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COMMONWEALTH OF PENNSYLVANIA

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Pennsylvania Code



Subchapter A. GENERAL PROVISIONS


Sec.


49.1.    Definitions.
49.2.    Scope.
49.3.    Certification and compliance.
49.4.    Records and labeling.
49.5.    Inspection and sampling.
49.6.    Source.
49.7.    Freight-forwarders.

§ 49.1. Definitions.

 The following words and terms, when used in this chapter, have the following meanings, unless otherwise defined in the NSSP Model Ordinance:

   Dealer—A shellstock shipper, shucker-packer, repacker, reshipper or depuration processor.

   Department—The Department of Agriculture of the Commonwealth.

   Depuration or controlled purification—The process that uses a controlled aquatic environment to reduce the level of pathogens or poisonous or deleterious substances in live shellfish.

   Facility—A structure.

   Food Act—The Food Act (31 P. S. § §  20.1—20.18).

   Freight-forwarder—A person who transports shellfish for a third party owner by vehicle or vessel, or who stores shellfish at a location for a short period of time while the shellfish are in transit.

   HACCP—Hazard Analysis Critical Control Point—A system devedoped by the National Advisory Committee on Microbiological Criteria for Foods that identifies and monitors specific foodborne hazards that can adversely affect the safety of the food products.

   NSSP Model Ordinance or National Shellfish Sanitation Program Model Ordinance—As set forth in the Guide for the Control of Molluscan Shellfish under the purview of the Interstate Shellfish Sanitation Conference, and published by the United States Department of Health and Human Services; Public Health Services; Food and Drug Administration, or the most current successor document.

   Person—An individual, partnership, association, company, corporation or other legal entity. The term includes the officers, employes and agents of a partnership, association, company, corporation or other legal entity.

   Repacker—A person other than the original certified shucker-packer who repacks shucked shellfish into other containers for distribution or sale, or repacks and resells shellstock but does not shuck shellfish.

   Reshipper—A person who purchases shucked shellfish or shellstock from other certified shippers and sells the product, without repacking or relabeling, to other certified shippers, wholesalers or retailers.

   Secretary—The Secretary of the Department.

   Shellstock shipper—A person who grows, harvests, buys or repacks, and sells shellstock. The term includes a shipper who ships previously shucked and packed shellfish, but does not shuck shellfish nor repack shucked shellfish.

   Shucker-packer—A person who shucks and packs shellfish or who acts as a shellstock shipper or reshipper, or who repacks shellfish originating from other shellfish facilities that are certified in accordance with §  49.3 (relating to certification and compliance).

Authority

   The provisions of this §  49.1 amended under the act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § §  655.1—655.13); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P. S. § §  510-17 and 510-20).

Source

   The provisions of this §  49.1 adopted September 8, 1971, effective September 9, 1971, 1 Pa.B. 1828; amended December 14, 1990, effective December 15, 1990, 20 Pa.B. 6155; amended October 13, 2006, effective October 14, 2006, 36 Pa.B. 6285. Immediately preceding text appears at serial pages (301713) to (301714) and (217565).

§ 49.2. Scope.

 A person who processes, distributes, ships, transports, stores, offers for sale or sells shellfish in this Commonwealth shall comply with this chapter and the NSSP Model Ordinance. The NSSP Model Ordinance can be viewed at www.cfsan.fda.gov/[tilde ]ear/nss2-toc.html.

Authority

   The provisions of this §  49.2 amended under the act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § §  655.1—655.13); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P. S. § §  510-17 and 510-20).

Source

   The provisions of this §  49.2 adopted September 8, 1971, effective September 9, 1971, 1 Pa.B. 1828; amended December 14, 1990, effective December 15, 1990, 20 Pa.B. 6155; amended October 13, 2006, effective October 14, 2006, 36 Pa.B. 6285. Immediately preceding text appears at serial pages (217565) to (217566).

§ 49.3. Certification and compliance.

 (a)  A dealer may not engage commercially in the wholesale sale, shipping, processing, purchasing or selling of shellfish without the following:

   (1)  Compliance with this chapter, the NSSP Model Ordinance and the Food Act.

   (2)  Application for and receipt of a valid shellfish facility certificate from the Department.

 (b)  A shellfish facility certificate shall show the dealer’s name, address and certification number. The activities of the dealer shall be limited to activities covered by the certification. The certification number will indicate the type of shellfish facility the dealer is authorized to operate. These types of shellfish facilities, and acceptable abbreviations, are as follows:

   (1)  RP—Repacker.

   (2)  RS—Reshipper.

   (3)  SP—Shucker-Packer.

   (4)  SS—Shellstock Shipper.

   (5)  DP—Depuration processor.

 (c)  The shellfish facility certificate shall be posted in the facility in a conspicuous place.

 (d)  The certification requirements do not apply to the sale of shellfish for consumption on the premises or by a retail food establishment that sells shellfish to ultimate consumers.

 (e)  The Department is empowered to revoke or suspend a shellfish facility certification held by a dealer who violates this chapter, or who violates any provision of the NSSP Model Ordinance.

 (f)  Whenever the shellfish facility certification is revoked or suspended, the certificateholder will be notified in writing of the violations which caused the revocation or suspension. The Department will notify the United States Food and Drug Administration (FDA) of the action when interstate certified shellfish dealers are involved so that the dealer’s business name and certification number may be removed from the FDA Interstate Certified Shellfish Shippers List.

 (g)  A person required to obtain shellfish facility certification from the Department under this section shall apply annually for the certificate on forms provided by the Department. The certification expires automatically on October 31 following the date of issue.

