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Proposed Rule

Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Identification of the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish; Reopening of the Comment Period

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Information about this document as published in the Federal Register.

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; reopening of the comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening until June 3, 2005, the comment period for a proposed rule published in the Federal Register of March 20, 2002. In that document, FDA proposed to amend its voluntary nutrition labeling regulations by updating the names and nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. Since publication of the proposed rule, the agency has received new data in comments that it intends to use to further update the nutrition labeling values. The agency also intends to use additional data from the U.S. Department of Agriculture (USDA) for certain nutrients in raw produce. Those data became available after the close of the comment period. FDA is reopening the comment period to allow all interested parties the opportunity to review its tentative nutrition labeling values based upon data FDA received within and after the comment period, and to comment on the additional nutrient data for some of the 20 most frequently consumed raw fruits, vegetables, and fish. FDA will evaluate any new data submissions during this reopened comment period and will consider use of those data in a final rule.

DATES:

Submit written or electronic comments by June 3, 2005.

ADDRESSES:

You may submit comments, identified by Docket No. 2001N-0548, by any of the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
  • Agency Web site: http://www.fda.gov/​dockets/​ecomments. Follow the instructions for submitting comments on the agency Web site.
  • E-mail: fdadockets@oc.fda.gov. Include Docket No. 2001N-0548 in the subject line of your e-mail message.
  • FAX: 301-827-6870.
  • Mail/hand delivery/courier [for paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the agency name and docket number or regulatory information number for this rulemaking. All comments received will be posted without change to http://www.fda.gov/​ohrms/​dockets/​default.htm, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/​ohrms/​dockets/​default.htm and insert the relevant docket number, 01N-0548, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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FOR FURTHER INFORMATION CONTACT:

Mary Brandt, Center for Food Safety and Applied Nutrition (HFS-840), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1788.

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SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 20, 2002 (67 FR 12918) (the proposed rule), FDA proposed to amend its voluntary nutrition labeling regulations by updating the names and nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States based upon new data submitted or made available to the agency. In that document, we requested comments on the proposal by June 3, 2002. In the Federal Register of June 6, 2002 (67 FR 38913), we corrected the proposed rule that published with an incorrect docket number (i.e., Docket No. 01N-0458) and provided additional time to submit comments, until August 20, 2002.

In a comment to the proposed rule, USDA submitted nutrient data from its 2001-2002 nationwide sampling of fruits and vegetables (see http://www.fda.gov/​ohrms/​dockets/​dailys/​02/​Aug02/​080602/​01n-0548-c000006-vol1.pdf). USDA provided data for 16 of the 20 most frequently consumed fruits: Apple, avocado (California), banana, cantaloupe, grapefruit, honeydew melon, kiwifruit, nectarine, orange, peach, pear, pineapple, plums, strawberries, sweet cherries, and watermelon; and 12 of the top 20 vegetables: Bell pepper, broccoli, carrot, celery, cucumber, iceberg lettuce, leaf lettuce, onion, potato, radish, sweet potato, and tomato. At the time USDA submitted the comment, the data results for vitamin C, sodium, and potassium were not yet available, and the analysis of carotenoids for carrots, sweet potatoes, cucumbers, onions, and sweet peppers had not been completed. In June and July of 2003, after the close of the comment period, USDA provided sodium, potassium, and some carotenoid values that it did not submit earlier (Ref. 1). It also submitted vitamin C values for pineapple.

In other comments to the proposed rule, the Citrus Research Board and Food Research, Inc., provided nutrient data from 1998 for oranges, grapefruit, tangerines (Mandarin oranges), and lemons (see http://www.fda.gov/​ohrms/​dockets/​dailys/​02/​Aug02/​081602/​8001f4e1.pdf, http://www.fda.gov/​ohrms/​dockets/​dailys/​02/​Aug02/​082902/​01N-0548-cr00001-01-vol1.htm, and http://www.fda.gov/​ohrms/​dockets/​dailys/​02/​Aug02/​082902/​8002574a.doc).

Two comments recommended that Chinook salmon be included with the revised species of fish (see http://Start Printed Page 16996www.fda.gov/​ohrms/​dockets/​dailys/​02/​Aug02/​082102/​800222f0.pdf and http://www.fda.gov/​ohrms/​dockets/​dailys/​02/​Aug02/​082202/​8002239d.pdf). One comment noted that according to nutrient data from the USDA Nutrient Database for Standard Reference, the nutrient profile of Chinook salmon is most similar to the proposed category and values for Atlantic, Coho, and Sockeye salmon (Ref. 2).

