PROPOSED RULEMAKING
DEPARTMENT OF AGRICULTURE
[7 PA. CODE CH. 49]
Shellfish
[36 Pa.B. 936] The Department of Agriculture (Department) proposes to amend Chapter 49 (relating to shellfish) to read as set forth in Annex A.
Statutory Authority
The Food Act (act) (31 P. S. §§ 20.1--20.18) and section 1705(d) of The Administrative Code of 1929 (71 P. S. § 445(d)) provide the legal authority for this proposed rulemaking.
The act charges the Department with the responsibility to: (1) regulate, register and inspect ''food establishments'' in this Commonwealth under section 14(a) of the act (31 P. S. § 20.14(a)); (2) promulgate regulations and food safety standards necessary to the proper enforcement of the food safety requirements set forth in section 13(a) of the act (31 P. S. § 20.13(a)); and (3) construe the statute and its attendant regulations in a manner that is as consistent with Federal statutory and regulatory authority as practicable, and would not unduly burden interstate commerce under section 16 of the act (31 P. S. § 20.16).
Section 1705(d) of The Administrative Code of 1929 requires the Department to establish regulatory standards necessary to enforce food safety laws.
Purpose
The proposed rulemaking: (1) updates the Department's shellfish food safety standards to reflect the current state of food science knowledge; (2) brings these standards into greater conformity with those of other states by establishing standards and procedures recommended in the widely-adopted National Shellfish Sanitation Program (NSSP) Model Ordinance; (3) improves the Department's ability to trace-back foodborne illness outbreaks related to shellfish; and (4) facilitates interstate and intraState commerce in shellfish by promoting consistency in shellfish standards among various jurisdictions.
Background
The NSSP Model Ordinance is the product of a collaborative effort among the Department, the Food and Drug Administration, various shellfish regulatory authorities in other states and nations, shellfish industry representatives, academia and consumers. The NSSP Model Ordinance represents the state-of-the-science with respect to shellfish safety, handling and processing and, in the event of a foodborne illness outbreak relating to shellfish, facilitates the trace-back of shellfish to its source harvest area. Food safety science is an evolving body of knowledge. It is the Department's intention to adopt regulatory food safety standards that reflect current recommended National standards and to amend these standards in the future as necessary to track with relevant revisions to these National standards. The NSSP Model Ordinance is reviewed and updated regularly, at meetings of the Interstate Shellfish Sanitation Conference.
As more states adopt the NSSP Model Ordinance as a basis for their respective shellfish regulations, the Commonwealth's current shellfish regulations become more out-of-step with shellfish industry practices and the state-of-the-science with respect to shellfish safety. This Commonwealth's shellfish industry is, in many respects, ahead of the Department in terms of sanitation and recordkeeping requirements to keep its products competitive in interstate commerce. The proposed rulemaking brings the Department current with widely-used and well-regarded industry standards for shellfish.
Need for the Proposed Rulemaking
The proposed rulemaking establishes uniform shellfish standards and tracks neighboring states, and thereby facilitates interstate commerce in shellfish. It also helps protect human health and facilitates the trace-back of shellfish to its harvest area in the event of a foodborne illness outbreak involving shellfish. The Department is satisfied there are no reasonable alternatives to proceeding with the proposed rulemaking.
Overview of the Major Provisions of the Proposed Rulemaking
Proposed Subchapter A (relating to general provisions) defines terms in the same language as presented in the NSSP Model Ordinance and also expands defined terms.
Proposed Subchapters B and C (relating to packing, storing and shipping of shellfish; and construction and maintenance of physical facilities) supplant the Department's current regulatory standards for shellfish with the standards prescribed in the current version of the NSSP Model Ordinance.
Affected Individuals and Organizations
The proposed rulemaking helps protect public health in the event of a foodborne illness outbreak involving shellfish. It also helps this Commonwealth's shellfish dealers by establishing regulatory standards that are consistent with those of other states and nations, thereby facilitating commerce.
Fiscal Impact
Commonwealth
The proposed rulemaking imposes no costs and has no fiscal impact on the Commonwealth.
Political subdivisions
The proposed rulemaking imposes no costs and has no fiscal impact upon political subdivisions.