Authority

   The provisions of this §  49.3 amended under the act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § §  655.1—655.13); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P. S. § §  510-17 and 510-20).

Source

   The provisions of this §  49.3 adopted September 8, 1971, effective September 9, 1971, 1 Pa.B. 1828; amended December 14, 1990, effective December 15, 1990, 20 Pa.B. 6155; amended October 13, 2006, effective October 14, 2006, 36 Pa.B. 6285. Immediately preceding text appears at serial pages (217566) to (217567).

Cross References

   This section cited in 7 Pa. Code §  49.1 (relating to definitions).

§ 49.4. Records and labeling.

 A dealer shall maintain complete, accurate and legible transaction records which provide the information necessary to trace purchases and sales of shellfish back to their source. A dealer shall keep and retain records and maintain product labeling in compliance with the standards and requirements of this chapter and the NSSP Model Ordinance and the Food Act. Current HACCP plans for molluscan shellfish shall be readily available and easily identified for the Department.

Authority

   The provisions of this §  49.4 amended under the act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § §  655.1—655.13); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P. S. § §  510-17 and 510-20).

Source

   The provisions of this §  49.4 adopted September 8, 1971, effective September 9, 1971, 1 Pa.B. 1828; amended December 14, 1990, effective December 15, 1990, 20 Pa.B. 6155; amended October 13, 2006, effective October 14, 2006, 36 Pa.B. 6285. Immediately preceding text appears at serial pages (217567) to (217568).

Cross References

   This section cited in 7 Pa. Code §  49.18 (relating to packing of shucked shellfish).

§ 49.5. Inspection and sampling.

 (a)  The Department may inspect facilities falling under this chapter to ascertain compliance or noncompliance with this chapter.

 (b)  After the Department’s personnel present identification, the shellfish facility operator and its personnel shall allow the Department to determine if the shellfish facility is in compliance with this chapter by allowing Department personnel access to the shellfish facility, allowing inspection and providing information and records to which the Department is entitled under the Food Act or this chapter, during the shellfish facility’s hours of operation and other reasonable times if the facility is not open during normal business hours.

 (c)  The Department and its employees and agents may also conduct inspections whenever a person presents information to the Department giving the Department reason to believe that there exists a violation of this chapter, of a shellfish facility certification issued under this chapter, or of orders issued by the Department.

 (d)  The Department and its authorized agents may secure samples of shellfish and processed shellfish products for laboratory examination from any lot of shellfish and will be permitted to examine the records of the facility to obtain information pertaining to shellfish harvested, purchased, received, processed, sold, held, distributed or shipped, and to personnel employed.

 (e)  The Department or its authorized agent is authorized to detain a shellfish product if there is cause to believe it is adulterated or misbranded. It is unlawful to remove or dispose of a detained product without a determination of the Secretary, in accordance with section 6 of the Food Act (31 P. S. §  20.6), authorizing the removal or disposition.

 (f)  Laboratory analyses to be performed shall be conducted in accordance with the most current edition of the following:

   (1)  The American Public Health Association’s Recommended Laboratory Procedures for the Examination of Seawater and Shellfish.

   (2)  The United States Food and Drug Administration’s Bacteriological Analytical Manual.

   (3)  Official Methods of Analysis of the Association of Official Analytical Chemists.

   (4)  Compendium of Methods for the Microbiological Examination of Foods, compiled by the American Public Health Association’s Technical Committee on Microbiological Methods for Foods.

   (5)  Standard Methods for the Examination of Water and Wastewater, prepared and published jointly by the American Public Health Association.

Authority

   The provisions of this §  49.5 amended under the act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § §  655.1—655.13); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P. S. § §  510-17 and 510-20).

Source

   The provisions of this §  49.5 adopted September 8, 1971, effective September 9, 1971, 1 Pa.B. 1828; amended December 14, 1990, effective December 15, 1990, 20 Pa.B. 6155; amended October 13, 2006, effective October 14, 2006, 36 Pa.B. 6285. Immediately preceding text appears at serial pages (217568) to (217570).

§ 49.6. Source.

 (a)  A dealer in this Commonwealth may not have in his possession for processing, offer for sale or sell shellfish unless the shellfish have been obtained from interstate dealers who are listed in the United States Food and Drug Administration’s Interstate Certified Shellfish Shippers List, or intraState dealers certified by the Department.

 (b)  A dealer who knowingly or willfully alters or damages or loans or transfers to another dealer a shellfish facility certification number or shellfish tags, or a dealer who uses the shellfish facility certification number or shellfish tags other than the dealer to whom it was issued, is in violation of this chapter.

Authority

   The provisions of this §  49.6 issued under the act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § §  655.1—655.13); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P. S. § §  510-17 and 510-20).

Source

   The provisions of this §  49.6 adopted December 14, 1990, effective December 15, 1990, 20 Pa.B. 6155; amended October 13, 2006, effective October 14, 2006, 36 Pa.B. 6285. Immediately preceding text appears at serial page (217570).

§ 49.7. Freight-forwarders.

 A freight-forwarder shall maintain shellfish (other than frozen shellfish) at an ambient temperature of 45° Fahrenheit while being transported. A freight-forwarder shall maintain shell fish (other than frozen shellfish) at an ambient temperature of 45° Fahrenheit when maintained in a staging or layover area for more than 1 hour.

Source

   The provisions of this §  49.7 adopted October 13, 2006, effective October 14, 2006, 36 Pa.B. 6285.



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