[Federal Register Volume 59, Number 51 (Wednesday, March 16, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-6011] [[Page Unknown]] [Federal Register: March 16, 1994] _______________________________________________________________________ Part III Department of Agriculture _______________________________________________________________________ Food Safety and Inspection Service _______________________________________________________________________ 9 CFR Parts 317 and 381 Placement of Nutrition Labeling and Other Mandatory Labeling on Meat and Poultry Products; Proposed Rule ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 317 and 381 [Docket No. 93-020P] RIN 0583-AB72 Placement of Nutrition Labeling and Other Mandatory Labeling on Meat and Poultry Products AGENCY: Food Safety and Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat and poultry products inspection regulations by defining the information panel on the labeling of meat and poultry products; allowing mandatory labeling information to be shown in the information panel, in addition to the principal display panel; allowing nutrition information to be shown on other than the principal display panel or the informational panel of meat and poultry products; and allowing final labeling bearing nutrition information, which has been approved by FSIS in sketch form, to be generically approved. This action would provide increased flexibility in the placement of nutrition information and other mandatory information on the labeling of meat and poultry products and streamline the nutrition labeling approval process. Portions of this proposal parallel a Food and Drug Administration (FDA) proposal concerning placement of the nutrition information on food packages. DATES: Comments must be received on or before May 16, 1994. ADDRESSES: Written comments to: Policy Office, ATTN: Diane Moore, FSIS Hearing Clerk, room 3171, South Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. Oral comments as provided by the Poultry Products Inspection Act should be directed to Mr. Charles Edwards at (202) 254-2565. (See also ``Comments'' under ``Supplementary Information.'') FOR FURTHER INFORMATION CONTACT: Charles Edwards, Director, Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, (202) 254-2565. SUPPLEMENTARY INFORMATION: Executive Order 12866 This proposed rule has been reviewed under Executive Order 12866. Executive Order 12778 This proposed rule has been reviewed under Executive Order 12778, Civil Justice Reform. States and local jurisdictions are preempted under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) from imposing any marking, labeling, packaging, or ingredient requirement on federally inspected meat and poultry products that are in addition to, or different than, those imposed under the FMIA or PPIA. States and local jurisdictions may, however, exercise concurrent jurisdiction over meat and poultry products that are outside official establishments for the purpose of preventing the distribution of meat and poultry products that are misbranded or adulterated under the FMIA or PPIA, or, in the case of imported articles, which are not at such an establishment, after their entry into the United States. Under the FMIA and PPIA, States that maintain meat and poultry inspection programs must impose requirements that are at least equal to those required under the FMIA and PPIA. The States may, however, impose more stringent requirements on such State inspected products and establishments. No retroactive effect will be given to this proposed rule. The administrative procedures specified in 9 CFR 306.5 and 381.35 must be exhausted prior to any judicial challenge of the application of the provisions of this proposed rule, if the challenge involves any decision of an inspector relating to inspection services provided under the FMIA or PPIA. The administrative procedures specified in 9 CFR parts 335 and 381, subpart W, must be exhausted prior to any judicial challenge of the application of the provisions of this proposed rule with respect to labeling decisions. Effect on Small Entities The Administrator has determined that this proposed rule would not have a significant effect on small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). The proposed rule would provide official establishments with additional flexibility in placing nutrition labeling and other mandatory information on the labeling of meat and poultry products. Small meat and poultry establishments are exempt from nutrition labeling, provided the labels of their products bear no nutrition claims or nutrition information. Therefore, most small establishments would not be affected by the portion of this proposed rule pertaining to the placement of nutrition information on the labeling. The other portion of this proposed rule would provide regulatory flexibility in placing other mandatory information, such as the ingredients statement or the name of the company, on the labeling. Such flexibility is already provided to all establishments under current labeling regulations and policy. Therefore, small establishments would see minimal, if any, impact from this portion of the proposed rule. Small businesses referred to as label expeditors, however, would be affected by the portion of the proposed rule pertaining to the generic approval of nutrition labeling which has been approved in sketch form. While such entities would be affected because the number of labels requiring the existing expediting service would decrease, the number of firms expediting label approvals is not substantial. Moreover, the Agency believes that since the proposed rule would only affect that category of labeling bearing nutrition information, the economic impact on the expediting service may not be significant because many of the existing label expeditors are likely to modify the services they offer and provide consulting services to their existing clients. This portion of the proposed rule would have a positive, but not significant, impact on a large number of small meat and poultry processors because it would reduce their direct labeling application costs. Paperwork Requirements This proposed rule would require the category of labels addressed in this rule to be approved only once by FSIS's Food Labeling Division (FLD) in sketch, and if no changes are made, no additional approval would be necessary (generic approval). Therefore, to receive final approval, establishments would not have to complete FSIS Form 7234, ``Application for Approval of Labels, Marking or Device,'' which transmits labels to FLD