Private sector
The proposed rulemaking imposes no costs and has no fiscal impact on the private sector. Since the NSSP Model Ordinance is the widely-accepted industry standard for shellfish sanitation, the private sector (approximately 95 shellfish dealers) is either already in compliance with this standard or can readily come into compliance with this standard without appreciable costs.
General public
The proposed rulemaking imposes no costs and has no fiscal impact on the general public. The proposed rulemaking enhances public health and safety.
Paperwork Requirements
The proposed rulemaking is not likely to impact upon the paperwork generated by the Department or shellfish facilities.
Effective Date
The proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin.
Sunset Date
There is no sunset date for the proposed rulemaking. The Department will review the efficacy of this regulation on an ongoing basis.
Public Comment Period/Contact Person
Interested persons are invited to submit written comments regarding the proposed rulemaking within 30 days following publication in the Pennsylvania Bulletin. Comments are to be submitted to the Department of Agriculture, Bureau of Food Safety and Laboratory Services, 2301 North Cameron Street, Harrisburg, PA 17110-9408, Attention: Garry Orner.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 13, 2006, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.
DENNIS C WOLFF,
SecretaryFiscal Note: 2-151. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 7. AGRICULTURE
PART III. BUREAU OF FOOD SAFETY AND LABORATORY SERVICES
Subpart A. SOLID FOODS
CHAPTER 49. SHELLFISH
Subchapter A. GENERAL PROVISIONS § 49.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless [the context clearly indicates otherwise] otherwise defined in the NSSP Model Ordinance:
[Adulterated or misbranded shellfish--The term includes shellfish which meet one of the following conditions:
(i) Harvested from closed waters.
(ii) Shucked, packed or otherwise processed in a plant which has not been certified by the Department under this chapter or not currently listed on the United States Food and Drug Administration's Interstate Certified Shellfish Shippers List, available from: Chief, Shellfish Sanitation Branch, HFF-344, Food and Drug Administration, 200 ''C'' Street, S. W., Washington, D. C. 20204, (202) 485-0149, Telex: 898488 PHS PKLN ROVE
(iii) Contaminated as determined by bacteriological or other analysis.
(iv) Consisting in whole or in part of filthy, putrid or decomposed substance, or if it is otherwise unfit for food.
(v) Prepared, packed or held under or exposed to unsanitary conditions where it may become contaminated with filth, or whereby it may have been rendered injurious to health.
(vi) Not labeled in accordance with this chapter.
Backsiphonage--The flowing back of used, contaminated or polluted water from a plumbing fixture or vessel or other source into a potable water supply pipe due to negative pressure in the pipe.
Cross connection--A physical connection or arrangement between two otherwise separate piping systems, one of which contains potable water, and the other, water of unknown or questionable safety, or steam, gases or chemicals, whereby there may be a flow from one system to the other, the direction of flow depending on the pressure differential between the two systems.]
Dealer--A shellstock shipper, shucker-packer, repacker, reshipper or depuration processor.
Department--The Department of Agriculture of the Commonwealth [or local department of health approved by the Department].
* * * * * [Employe--A person employed by a shellfish processor, distributor, shipper or reshipper who does or may handle or come in contact with handling, storing, transporting or selling and distributing shell stock or 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 developed 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.
[Lot of shellfish--A collection of bulk shellstock or containers of shellstock of no more than one day's harvest from a single defined growing area harvested by one or more harvesters; or a collection of containers of no more than 1 day's shucked shellfish product produced under conditions as nearly uniform as possible, and designated by a common container code or marking.]
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.
* * * * * [Plant--An establishment where shellfish are processed or stored.
Processing--The act of depurating, shucking, packing or repacking of shellfish.]
* * * * * [Retail sale--Sale to the ultimate consumer or to another person who will not resell the product.
Sanitize--To effectively treat equipment and utensils by a process that provides enough accumulative heat or concentration of chemicals for enough time to reduce the bacterial count, including pathogens, to a safe level on utensils and equipment.]
Secretary--The Secretary of the Department.
[Shellfish--Edible species of oysters, clams and mussels, either shucked or in the shell, fresh or fresh frozen, whole or in part. The term does not include scallop species of the family Pectinidae.
Shellstock--Shellfish which remain intact in the original shells.]
* * * * * [Shucked shellfish--Shellfish which have been removed from their shells.]
