9 CFR Part 317 -- Labeling, Marking Devices, and Containers - eCFR

(h)

Click here to get more.

(1) The statement of net quantity of contents shall appear on the principal display panel of all containers to be sold at retail intact, in conspicuous and easily legible boldface print or type in distinct contrast to other matter on the container, and shall be declared in accordance with the provisions of this paragraph.

(2) The statement as it is shown on a label shall not be false or misleading and shall express an accurate statement of the quantity of contents of the container. Reasonable variations caused by loss or gain of moisture during the course of good distribution practices or by unavoidable deviations in good manufacturing practices will be recognized. Variations from stated quantity of contents shall be as provided in § 317.19. The statement shall not include any term qualifying a unit of weight, measure, or count such as “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “minimum,” or words of similar importance.

(3) The statement shall be placed on the principal display panel within the bottom 30 percent of the area of the panel in lines generally parallel to the base: Provided, That on packages having a principal display panel of 5 square inches or less, the requirement for placement within the bottom 30 percent of the area of the label panel shall not apply when the statement meets the other requirements of this paragraph (h). In any case, the statement may appear in more than one line. The terms “net weight” or “net wt.” shall be used when stating the net quantity of contents in terms of weight, and the term “net contents” or “content” when stating the net quantity of contents in terms of fluid measure.

(4) Except as provided in § 317.7, the statement shall be expressed in terms of avoirdupois weight or liquid measure. Where no general consumer usage to the contrary exists, the statement shall be in terms of liquid measure, if the product is liquid, or in terms of weight if the product is solid, semisolid viscous or a mixture of solid and liquid. For example, a declaration of 3⁄4-pound avoirdupois weight shall be expressed as “Net Wt. 12 oz.” except as provided for in paragraph (h)(5) of this section for random weight packages; a declaration of 11⁄2 pounds avoirdupois weight shall be expressed as “Net Wt. 24 oz.,” “Net Wt. 1 lb. 8 oz.,” “Net Wt. 11⁄2 lb.,” or “Net Wt. 1.5 lbs.”.

(5) On packages containing 1 pound or 1 pint and less than 4 pounds or 1 gallon, the statement shall be expressed in ounces or in pounds, with any remainder in terms of ounces or common or decimal fraction of the pound, or in the case of liquid measure, in the largest whole units with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart, except that on random weight packages the statement shall be expressed in terms of pounds and decimal fractions of the pound, for packages over 1 pound, and for packages which do not exceed 1 pound the statement may be in decimal fractions of the pound in lieu of ounces. Paragraph (h)(9) of this section permits certain exceptions from the provisions of this paragraph for margarine packages, random weight consumer size packages, and packages of less than 1⁄2 ounce net weight. Pargraph (h)(12) of this section permits certain exceptions from the provision of this paragraph for multi-unit packages.

(6) The statement shall be in letters and numerals in type size established in relationship to the area of the principal display panel of the package and shall be uniform of all packages of substantially the same size by complying with the following type specifications:

(i) Not less than one-sixteenth inch in height on packages, the principal display panel of which has an area of 5 square inches or less;

(ii) Not less than one-eighth inch in height on packages, the principal display panel of which has an area of more than 5 but not more than 25 square inches;

(iii) Not less than three-sixteenths inch in height on packages, the principal display panel of which has an area of more than 25 but not more than 100 square inches;

(iv) Not less than one-quarter inch in height on packages, the principal display panel of which has an area of more than 100 but not more than 400 square inches.

(v) Not less than one-half inch in height on packages, the principal display panel of which has an area of more than 400 square inches.

(7) The ratio of height to width of letters and numerals shall not exceed a differential of 3 units to 1 unit (no more than 3 times as high as it is wide). Heights pertain to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter “o” or its equivalent that shall meet the minimum standards. When fractions are used, each component numeral shall meet one-half the height standards.

(8) The statement shall appear as a distinct item on the principal display panel and shall be separated by a space at least equal to the height of the lettering used in the statement from other printed label information appearing above or below the statement and by a space at least equal to twice the width of the letter “N” of the style of type used in the quantity of contents statement from other printed label information appearing to the left or right of the statement. It shall not include any term qualifying a unit of weight, measure, or count such as, “jumbo quart,” “full gallon,” “giant quart,” “when packed,” “Minimum” or words of similar import.

(9) The following exemptions from the requirements contained in this paragraph (h) are hereby established:

(i) Individually wrapped, random weight consumer size packages shipped in bulk containers (as specified in paragraph (h)(11) of this section) and meat products that are subject to shrinkage through moisture loss during good distribution practices and are designated as gray area type of products as defined under § 317.19 need not bear a net weight statement when shipped from an official establishment, provided that a net weight shipping statement which meets the requirements of paragraph (h)(2) of this section is applied to their shipping container prior to shipping it from the official establishment. Net weight statements so applied to the shipping container are exempt from the type size and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the shipping container. The net weight also shall be applied directly to random weight consumer size packages prior to retail display and sale. The net weight statement on random weight consumer size packages for retail sale shall be exempt from the type size and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.

(ii) Individually wrapped and labeled packages of less than 1⁄2 ounce net weight and random weight consumer size packages shall be exempt from the requirements of this paragraph if they are in a shipping container and the statement of net quantity of contents on the shipping container meets the requirements of paragraph (h)(2) of this section;

(iii) Individually wrapped and labeled packages of less than 1⁄2 ounce net weight bearing labels declaring net weight, price per pound, and total price, shall be exempt from the type size and placement requirements of this paragraph, if an accurate statement of net weight is shown conspicuously on the principal display panel of the package.

(iv) Margarine in 1 pound rectangular packages (except packages containing whipped or soft margarine or packages that contain more than four sticks) is exempt from the requirements of paragraph (h)(3) of this section regarding the placement of the statement of the net quantity of contents within the bottom 30 percent of the principal display panel and that the statement be expressed both in ounces and in pounds, if the statement appears as “1 pound” or “one pound” in a conspicuous manner on the principal display panel.

(v) Sliced shingle packed bacon in rectangular packages is exempt from the requirements of paragraph (h)(3) of this section regarding the placement of the statement of the net quantity of contents within the bottom 30 percent of the principal display panel if the statement appears in a conspicuous manner on the principal display panel.

(10) Labels for containers which bear any representation as to the number of servings contained therein shall bear, contiguous to such representation, and in the same size type as is used for such representation, a statement of the net quantity of each such serving.

(11) As used in this section, a “random weight consumer size package” is one which is one of a lot, shipment or delivery of packages of the same product with varying weights and with no fixed weight pattern.

(12) On a multiunit retail package, a statement of the net quantity of contents shall appear on the outside of the package and shall include the number of individual units, the quantity of each individual unit, and in parentheses, the total net quantity of contents of the multiunit package in terms of avoirdupois or fluid ounces. For the purposes of this section, “multiunit retail package” means a package containing two or more individually packaged units of the identical commodity and in the same quantity, with the individual packages intended to be sold as part of the multiunit retail package but capable of being individually sold in full compliance with all requirements of the regulations in this part. Open multiunit retail packages that do not obscure the number of units and the labeling thereon are not subject to this paragraph if the labeling of each individual unit complies with the requirements of paragraphs (h) (2), (3), (6), and (8) of this section.

(j) Labels of any product within any of the following paragraphs shall show the information required by such paragraph for such product:

(1) A label for product which is an imitation of another food shall bear the word “imitation” immediately preceding the name of the food imitated and in the same size and style of lettering as in that name and immediately thereafter the word “ingredients:” and the names of the ingredients arranged in the order of their predominance.

(2) If a product purports to be or is represented for any special dietary use by man, its label shall bear a statement concerning its vitamin, mineral, and other dietary properties upon which the claim for such use is based in whole or in part and shall be in conformity with regulations (21 CFR part 125) established pursuant to sections 403, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343, 371).

(3) When an artificial smoke flavoring or a smoke flavoring is added as an ingredient in the formula of a meat food product, as permitted in part 318 of this subchapter, there shall appear on the label, in prominent letters and contiguous to the name of the product, a statement such as “Artificial Smoke Flavoring Added” or “Smoke Flavoring Added,” as may be applicable, and the ingredient statement shall identify any artificial smoke flavoring or smoke flavoring so added as an ingredient in the formula of the meat food product.

(4) When any other artificial flavoring is permitted under part 318 of this subchapter to be added to a product, the ingredient statement shall identify it as “Artificial Flavoring.”

(5) When artificial coloring is added to edible fats as permitted under part 318 of this subchapter such substance shall be declared on the label in a prominent manner and contiguous to the name of the product by the words “Artificially colored” or “Artificial coloring added” or “With added artificial coloring.” When natural coloring such as annatto is added to edible fats as permitted under part 318 of this subchapter, such substance shall be declared on the label in the same manner by a phrase such as “Colored with annatto.”

(6) When product is placed in a casing to which artificial coloring is applied as permitted under part 318 of this subchapter, there shall appear on the label, in a prominent manner and contiguous to the name of the product, the words, “Artificially colored.”