for review and approval. This would eliminate duplication in the labeling approval system and reduce the number of labels reviewed and processed by FLD. Therefore, this proposal would expedite the labeling approval process for the specific category of labeling addressed in this rule and would also reduce official establishments' paperwork burden. Comments Interested persons are invited to submit comments concerning this proposal. Written comments should be sent to the Policy Office and refer to Docket No. 93-020P. Any person desiring an opportunity for an oral presentation of views, as provided by the Poultry Products Inspection Act, should make such a request to Mr. Charles Edwards, so that arrangements can be made for such views to be presented. A record will be made of all views orally presented. All comments submitted in response to this proposal will be available for public inspection at the Policy Office from 9 a.m. to 12:30 p.m. and from 1:30 p.m. to 4 p.m., Monday through Friday. Background FSIS published its final nutrition labeling regulations in the Federal Register on January 6, 1993 (58 FR 632). Corrections and technical amendments to this final rule were published on August 18, 1993 (58 FR 43787) and September 10, 1993 (58 FR 47624), respectively. The final rule permits voluntary nutrition labeling on single- ingredient, raw meat and poultry products, and establishes mandatory nutrition labeling for all other meat and poultry products, with certain exceptions. The rule also specifies a new format for nutrition information and the location of nutrition information on the label of packaged products. Nutrition information on a label of packaged meat or poultry products must appear on the label's principal display panel or on the information panel, except for gift packs. Nutrition information for gift packs may be displayed at a location other than on the product label, such as label inserts. Recognizing label space constraints, FSIS included provisions in the final rule that allow a modified nutrition label on products in packages that have a total surface area available to bear labeling of 40 or less square inches, so that the required nutrition information could be presented on any label panel. The flexibility provided by these provisions reflects FSIS's recognition that is more important that the nutrition information be presented on the immediate package than in any particular place. In addition, FSIS, stated in the preamble to the final rule that it will consider, on a case-by-case basis, allowing the modified nutrition label for packages larger than 40 square inches that have a surface area which precludes the presentation of the full nutrition label. Such determinations are made by FSIS at the time meat and poultry manufacturers obtain prior approval for the content and design if labeling for their products before the products may be marketed. Following publication of its final rule on nutrition labeling, FSIS received many comments from the meat and poultry industry requesting greater flexibility in the placement of nutrition information on the product label. The commenters stated that the type size and spacing requirements for the display of the nutrition information prevented its placement in compliance with current labeling regulations and policy. FSIS agrees that new nutrition information displays often require more space on the label than current nutrition information displays, and that it is sometimes difficult to fit all required information on the information panel. FSIS has concluded that increased flexibility in regard to the placement of nutrition information is necessary to ensure that mandatory information on labels is readable and not overcrowded. FSIS believes this flexibility can be achieved without hindering consumer use of labeling information. FDA reached similar conclusions based on its review of layouts to implement its nutrition labeling regulations, as well as its review of comments received after publication of its final rule. Based on its conclusion that greater flexibility in the placement of nutrition information is needed, FDA published a proposed rule in the Federal Register on August 18, 1993 (58 (FR 44091), to permit such flexibility. Under the nutrition labeling regulations, most meat and poultry product labels, with certain exceptions, must be revised and resubmitted for review and approval by FSIS. FSIS anticipates that approximately 120,000 labels would require nutrition labeling under the final nutrition labeling regulations. FSIS has acknowledged the extensive economic impact of the nutrition labeling requirements, as well as the need for substantive Agency resources to review all such revised labels. The volume of labels bearing nutrition labeling, compounded by the routine submittal of labels requiring approval, is expected to place a tremendous burden upon the current prior label approval system. FSIS believes this burden would be reduced without loss of information to consumers by allowing the labeling to be generically approved once it has been approved by FSIS in sketch form. Current Regulations and Agency Policy Currently, 9 CFR 317.2(d) and 381.116(b) define the ``principal display panel'' as the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. Under 9 CFR 317.2(c), 381.117, 381.118, 381.121, 381.121a, 381.122, and 381.123, this panel must include the name of the product; the ingredients statement, if the product is fabricated from two or more ingredients; the name and place of business of the manufacturer, packer, or distributor; the net quantity of contents; an official inspection legend and the number of the official establishment; and any other information required by the regulations. Section 381.116(a) of the poultry products inspection regulations (9 CFR 381.116(a)) prescribes that information required to appear on the principal display panel, except as otherwise permitted in the regulations, shall be in distinctly legible form, read in the same general direction, generally parallel to each other, and appear in the English language, except that Spanish may be substituted for English, under certain cases, for all information except the inspection legend. The Federal meat inspection regulations contain similar provisions, except that mandatory information on the principal display panel is not required to read in the same general direction and be generally parallel to each other. In August 1980, the Food Labeling Division of FSIS issued Policy Memo 7, Information Panel, which permits the use of an information panel, in addition to the principal display panel, for providing mandatory labeling information on meat and poultry products.