9 CFR 381.144 - Packaging materials.

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§ 381.144 Packaging materials.
(a) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which may render the contents adulterated or injurious to health. All packaging materials must be safe for the intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA).
(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 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.
(c) The guaranty by the packaging supplier will be accepted by Program inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations.
(d) The Department will monitor the use of packaging materials in official establishments to assure that the requirements of paragraph (a) of this section are met, and may question the basis for any guaranty described under paragraph (b) of this section. Official establishments and packaging suppliers providing written guaranties to those official establishments will be permitted an opportunity to provide information to designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm's name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material's acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request—a minimum of 30 days—any applicable guaranty shall cease to be effective and approval to continue using the specified packaging material in official establishments may be denied. The Administrator may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers.
(e) The Administrator may disapprove for use in official establishments packaging materials whose use cannot be confirmed as complying with the FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Administrator, the affected official establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Administrator. If the official establishment and the supplier do not accept the Administrator's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Administrator determines that such use may present an imminent hazard to public health.
(f) Periodically, the Administrator will issue to inspectors a listing, by distinguishing brand name or code designation, of packaging materials that have been reviewed and that fail to meet the requirements of paragraph (a) of this section. Listed materials will not be permitted for use in official establishments. If a subsequent review of any material indicates that it meets the requirements of paragraph (a), the material will be deleted from the listing.
(g) Nothing in this section shall affect the authority of Program inspectors to refuse a specific material if he/she determines the material may render products adulterated or injurious to health.
[49 FR 2236, Jan. 19, 1984]

Title 9 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 9.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-08-21; vol. 79 # 162 - Thursday, August 21, 2014
    1. 79 FR 49566 - Modernization of Poultry Slaughter Inspection
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Food Safety and Inspection Service
      Final rule.
      Effective Date: October 20, 2014. Notification Date: All young chicken and turkey slaughter establishments will initially have until February 23, 2015, to notify their District Office in writing of their intent to operate under the New Poultry Inspection System (NPIS). Establishments that do not notify their District Office of their intent by February 23, 2015, will be deemed to have chosen the inspection system that they are currently operating under. Young chicken and turkey slaughter establishments that decide that they would like to convert to NPIS after the initial notification date may notify FSIS of their intent at any time after that date. The Agency will implement the NPIS in the additional establishments that intend to convert on a schedule consistent with Agency resources and readiness. The Agency intends to implement the NPIS in all young chicken and turkey establishments that choose to operate under the NPIS, regardless of when the establishment notifies FSIS of its intent to transition to the NPIS. However, the initial implementation wave will only include those establishments that submitted their notifications within the initial notification period. After October 20, 2014, FSIS will begin selecting from those establishments that have notified FSIS of their intent to switch to the NPIS. The Agency will use a computerized ranking system to determine the schedule of establishments for implementation of the NPIS. This ranking system will take into consideration several factors, such as FSIS staffing needs, past performance of the establishment, the location of the establishment with respect to other federally-inspected establishments, and establishment readiness to transition to the NPIS. FSIS will implement the NPIS in phases by clusters of establishments in close geographic proximity to one another. The initial implementation wave will only include those establishments that notified FSIS of their intent to switch to the NPIS during the initial six-month notification period. FSIS expects that in subsequent years many more establishments will choose to transition to the new system. The Agency's implementation strategy for the NPIS is described in more detail in the preamble to this final rule. Applicability Dates: The regulations that prescribe procedures for controlling visible fecal contamination in 9 CFR 381.65(f), the regulations that prescribe procedures for controlling contamination throughout the slaughter and dressing process in 9 CFR 381.65(g), and the regulations that prescribe recordkeeping requirements in 9 CFR 381.65(h) will be applicable as follows: • In large establishments, defined as all establishments with 500 or more employees, on November 19, 2014; • In small establishments, defined as all establishments with 10 or more employees but fewer than 500, on December 19, 2014; • In very small establishments, defined as all establishments with fewer than 10 employees or annual sales of less than $2.5 million February 17, 2015.
      9 CFR Parts 381 and 500