(7) If a casing is removed from product at an official establishment and there is evidence of artificial coloring on the surface of the product, there shall appear on the label, in a prominent manner and contiguous to the name of product, the words “Artificially colored.”

(8) When a casing is colored prior to its use as a covering for product and the color is not transferred to the product enclosed in the casing, no reference to color need appear on the label but no such casing may be used if it is misleading or deceptive with respect to color, quality, or kind of product, or otherwise.

(9) Product which bears or contains any other artificial coloring, as permitted under part 318 of this subchapter, shall bear a label stating that fact on the immediate container or if there is none, on the product.

(10) When an antioxidant is added to product as permitted under part 318 of this subchapter, there shall appear on the label in prominent letters and contiguous to the name of the product, a statement identifying the officially approved specific antioxidant by its common name or abbreviation thereof and the purpose for which it is added, such as, “BHA, BHT, and Propylgallate added to help protect flavor.”

(11) Containers of meat packed in borax or other preservative for export to a foreign country which permits the use of such preservative shall, at the time of packing, be marked “for export,” followed on the next line by the words “packed in preservative,” or such equivalent statement as may be approved for this purpose by the Administrator and directly beneath this there shall appear the word “establishment” or abbreviation thereof, followed by the number of the establishment at which the product is packed. The complete statement shall be applied in a conspicuous location and in letters not less than 1 inch in height.

(12) Containers of other product packed in, bearing, or containing any chemical preservative shall bear a label stating that fact.

(13)

(i) On the label of any “Mechanically Separated (Species)” described in § 319.5(a) of this subchapter, the name of such product shall be followed immediately by the phrase “for processing” unless such product has a protein content of not less than 14 percent and a fat content of not more than 30 percent.

(ii) When any “Mechanically Separated (Species)” described in § 319.5 of this subchapter is used as an ingredient in the preparation of a meat food product and such “Mechanically Separated (Species)” contributes 20 mg or more of calcium to a serving of such meat food product, the label of such meat food product shall state the calcium content of such meat food product, determined and expressed as the percentage of the U.S. Recommended Daily Allowance (U.S. RDA) in a serving in accordance with 21 CFR 101.9(b)(1), (c)(7) (i) and (iv), and (e), as part of any nutrition information included on such label, or if such meat food product does not bear nutrition labeling information, as part of a prominent statement in immediate conjunction with the list of ingredients, as follows: “A ______ serving contains ____% of the U.S. RDA of calcium”, with the blanks to be filled in, respectively, with the quantity of such product that constitutes a serving and the amount of calcium provided by such serving: Provided, That, calcium content need not be stated where (a) the percent of the U.S. RDA of calcium to be declared would not differ from the percent of the U.S. RDA that would be declared if the meat food product contained only hand deboned ingredients or (b) the calcium content of a serving of the meat food product would be 20 percent of the U.S. RDA or more if the meat food product contained only hand deboned ingredients.

(b) The labels and containers of product shall comply with the following provisions, as applicable:

(1) Establishments may only use statements, words, pictures, designs, or devices on the label having geographical significance with reference to a locality other than where the animal from which the product was derived was born, raised, slaughtered, and processed if the statements, words, pictures, designs, or devices are qualified by the word “style,” “type,” or “brand,” as the case may be, in the same size and style of lettering as in the geographical statement, word, picture, design, or device, and accompanied with a prominent qualifying statement identifying the country, State, Territory, or locality, using terms appropriate to effect the qualification. When the word “style” or “type” is used, there must be a recognized style or type of product identified with and peculiar to the area represented by the geographical statement, word, picture, design, or device and the product must possess the characteristics of such style or type, and the word “brand” shall not be used in such a way as to be false or misleading: Provided, That a geographical statement, word, picture, design, or device which has come into general usage as a trade name and which has been approved by the Administrator as being a generic statement, word, picture, design, or device may be used without the qualifications provided for in this paragraph. The terms “frankfurter,” “vienna,” “bologna,” “lebanon bologna,” “braunschweiger,” “thuringer,” “genoa,” “leona,” “berliner,” “holstein,” “goteborg,” “milan,” “polish,” “italian,” and their modifications, as applied to sausages, the terms “brunswick” and “irish” as applied to stews and the term “boston” as applied to pork shoulder butts need not be accompanied with the word “style,” “type,” or “brand,” or a statement identifying the locality in which the product is prepared.

(2) Such terms as “farm” or “country” shall not be used on labels in connection with products unless such products are actually prepared on the farm or in the country: Provided, That if the product is prepared in the same way as on the farm or in the country these terms, if qualified by the word “style” in the same size and style of lettering, may be used: Provided further, That the term “farm” may be used as part of a brand designation when qualified by the word “brand” in the same size and style of lettering, and followed with a statement identifying the locality in which the product is prepared: And Provided further, That the provisions of this paragraph shall not apply to products prepared in accordance with § 319.106 of this subchapter. Sausage containing cereal shall not be labeled “farm style” or “country style,” and lard not rendered in an open kettle shall not be designated as “farm style” or “country style.”

(3) The requirement that the label shall contain the name and place of business of the manufacturer, packer, or distributor shall not relieve any establishment from the requirement that its label shall not be misleading in any particular.

(4) The term “spring lamb” or “genuine spring lamb” is applicable only to carcasses of new-crop lambs slaughtered during the period beginning in March and terminating not beyond the close of the week containing the first Monday in October.

(5)

(i) Coverings shall not be of such color, design, or kind as to be misleading with respect to color, quality, or kind of product to which they are applied. For example, transparent or semitransparent coverings for such articles as sliced bacon or fresh (uncooked) meat and meat food products shall not bear lines or other designs of red or other color which give a false impression of leanness of the product. Transparent or semitransparent wrappers, casings, or coverings for use in packaging cured, cured and smoked, or cured and cooked sausage products, and sliced ready-to-eat meat food products may be color tinted or bear red designs on 50 percent of such wrapper or covering: Provided, That the transparent or semitransparent portion of the principal display panel is free of color tinting and red designs: And provided further, That the principal display panel provides at least 20 percent unobstructed clear space, consolidated in one area so that the true nature and color of the product is visible to the consumer.

(ii) Packages for sliced bacon that have a transparent opening shall be designed to expose, for viewing, the cut surface of a representative slice. Packages for sliced bacon which meet the following specifications will be accepted as meeting the requirements of this subparagraph provided the enclosed bacon is positioned so that the cut surface of the representative slice can be visually examined:

(a) For shingle-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the length (longest dimension) of the representative slice, and this window shall be at least 11⁄2 inches wide. The transparent window shall be located not more than five-eighths inch from the top or bottom edge of a 1-pound or smaller package and not more than three-fourths inch from either the top or bottom edge of a package larger than 1 pound.

(b) For stack-packed sliced bacon, the transparent window shall be designed to reveal at least 70 percent of the length (longest dimension) of the representative slice and be at least 11⁄2 inches wide.

(6) The word “fresh” shall not be used on labels to designate product which contains any sodium nitrate, sodium nitrite, potassium nitrate, or potassium nitrite, or which has been salted for preservation.

(7)

(i) No ingredient shall be designated on the label as a spice, flavoring, or coloring unless it is a spice, flavoring, or coloring, as the case may be. An ingredient that is both a spice and a coloring, or both a flavoring and a coloring, shall be designated as “spice and coloring”, or “flavoring and coloring”, as the case may be, unless such ingredient is designated by its common or usual name.

(ii) Any ingredient not designated in § 317.2(f)(1)(i) of this part whose function is flavoring, either in whole or in part, must be designated by its common or usual name. Those ingredients which are of livestock and poultry origin must be designated by names that include the species and livestock and poultry tissues from which the ingredients are derived.

(8) As used on labels of product, the term “gelatin” shall mean

(i) the jelly prepared in official establishments by cooking pork skins, tendons, or connective tissue from inspected and passed product, and

(ii) dry commercial gelatin or the jelly resulting from its use.

(9) Product (other than canned product) labeled with the term “loaf” as part of its name:

(i) If distributed from the official establishment in consumer size containers may be in any shape;

(ii) If distributed in a container of a size larger than that sold intact at retail the product shall be prepared in rectangular form, or as in paragraph (b)(9)(iii) of this section;

(iii) If labeled as an “Old Fashioned Loaf” shall be prepared in a traditional form, such as rectangular with rounded top or circular with flat bottom and rounded top.

(10) The term “baked” shall apply only to product which has been cooked by the direct action of dry heat and for a sufficient time to permit the product to assume the characteristics of a baked article, such as the formation of a brown crust on the surface, rendering out of surface fat, and the caramelization of the sugar if applied. Baked loaves shall be heated to a temperature of at least 160 °F. and baked pork cuts shall be heated to an internal temperature of at least 170 °F.

(11) When products such as loaves are browned by dipping in hot edible oil or by a flame, the label shall state such fact, e.g., by the words “Browned in Hot Cottonseed Oil” or “Browned by a Flame,” as the case may be, appearing as part of the product name.

(12) The term “meat” and the names of particular kinds of meat, such as beef, veal, mutton, lamb, and pork, shall not be used in such manner as to be false or misleading.