Based upon data received during the comment period and USDA data received after the comment period, we have calculated updated nutrition labeling values for some of the 20 most frequently consumed raw fruits, vegetables, and fish. FDA is now reopening the comment period to allow the raw produce and fish industries and other interested parties the opportunity to review and react to updated nutrition labeling values based upon data FDA received within and after the comment period. Reopening the comment period may also provide an impetus for completion of additional nutrient analyses. We will evaluate any new data submissions received during this reopened comment period and will consider use of those data in a final rule.

II. Updating the Nutrition Labeling Values

We are reopening the comment period to revise the nutrition labeling values of the 20 most frequently consumed raw fruits, vegetables, and fish, which are included in appendices C and D to part 101. The proposed appendices C and D that we are publishing in this document include the updated values described in tables 1 and 2 of this document. As noted in the proposed rule, the agency believes that the values in proposed appendices C and D could be used on an interim basis prior to completion of the rulemaking, provided that the nutrition information is presented in a manner consistent with this document. However, firms should be aware that values included in a final rule may differ and would need to be changed.

Reference 3 provides complete documentation of the derivation of each nutrition labeling value for the 20 most frequently consumed raw fruits, vegetables, and fish.

A. FDA Analysis of the Data

1. Outlier Screening

Originally, for the proposed rule, we completed outlier screening of the data using the Grubbs outlier screening method to determine influential observations in the distributions of data for each nutrient and food. However, based upon comments received in response to the proposed rule and discussion of outliers in the statistical literature, we have determined not to conduct Grubbs outlier screening on the nutrient data for raw produce and fish.

In developing the nutrient values in the proposed rule, we took a conservative approach to outliers and deleted those data points identified through outlier screening.

There were several comments in response to the proposed rule that addressed outlier screening. Comments questioned the validity of using Grubbs outlier screening for fruits and recommended the use of visual scattergrams and bar graphs. Another comment questioned the removal of outliers.

The National Institute of Standards and Technology (NIST) e-Handbook of Statistical Methods states that the Grubbs test is based on the assumption of normality and should only be used with data that are normally distributed (Ref. 4). NIST also recommends that the test should not be used for sample sizes of six or less since it frequently tags most of the points as outliers. Many of the nutrient levels in the voluntary nutrition labeling program are based on small sample sizes because that is all the data that are available to FDA. Small sample sizes simply do not contain enough information to make inferences about the shape of the distribution in the entire population (Ref. 5).

Therefore, based on the information in the previous paragraphs, we have decided not to conduct Grubbs outlier screening on the nutrient data.

B. Changes in Nutrition Labeling Values for Raw Fruits and Vegetables

The following is a summary of tentative changes from the nutrition labeling values in the proposed rule for some of the 20 most frequently consumed raw fruits and vegetables. FDA derived the updated values from the raw data provided by USDA and the Citrus Research Board during the comment period, as well as existing data. We also considered data for sodium, potassium, carotenoids, and vitamin C that USDA submitted after the comment period. Other changes were related to discontinuance of outlier screening. As explained in the proposed rule, when possible, FDA used compliance calculations based on 95 percent intervals to derive nutrition labeling values.

Table 1.—Proposed Changes to the Nutrition Labeling Information for Raw Fruits and Vegetables