\1\ This policy memo was issued because establishments were experiencing difficulty in providing all required information on the principal display panel. Policy Memo 7 provides that the mandatory information that may appear on an information panel includes nutrition information, an ingredients statement, and the firm's name and address. The inspection legend and number on cylindrical cans may also appear on the information panel, but must be placed on the 20 percent area immediately to the right of the principal display panel. --------------------------------------------------------------------------- \1\A copy of this policy memo is available for public inspection in the office of the FSIS Hearing Clerk. --------------------------------------------------------------------------- Policy Memo 7 also defines an information panel as the first usable surface to the right of the principal display panel. Usable surfaces exclude those having folded flaps, tear strips, opening flaps, heat- sealed type flaps, or less than adequate space to accommodate the mandatory information. Surfaces having information, such as vignettes, UPC codes, preparation instructions, and serving suggestions are considered usable and such information should be displaced if an information panel is used. The policy memo specifies that where a surface is larger than needed to accommodate the mandatory information, the information panel is a section of that surface and must contain all mandatory information in one place without intervening nonmandatory information. The information panel must be located on the left side of any such large surface. Sections 317.4, 327.14, 327.15, 381.132, and 381.205 of the regulations describes FSIS's prior label approval program. Under this program, official establishments may submit labeling in sketch form (i.e., printer's proof or other version that clearly shows all required features, size, location, and indication of final color) to the Food Labeling Division for approval. After official establishments print final labels based on approved sketches, the final labeling must be resubmitted for approval by either the Food Labeling Division or an inspector-in-charge, depending on the modification made to the final labeling. In addition, Secs. 317.5 and 381.134 of the regulations provide that labeling can be generically approved for use without additional authorization, provided the labeling shows all mandatory information in a sufficiently prominent manner and is not otherwise false or misleading in any particular. The Proposal FSIS is proposing to amend the Federal meat and poultry products inspection regulations by allowing mandatory labeling information to be placed on the information panel and by defining ``information panel.'' This action is necessary to specify in the regulations the location of mandatory information which cannot be accommodated on the principal display panel due to insufficient space. These new provisions would replace current directions on use of the information panel and would rescind Policy Memo 7. Accordingly, FSIS proposes to add a new paragraph (m) to 9 CFR 317.2 and a new paragraph (c) to 9 CFR 381.116 to define the information panel as the first usable surface to the right of the principal display panel or alternate principal display panel that can be readily seen by consumers. These added provisions would also require that all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining whether sufficient space is available, any vignettes, designs, and other nonmandatory information shall not be considered. If either panel cannot accommodate all mandatory information, the information may be divided between the principal display panel or the information panel. However, information required by any single regulation, such as the ingredients statement, must appear complete on a single panel. All information on the information panel shall appear in one place without intervening material, such as vignettes. FSIS proposes to add the information panel as a location for the ingredients statement and the name and place of business of the manufacturer, packer, or distributor, except as otherwise specified in the regulations, by amending 9 CFR 317.2(f), 317.2(g)(2), 381.118, and 381.122 to this effect. FSIS is aware that, in certain instances, such as when only a principal display panel is used on a package with no other surface area to place a label, it is not always possible for all mandatory information to fit and read in the same direction on the principal display panel. In such cases, it is necessary to provide some information perpendicular to the other mandatory information on the panel to fit all information on the panel. Therefore, FSIS proposes to delete the wording from 9 CFR 381.116 that requires all mandatory information on the principal display panel to read in the same general direction for the reasons discussed in the preceding section of the preamble. FSIS is proposing to allow the nutrition information to be placed on any panel that can be readily seen by consumers when a package has a total surface area available to bear labeling of greater than 40 square inches, but its principal display and information panels cannot accommodate all mandatory information. Thus, if the first panel to the right of the principal display panel, such as the right side of a box, can accommodate all mandatory information other than the nutrition information, the nutrition information may be placed on any other panel, such as the left side or the top of the box. The establishment would also have the option of placing all mandatory information, including the nutrition information, on the next usable right panel big enough to accommodate all information, such as the back of the box. This action would provide increased flexibility by allowing establishments to position the nutrition information to reduce crowding of mandatory information. FSIS believes that providing this flexibility would not produce any loss of comprehensibility, understandability, or information for consumers. Current rules for determining the space available to bear mandatory labeling information in 9 CFR 317.2(d) and 381.116(b) are that the principal display panel be large enough to accommodate all mandatory information with clarity and conspicuousness without it being obscured by nonmandatory label information or crowding. Thus, nonmandatory labeling information on the principal display panel must be