(13) The word “ham,” without any prefix indicating the species of animal from which derived, shall be used in labeling only in connection with the hind legs of swine. Ham shanks as such or ham shank meat as such or the trimmings accruing in the trimming and shaping of hams shall not be labeled “ham” or “ham meat” without qualification. When used in connection with a chopped product the term “ham” or “ham meat” shall not include the skin.

(14) The terms “shankless” and “hockless” shall apply only to hams and pork shoulders from which the shank or hock has been completely removed, thus eliminating the entire tibia and fibula, or radius and ulna, respectively, together with the overlying muscle, skin, and other tissue.

(15) Such terms as “meat extract” or “extract of beef” without qualification shall not be used on labels in connection with products prepared from organs or other parts of the carcass, other than fresh meat. Extracts prepared from any parts of the carcass other than fresh meat may be properly labeled as extracts with the true name of the parts from which prepared. In the case of extract in fluid form, the word “fluid” shall also appear on the label, as, for example, “fluid extract of beef.”

(16) [Reserved]

(17) When any product is enclosed in a container along with a packing substance such as brine, vinegar, or agar jelly, a declaration of the packing substance shall be printed prominently on the label as part of the name of the product, as for example, “frankfurts packed in brine,” “lamb tongue packed in vinegar,” or “beef tongue packed in agar jelly,” as the case may be. The packing substance shall not be used in such a manner as will result in the container being so filled as to be misleading.

(18) “Leaf lard” is lard prepared from fresh leaf fat.

(19) When lard or hardened lard is mixed with rendered pork fat or hardened rendered pork fat, the mixture shall be designated as “rendered pork fat” or “hardened rendered pork fat,” as the case may be.

(20) Oil, stearin, or stock obtained from beef or mutton fats rendered at a temperature above 170 °F. shall not be designated as “oleo oil,” “oleo stearin,” or “oleo stock,” respectively.

(21) When not more than 20 percent of beef fat, mutton fat, oleo stearin, vegetable stearin, or hardened vegetable fat is mixed with lard or with rendered pork fat, there shall appear on the label, contiguous to and in the same size and style of lettering as the name of the product, the words “beef fat added,” “mutton fat added,” “oleo stearin added,” “vegetable stearin added,” or “hardened vegetable fat added,” as the case may be. If more than 20 percent is added, the product name shall refer to the particular animal fat or fats used, such as, “Lard and Beef Fat.” The designation “vegetable fat” is applicable to vegetable oil, vegetable stearin, or a combination of such oil and stearin, whereas the designations “vegetable oil” and “vegetable stearin” shall be applicable only to the oil and the stearin respectively, when used in meat food products.

(22) Cooked, cured, or pickled pigs feet, pigs knuckles, and similar products, shall be labeled to show that the bones remain in the product, if such is the case. The designation “semi-boneless” shall not be used if less than 50 percent of the total weight of bones has been removed.

(23) When monoglycerides, diglycerides, and/or polyglycerol esters of fatty acids are added to rendered animal fat or a combination of such fat and vegetable fat, there shall appear on the label in a prominent manner and contiguous to the name of the product a statement such as “With Monoglycerides and Diglycerides Added,” or “With Diglycerides and Monoglycerides,” or “With Polyglycerol Esters of Fatty Acids” as the case may be.

(24) Section 407 of the Federal Food, Drug, and Cosmetic Act contains provisions with respect to colored margarine or colored oleomargarine (21 U.S.C. 347) which are set forth herein as footnote.[ ]

(25) When approved proteolytic enzymes as permitted in part 318 of this subchapter are used on steaks or other raw meat cuts, there shall appear on the label, in a prominent manner, contiguous to the product name, the statement, “Tenderized with [approved enzyme],” to indicate the use of such enzymes. Any other approved substance which may be used in the solution shall also be included in the statement.

When approved inorganic chlorides as permitted in part 318 of this subchapter are used on steaks or other raw meat cuts there shall appear on the label in a prominent manner, contiguous to the product name, the statement, “Tenderized with (names of approved inorganic chloride(s))” to indicate the use of such inorganic chlorides. Any other approved substance which may be in the solution shall also be included in the statement.

(26) When dimethylpolysiloxan is added as an antifoaming agent to rendered fats, its presence shall be declared on the label contiguous to the name of the product. Such declaration shall read “Dimethylpolysiloxan Added.”

(27) When pizzas are formulated with crust containing calcium propionate or sodium propionate, there shall appear on the label contiguous to the name of the product the statement “________ added to retard spoilage of crust” preceded by the name of the preservative.

(28) Sausage of the dry varieties treated with potassium sorbate or propylparaben (propyl p-hydroxybenzoate) as permitted by part 318 of this subchapter, shall be marked or labeled with a statement disclosing such treatment and the purpose thereof, such as “dipped in a potassium sorbate solution to retard mold growth.”

(29) Meat of goats shall be identified as goat meat or chevon.

(30) The term “Chitterlings” shall apply to the large intestines of swine, or young bovine animals when preceded with the word “Calf” or “Veal.” Meat food products that contain chitterlings or calf or veal chitterlings, in accordance with § 318.6(b)(8) of this subchapter shall be identified with product names that refer to such ingredients, as for instance, “Chitterling Loaf,” “Chitterling Pie,” or “Calf Chitterlings and Gravy,” and shall be packed in containers having a capacity of 3 pounds or less and of a kind usually sold at retail intact and bearing such other information as is required by this part.

(31) Products that contain blood from livestock as permitted by part 318 of this subchapter shall be labeled with a name that includes the term “blood,” and the specific kind of blood shall be declared in the ingredient statement, e.g., “Swine blood,” in the manner required by this part.

(32) A calendar date may be shown on labeling when declared in accordance with the provisions of this subparagraph:

(i) The calendar date shall express the month of the year and the day of the month for all products and also the year in the case of products hermetically sealed in metal or glass containers, dried or frozen products, or any other products that the Administrator finds should be labeled with the year because the distribution and marketing practices with respect to such products may cause a label without a year identification to be misleading.

(ii) Immediately adjacent to the calendar date there must be a phrase explaining the meaning of the date, in terms of “packing” date, “sell by” date, or “use before” date, with or without a further qualifying phrase, e.g., “For Maximum Freshness” or “For Best Quality.”

(33) [Reserved]

(34) The terms “All,” “Pure,” “100%,” and terms of similar connotation shall not be used on labels for products to identify ingredient content, unless the product is prepared solely from a single ingredient.

(35) When agar-agar is used in canned jellied meat food products, as permitted in part 318 of this subchapter, there shall appear on the label in a prominent manner, contiguous to the product name, a statement to indicate the use of agar-agar.

(36) When sodium alginate, calcium carbonate, and lactic acid and calcium carbonate (or glucono delta-lactone) are used together in a dry binding matrix in restructured, formed meat food products, as permitted in part 318 of this subchapter, there shall appear on the label contiguous to the product name, a statement to indicate the use of sodium alginate, calcium carbonate and lactic acid and calcium carbonate (or glucono delta-lactone).

(37) The labels of sausages encased in natural casings made from meat or poultry viscera shall identify the type of meat or poultry from which the casings were derived, if the casings are from a different type of meat or poultry than the encased meat or poultry. The identity of the casing, if required, may be placed on the principal display panel or in the ingredient statement. Establishments producing, manufacturing, or using natural sausage casings are to maintain records documenting the meat or poultry source in accordance with part 320 of this chapter.

(38) The labels of sausages encased in regenerated collagen casings shall disclose this fact on the product label. The fact that the sausage is encased in collagen may be placed on the principal display panel or in the ingredient statement.

(39) When transglutaminase enzyme is used to bind pieces of meat to form a cut of meat, or to reform a piece of meat from a multiple cuts, there shall appear on the label, as part of the product name, a statement that indicates that the product has been “formed” or “reformed,” in addition to other preparation steps, e.g., “Formed Beef Tenderloin” or “Reformed and Shaped Beef Tenderloin.”

(40) A country of origin statement on the label of any meat “covered commodity” as defined in 7 CFR Part 65, Subpart A, that is to be sold by a “retailer,” as defined in 7 CFR 65.240, must comply with the requirements in 7 CFR 65.300 and 65.400.

(b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and any other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to Program inspectors or other Department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty.

(b)

(1) The term “serving” or “serving size” means an amount of food customarily consumed per eating occasion by persons 4 years of age or older, which is expressed in a common household measure that is appropriate to the product. When the product is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively.

(2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of this section and for products that are intended for weight control and are available only through a weight-control or weight-maintenance program, serving size declared on a product label shall be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply” (Reference Amount(s)) that appear in § 317.312(b) using the procedures described in this paragraph (b). For products that are both intended for weight control and available only through a weight-control program, a manufacturer may determine the serving size that is consistent with the meal plan of the program. Such products must bear a statement, “for sale only through the ______ program” (fill in the blank with the name of the appropriate weight-control program, e.g., Smith's Weight Control), on the principal display panel. However, the Reference Amounts in § 317.312(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrition claims.

