457(b)));
    11. Comments and research on any advantages of sodium to consumers, 
including but not limited to, food safety, nutrition, and palatability;
    12. Comments and research on the economic impacts of reducing 
sodium, including but not limited to, the cost of food, agricultural 
production, small businesses, jobs, and the health care system;
    13. Comments and research on the impact of sodium reduction 
initiatives on consumer food choices and compliance with 2010 Dietary 
Guidelines for Americans recommendations;
    14. Comments and research related to how consumers respond to 
sodium reductions (i.e., adding back salt to foods, consumption of 
reformulated products); and
    15. Comments and research related to effective methods for 
communicating to the public the health benefits associated with the 
sodium intake levels recommended by the 2010 Dietary Guidelines for 
Americans.
    We anticipate that some interested persons may wish to provide FDA 
and FSIS with certain comments, research, data, and information that 
they consider to be trade secret or confidential commercial information 
(CCI) that would be exempt under Exemption 4 of the Freedom of 
Information Act (5 U.S.C. 552). You may claim information that you 
submit to FDA and FSIS as CCI or trade secret by clearly marking both 
the document and the specific information as ``confidential.'' 
Information so marked will not be disclosed except in accordance with 
the Freedom of Information Act (5 U.S.C. 552) and the specific agency's 
disclosure regulations (FDA's regulations under 21 CFR part 20; FSIS's 
regulations under 9 CFR part 390). For electronic submissions to http://www.regulations.gov, indicate in the ``comments'' box of the 
appropriate docket that your submission contains confidential 
information. You must also submit a copy of the comment that does not 
contain the information claimed as confidential for inclusion in the 
public version of the official record. Information not marked 
confidential will be included in the public version of the official 
record without prior notice.

III. Public Meeting

    A Federal Register notice will be published in the near future 
announcing a public meeting to discuss the topics set forth in this 
notice.

IV. Comments

    FDA: Interested persons may submit to FDA's Division of Dockets 
Management (see ADDRESSES) either electronic or written comments 
regarding this document. It is only necessary to send one set of 
comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    FSIS: Interested persons may submit to FSIS's Docket Clerk (see 
ADDRESSES) either electronic or written comments regarding this 
document. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the FSIS 
Docket Room between 8:30 a.m. and 4:30 p.m., Monday through Friday.
    Because two docket numbers are associated with this document, 
please include with your comments the docket number that corresponds 
with the appropriate agency. Comments submitted for inclusion in both 
dockets should be separately submitted to each identified docket number 
to ensure consideration.

V. References

    FDA has placed the following references on display in FDA's 
Division of Dockets Management (see ADDRESSES). You may see them 
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the 
Web site addresses, but FDA is not responsible for any subsequent 
changes to Web sites after this document publishes in the Federal 
Register.)

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    Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy, Food and Drug Administration.
    Dated: September 12, 2011.
Alfred V. Almanza,
Administrator, Food Safety and Inspection Service.
[FR Doc. 2011-23753 Filed 9-13-11; 11:15 am]
BILLING CODE 4160-01-P