counted as usable space for mandatory information in determining sufficiency of space. The purpose of these provisions is to ensure that mandatory labeling information is prominently displayed on meat or poultry product labels, so that consumers can easily locate such information. FSIS believes that a different treatment of nonmandatory information on the principal display panel is appropriate in deciding where nutrition information is to be presented because the graphic requirements for nutrition information required by 9 CFR 317.309(e) and 381.409(e) result in a ``Nutrition Facts'' panel that is easy to locate regardless of its placement on the label. Given the demand for labeling space made by nutrition information, FSIS is proposing to exclude designs, vignettes, and other nonmandatory information on the principal display panel in calculating the amount of available space for determining the panel on which nutrition information should appear. To displace these items could significantly affect the appearance of many packages with little gain in comprehensibility for consumers. In addition, current industry practice almost never places the nutrition information on the principal display panel unless there is no alternative panel on the package. These proposed actions would require an accompanying modification to the nutrition labeling regulations pertaining to relative nutrient content claims. The specific provisions to be modified would be provisions of FDA's final nutrition labeling regulations of January 6, 1993 (58 FR 2302) (as corrected at 58 FR 17341, April 2, 1993, and adopted by FSIS at 58 FR 43787, August 18, 1993), that FSIS cross- referenced in its codified language. To incorporate the modifications into its codified language, FSIS would subdivide existing paragraphs and add new paragraphs. The existing portions of text are included only to define the subdivisions, place the proposed requirements in the framework of existing provisions, and make the revised sections easier to interpret. In its final rule, FSIS cross-referenced 21 CFR 101.13(j)(2)(iv)(B), which requires that when a relative nutrient content claim is made, clear and concise quantitative information comparing the amount of the subject nutrient in the product per labeled serving with that in the reference food shall appear adjacent to the most prominent claim or on the information panel. FDA repeated this requirement in each regulation in 21 CFR part 101 pertaining to relative claims (i.e., claims about ``more,'' ``light,'' calories, sodium, and fat, fatty acids, and cholesterol) and FSIS cross- referenced most of these provisions. FSIS is proposing to amend these provisions to require that the comparative quantitative information be placed adjacent to the most prominent claim or to the nutrition information. Likewise, FSIS is proposing to modify the provision that pertains to the placement of the statement ``not a sodium free food'' on products that are not sodium free and yet whose label bears a claim of ``unsalted.'' FSIS is proposing to require that the statement be placed adjacent to the nutrition information. FSIS finds that these comparative statements and the statements about the sodium content of products provide information about the nutritional content of the product. They are of the greatest value to consumers when presented in conjunction with other nutrition information about the product. Because nutrition information may or may not appear on the principal display panel or the information panel, FSIS believes that the location of the comparative statements and the statement on sodium content should be tied to the placement of the nutrition information rather than placed on the principal display panel or the information panel. The nutrition labeling regulations require extensive revision of existing meat and poultry product labels. All labels modified to meet the nutrition labeling regulations must be submitted to FSIS for review and approval prior to use. FSIS anticipates that approximately 120,000 labels would require nutrition labeling under the final nutrition labeling regulations. Since publication of the nutrition labeling regulations on January 6, 1993, only about 5,000 labels designed to implement the nutrition labeling regulations have been approved by FSIS. The projected increase in the volume and complexity of labeling applications submitted to FSIS for approval from companies seeking to comply with the nutrition labeling regulations, compounded by the routine submittal of labels requiring approval, but exempt from nutrition labeling, is expected to place a tremendous burden on the current prior labeling approval system. On November 23, 1993, FSIS published a proposed rule in the Federal Register (58 FR 62014) which proposes to change the prior labeling approval system, in part, by allowing final labeling, which was approved by FSIS in sketch form, to be used without further FSIS authorization. However, because the prior labeling approval proposal encompasses various labeling issues, a final rule may not be issued in a timely manner to alleviate the anticipated burden on the prior labeling approval system resulting from nutrition labeling applications. Therefore, FSIS is proposing to allow final labeling bearing nutrition information to be generically approved. Under the proposed system, official establishments would be permitted to use final labeling bearing nutrition information, which has been approved by FSIS in sketch form, without additional authorization, provided the final labeling has been prepared without modifications or with modifications permitted in 9 CFR 317.5(b) and 381.134(b), and the final labeling is not false or misleading. Such labeling must be designed in accordance with 9 CFR part 317, subpart B, and 381, subpart Y. FSIS believes it is an unnecessary burden on industry to require the submission of final labeling when the sketch has been previously approved. Because the labeling would have been reviewed and approved by FSIS in the sketch form, the proposed action would not compromise the truthfulness and accuracy of the meat and poultry product labeling. The proposal would eliminate unnecessary duplication in the labeling approval system and reduce the number of labels reviewed and processed by FSIS. Consequently, the proposal would improve the efficiency of FSIS by expediting the label approval process for a specific category of labeling, and would also reduce the paperwork burden on official establishments. Since only 5,000 labeling applications have been approved during the first 11 months of the 18- month implementation period for the nutrition labeling regulations, the majority of meat and poultry product manufacturers would benefit from timely implementation of measures to ease compliance with the regulations. List of Subjects 9 CFR Part 317 Food labeling, Food packaging, Meat inspection. 