(3) The declaration of nutrient and food component content shall be on the basis of the product “as packaged” for all products, except that single-ingredient, raw products that are not ground or chopped meat products described in § 317.301 may be declared on the basis of the product “as consumed”. For single-ingredient, raw products that are not ground or chopped meat products described in § 317.301, if data are based on the product ‘as consumed,’ the data must be presented in accordance with § 317.345(d). In addition to the required declaration on the basis of “as packaged” for products other than single-ingredient, raw products that are not ground or chopped meat products described in § 317.301, the declaration may also be made on the basis of “as consumed,” provided that preparation and cooking instructions are clearly stated.

(4) For products in discrete units (e.g., hot dogs, and individually packaged products within a multi-serving package), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., beef fritters and barbecue sauce), the serving size shall be declared as follows:

(i) If a unit weighs 50 percent or less of the Reference Amount, the serving size shall be the number of whole units that most closely approximates the Reference Amount for the product category.

(ii) If a unit weighs more than 50 percent but less than 67 percent of the Reference Amount, the manufacturer may declare one unit or two units as the serving size.

(iii) If a unit weighs 67 percent or more but less than 200 percent of the Reference Amount, the serving size shall be one unit.

(iv) If a unit weighs 200 percent or more of the Reference Amount, the manufacturer may declare one unit as the serving size if the whole unit can reasonably be consumed at a single eating occasion.

(v) For products that have Reference Amounts of 100 grams (or milliliter) or larger and are individual units within a multi-serving package, if a unit contains more than 150 percent but less than 200 percent of the Reference Amount, the manufacturer may decide whether to declare the individual unit as 1 or 2 servings.

(vi) For products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is in discrete units (e.g., beef fritters and barbecue sauce), the serving size may be the number of discrete units represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product as determined in § 317.312(c).

(vii) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the serving size shall be 1 unit.

(5) For products in large discrete units that are usually divided for consumption (e.g., pizza), for unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g. pizza kit), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a large discrete unit usually divided for consumption, the serving size shall be the fractional slice of the ready-to-eat product (e.g., 1⁄8 quiche, 1⁄4 pizza) that most closely approximates the Reference Amount for the product category. The serving size may be the fraction of the package used to make the Reference Amount for the unprepared product determined in § 317.312(d) or the fraction of the large discrete unit represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount of the combined product determined in § 317.312(c). In expressing the fractional slice, manufacturers shall use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions that can be generated by further division by 2 or 3.

(6) For nondiscrete bulk products (e.g., whole roast beef, marinated beef tenderloin, large can of chili), and for products which consist of two or more foods packaged and presented to be consumed together where the ingredient represented as the main ingredient is a bulk product (e.g., roast beef and gravy), the serving size shall be the amount in household measure that most closely approximates the Reference Amount for the product category and may be the amount of the bulk product represented as the main ingredient plus proportioned minor ingredients used to make the Reference Amount for the combined product determined in § 317.312(c).

(7) For labeling purposes, the term “common household measure” or “common household unit” means cup, tablespoon, teaspoon, piece, slice, fraction (e.g., 1⁄4 pizza), ounce (oz), or other common household equipment used to package food products (e.g., jar or tray). In expressing serving size in household measures, except as specified in paragraphs (b)(7)(iv), (v), and (vi) of this section, the following rules shall be used:

(i) Cups, tablespoons, or teaspoons shall be used wherever possible and appropriate. Cups shall be expressed in 1⁄4- or 1⁄3-cup increments, tablespoons in whole number of tablespoons for quantities less than 1⁄4 cup but greater than or equal to 2 tablespoons (tbsp), 1, 11⁄3, 11⁄2, or 12⁄3 tbsp for quantities less than 2 tbsp but greater than or equal to 1 tbsp, and teaspoons in whole number of teaspoons for quantities less than 1 tbsp but greater than or equal to 1 teaspoon (tsp), and in 1⁄4-tsp increments for quantities less than 1 tsp.

(ii) If cups, tablespoons or teaspoons are not applicable, units such as piece, slice, tray, jar, and fraction shall be used.

(iii) If cups, tablespoons and teaspoons, or units such as piece, slice, tray, jar, or fraction are not applicable, ounces may be used. Ounce measurements shall be expressed in 0.5-ounce increments most closely approximating the Reference Amount with rounding indicated by the use of the term “about” (e.g., about 2.5 ounces).

(iv) A description of the individual container or package shall be used for single-serving containers and for individually packaged products within multi-serving containers (e.g., can, box, package, meal, or dinner). A description of the individual unit shall be used for other products in discrete units (e.g., chop, slice, link, or patty).

(v) For unprepared products where the entire contents of the package is used to prepare large discrete units that are usually divided for consumption (e.g., pizza kit), the fraction or portion of the package may be used.

(vi) For products that consist of two or more distinct ingredients or components packaged and presented to be consumed together (e.g., ham with a glaze packet), the nutrition information may be declared for each component or as a composite. The serving size may be provided in accordance with the provisions of paragraphs (b)(4), (b)(5), and (b)(6) of this section.

(vii) For nutrition labeling purposes, a teaspoon means 5 milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 oz in weight means 28 grams (g).

(viii) When a serving size, determined from the Reference Amount in § 317.312(b) and the procedures described in this section, falls exactly half way between two serving sizes (e.g., 2.5 tbsp), manufacturers shall round the serving size up to the next incremental size.

(8) A product that is packaged and sold individually and that contains less than 200 percent of the applicable Reference Amount shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving, except for products that have Reference Amounts of 100 g (or mL) or larger, manufacturers may decide whether a package that contains more than 150 percent but less than 200 percent of the Reference Amount is 1 or 2 servings. Packages sold individually that contain 200 percent or more of the applicable Reference Amount may be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion.

(9) A label statement regarding a serving shall be the serving size expressed in common household measures as set forth in paragraphs (b)(2) through (b)(8) of this section and shall be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams), except for single-serving containers.

(i) For a single-serving container, the parenthetical metric quantity, which will be presented as part of the net weight statement on the principal display panel, is not required except where nutrition information is required on a drained weight basis according to paragraph (b)(11) of this section. However, if a manufacturer voluntarily provides the metric quantity on products that can be sold as single-servings, then the numerical value provided as part of the serving size declaration must be identical to the metric quantity declaration provided as part of the net quantity of contents statement.

(ii) The gram or milliliter quantity equivalent to the household measure should be rounded to the nearest whole number except for quantities that are less than 5 g (mL). The gram (mL) quantity between 2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL) increments.

(iii) In addition, serving size may be declared in ounce, in parenthesis, following the metric measure separated by a slash where other common household measures are used as the primary unit for serving size, e.g., 1 slice (28 g/1 oz) for sliced bologna. The ounce quantity equivalent to the metric quantity should be expressed in 0.1-oz increments.

(iv) If a manufacturer elects to use abbreviations for units, the following abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram, mL for milliliter, and oz for ounce.

(10) Determination of the number of servings per container shall be based on the serving size of the product determined by following the procedures described in this section.

(i) The number of servings shall be rounded to the nearest whole number except for the number of servings between 2 and 5 servings and random weight products. The number of servings between 2 and 5 servings shall be rounded to the nearest 0.5 serving. Rounding should be indicated by the use of the term “about” (e.g., about 2 servings; about 3.5 servings).

(ii) When the serving size is required to be expressed on a drained solids basis and the number of servings varies because of a natural variation in unit size (e.g., pickled pigs feet), the manufacturer may state the typical number of servings per container (e.g., usually 5 servings).

(iii) For random weight products, a manufacturer may declare “varied” for the number of servings per container provided the nutrition information is based on the Reference Amount expressed in ounces. The manufacturer may provide the typical number of servings in parenthesis following the “varied” statement (e.g., varied (approximately 8 servings per pound)).

(iv) For packages containing several individual single-serving containers, each of which is labeled with all required information including nutrition labeling as specified in this section (i.e., are labeled appropriately for individual sale as single-serving containers), the number of servings shall be the number of individual packages within the total package.

(v) For packages containing several individually packaged multi-serving units, the number of servings shall be determined by multiplying the number of individual multi-serving units in the total package by the number of servings in each individual unit. The declaration of the number of servings per container need not be included in nutrition labeling of single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301, including those that have been previously frozen.

(11) The declaration of nutrient and food component content shall be on the basis of product as packaged or purchased with the exception of single-ingredient, raw products that are not ground or chopped meat products described in § 317.301 and products that are packed or canned in water, brine, or oil but whose liquid packing medium is not customarily consumed. Declaration of the nutrient and food component content of products that are packed in liquid which is not customarily consumed shall be based on the drained solids.

(12) The serving size for meal-type products and main-dish products as defined in § 317.313(l) and § 317.313(m) in single-serving containers will be the entire edible content of the package. Serving size for meal-type products and main-dish products in multi-serve containers will be based on the reference amount applicable to the product in § 317.312(b) if the product is listed in § 317.312(b). Serving size for meal-type products and main-dish products in multi-serve containers that are not listed in § 317.312(b) will be based on the reference amount according to § 317.312(c), (d), and (e).