Shucker-packer--A person who shucks and packs shellfish or who acts as a [shell stock] shellstock shipper or reshipper, or who repacks shellfish originating from other [certified sources] shellfish facilities that are certified in accordance with § 49.3 (relating to certification and compliance).
[Wholesale sale--A sale to anyone other than the ultimate purchasing consumer.]
§ 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.
§ 49.3. [Permits] Certification and compliance.
(a) A [person] dealer may not engage commercially in the wholesale sale, shipping, processing, purchasing or selling of shellfish without the following:
(1) Compliance with this chapter, [except as stated in § 49.4(d) (relating to records and labeling)] the NSSP Model Ordinance and the Food Act.
(2) Application for and receipt of a valid shellfish [plant permit] facility certificate from the Department.
(b) A shellfish [plant permit will] facility certificate shall show the dealer's name, address and [permit] certification number. The activities of the [permitee] dealer shall be limited to activities covered by the [permit] certification. The [permit] certification number will indicate the type of shellfish [plant] facility the dealer is authorized to operate [as follows:]. These types of shellfish facilities, and acceptable abbreviations, are as follows:
* * * * * (5) DP--Depuration processor.
(c) The shellfish [plant permit] facility certificate shall be posted [on the plant premises] in the facility in a conspicuous place.
(d) The [permit] certification requirements do not apply to [:
(1) The] the sale of shellfish for consumption on the premises or by a retail food establishment that sells shellfish to ultimate consumers.
[(2) A wholesale shellfish distributor or reshipper who does not break down for repacking any quantity of shellstock or break a unit container of shucked shellfish.
(3) Anyone who provides for only the transportation of shellfish.]
(e) The Department is empowered to revoke or suspend a shellfish [plant permit] facility certification held by a [proprietor] dealer who violates this chapter, or who violates any provision of the NSSP Model Ordinance.
(f) Whenever the shellfish [plant permit] facility certification is revoked or suspended, the [permit holder] 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 [permit] certification number may be removed from the FDA Interstate Certified Shellfish Shippers List.
(g) A person required to obtain [a permit] shellfish facility certification from the Department under this section shall apply annually for the [permit] certificate on forms provided by the Department. The [permit] certification expires automatically on October 31 following the date of issue.
§ 49.4. Records and labeling.
[(a)] 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. [The records shall include the growing area name; the name, address and permit number of the shipper; the amount and type of shellfish; the date of receipt; and the date of sale. Shellfish records shall be subject to inspection by the Department.] 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.
[(1) Records covering purchases and sales of fresh shellfish shall be retained for a minimum of 1 year.
(2) Records covering purchases and sales of frozen shellfish shall be retained for at least 2 years or for a period that exceeds the shelf-life of the product, if that is longer than 2 years.
(b) An individual package of shellstock, and each individual package of fresh or frozen shucked shellfish, shall have permanently affixed on the package, an easily visible, durable, waterproof tag or label approved by the Department.
(1) The tag or label on the shellstock container shall contain the following information: the dealer's name, address, shellfish permit number, growing area identification, the date of harvest, type and quantity of shellstock. When waxed cardboard boxes are used, the required information may be printed on the sides of the box.
(2) An individual package of fresh or frozen shucked shellfish shall have permanently recorded on the principal display panel the dealer's or processor's shellfish plant permit number and sell by date. The sidewall is considered the principal display panel. Packages of shucked shellfish containing 1/2 gallon--64 ounces--or more, shall have the dealer's shellfish plant permit number and the packer's name printed or embossed on the sidewall of the package, and the date shucked marked on both the lid and also the side wall or bottom. The date shall consist of either the number of the day of the year or the abbreviation for the month and number of the day of the month. The year shall be added for frozen shellfish. Frozen shellfish shall be clearly labeled as frozen in a type size of equal prominence to the name of the shellfish and located immediately adjacent thereto.
(c) Required label and product identification shall be provided in a legible and indelible form.
(d) The fraudulent use of tags or the placing of fraudulent or misleading information on the tags is considered a violation of this chapter.
(e) Public eating and drinking places licensed under the act of May 23, 1945 (P. L. 926, No. 369), known as the Public Eating and Drinking Place Law (35 P. S. §§ 655.1--655.13) and establishments authorized to conduct retail sales shall receive shellstock and fresh or frozen shucked shellfish labeled and identified according to subsections (b)--(d), and shall maintain for 90 days the tags and accurate records of the sources and quantity of all lots of shellfish.]