9 CFR Part 381 Food labeling, Poultry and poultry products, Poultry inspection. Proposed Rule For the reasons discussed in the preamble, FSIS is proposing to amend 9 CFR parts 317 and 381 of the Federal meat and poultry products inspection regulations to read as follows: PART 317--LABELING, MARKING DEVICES, AND CONTAINERS 1. The authority citation for part 317 would continue to read as follows: Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55. 2. Section 317.2 would be amended by adding paragraphs (f)(4), (g)(2)(iv), and (m), and revising paragraph (g)(2)(iii) to read as follows: Sec. 317.2 Labels: definition; required features. * * * * * (f) * * * (4) The ingredient statement may be placed on the information panel, except as otherwise permitted in the subchapter. (g) * * * (2) * * * (iii) On the front riser panel of frozen food cartons, or (iv) On the information panel. * * * * * (m)(1) The information panel is that part of a label that is the first surface to the right of the principal display panel as observed by an individual facing the principal display panel, with the following exceptions: (i) If the first surface to the right of the principal display panel is too small to accommodate the required information or is otherwise unusable label space, e.g., folded flaps, tear strips, opening flaps, heat-sealed flaps, the next panel to the right of this part of the label may be used. (ii) If the package has one or more alternate principal display panels, the information panel is to the right of any principal display panel. (iii) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel. (2)(i) Except as otherwise permitted in this part, all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as otherwise prescribed in this part, any vignettes, designs, and any other nonmandatory information shall not be considered. If there is insufficient space for all required information to appear on a single panel, it may be divided between the principal display panel and the information panel, provided that the information required by any given provision of this part, such as the ingredients statement, is not divided and appears on the same panel. (ii) All information appearing on the information panel pursuant to this section shall appear in one place without intervening material, such as designs or vignettes. 3. Section 317.5 would be amended by adding paragraph (c) to read as follows: Sec. 317.5 Generically approved labeling. * * * * * (c) Labeling bearing nutrition information which has been approved by the Food Labeling Division, Washington, DC, in sketch form (i.e., printer's proof or other version that clearly shows all required features, size, location, and indication of final color) is approved for use without additional authorization by the Administrator: Provided, (1) That the final label has not been modified, except as permitted in paragraph (b) of this section; and (2) That the final label is not false or misleading. 4. Section 317.302 would be amended by revising paragraph (a) and adding paragraph (c) to read as follows: Sec. 317.302 Location of nutrition information. (a) Nutrition information on a label of a packaged meat product shall appear on the label's principal display panel or on the information panel, except as provided in paragraphs (b) and (c) of this section. (b) * * * (c) Meat products in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition information. In determining the sufficiency of available space for the nutrition information, the space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered. 5. Section 317.313 would be amended by revising paragraph (j) to read as follows: Sec. 317.313 Nutrient content claims; general principles. * * * * * (j)(1) Products may bear a statement that compares the level of a nutrient in the product with the level of a nutrient in a reference food in accordance with 21 CFR 101.13(j), except: (i) Comparison to product of another manufacturer at 21 CFR 101.13(j)(1)(ii)(B); and (ii) The placement of the comparison statement on the product label at 21 CFR 101.13(j)(2)(iv)(B). (2) This statement shall appear adjacent to the most prominent claim or to the nutrition information. * * * * * 6. Section 317.354 would be revised to read as follows: Sec. 317.354 Nutrient content claims for ``good source,'' ``high,'' and ``more.'' (a) Nutrient content claims about a nutrient in a product in relation to the Reference Daily Intake (RDI) established for that nutrient in 21 CFR 101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in 21 CFR 101.9(c)(9), excluding total carbohydrate, may be used on the label or in labeling, in accordance with 21 CFR 101.54, except: (1) The placement of the comparison statement on the product label at 21 CFR 101.54(e)(1)(iii)(B) and (e)(2)(iii)(B); and (2) The meal products definition shall be as prescribed in Sec. 317.313(l), and there shall be no provision for main dish products. (b) Quantitative information comparing the level of the nutrient in the individual food product per labeled serving, with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``fiber content of `reference food' is 1 g per serving; `this product' contains 4 g per serving''). (c) Quantitative information comparing the level of the nutrient in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``fiber content of `reference product' is 2 g per 3 oz; `this product' contains 5 g per 3 oz''). 