(13) Another column of figures may be used to declare the nutrient and food component information in the same format as required by § 317.309(e),

(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as packaged or purchased.

(ii) Per one unit if the serving size of a product in discrete units in a multi-serving container is more than one unit.

(14) If a product consists of assortments of meat or meat food products (e.g., variety packs) in the same package, nutrient content shall be expressed on the entire package contents or on each individual product.

(15) If a product is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare the nutrient contents on the basis of the product as consumed for the product alone (e.g., a cream soup mix may be labeled with one set of Daily Values for the dry mix (per serving), and another set for the serving of the final soup when prepared (e.g., per serving of cream soup mix and 1 cup of vitamin D fortified whole milk)): Provided, That the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label.

(c) The declaration of nutrition information on the label or in labeling of a meat or meat food product shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraph (f) or (g) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraph (d) or (e) of this section.

(1) “Calories, total,” “Total calories,” or “Calories”: A statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. Energy content per serving may also be expressed in kilojoule units, added in parenthesis immediately following the statement of the caloric content.

(i) Caloric content may be calculated by the following methods. Where either specific or general food factors are used, the factors shall be applied to the actual amount (i.e., before rounding) of food components (e.g., fat, carbohydrate, protein, or ingredients with specific food factors) present per serving.

(A) Using specific Atwater factors (i.e., the Atwater method) given in Table 13, page 25, “Energy Value of Foods—Basis and Derivation,” by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA), Agriculture Handbook No. 74 (Slightly revised February ), which is incorporated by reference. Table 13 of the “Energy Value of Foods—Basis and Derivation,” Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room , South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC -;

(B) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February ), pages 9-11, which is incorporated by reference. Pages 9-11, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.);

(C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate less the amount of insoluble dietary fiber, and total fat, respectively, as described in USDA's Agriculture Handbook No. 74 (Slightly revised February ), pages 9-11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.); or

(D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of 21 CFR, or by other means, as appropriate.

(ii) “Calories from fat”: A statement of the caloric content derived from total fat as defined in paragraph (c)(2) of this section per serving, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that label declaration of “calories from fat” is not required on products that contain less than 0.5 gram of fat per serving and amounts less than 5 calories may be expressed as zero. This statement shall be declared as provided in paragraph (d)(5) of this section.

(iii) “Calories from saturated fat” or “Calories from saturated” (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section per serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories from fat as provided in paragraph (d)(5) of this section.

(2) “Fat, total” or “Total fat”: A statement of the number of grams of total fat per serving defined as total lipid fatty acids and expressed as triglycerides. Amounts shall be expressed to the nearest 0.5 (1⁄2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(i) “Saturated fat” or “Saturated”: A statement of the number of grams of saturated fat per serving defined as the sum of all fatty acids containing no double bonds, except that label declaration of saturated fat content information is not required for products that contain less than 0.5 gram of total fat per serving if no claims are made about fat or cholesterol content, and if “calories from saturated fat” is not declared. Saturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1⁄2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(A) “Stearic Acid” (VOLUNTARY): A statement of the number of grams of stearic acid per serving may be declared voluntarily, except that when a claim is made about stearic acid, label declaration shall be required. Stearic acid content shall be indented under saturated fat and expressed to the nearest 0.5 (1⁄2)-gram increment below 5 grams and the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(B) [Reserved]

(ii) “Polyunsaturated fat” or “Polyunsaturated” (VOLUNTARY): A statement of the number of grams of polyunsaturated fat per serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, except that when monounsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 317.362(b)(1) for a claim for “fat free,” label declaration of polyunsaturated fat is required. Polyunsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1⁄2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(iii) “Monounsaturated fat” or “Monounsaturated” (VOLUNTARY): A statement of the number of grams of monounsaturated fat per serving defined as cis-monounsaturated fatty acids may be declared voluntarily, except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a product other than one that meets the criteria in § 317.362(b)(1) for a claim for “fat free,” label declaration of monounsaturated fat is required. Monounsaturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 (1⁄2)-gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.

(3) “Cholesterol”: A statement of the cholesterol content per serving expressed in milligrams to the nearest 5-milligram increment, except that label declaration of cholesterol information is not required for products that contain less than 2 milligrams of cholesterol per serving and make no claim about fat, fatty acids, or cholesterol content, or such products may state the cholesterol content as zero. If the product contains 2 to 5 milligrams of cholesterol per serving, the content may be stated as “less than 5 milligrams.”

(4) “Sodium”: A statement of the number of milligrams of sodium per serving expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.

(5) “Potassium” (VOLUNTARY): A statement of the number of milligrams of potassium per serving may be declared voluntarily, except that when a claim is made about potassium content, label declaration shall be required. Potassium content shall be expressed as zero when the serving contains less than 5 milligrams of potassium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of potassium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams.

(6) “Carbohydrate, total” or “Total carbohydrate”: A statement of the number of grams of total carbohydrate per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, or, if the serving contains less than 0.5 gram, the content may be expressed as zero. Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, and ash from the total weight of the product. This calculation method is described in USDA's Agriculture Handbook No. 74 (Slightly revised February ), pages 2 and 3, which is incorporated by reference. Pages 2 and 3, Agriculture Handbook No. 74 is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (The availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section.)

(i) “Dietary fiber”: A statement of the number of grams of total dietary fiber per serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required, or, alternatively, the statement “Contains less than 1 gram” or “less than 1 gram” may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

LANTON PACK Product Page

(A) “Soluble fiber” (VOLUNTARY): A statement of the number of grams of soluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(B) “Insoluble fiber” (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber per serving may be declared voluntarily except when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(ii) “Sugars”: A statement of the number of grams of sugars per serving, except that label declaration of sugars content is not required for products that contain less than 1 gram of sugars per serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose). Sugars content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(iii) “Sugar alcohol” (VOLUNTARY): A statement of the number of grams of sugar alcohols per serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the product, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of the term “sugar alcohol,” the name of the specific sugar alcohol (e.g., “xylitol”) present in the product may be used in the nutrition label, provided that only one sugar alcohol is present in the product. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less then 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(iv) “Other carbohydrate” (VOLUNTARY): A statement of the number of grams of other carbohydrate per serving may be declared voluntarily. Other carbohydrate shall be defined as the difference between total carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared (even if present), it shall be defined as the difference between total carbohydrate and the sum of dietary fiber and sugars. Other carbohydrate content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.

(7) “Protein”: A statement of the number of grams of protein per serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement “Contains less than 1 gram” or “less than 1 gram” may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in products represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a product represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement “not a significant source of protein,” or a listing aligned under the column headed “Percent Daily Value” of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as percent of Daily Value. When the protein quality in a product as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a product represented or purported to be for infants, the statement “not a significant source of protein” shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor of 6.25 times the nitrogen content of the food as determined by appropriate methods of analysis in accordance with § 317.309(h), except when the procedure for a specific food requires another factor.

(i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be for infants or children under 4 years of age. When such a declaration is provided, it shall be placed on the label adjacent to the statement of grams of protein and aligned under the column headed “Percent Daily Value,” and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the product is represented or purported to be for infants and the protein quality value is less than 40 percent of the reference standard.

(ii) The corrected amount of protein (grams) per serving for products represented or purported to be for adults and children 1 or more years of age is equal to the actual amount of protein (grams) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8 in “Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, , which is incorporated by reference. Sections 5.4.1, 7.2.1, and 8 of the “Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” as published by the Food and Agriculture Organization of the United Nations/World Health Organization, is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is available for inspection at the office of the FSIS Docket Clerk, Room , South Building, 14th and Independence Avenue, SW., Washington, DC, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of the incorporation by reference are available from the Product Assessment Division, Regulatory Programs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 329, West End Court Building, Washington, DC -. For products represented or purported to be for infants, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject product's protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00.

(iii) For the purpose of labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, and the RDI for protein for children less than 4 years of age, infants, pregnant women, and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, respectively.

(8) Vitamins and minerals: A statement of the amount per serving of the vitamins and minerals as described in this paragraph, calculated as a percent of the RDI and expressed as percent of Daily Value.

(i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d) through (g) of this section, products represented or purported to be for use by infants, children less than 4 years of age, pregnant women, or lactating women shall use the RDI's that are specified for the intended group. For products represented or purported to be for use by both infants and children under 4 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants from birth to 12 months of age and for children under 4 years of age. Similarly, the percent of Daily Value based on both the RDI values for pregnant women and for lactating women shall be declared separately on products represented or purported to be for use by both pregnant and lactating women. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. All other products shall use the RDI for adults and children 4 or more years of age.

(ii) The declaration of vitamins and minerals as a percent of the RDI shall include vitamin A, vitamin C, calcium, and iron, in that order, and shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added, or when a claim is made about them. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or in labeling or advertising and the vitamins and minerals are:

(A) Required or permitted in a standardized food (e.g., thiamin, riboflavin, and niacin in enriched flour) and that standardized food is included as an ingredient (i.e., component) in another product; or

(B) Included in a product solely for technological purposes and declared only in the ingredients statement. The declaration may also include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are naturally occurring in the food. The additional vitamins and minerals shall be listed in the order established in paragraph (c)(8)(iv) of this section.

(iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50-percent level, and the nearest 10-percent increment above the 50-percent level. Amounts of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement “Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).” Alternatively, if vitamin A, vitamin C, calcium, or iron is present in amounts less than 2 percent of the RDI, label declaration of the nutrient(s) is not required if the statement “Not a significant source of ______ (listing the vitamins or minerals omitted)” is placed at the bottom of the table of nutrient values.

(iv) The following RDI's and nomenclature are established for the following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units

Vitamin C, 60 milligrams

Calcium, 1.0 gram

Iron, 18 milligrams

Vitamin D, 400 International Units

Vitamin E, 30 International Units

Thiamin, 1.5 milligrams

Riboflavin, 1.7 milligrams

Niacin, 20 milligrams

Vitamin B6, 2.0 milligrams

Folate, 0.4 milligram

Vitamin B12, 6 micrograms

Biotin, 0.3 milligram

Pantothenic acid, 10 milligrams

Phosphorus, 1.0 gram

Iodine, 150 micrograms

Magnesium, 400 milligrams

Zinc, 15 milligrams

Copper, 2.0 milligrams

(v) The following synonyms may be added in parenthesis immediately following the name of the nutrient or dietary component:

Vitamin C—Ascorbic acid

Thiamin—Vitamin B1

Riboflavin—Vitamin B2

Folate—Folacin

Calories—Energy

(vi) A statement of the percent of vitamin A that is present as beta-carotene may be declared voluntarily. When the vitamins and minerals are listed in a single column, the statement shall be indented under the information on vitamin A. When vitamins and minerals are arrayed horizontally, the statement of percent shall be presented in parenthesis following the declaration of vitamin A and the percent of Daily Value of vitamin A in the product (e.g., “Percent Daily Value: Vitamin A 50 (90 percent as beta-carotene)”). When declared, the percentages shall be expressed in the same increments as are provided for vitamins and minerals in paragraph (c)(8)(iii) of this section.

(9) For the purpose of labeling with a percent of the DRV, the following DRV's are established for the following food components based on the reference caloric intake of 2,000 calories:

Food component Unit of measurement DRV Fat grams (g) 65 Saturated fatty acids do 20 Cholesterol milligrams (mg) 300 Total carbohydrate grams (g) 300 Fiber do 25 Sodium milligrams (mg) 2,400 Potassium do 3,500 Protein grams (g) 50

(h) Compliance with this section shall be determined as follows:

(1) A production lot is a set of food production consumer units that are from one production shift. Alternatively, a collection of consumer units of the same size, type, and style produced under conditions as nearly uniform as possible, designated by a common container code or marking, constitutes a production lot.

(2) The sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each from a production lot. Alternatively, the sample for nutrient analysis shall consist of a composite of a minimum of six consumer units, each randomly chosen to be representative of a production lot. In each case, the units may be individually analyzed and the results of the analyses averaged, or the units would be composited and the composite analyzed. In both cases, the results, whether an average or a single result from a composite, will be considered by the Agency to be the nutrient content of a composite. All analyses shall be performed by appropriate methods and procedures used by the Department for each nutrient in accordance with the “Chemistry Laboratory Guidebook,” or, if no USDA method is available and appropriate for the nutrient, by appropriate methods for the nutrient in accordance with the edition of the “Official Methods of Analysis” of the AOAC International, formerly Association of Official Analytical Chemists, 15th ed., which is incorporated by reference, unless a particular method of analysis is specified in § 317.309(c), or, if no USDA, AOAC, or specified method is available and appropriate, by other reliable and appropriate analytical procedures as so determined by the Agency. The “Official Methods of Analysis” is incorporated as it exists on the date of approval. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be purchased from the AOAC International, Wilson Blvd., suite 400, Arlington, VA . It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) Two classes of nutrients are defined for purposes of compliance:

(i) Class I. Added nutrients in fortified or fabricated foods; and

(ii) Class II. Naturally occurring (indigenous) nutrients. If any ingredient which contains a naturally occurring (indigenous) nutrient is added to a food, the total amount of such nutrient in the final food product is subject to Class II requirements unless the same nutrient is also added, which would make the total amount of such nutrient subject to Class I requirements.

(4) A product with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium shall be deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) unless it meets the following requirements:

(i) Class I vitamin, mineral, protein, dietary fiber, or potassium. The nutrient content of the composite is at least equal to the value for that nutrient declared on the label.

(ii) Class II vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium. The nutrient content of the composite is at least equal to 80 percent of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls below this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.

(5) A product with a label declaration of calories, sugars, total fat, saturated fat, cholesterol, or sodium shall be deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label; Provided, That no regulatory action will be based on a determination of a nutrient value which falls above this level by an amount less than the variability generally recognized for the analytical method used in that product at the level involved, and inherent nutrient variation in a product.

(6) The amount of a vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or potassium may vary over labeled amounts within good manufacturing practice. The amount of calories, sugars, total fat, saturated fat, cholesterol, or sodium may vary under labeled amounts within good manufacturing practice.

(7) Compliance will be based on the metric measure specified in the label statement of serving size.

(8) The management of the establishment must maintain records to support the validity of nutrient declarations contained on product labels. Such records shall be made available to the inspector or any duly authorized representative of the Agency upon request.

(9) The compliance provisions set forth in paragraph (h) (1) through (8) of this section shall not apply to single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301, including those that have been previously frozen, when nutrition labeling is based on the most current representative data base values contained in USDA's National Nutrient Data Bank or its released form, the USDA National Nutrient Database for Standard Reference as provided in § 317.345(e) and (f).

(g) The Administrator, on his or her own initiative or on behalf of any interested person who has submitted a labeling application, may issue a proposal to establish or amend a Product Category or Reference Amount identified in paragraph (b) of this section.

(1) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address.

(2) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references.

(3) The availability for public disclosure of labeling applications, along with supporting documentation, submitted to the Agency under this section will be governed by the rules specified in subchapter D, title 9.

(4) Data accompanying the labeling application, such as food consumption data, shall be submitted on separate sheets, suitably identified. If such data has already been submitted with an earlier labeling application from the applicant, the present labeling application must provide the data.

(5) The labeling application must be signed by the applicant or by his or her attorney or agent, or (if a corporation) by an authorized official.

(6) The labeling application shall include a statement signed by the person responsible for the labeling application, that to the best of his or her knowledge, it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him or her pertinent to the evaluation of the labeling application.

(7) Labeling applications for a new Reference Amount and/or Product Category shall be accompanied by the following data which shall be submitted in the following form to the Director, Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, Washington, DC :

(Date)

The undersigned, ____________ submits this labeling application pursuant to 9 CFR 317.312 with respect to Reference Amount and/or Product Category.

Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part of this labeling application, are the following:

(i) A statement of the objective of the labeling application;

(ii) A description of the product;

(iii) A complete sample product label including nutrition label, using the format established by regulation;

(iv) A description of the form in which the product will be marketed;

(v) The intended dietary uses of the product with the major use identified (e.g., ham as a luncheon meat);

(vi) If the intended use is primarily as an ingredient in other foods, list of foods or food categories in which the product will be used as an ingredient with information on the prioritization of the use;

(vii) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);

(viii) The names of the most closely-related products (or in the case of foods for special dietary use and imitation or substitute foods, the names of the products for which they are offered as substitutes);

(ix) The suggested Reference Amount (the amount of edible portion of food as consumed, excluding bone, skin or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested Reference Amount. In determining the Reference Amount, general principles and factors in paragraph (a) of this section should be followed.

(x) The suggested Reference Amount shall be expressed in metric units. Reference Amounts for foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density such as mixed dishes measurable with a cup.

(A) In expressing the Reference Amount in grams, the following general rules shall be followed:

(1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 grams increment.

(2) For quantities less than 10 grams, exact gram weights shall be used.

(B) [Reserved]

(xi) A labeling application for a new subcategory of food with its own Reference Amount shall include the following additional information:

(A) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the Reference Amount for the parent category to warrant a separate Reference Amount. Data must include sample size, and the mean, standard deviation, median, and modal consumed amount per eating occasion for the product identified in the labeling application and for other products in the category. All data must be derived from the same survey data.

(B) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the product identified in the labeling application from the rest of the products in the category.

(xii) In conducting research to collect or process food consumption data in support of the labeling application, the following general guidelines should be followed.

(A) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.

(B) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.

(C) The study protocol should identify potential biases and describe how potential biases are controlled for or, if not possible to control, how they affect interpretation of results.

(D) The methodology used to collect or process data including study design, sampling procedures, materials used (e.g., questionnaire, interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse, should be fully documented.

(xiii) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule.

Yours very truly,

Applicant

By

(Indicate authority)

(8) Upon receipt of the labeling application and supporting documentation, the applicant shall be notified, in writing, of the date on which the labeling application was received. Such notice shall inform the applicant that the labeling application is undergoing Agency review and that the applicant shall subsequently be notified of the Agency's decision to consider for further review or deny the labeling application.