§ 49.5. Inspection and sampling.
(a) The Department may inspect [plants] facilities falling under this chapter to ascertain compliance or noncompliance with this chapter. [Plants involved in the interstate shipment of shellfish are subject to inspection by the Department and its employes and authorized agents at least four times per year. Other plants are subject to inspection by the Department and its employes and authorized agents at least once per year.]
(b) [The Department and its employes and agents may conduct additional inspections, including the following:] 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.
[(1) Follow-up inspections.
(2) Inspections to determine compliance with environmental protection acts or regulations or requirements of an order issued by the Department.]
(c) The Department and its [employes] 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 [permit] shellfish facility certification issued under this chapter, or of orders issued by the Department.
(d) [Nothing in this section places duty or obligation upon the Department to conduct a minimum number of inspections per year, to conduct a minimum number of inspections during a certain period or to inspect for particular reasons.
(e)] 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.
[(f)](e) The Department or its authorized agent is authorized to [embargo] detain a shellfish product if there is cause to believe it is adulterated or misbranded. It is unlawful to remove or dispose of [an embargoed] a detained product without [permission of one of the following:
(1) The Department or its authorized agent who placed the embargo.
(2) A court.] a determination of the Secretary, in accordance with section 6 of the Food Act (31 P. S. § 20.6), authorizing the removal or disposition.
[(g)](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[, available from: American Public Health Association, 1015 15th Street, N. W., Washington, D.C. 20005, (202) 789-5600].
(2) The United States Food and Drug Administration's Bacteriological Analytical Manual[, available from: Association of Official Analytical Chemists, Inc., 1111 N. 19th Street, Suite 210, Arlington, VA 22209, (703) 522-3032].
(3) Official Methods of Analysis of the Association of Official Analytical Chemists[, available from: Association of Official Analytical Chemists, Inc., 1111 N. 19th Street, Suite 210, Arlington, VA 22209, (703) 522-3032].
(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[, available from: American Public Health Association, 1015 15th Street, N. W., Washington, D.C. 20005, (202) 789-5600].
(5) Standard Methods for the Examination of Water and Wastewater, prepared and published jointly by the American Public Health Association[, American Waterworks Association and the Water Pollution Control Federation, available from: American Public Health Association, 1015 15th Street, N. W., Washington, D.C. 20005, (202) 789-5600].
§ 49.6. Source.
(a) A [person] 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 [approved by the Department and are] listed in the United States Food and Drug Administration's Interstate Certified Shellfish Shippers List, or [intrastate] intraState dealers [permitted] certified by the Department.
(b) A [person] dealer who knowingly or willfully alters or damages or loans or transfers to another [person] dealer a shellfish [permit] facility certification number or shellfish tags, or a [person] dealer who uses the shellfish [permit] facility certification number or shellfish tags other than the [person] dealer to whom it was issued, is in violation of this chapter.
§ 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 shellfish (other than frozen shellfish) at an ambient temperature of 45° Fahrenheit when maintained in a staging or layover area for more than 1 hour.
Subchapter B. (Reserved) (Editor's Note: As part of this proposed rulemaking, the Department is proposing to delete the existing text of §§ 49.11--49.20, which appears in 7 Pa. Code pages 49-8--49-12, serial pages (217570)--(217574).)
§§ 49.11--49.20. (Reserved).
Subchapter C. CONSTRUCTION AND MAINTENANCE OF PHYSICAL FACILITIES § 49.31. Submission of plans.
(a) Whenever a shellfish processing, depuration or controlled purification [plant] facility is constructed, remodeled or altered and whenever an existing structure is converted to use as a shellfish processing, depuration or controlled purification [plant] facility, properly prepared plans and specifications for the construction, remodeling or conversion shall be submitted to the Department for review and approval before construction, remodeling or conversion is begun.