7. Section 317.356 would be amended by revising paragraph (a) and adding paragraphs (c), (d), and (e) to read as follows: Sec. 317.356 Nutrient content claims for ``light'' or ``lite.'' (a) General requirements. The following nutrient content claims using the term ``light'' or ``lite'' to describe a product may be used on the label and in labeling, provided that the product is labeled in compliance with 21 CFR 101.56, except: (1) The placement of the comparison statement on the product label at 21 CFR 101.56 (b)(3)(ii), (c)(1)(ii)(B), (c)(2)(ii)(B), and (g); and (2) The meal products definition shall be as prescribed in Sec. 317.313(l), and there shall be no provision for main dish products. (b) * * * (c) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``lite `this product'--200 calories, 4 g fat; regular `reference product'--300 calories, 8 g fat per serving''); and (d) Quantitative information comparing the level of sodium per labeled serving size with that of the reference food it replaces, regardless of the level of calories and fat content in the reference food, is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``lite `this product'--500 mg sodium per serving; regular `reference product'--1,000 mg per serving''; or ``lite `this product'--170 mg sodium per serving; regular `reference product'--350 mg per serving''). (e) The term ``lightly salted'' may be used on a product to which has been added 50 percent less sodium than is normally added to the reference food as described in 21 CFR 101.13(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as defined in 21 CFR 101.61(b)(4), the statement ``not a low sodium food'' shall appear adjacent to the nutrition information and the information required to accompany a relative claim shall appear on the label or labeling as specified in 21 CFR 101.13(j)(2). 8. Section 317.360 would be revised to read as follows: Sec. 317.360 Nutrient content claims for calorie content. (a) Nutrient content claims about the calorie content of a product may be used on the label on in labeling in accordance with 21 CFR 101.60, except: (1) The placement of the comparison statement on the product label at 21 CFR 101.60(b)(4)(ii)(B), (b)(5)(ii)(B), (c)(4)(ii)(B), and (c)(5)(ii)(B); and (2) The meal products definition shall be as prescribed in Sec. 317.313(l), and there shall be no provision for main dish products. (b) Quantitative information comparing the level of calories and sugars in the individual food product per labeled serving size with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``calorie content has been reduced from 150 to 100 calories per serving''; or ``sugar content has been lowered from 8 g to 6 g per serving''). (c) Quantitative information comparing the level of calories and sugars in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``calorie content has been reduced from 110 calories per 3 oz to 80 calories per 3 oz''; or ``sugar content has been reduced from 17 g per 3 oz to 13 g per 3 oz''). 9. Section 317.361 would be revised to read as follows: Sec. 317.361 Nutrient content claims for the sodium content. (a) Nutrient content claims about the sodium content of a product may be used on the label and in labeling in accordance with 21 CFR 101.61, except: (1) The placement of the comparison statement on the product label at 21 CFR 101.61(b)(6)(ii)(B), (b)(7)(ii)(B), and (c)(2)(iii); and (2) The meal products definition shall be as prescribed in Sec. 317.313(l), and there shall be no provision for main dish products. (b) Quantitative information comparing the level of the sodium in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``sodium content has been lowered from 300 to 150 mg per serving''). (c) Quantitative information comparing the level of sodium in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``sodium content has been reduced from 220 mg per 3 oz to 150 mg per 3 oz''). (d) If the product is not sodium free, the statement ``not a sodium free food'' or ``not for control of sodium in the diet'' appears adjacent to the nutrition information of the product bearing the claim. 10. Section 317.362 would be amended by revising paragraphs (a)(2), (a)(3), (a)(5), (a)(11), (a)(13), and (a)(16), and adding paragraphs (d) through (f) to read as follows: Sec. 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content of meat products. (a) * * * (2) 21 CFR 101.62(b), except: (i) The placement of the comparison statement on the product label at 21 CFR 101.62(b)(4)(ii)(B) and (5)(ii)(B), and (ii) The meal products definition shall be as prescribed in Sec. 317.313(l), there will be no provision for main dish products, and the following provision shall be added: A synonym for the term ``______ percent fat free'' is `` ______ percent lean''; (3) 21 CFR 101.62(c), except: (i) The placement of the comparison statement on the product label at 21 CFR 101.62(c)(4)(ii)(B) and (5)(ii)(B); and (ii) There will be no disclosure of the level of total fat and cholesterol in the food in immediate proximity to such claim each time the claim is made, the meal products definition shall be as prescribed in Sec. 317.313(l), and there will be no provision for main dish products; (4) * * * (5) 21 CFR 101.62(d)(1)(i)(A) through (D) and (d)(1)(ii)(F), except the placement of the comparison statement on the product label at 21 CFR 101.62(d)(1)(ii)(F)(2), and there will be no provision for main dish products; * * * * * (11) 21 CFR 101.62(d)(2)(iii)(E), except the placement of the comparison statement at 21 CFR 101.62(d)(2)(iii)(E)(2); (12) * * * (13) 21 CFR 101.62(d)(4)(i)(A) through (C), except the placement of the comparison statement at 21 CFR 101.62(d)(4)(i)(C)(2); * * * * * (16) 21 CFR 101.62(d)(5)(i)(A) through (C), except the placement of the comparison statement at 21 CFR 101.62(d)(5)(1)(C)(2). * * * * * (d)(1) Quantitative information comparing the level of fat in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``fat content has been reduced from 8 g to 4 g per serving''). (2) Quantitative information comparing the level of fat in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent such claim or to the nutrition information (e.g., ``fat content has been reduced from 8 g per 3 oz to 5 g per 3 oz''). (e)(1) Quantitative information comparing the level of saturated fat in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``saturated fat reduced from 3 g to 1.5 g per serving''). (2) Quantitative information comparing the level of saturated fat in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``saturated fat content has been reduced from 2.5 g per 3 oz to 1.5 g per 3 oz''). (f)(1) Quantitative information for claims of cholesterol free, low cholesterol or reduced cholesterol comparing the level of cholesterol in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``contains no cholesterol compared with 30 mg in one serving of `reference food'; contains 11 g of fat per serving''; or ``cholesterol lowered from 30 mg to 5 mg per serving; contains 13 g of fat per serving''). (2) Quantitative information comparing the level of cholesterol in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 3 oz''). PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS 11. The authority citation for part 381 would continue to read as follows: Authority: 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR 2.17, 2.55. 