(9) Upon review of the labeling application and supporting documentation, the Agency shall notify the applicant, in writing, that the labeling application is either being considered for further review or that it has been summarily denied by the Administrator.

(10) If the labeling application is summarily denied by the Administrator, the written notification shall state the reasons therefor, including why the Agency has determined that the proposed Reference Amount and/or Product Category is false or misleading. The notification letter shall inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.

(i) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of the answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.

(ii) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.

(11) If the labeling application is not summarily denied by the Administrator, the Administrator shall publish in the Federal Register a proposed rule to amend the regulations to authorize the use of the Reference Amount and/or Product Category. The proposal shall also summarize the labeling application, including where the supporting documentation can be reviewed. The Administrator's proposed rule shall seek comment from consumers, the industry, consumer and industry groups, and other interested persons on the labeling application and the use of the proposed Reference Amount and/or Product Category. After public comment has been received and reviewed by the Agency, the Administrator shall make a determination on whether the proposed Reference Amount and/or Product Category shall be approved for use on the labeling of meat food products.

(i) If the Reference Amount and/or Product Category is denied by the Administrator, the Agency shall notify the applicant, in writing, of the basis for the denial, including the reason why the Reference Amount and/or Product Category on the labeling was determined by the Agency to be false or misleading. The notification letter shall also inform the applicant that the applicant may submit a written statement by way of answer to the notification, and that the applicant shall have the right to request a hearing with respect to the merits or validity of the Administrator's decision to deny the use of the proposed Reference Amount and/or Product Category.

(A) If the applicant fails to accept the determination of the Administrator and files an answer and requests a hearing, and the Administrator, after review of an answer, determines the initial determination to be correct, the Administrator shall file with the Hearing Clerk of the Department the notification, answer, and the request for a hearing, which shall constitute the complaint and answer in the proceeding, which shall thereafter be conducted in accordance with the Department's Uniform Rules of Practice.

(B) The hearing shall be conducted before an administrative law judge with the opportunity for appeal to the Department's Judicial Officer, who shall make the final determination for the Secretary. Any such determination by the Secretary shall be conclusive unless, within 30 days after receipt of the notice of such final determination, the applicant appeals to the United States Court of Appeals for the circuit in which the applicant has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit.

(ii) If the Reference Amount and/or Product Category is approved, the Agency shall notify the applicant, in writing, and shall also publish in the Federal Register a final rule amending the regulations to authorize the use of the Reference Amount and/or Product Category.

First, dry bags are made out of 100% waterproof material. A material that can be left lying in the water for a month and not a single drop will get through. These are not “waterproof” materials that breathe (GoreTex etc..) because even the best breathable waterproof material can only stop water for a while and under certain conditions. A real waterproof material has absolutely no holes and it does not breathe. Completely closing all the holes in the fabric is usually achieved by laminating it with PVC. Premium dry bags usually use heavy duty, robust and easy to maintain 500D Lined PVC Tarpaulin. Thin lightweight dry bags usually use Nylon fabric. Nylon dry bags will only stop water for a while as this material soaks up water. These thin bags are mostly used for added protection inside your backpacks, duffel bags etc… and not for stand alone use. Nylon is often treated with waterproof coatings or laminates that improve it’s waterproof capabilities, but for a durable and really waterproof dry bag go with lined tarpaulin.

And second, dry bag construction. Dry bags must be “sewn” together without making holes into the material. This is achieved either by:

• sewing the bags together and then taping the seams or covering the whole inside of the bag with a waterproof coating (usually used with thinner bags, this method is not very durable and less reliable).
• gluing the bag together (more reliable method).
• welding the materials together and creating a completely waterproof bond. This is the most reliable and durable method.

Making waterproof bags, backpacks, duffel bags etc… using waterproof materials and welding is not easy. Material and construction method put all sorts of limitations on how the bags can be produced. Limitations that don’t exist in regular bags that are simply sewn together.

Why and Where Are Dry Bags Used?

It is no wonder dry bags are becoming more common. There are just so many different situations where a dry bag can save your things from getting wet. Generally speaking there are two basic reasons for using dry bags:

• to keep your things dry inside the dry bag when things get wet or
• to put your wet things inside a dry bag so they don’t drip all over your other dry things.

Here is a huge list of all the sports and situations where you can use a dry bag:

• kayaking (inside of the kayak can get wet, you can also put dry bags on top of the kayak),
• stand up paddling,
• boat rides,
• sailing,
• canoeing,
• rafting,
• canyoning,
• skiing and snowboarding,
• cave exploration,
• diving (storing wet gear),
• snorkeling (storing wet gear),
• traveling (especially to rainy and wet corners of the Earth),
• going to the beach (dry bags also protect from sand),
• hiking,
• motor bike travel,
• going outdoors (walking up rivers, under waterfalls…),
• fishing (keep your gear dry),
• hunting (keep your gear dry),
• hunting and fishing (store your catch in a dry bag so blood and guts don’t go all over your other things),
• surfing (for keeping things dry when on the beach, boat trips, tropical island travels…),
• storing wet wetsuits so they don’t drip all over your car (surfing, diving, rafting, swimming-triathlon…),
• storing wet smelly clothes after working out,
• laundry bag (same reason),
• windsurfing,
• kite surfing,
• protecting your gear in dry, dust, deserts…miles away from the sea (dust and sand can be even more harmful to electronics than water!),
• camping (things in tents tend to get humid, store your clean clothes and your sleeping bag in a dry bag when you don’t need them),
• emergency pillow (the dry bags with air and put it under your head),
• working out (fill it with water),
• washing clothes (you can use a dry bag as a simple bucket),
• protecting your , camera, drone and other electronics from humidity and dust,
• etc…

Can you think of any other uses? Let us know! The most original use might get a reward :)!

Closing a Dry Bag

When a dry bag is properly constructed it will only have one hole – the top opening that you use to put your things inside the bag. Everything else is sealed and waterproof. This leaves us with the big question – how to close a dry bag so it does not leak?

There are three options that are used these days:

• Roll down top
• Ziplock seal (similar to ziplock freezer bags for your food etc)
• Waterproof zipper

All three have their pros and cons, lets take a look.

Roll Down Top

Roll down top it the most popular way to close a dry bag. If we only count dry bags (without other types of waterproof packs and luggage) I would say 99% of the dry bags use this closing system. Why?

Roll down top PROs:

• It is easy to use and it works.
• It can not break down.
• Needs no maintenance.
• It’s cheap.
• It creates a handle that can be used to carry a dry bag or tie it to other bags etc…

Roll down top CONs:

• Not suitable for submersion. No matter what some brands, shops etc… claim, a roll down top will slowly leak if the bag is pushed underwater.

How To Properly Close a Dry Bag?

Although leaking in case of submerging a dry bag is unavoidable, the amount of leaking depends on how carefully you close the bag. This is how you properly close a dry bag:

Dry Bags Closing Instructions

1. Align the top edges of the bag and squeeze them together.
2. Tightly roll down the top of the bag at least 3 times (it is better to roll it down all the way until you reach the content of your bag, this puts more tension on the closure and makes the seal better).
3. Bend the ends in the opposite direction towards the back, away from the side where you rolled the top down (again this puts more tension on the fold and makes a better seal).
4. Buckle the ends together and you are done.

Extra Tip

When you close a dry bag there will be air trapped inside. This makes all dry bags float on the surface of the water which is very useful. If for some reason you want to make the dry bag smaller, like when you are packing, then squeeze the air out before closing the bag.

Ziplock Seal

Another way for closing dry bags is ziplock seal. You know, the kind of zip seal you find in plastic bags that you use for putting your food into the freezer etc. This type of seal is very popular with really small bags, “bags” that are only meant to protect your etc… Here is why.

Zip seal PROs:

• Simple to use
• It’s cheap.
• 100% waterproof.

Zip seal CONs:

• Works for extra small bags. With bigger bags the zip seal would have to be so strong it would be really hard to close and open or it would open by itself. To solve this some bag use ziplock type seal together with roll down top. This way the ziplock stays closed even if you pull on the bag.
• Sand and dirt can break the seal.
• Usually needs some maintenance (lubrication).

Waterproof Zipper

Recently special waterproof zippers also became available. Here are their pros and cons.

Waterproof zipper PROs:

• Simple to use
• Can be 100% waterproof, but be careful, real waterproof zippers that can also survive submersion are expensive and lots of time zippers that are not really waterproof but more like splash proof are called “waterproof”.

Waterproof zipper CONs:

• Expensive.
• Hard to open and close. The way waterproof zippers work is that they are so tight, that water and air can not get through zipper teeth. To achieve this tightness it takes more effort to open/close the zipper than it does with regular zippers.
• Need maintenance and can break down due to dirt and salt deposits etc.

How To Choose and Buy a Dry Bag?

There are a couple of things that influence what kind of bag do you want and need.

How Much Gear Do I Have and What Dry Bag Size Do I Need?