(b) The plans and specifications [shall] must indicate the proposed layout, arrangement, mechanical plans and construction materials of work areas and the type and model of proposed fixed equipment and facilities. A shellfish processing [plant] facility, depuration or controlled purification plant may not be constructed, remodeled, altered or converted unless the plans and specifications are first approved by the Department. The approval will be based on compliance with this [subchapter, § 49.15 (relating to storage) and Subchapters D and E (relating to shellfish processing: sanitary facilities and controls; and shucking area and equipment) and the Department's Guidelines for Preparation of Plans--Food Service Facilities. Copies of the guidelines may be obtained from the Department of Agriculture, Bureau of Food Safety and Laboratory Services, 2301 N. Cameron St., Harrisburg, Pennsylvania 17110, (717) 772-8353] chapter and the NSSP Model Ordinance.
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to delete the existing text of §§ 49.32--49.34, which appears in 7 Pa. Code pages 49-14--49-15, serial pages (217576)--(217577).)
§§ 49.32--49.34. (Reserved).
Subchapter D. SHELLFISH PROCESSING: SANITARY FACILITIES AND CONTROLS § 49.41. Water supply.
(a) Potable water of sufficient quantity to meet the needs of the shellfish [plant] facility shall be provided from a source approved by the Department or be under permit from the Department of Environmental Protection. Water quality [shall] must meet the requirements of 25 Pa. Code Chapter 109 (relating to safe drinking water). Noncommunity water supplies shall be designed, constructed and operated in accordance with the Department of Environmental Protection's Bureau of Water Supply and Community Health Manual and 25 Pa. Code Chapter 109.
(b) Hot and cold water under pressure shall be provided to each plumbing fixture used for cleaning, washing or sanitizing purposes in:
* * * * * § 49.42. Plumbing.
(a) Plumbing [shall] must be sized, installed and maintained in compliance with the provisions of the local plumbing code or, in the absence thereof, in a manner that prevents contamination of the water supply or the creation of an unsanitary condition.
* * * * * § 49.43. Toilet facilities.
(a) [Conveniently located, separate toilets shall be provided for each sex. When the plant has fewer than ten employes, toilet facilities shall be provided, but need not be separate for each sex.] At least one conveniently-located toilet facility shall be provided for employees. There need not be a separate toilet facility for each gender.
* * * * * § 49.44. [Lavatories] Hand wash sinks.
(a) [Lavatories] Hand wash sinks shall be provided, adequate in number and size for the number of [employes] employees, convenient to work areas and equipped with cold and hot running water. Hot water of at least [100°F] the minimum temperature required by the NSSP Model Ordinance shall be provided [either from a controlled temperature source with a maximum temperature of 115°F, or] from a hot and cold mixing or combination faucet. [Lavatories] Hand wash sinks shall be located within or immediately adjacent to toilets and within processing areas.
(b) [There shall be at least one lavatory for each 15 employes.
(c)] Hand cleansing soap or detergent and approved sanitary towels or other approved hand-drying devices shall be provided at [lavatories] hand wash sinks.
[(d) Handwashing signs shall be posted at each lavatory location directing employes to wash their hands before starting work and after each interruption.
(e)] (c) * * *
§ 49.45. Sewage.
Sewage disposal systems shall be approved by the local authority and [shall] must comply with 25 Pa. Code Chapters 71, 73 and 243 (relating to the administration of sewage facilities planning program; standards for onlot sewage treatment facilities; and nuisances), and The Clean Streams Law (35 P. S. §§ 691.1--691.1001).
§ 49.47. [Arthropod] Insect and rodent control.
(a) Safe and effective measures shall be used to prevent the entry of insects, rodents and other vermin, and to kill and capture insects and vermin which enter the [plant] facility despite other control measures.
* * * * * (d) The storage and use of pesticides in [shellfish plants] a shellfish facility shall be prohibited unless used in full compliance with the manufacturer's label or used under the control of a certified pesticide applicator.
Subchapter E. SHUCKING AREA AND EQUIPMENT § 49.51. Shucking.
* * * * * (d) [Shellfish shucking and packing operations shall be conducted in separate rooms and shall be protected from contamination by splash or by other means from adjacent areas. Packing rooms shall be of sufficient size to permit sanitary handling of the product and thorough cleaning of the equipment.
(e) When shucking and packing operations occur in separate rooms, a delivery window or area shall be provided so that shuckers do not have direct access to the packing area.
(f)] A shellfish shucker may not go into or through the packing room for any purpose, except when he operates in a dual shucking packing capacity. If the shucker is operating in a dual capacity, [he] the shucker shall first change to clean clothing and thoroughly wash his hands and exposed portions of his arms.