12. Section 381.116 would be amended by revising the second sentence of paragraph (a) and adding a new paragraph (c) to read as follows: Sec. 381.116 Wording on labels of immediate containers. (a) * * *. Such items of information shall be in distinctly legible form and shall be generally parallel to each other.* * * (b) * * * (c)(1) The information panel is that part of a label that is the first surface to the right of the principal display panel as observed by an individual facing the principal display panel, with the following exceptions: (i) If the first surface to the right of the principal display panel is too small to accommodate the required information or is otherwise unusable label space, e.g., folded flaps, tear strips, opening flaps, heat-sealed flaps, the next panel to the right of this part of the label may be used. (ii) If the package has one or more alternate principal display panels, the information panel is to the right of any principal display panel. (iii) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel. (2)(i) Except as otherwise permitted in this part, all information required to appear on the principal display panel or permitted to appear on the information panel shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as otherwise prescribed in this part, any vignettes, designs, and any other nonmandatory information shall not be considered. If there is insufficient space for all required information to appear on a single panel, it may be divided between the principal display panel and the information panel, provided that the information required by any given provision of this part, such as the ingredients statement, is not divided and appears on the same panel. (ii) All information appearing on the information panel pursuant to this section shall appear in one place without intervening material, such as designs or vignettes. 13. Section 381.118 would be amended by adding a new paragraph (e) to read as follows: Sec. 381.118 Ingredients statement. * * * * * (e) The ingredients statement may be placed on the information panel, except as otherwise permitted in this subchapter. 14. Section 381.122 would be amended by revising the last sentence of the paragraph to read as follows: Sec. 381.122 Identification of manufacturer, packer, or distributor. * * *. The name and place of business of the manufacturer, packer, or distributor may be shown on the principal display panel, on the 20- percent panel of the principal display panel reserved for required information, on the front riser panel of frozen food cartons, or on the information panel. 15. Section 381.134 would be amended by adding paragraph (c) to read as follows: Sec. 381.134 Generically approved labeling. * * * * * (c) Labeling bearing nutrition information which has been approved by the Food Labeling Division, Washington, DC, in sketch form (i.e., printer's proof or other version that clearly shows all required features, size, location, and indication of final color) is approved for use without additional authorization by the Administrator: Provided, (1) That the final label has not been modified, except as permitted in paragraph (b) of this section; and (2) That the final label is not false or misleading. 16. Section 381.402 would be amended by revising paragraph (a) and adding paragraph (c) to read as follows: Sec. 381.402 Location of nutrition information. (a) Nutrition information on a label of a packaged poultry product shall appear on the label's principal display panel or on the information panel, except as provided in paragraphs (b) and (c) of this section. (b) * * * (c) Poultry products in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition information. In determining the sufficiency of available space for the nutrition information, the space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered. 17. Section 381.413 would be amended by revising paragraph (j) to read as follows: Sec. 381.413 Nutrient content claims; general principles. * * * * * (j)(1) Products may bear a statement that compares the level of a nutrient in the product with the level of a nutrient in a reference food in accordance with 21 CFR 101.13(j), except: (i) Comparison to product of another manufacturer at 21 CFR 101.13(j)(1)(ii)(B); and (ii) The placement of the comparison statement on the product label at 21 CFR 101.13(j)(2)(iv)(B). (2) This statement shall appear adjacent to the most prominent claim or to the nutrition information. * * * * * 18. Section 381.454 would be revised to read as follows: Sec. 381.454 Nutrient content claims for ``good source,'' ``high,'' and ``more.'' (a) Nutrient content claims about a nutrient in a product in relation to the Reference Daily Intake (RDI) established for that nutrient in 21 CFR 101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in 21 CFR 101.9(c)(9), excluding total carbohydrate, may be used on the label or in labeling, in accordance with 21 CFR 101.54, except: (1) The placement of the comparison statement on the product label at 21 CFR 101.54(e)(1)(iii)(B) and (e)(2)(iii)(B); and (2) The meal products definition shall be as prescribed in Sec. 381.413(l), and there shall be no provision for main dish products. (b) Quantitative information comparing the level of the nutrient in the individual food product per labeled serving, with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``fiber content of `reference food' is 1 g per serving; `this product' contains 4 g per serving''). (c) Quantitative information comparing the level of the nutrient in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``fiber content of `reference product' is 2 g per 3 oz; `this product' contains 5 g per 3 oz''). 19. Section 381.456 would be amended by revising paragraph (a) and adding paragraphs (c), (d), and (e) to read as follows: Sec. 381.456 Nutrient content claims for ``light'' or ``lite.'' (a) General requirements. The following nutrient content claims using the term ``light'' or ``lite'' to describe a product may be used on the label and in labeling, provided that the product is labeled in compliance with 21 CFR 101.56, except: (1) The placement of the comparison statement on the product label at 21 CFR 101.56 (b)(3)(ii), (c)(1)(ii)(B), (c)(2)(ii)(B), and (g); and (2) The meal products definition shall be as prescribed in Sec. 381.413(l), and there shall be no provision for main dish products. (b) * * * (c) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``lite `this product'--200 calories, 4 g fat; regular `reference product'--300 calories, 8 g fat per serving''); and (d) Quantitative information comparing the level of sodium per labeled serving size with that of the reference food it replaces, regardless of the level of calories and fat content in the reference food, is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``lite `this product'--500 mg sodium per serving; regular `reference product'--1,000 mg per serving''; or ``lite `this product'--170 mg sodium per serving; regular `reference product'--350 mg per serving''). (e) The term ``lightly salted'' may be used on a product to which has been added 50 percent less sodium than is normally added to the reference food as described in 21 CFR 101.13(j)(1)(i)(B) and (j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as defined in 21 CFR 101.61(b)(4), the statement ``not a low sodium food'' shall appear adjacent to the nutrition information and the information required to accompany a relative claim shall appear on the label or labeling as specified in 21 CFR 101.13(j)(2). 