Obviously, longer trips and more gear require more space in your dry bags. But bigger dry bags are not always better. Ideally you want just the right sized dry bag, so that it is almost full. This way the roll down works better. But that is not the only reason…

Most Useful Dry Bag Sizes

Dry bags come in different sizes usually ranging from small 2 liter bags to huge 50, 60 or even 90 liter bags. In my experience the most useful bag sizes are between 5 and 50 liters. Bigger bags are very useful when you need to haul huge amounts of gear, but bags this big will be heavy and clumsy when they are full. Use these bags for transport etc… when the gear just sits inside a huge dry bag on the back of the pickup truck or similar. Not for carrying around. It is also easier to handle and pack two 30L bags than one 60L.

Gear Organization

Another downside of huge bags is that things get lost inside them. Use huge bags for big gear. Like, if you need to throw 4 wet wetsuits inside your car, you can put them inside one huge 90L bag. But when packing clothes, towels, snacks… smaller bags work much better. With a huge bag you will be constantly fishing inside the bag for some small item that always miraculously ends up somewhere at the bottom of the bag. So think about how many things you need to store inside your bag and consider using more differently sized bags instead of one huge bag. Finding things will be much easier.

How Much Room Is There For Dry Bags?

Smaller bags will fit into tighter spaces. In some cases this is a big issue. For instance if you will be using your dry bags for kayaking, you will want smaller and also a bit narrower bags. They will easily fit inside kayaks narrow hull. Also, with multiple smaller bags you can weight your boat more evenly.

Examples: What Different Sized Dry Bags Can Fit?

Here is what some of the popular dry bag sizes will fit (take this with a grain of salt off course, one persons clothes for a week could be another persons clothes for a day :), then it’s the season and temperatures etc..):

• 5 liter dry bag will fit all your smaller personal items (, wallet, keys, snacks, first aid…) or also a DSLR camera with two lenses or a Mavic Pro sized drone. 5 liter bag can be pushed under the bungee cords on your kayak. It is also perfect to use with bigger bags for organisation.
• 15 liter dry bag will fit for instance one thick winter wetsuit, gloves and booties. It will fit a small sleeping bag and some clothes. Or food for the weekend.
• 30 liter dry bag will fit two thick wetsuits or a wetsuit and a poncho/towel and some clothes. This would be IMHO the perfect size for day trips on and around the water. If you just pack it with clothes it fits enough clothes for a week long trip for one person or for a weekend trip for two people.
• 50 liter dry bag will fit three wet wetsuits, or all your food for a few day kayak trip together with a small camping gas stove and some dishes.

Production Quality

Materials and production process are standard these days. This means that an average dry bag that you buy will work alright. A couple of things to keep in mind:

• If you want a durable dry bag get one made out of heavy duty materials and put together using welded seams.
• Thin Nylon dry bag are meant to be used inside other bags/backpacks for added protection and not as a stand alone bags.

Dry Bags Extra Features

POCKETS

Internal and external pockets. Internal pocket lets you organise things inside the bag which is great. If you want to have some things close and ready then look for external pocket. There are two types of external pockets. Usually dry bags don’t have waterproof external pockets since they are more expensive and you can always just store the things that can not get wet inside your dry bag.

On the other hand, things that you usually want to keep close and ready are your , wallet, maybe your car keys. Things that can not get wet. So a waterproof external pocket can be a plus.

MESH POCKETS

Some dry bags also have external mesh pockets for holding water bottles.

CARRYING STRAPS

If you think there is a chance you will carry your dry bags around more than just from your car to your boat, then get bags with shoulder straps. Get straps that you can remove when you don’t need them. If you will carry a heavier dry bag around a lot (dry bags 30L and more) get one with double shoulder straps, so it can be carried as a backpack. For smaller bags one strap is plenty. More on carrying a bit further down.

EXTERNAL LOOPS, D RINGS, HANDLES ETC…

Most dry bags will have one or more D rings on them. Look for solid D rings, preferably plastic ones so salt water doesn’t harm them. You can use them to attach the bag to boats, kayaks, stand up paddle boards, motorbikes etc…

External loop allow you to tie things to the bag or clip things on with carabiners.

Additional external handles are useful with bigger bags. A full 90 liter bag can be a heavy beast, so just the roll down top handle might not be enough.

EXTERNAL NET OR BUNGEE CORD

External net or bungee cord can be used to secure your wet gear on the outside of the dry bag while your dry things are safe inside the bag. Usually people just use two separate dry bags. This way the wet gear doesn’t drip all over the place.

REFLECTIVE PRINT

In some cases you will also want your bag to be visible at night or to help you be more visible. In this case look for dry bags with reflective print on the outside.

DESIGN

I don’t know why, but most of the dry bags don’t put much effort into looking good. One of the reasons is that you want the bags to be visible if you drop them into the sea. This is why ugly bright neon colors are often used. We decided to go another way and tried to take the design a step further with our Seagull, Bear and Whale bags.

Intended Use

You also need to ask your self where and why will you use the bag the most? I will assume that for a start, you want to protect your things from getting wet. But apart from that, ask yourself a couple of questions:

How Much Carrying of Dry Bags Will I Be Doing?

• No carrying. A regular style dry bag without shoulder straps will do fine.
• A little carrying and/or smaller sized bag. Make sure the bag has at least one shoulder strap, this way you can carry it around and keep your hands free.
• Some carrying and mid sized bags. Dry bag should have two simple shoulder straps.
• Lots of carrying. Using dry bag for longer hiking trips and travelling. Medium amount of gear. In this case get either a bag with two shoulder straps (padded shoulder straps if possible) or even better, get a small waterproof backpack. It is much more comfortable to carry than a dry bag.
• Lots of carrying. Using dry bag for longer hiking trips and travelling. Big amount of gear. – In this case get a big waterproof backpack. It is much more comfortable to carry than a dry bag. Get one that has padded shoulder straps, padded back, hip belt and a sternum strap.

Are There Any Sport/Type of Use Specific Requirements?

I have already listed most of the dry bag features. Now lets look when they are necessary.

Kayaking and Similar

Go for smaller sized bags, I would say up to 30 liter and don’t get ones that are really wide. Smaller and narrower bags will fit better inside the kayak. Big dry bags can be only attached to the top of your kayak (which is sometimes also useful).

Attaching Dry Bags To Kayaks, Canoes, Rafts, Motorbikes, Car Rooftops, Boats etc…

If there is a need to attach the dry bag so it does not fall off, then you will need a dry bag that has multiple D rings.  D rings that are there for attaching shoulder straps work great to. In any case, you will also want to secure them with a bungee cords so they stay put.

Motorbikes and Bike Travel

You will want dry bags that have some reflective surfaces on them. This way you are better visible at night and again, D rings for attaching the dry bags to the bike.

Extreme Use With High Chance of Submersion (Wild Rivers…)

If you will use the bags on wild rivers, as a flotation device when swimming or if there is a chance that the dry bag will be pushed underwater during use, then get a dry bag that uses either expensive waterproof zipper or ziplock + roll down top closing system. A cheaper alternative is also using a smaller dry bag inside a bigger dry bag. Put your DSLR in 5 liter bag and put your 5 liter bag inside a 30 liter bag and your are good.

What Kind of Gear Are You Packing?

This also influences what kind of bag should you get.

Clothes, Sleeping Bags, Jackets, Towels

These items will not break when dropped and they are also don’t have sharp parts that could damage the dry bag. So pretty much any dry bag will do.

We get lot’s of questions regarding sleeping bags – I like to store my sleeping bag in a separate dry bag that holds only the sleeping bag. This way I only open it when I go to sleep. What size dry bag for sleeping bag should you get? Most of the regular sleeping bags will fit comfortably inside a 15L dry bag. A comfortable fit means that the sleeping bag is not completely compressed and you can leave it inside the dry bag for a long time (for down sleeping bags it is recommended that they are not completely compressed when stored). If you are tight with space then most sleeping bags can be compressed into 5L – 10L dry bags, but in this case take the sleeping bag out after the trip.

Food and Cooking Gear

Food, gas stoves, pans, plates, knifes and other cooking gear is harder and pointier. Do not use thin nylon bags, use regular, thicker and more durable bags. No matter the bag, wrap really sharp and pointy things like knifes into a kitchen towel or put them in an extra box. You don’t want holes in your bag.

Various Other Equipment

Again, if your gear is not soft and round get a durable dry bag and again, if something is really sharp and pointy, wrap it.

Electronics and Highly Sensitive Gear

Cameras, laptops, and other electronics are likely the most sensitive gear you’ll bring along. So make sure you get a durable dry bag, use things as camera cubes (or combine with towels) to protect your electronics when things get rough and if your finances allow it, get a bag that uses either expensive waterproof zipper or ziplock + roll down top closing system. A cheaper alternative is also using a smaller dry bag inside a bigger dry bag. Put your DSLR in 5 liter bag and put your 5 liter bag inside a 30 liter bag and your are good.

Dry Bag Care and Maintenance

Dry bags are pretty low maintenance items. They can not break down, especially if they use the fold down closure. But there are a few things that you can do to make them last longer:

If you want to learn more, please visit our website roll stock labeled mesh bag.