Food and Nutrient2002 Proposed ValuesReopening Comment Period Proposed Values
% DV% DV
Apple (154 grams (g))
Potassium170 milligrams (mg)5%160 mg5%
Total carbohydrate22 g7%21 g7%
Dietary fiber5 g20%3 g12%
Iron2%0%
Avocado (30 g)
Total fat6 g9%5 g8%
Saturated fat0.5 g3%1 g5%
Potassium160 mg5%140 mg4%
Start Printed Page 16997
Banana (126 g)
Sodium0 mg0%5 mg0%
Potassium400 mg11%450 mg13%
Total carbohydrate29 g10%30 g10%
Dietary fiber4 g16%2 g8%
Sugars21 g19 g
Cantaloupe (134 g)
Sodium25 mg1%20 mg1%
Potassium280 mg8%240 mg7%
Total carbohydrate13 g4%12 g4%
Sugars12 g11 g
Vitamin A100%120%
Calcium2%0%
Grapefruit (154 g)
Potassium230 mg7%160 mg5%
Total carbohydrate16 g5%15 g5%
Dietary fiber6 g24%2 g8%
Sugars10 g11 g
Vitamin A15%35%
Vitamin C110%100%
Calcium2%4%
Honeydew melon (134 g)
Sodium35 mg1%30 mg1%
Potassium310 mg9%210 mg6%
Total carbohydrate13 g4%12 g4%
Sugars12 g11 g
Kiwifruit (148 g)
Calories10090
Total fat1 g2%1.5 g2%
Potassium480 mg14%450 mg13%
Total carbohydrate24 g8%20 g7%
Sugars16 g13 g
Protein2 g1 g
Calcium6%4%
Iron4%2%
Start Printed Page 16998
Lemon (58 g)
Sodium5 mg0%0 mg0%
Potassium90 mg3%75 mg2%
Sugars1 g2 g
Nectarine (140 g)
Calories7060
Calories from fat05
Total fat0 g0%0.5 g1%
Potassium290 mg8%250 mg7%
Total carbohydrate17 g6%15 g5%
Sugars13 g11 g
Orange (154 g)
Potassium260 mg7%250 mg7%
Total carbohydrate21 g7%19 g6%
Dietary fiber7 g28%3 g12%
Vitamin A2%0%
Iron2%0%
Peach (147 g)
Calories7060
Total fat0 g0%0.5 g1%
Potassium260 mg7%230 mg7%
Total carbohydrate18 g6%15 g5%
Sugars14 g13 g
Vitamin A8%6%
Pear (166 g)
Calories from fat100
Total fat1 g2%0 g0%
Potassium210 mg6%180 mg5%
Sugars17 g16 g
Protein1 g0 g
Calcium2%0%
Pineapple (112 g)
Calories6050
Potassium115 mg3%120 mg3%
Total carbohydrate16 g5%13 g4%
Start Printed Page 16999
Sugars13 g10 g
Vitamin A0%2%
Vitamin C25%50%
Iron2%0%
Plums (151 g)
Calories8070
Potassium250 mg7%230 g7%
Total carbohydrate21 g7%19 g6%
Dietary fiber2 g8%1 g4%
Sugars13 g16 g
Iron2%0%
Strawberries (147 g)
Potassium270 mg8%170 mg5%
Total carbohydrate12 g4%11 g4%
Dietary fiber4 g16%2 g8%
Sugars8 g6 g
Calcium2%0%
Iron4%0%
Sweet cherries (140 g)
Calories90100
Potassium300 mg9%350 mg10%
Total carbohydrate23 g8%26 g9%
Dietary fiber3 g12%1 g4%
Sugars20 g16 g
Protein2 g1 g
Tangerine (109 g)
Calories from fat50
Total fat0.5 g1%0 g0%
Sodium0 g0%5 mg0%
Potassium180 mg5%160 mg5%
Dietary fiber3 g12%2 g8%
Sugars8 g9 g
Vitamin A0%6%
Vitamin C50%45%
Watermelon (280 g)
Start Printed Page 17000
Calories10080
Sodium10 mg0%0 mg0%
Potassium230 mg7%270 mg8%
Total carbohydrate27 g9%21 g7%
Dietary fiber2 g8%1 g4%
Sugars25 g20 g
Vitamin A20%30%
Bell pepper (148 g)
Calories3025
Sodium0 mg0%40 mg2%
Potassium270 mg8%220 mg6%
Total carbohydrate7 g2%6 g2%
Vitamin A8%4%
Iron2%4%
Broccoli (148 g)
Sodium55 mg2%80 mg3%
Potassium540 mg15%460 mg13%
Total carbohydrate8 g3%10 g3%
Dietary fiber5 g20%3 g12%
Sugars3 g2 g
Protein5 g2 g
Vitamin A15%6%
Iron6%4%
Carrot (78 g)
Calories3530
Sodium40 mg2%60 mg3%
Potassium280 mg8%250 mg7%
Total carbohydrate8 g3%7 g2%
Vitamin A270%110%
Celery (110 g)
Calories2015
Sodium100 mg4%115 mg5%
Potassium350 mg10%260 mg7%
Total carbohydrate5 g2%4 g1%
Dietary fiber2 g8%1 g4%
Start Printed Page 17001
Sugars1 g2 g
Protein1 g0 g
Vitamin A2%10%
Cucumber (99 g)
Potassium170 mg5%140 mg4%
Protein1 g0 g
Iceberg lettuce (89 g)
Calories1510
Potassium120 mg3%125 mg4%
Total carbohydrate3 g1%2 g1%
Vitamin A4%6%
Leaf lettuce (85 g)
Sodium30 mg1%35 mg1%
Potassium230 mg7%170 mg5%
Total carbohydrate4 g1%2 g1%
Dietary fiber2 g8%1 g4%
Sugars2 g1 g
Vitamin A40%130%
Iron0%4%
Onion (148 g)
Calories6045
Potassium240 mg7%160 mg5%
Total carbohydrate14 g5%11 g4%
Protein2 g1 g
Calcium4%2%
Iron2%4%
Potato (148 g)
Calories40110
Sodium10 mg0%0 mg0%
Potassium650 mg19%620 mg18%
Total carbohydrate7 g2%26 g9%
Dietary fiber4 g16%2 g8%
Sugars2 g1 g
Vitamin C40%45%
Iron8%6%
Start Printed Page 17002
Radishes (85 g)
Calories1510
Sodium25 mg1%55 mg2%
Potassium230 mg7%160 mg5%
Dietary fiber0 g0%1 g4%
Protein1 g0 g
Iron0%2%
Sweet potato (130 g)
Calories140100
Sodium45 mg2%70 mg3%
Potassium340 mg10%440 mg13%
Total carbohydrate32 g11%23 g8%
Vitamin A440%120%
Calcium2%4%
Tomato (148 g)
Calories3525
Calories from fat50
Total fat0.5 g1%0 g0%
Sodium5 mg0%35 mg1%
Potassium360 mg10%340 mg10%
Total carbohydrate7 g2%5 g2%
Sugars4 g3 g
Iron2%4%