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 7 - AGRICULTURE
U.S. Code: Title 21 - FOOD AND DRUGS

§ 451 - Congressional statement of findings

§ 452 - Congressional declaration of policy

§ 453 - Definitions

§ 454 - Federal and State cooperation in development and administration of State poultry product inspection programs

§ 455 - Inspection in official establishments

§ 456 - Operation of premises, facilities and equipment

§ 457 - Labeling and container standards

§ 458 - Prohibited acts

§ 459 - Compliance by all establishments

§ 460 - Miscellaneous activities subject to regulation

§ 461 - Offenses and punishment

§ 462 - Reporting of violations; notice; opportunity to present views

§ 463 - Rules and regulations

§ 464 - Exemptions

§ 465 - Limitations upon entry of poultry products and other materials into official establishments

§ 466 - Imports

§ 467 - Inspection services

§ 467a - Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks

§ 467b - Seizure and condemnation

§ 467c - Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas

§ 467d - Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts

§ 467e - Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments...purposes of adulterated or misbranded and imported articles; other matters

§ 467f - Federal Food, Drug, and Cosmetic Act applications

§ 468 - Cost of inspection; overtime

§ 469 - Authorization of appropriations

§ 470 - Omitted

Title 9 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR 381 after this date.

  • 2014-08-21; vol. 79 # 162 - Thursday, August 21, 2014
    1. 79 FR 49566 - Modernization of Poultry Slaughter Inspection
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Food Safety and Inspection Service
      Final rule.
      Effective Date: October 20, 2014. Notification Date: All young chicken and turkey slaughter establishments will initially have until February 23, 2015, to notify their District Office in writing of their intent to operate under the New Poultry Inspection System (NPIS). Establishments that do not notify their District Office of their intent by February 23, 2015, will be deemed to have chosen the inspection system that they are currently operating under. Young chicken and turkey slaughter establishments that decide that they would like to convert to NPIS after the initial notification date may notify FSIS of their intent at any time after that date. The Agency will implement the NPIS in the additional establishments that intend to convert on a schedule consistent with Agency resources and readiness. The Agency intends to implement the NPIS in all young chicken and turkey establishments that choose to operate under the NPIS, regardless of when the establishment notifies FSIS of its intent to transition to the NPIS. However, the initial implementation wave will only include those establishments that submitted their notifications within the initial notification period. After October 20, 2014, FSIS will begin selecting from those establishments that have notified FSIS of their intent to switch to the NPIS. The Agency will use a computerized ranking system to determine the schedule of establishments for implementation of the NPIS. This ranking system will take into consideration several factors, such as FSIS staffing needs, past performance of the establishment, the location of the establishment with respect to other federally-inspected establishments, and establishment readiness to transition to the NPIS. FSIS will implement the NPIS in phases by clusters of establishments in close geographic proximity to one another. The initial implementation wave will only include those establishments that notified FSIS of their intent to switch to the NPIS during the initial six-month notification period. FSIS expects that in subsequent years many more establishments will choose to transition to the new system. The Agency's implementation strategy for the NPIS is described in more detail in the preamble to this final rule. Applicability Dates: The regulations that prescribe procedures for controlling visible fecal contamination in 9 CFR 381.65(f), the regulations that prescribe procedures for controlling contamination throughout the slaughter and dressing process in 9 CFR 381.65(g), and the regulations that prescribe recordkeeping requirements in 9 CFR 381.65(h) will be applicable as follows: • In large establishments, defined as all establishments with 500 or more employees, on November 19, 2014; • In small establishments, defined as all establishments with 10 or more employees but fewer than 500, on December 19, 2014; • In very small establishments, defined as all establishments with fewer than 10 employees or annual sales of less than $2.5 million February 17, 2015.
      9 CFR Parts 381 and 500