[(g)] (e) * * *
§ 49.53. Utensils and equipment construction.
* * * * * (b) The Shellfish Industry Equipment Construction Guides, developed for use with the Public Health Service-States-Industry Cooperative Program for the Certification of Interstate Shellfish Shippers, [published by the United States Department of Health and Human Services, Appendix B of the 1988 NSSP Manual, and the uniform sanitation standards and criteria established by the National Sanitation Foundation, available from: National Sanitation Foundation, Post Office Box 1468, 3475 Plymouth Road, Ann Arbor, Michigan 48106, (313) 769-8010,] are incorporated by reference.
* * * * * § 49.54. Bactericidal treatment of utensils and equipment.
(a) Adequate cleaning facilities, including three-compartment sinks, or utensil washing machines, brushes, detergents, sanitizers, hot water and pressure hoses shall be available for use within the shellfish [plant] facility for proper cleaning and sanitizing of equipment and utensils.
* * * * * (c) If there is a need for a slop sink or device to discard liquid waste, the sink or device shall be provided in addition to the three-compartment sink. Cleaning wastes may not be emptied into sinks used for hand washing, or the processing of shellfish or the cleaning and sanitizing of utensils.
* * * * * (e) Equipment too large or impractical to treat by the methods in subsection (c) or (d) may be [treated using one of the following methods] cleaned, followed by spraying or swabbing the equipment with a chemical sanitizing solution of at least twice the minimum strength required for the particular sanitizing solution when used for immersion sanitization. This may be accomplished by either of the following systems:
(i) [With live steam from a hose, in the case of equipment in which steam can be confined] A clean-out-of-place system (C.O.P.) that allows the equipment to be moved (for cleaning purposes) from the position in which it is ordinarily used.
(ii) [By rinsing with boiling water] A central cleaning system that pipes a supply of hot or cold water, with or without chemicals, to a number of cleaning stations placed throughout the shellfish processing area.
[(iii) By spraying or swabbing with a chemical sanitizing solution of at least twice the minimum strength required for the particular sanitizing solution when used for immersion sanitization.]
* * * * * § 49.55. Equipment and utensil handling and storage.
* * * * * (c) Unused equipment and materials not necessary to [plant] facility operation may not be stored in rooms used for [shell stock] shellstock storage, shucking, packing, repacking or in equipment and container store rooms.
§ 49.56. General maintenance.
* * * * * (b) Only authorized equipment and persons shall be permitted in the shellfish processing area. Dogs, cats, birds or other animals or unauthorized persons may not be allowed in areas of the shellfish [plant] facility that are used for processing, holding, storing or transporting of shellfish except that patrol dogs accompanying security or police officers are permitted.
Subchapter F. [EMPLOYE] EMPLOYEE HEALTH AND CLEANLINESS § 49.61. Health.
(a) A person, while infected with a disease in a communicable form that can be transmitted by foods or who is a carrier of organisms that cause such a disease, or while afflicted with a boil, an infected wound or an acute respiratory infection, may not work in a shellfish [plant] facility in a capacity in which there is a likelihood of the person contaminating food or food-contact surfaces with pathogenic organisms or transmitting disease to other persons.
(b) An owner or manager who has reason to suspect that an [employe] employee has contracted a communicable disease shall immediately notify the Department. Pending appropriate action by the health officials, the [employe] employee shall be excluded from the [plant] facility.
§ 49.62. Cleanliness.
(a) [Employes] Employees and other persons who handle shellfish shall wash their hands and exposed portions of their arms with soap and warm water before beginning work, and during work as often as necessary following other activities, such as smoking, eating, cleaning or visits to the toilet. Hands, or rubber gloves when used, shall be washed and sanitized before manually handling shellfish.
* * * * * (c) [Employes] Employees shucking or handling shellfish meat shall wear clean aprons or coats and effective hair restraints. When manual handling of shellfish meat becomes necessary, sanitized rubber gloves or the equivalent shall be worn, or the hands shall be washed and [disinfected] sanitized immediately before the manual handling. Finger cots, gloves or shields, if worn by shuckers, shall be sanitized as often as necessary and shall be made of nonabsorbent material.
[Pa.B. Doc. No. 06-325. Filed for public inspection February 24, 2006, 9:00 a.m.]
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