C. Changes in Nutrition Labeling Values for Raw Fish

The following is a summary of tentative changes from the nutrition labeling values in the proposed rule for some of the 20 most frequently consumed raw fish. Changes were related to discontinuance of outlier screening and to inclusion of raw Chinook salmon with Atlantic, Coho, and Sockeye salmon. FDA derived values for fish using data from the USDA National Nutrient Databank (Ref. 6). When possible, FDA used compliance calculations based on 95 percent intervals to derive nutrition labeling values. When raw data were unavailable, FDA used data from the newest version of USDA Nutrient Database for Standard Reference, Release 17 (Ref. 2).

Table 2.—Proposed Changes to the Nutrition labeling for Cooked Fish

Food and Nutrient (per 84 grams (g)/3 ounces)2002 Proposed ValuesReopening Comment Period Proposed Values
% DV% DV
Cod
Sodium55 milligrams (mg)2%65 mg3%
Flounder/sole
Start Printed Page 17003
Potassium400 mg11%390 mg11%
Calcium0%2%
Haddock
Sodium75 mg3%85 mg4%
Halibut
Cholesterol35 mg12%40 mg13%
Calcium4%2%
Ocean perch
Cholesterol50 mg17%45 mg15%
Iron6%4%
Pollock
Calories10090
Rockfish
Calories100110
Total fat1.5 g2%2 g3%
Salmon, Atlantic/Coho/Sockeye—Chinook added in update
Calories190200
Cholesterol65 mg22%70 mg23%
Sodium65 mg3%55 mg2%
Potassium320 mg9%430 mg12%
Vitamin A2%4%
Vitamin C2%4%
Salmon, chum/pink
Calories from fat3540
Scallops
Cholesterol60 mg20%65 mg22%
Vitamin C6%0%
Iron2%14%
Shrimp
Sodium250 mg10%240 mg10%
Iron6%10%

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. 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.

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III. References

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

1. Brandt, M.M., memo to the file: Nutrient data from U.S. Department of Agriculture received after close of comment period, Center for Food Safety and Applied Nutrition, FDA, February 2005.

2. U.S. Department of Agriculture, Agricultural Research Service, USDA Nutrient Database for Standard Reference, Release 17, 2004. Available on the Internet at USDA's Nutrient Data Laboratory home page, http://www.nal.usda.gov/​fnic/​foodcomp/​.

3. LeGault, L.A. and M.M. Brandt, “Documentation for the Nutrition Labeling Values for the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish,” Center for Food Safety and Applied Nutrition, FDA, November 2004.

4. NIST/SEMATECH e-Handbook of Statistical Methods, http://www.itl.nist.gov/​div898/​handbook/​index.htm and http://www.itl.nist.gov/​div898/​handbook/​eda/​section3/​eda35h.htm. Accessed January 3, 2005.

5. The Prism Guide to Interpreting Statistical Results, excerpted from Analyzing Data With GraphPad Prism, http://www.graphpad.com/​articles/​interpret/​Analyzing_​two_​groups/​choos_​anal_​comp_​two.htm. Accessed March 21, 2005.

6. U.S. Department of Agriculture, National Nutrient Data Bank, maintained at the Nutrient Data Laboratory, Agricultural Research Service, Beltsville Human Nutrition Research Center, Beltsville, MD.

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Start Signature

Dated: March 25, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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BILLING CODE 4160-01-S

[FR Doc. 05-6475 Filed 4-1-05; 8:45 am]

BILLING CODE 4160-01-C