20. Section 381.460 would be revised to read as follows: Sec. 381.460 Nutrient content claims for calorie content. (a) Nutrient content claims about the calorie content of a product may be used on the label or in labeling in accordance with 21 CFR 101.60, except: (1) The placement of the comparison statement at 21 CFR 101.60(b)(4)(ii)(B), (b)(5)(ii)(B), (c)(4)(ii)(B), and (c)(5)(ii)(B); and (2) The meal products definition shall be as prescribed in Sec. 381.413(l), and there shall be no provision for main dish products. (b) Quantitative information comparing the level of calories and sugars in the individual food product per labeled serving size with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``calorie content has been reduced from 150 to 100 calories per serving''; or ``sugar content has been lowered from 8 g to 6 g per serving''). (c) Quantitative information comparing the level of calories and sugars in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``calorie content has been reduced from 110 calories per 3 oz to 80 calories per 3 oz''; or ``sugar content has been reduced from 17 g per 3 oz to 13 g per 3 oz''). 21. Section 381.461 would be revised to read as follows: Sec. 381.461 Nutrient content claims for the sodium content. (a) Nutrient content claims about the sodium content of a product may be used on the label and in labeling in accordance with 21 CFR 101.61, except: (1) The placement of the comparison statement on the product label at 21 CFR 101.61(b)(6)(ii)(B), (b)(7)(ii)(B), and (c)(2)(iii); and (2) The meal products definition shall be as prescribed in Sec. 381.413(l), and there shall be no provision for main dish products. (b) Quantitative information comparing the level of the sodium in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``sodium content has been lowered from 300 to 150 mg per serving''). (c) Quantitative information comparing the level of sodium in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``sodium content has been reduced form 220 mg per 3 oz to 150 mg per 3 oz''). (d) If the product is not sodium free, the statement ``not a sodium free food'' or ``not for control of sodium in the diet'' appears adjacent to the nutrition information of the product bearing the claim. 22. Section 381.462 would be amended by revising paragraphs (a)(2), (a)(3), (a)(5), (a)(11), (a)(13), and (a)(16), and adding paragraphs (d) through (f) to read as follows: Sec. 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content of meat products. (a) * * * (2) 21 CFR 101.62(b), except: (i) The placement of the comparison statement on the product label at 21 CFR 101.62(b)(4)(ii)(B) and (5)(ii)(B); and (ii) The meal products definition shall be as prescribed in Sec. 381.413(l), there will be no provision for main dish products, and the following provision shall be added: A synonym for the term ``______ percent fat free'' is ``______ percent lean''; (3) 21 CFR 101.62(c), except: (i) The placement of the comparison statement on the product label at 21 CFR 101.62(c)(4)(ii)(B) and (5)(ii)(B); and (ii) There will be no disclosure of the level of total fat and cholesterol in the food in immediate proximity to such claim each time the claim is made, the meal products definition shall be as prescribed in Sec. 381.413(l), and there will be no provision for main dish products; (4) * * * (5) 21 CFR 101.62(d)(1)(i) (A) through (D) and (d)(1)(ii)(F), except the placement of the comparison statement on the product label at 21 CFR 101.62(d)(1)(ii)(F)(2), and there will be no provision for main dish products; * * * * * (11) 21 CFR 101.62(d)(2)(iii)(E), except the placement of the comparison statement on the product label at 21 CFR 101.62(d)(2)(iii)(E)(2); (12) * * * (13) 21 CFR 101.62(d)(4)(i) (A) through (C), except the placement of the comparison statement on the product label at 21 CFR 101.62(d)(4)(i)(C)(2); * * * * * (16) 21 CFR 101.62(d)(5)(i) (A) through (C), except the placement of the comparison statement on the product label at 21 CFR 101.62(d)(5)(i)(C)(2). * * * * * (d)(1) Quantitative information comparing the level of fat in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``fat content has been reduced from 8 g to 4 g per serving''). (2) Quantitative information comparing the level of fat in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent such claim or to the nutrition information (e.g., ``fat content has been reduced from 8 g per 3 oz to 5 g per 3 oz''). (e)(1) Quantitative information comparing the level of saturated fat in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``saturated fat reduced from 3 g to 1.5 g per serving''). (2) Quantitative information comparing the level of saturated fat in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``saturated fat content has been reduced from 2.5 g per 3 oz to 1.5 g per 3 oz''). (f)(1) Quantitative information for claims of cholesterol free, low cholesterol, or reduced cholesterol comparing the level of cholesterol in the individual food product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``contains no cholesterol compared with 30 mg in one serving of `reference food'; contains 11 g of fat per serving''; or ``cholesterol lowered from 30 mg to 5 mg per serving; contains 13 g of fat per serving''). (2) Quantitative information comparing the level of cholestrol in the meal product per specified weight with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., ``cholesterol content has been reduced from 35 mg per 3 oz to 25 mg per 3 oz''). Done at Washington, DC, on March 9, 1994. Patricia Jensen, Acting Assistant Secretary, Marketing & Inspection Services. [FR Doc. 94-6011 Filed 3-15-94; 8:45 am] BILLING CODE 3410-DM-M