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RULES AND REGULATIONS

Title 7--AGRICULTURE

DEPARTMENT OF AGRICULTURE

[7 PA CODE CHS. 31, 35, 41, 43, 45--47, 53, 55, 61, 63 AND 78--81]

Food Code

[33 Pa.B. 6137]

   The Department of Agriculture (Department) revises 7 Pa. Code (relating to agriculture) by establishing the Food Code in Chapter 46 (relating to food code) and deleting Chapters 31, 35, 41, 43, 45, 47 53, 55, 61, 63 and 78--81 to read as set forth in Annex A.

Statutory Authority

   The Food Act (act) (31 P. S. §§ 20.1--20.18), the Public Eating and Drinking Places Law (law) (35 P. S. §§ 655.1--655.13) and section 1705(d) of The Administrative Code of 1929 (71 P. S. § 445(d)) provide the legal authority for this final-form 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 under 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 under section 16 of the act (31 P. S. § 20.16).

   The law charges the Department with responsibility to regulate, license and inspect ''public eating and drinking places'' in this Commonwealth under sections 2 and 6(a) of the law (35 P. S. §§ 655.2 and 655.6(a)) and to regulate the cleanliness and sanitation of these public eating and drinking places under section 9 of the law (35 P. S. § 655.9). This responsibility had originally been assigned the former Department of Environmental Resources, but was transferred to the Department by the act of December 12, 1994 (P. L. 903, No. 131).

   Section 1705(d) of The Administrative Code of 1929 requires the Department to establish regulatory standards necessary to enforce food safety laws.

Purpose

   This final-form rulemaking draws authority from several food safety statutes to establish a comprehensive Food Code for this Commonwealth. The primary purpose of this final-form rulemaking is to achieve the public health goal of reducing foodborne illness to the fullest extent possible.

   This final-form rulemaking will bring the Commonwealth's food safety standards into step with the current National standards for food safety set forth in the 2001 edition of the United States Public Health Service Food Code (2001 FDA Model Food Code). Although the proposed rulemaking was based upon the 1999 version of that same Model Food Code, that model code was revised during the regulatory promulgation process and supplanted by the 2001 FDA Model Food Code. The 2001 FDA Model Food Code is the product of a collaborative effort among the Department, the Food and Drug Administration (FDA), the Food Safety Inspection Service, the Centers for Disease Control, various State and local public health and food control agencies, food industry representatives, academia and consumers. It represents the state-of-the-science with respect to food handling and food safety.

   The standards set forth in this final-form rulemaking are also consistent with the content of many of the food safety training courses offered to food industry employees over the years. For this reason, the final-form rulemaking presents a set of standards with which a large segment of this Commonwealth's food industry is already familiar.

   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 revise these standards in the future as necessary to track with relevant revisions to these National standards.

   Food safety considerations and procedures are essentially the same, whether the entity being regulated is a ''food establishment'' as described in the act or a ''public eating and drinking place'' as described in the law. For this reason, the final-form rulemaking merges the definitions of these two terms into a single new term--''food facility''--and establishes sanitation and food safety standards and procedures for these facilities.

Need for the Final-Form Rulemaking

   The final-form rulemaking is needed to reduce foodborne illness to the fullest extent possible. This public health and safety objective is the primary reason for the final-form rulemaking.

   The food safety standards set forth in the final-form rulemaking will serve the regulated community by helping to lower the number of claims and lawsuits related to foodborne illness.

Comments

   Notice of proposed rulemaking was published at 32 Pa.B. 1046 (February 23, 2002) and provided for a 30-day public comment period. Comments were received from the Pennsylvania Food Merchants Association (PFMA), the Philadelphia County Health Department (PCHD), the Pennsylvania School Boards Association, Inc. (PSBA), the Chester County Health Department (CCHD), the Pennsylvania Catholic Conference (PCC), the Bucks County Health Department (BCHD) and the Independent Regulatory Review Commission (IRRC).

   Comment: IRRC, the PSBA, the PCC and IRRC requested clarification regarding the jurisdiction of the Department to apply this chapter to schools. The PCC also noted that school cafeterias and private clubs (such as lodges) are not public eating and drinking places. The PCC cited 3 Pa.C.S. § 6510(d) (relating to exemptions) as an example of legislative intent to limit the regulatory reach of the Department to commercial or for-profit food establishments.

   Response: The Department agrees that the definitions of ''food facility'' and ''food facility premises'' in proposed § 46.3 (relating to definitions) were too broad and has revised these definitions to clarify that school cafeterias (and other specific food facilities and food processing plants) are not included within the term and are not subject to the provisions of the final-form rulemaking. The Department has not, historically, regulated food service facilities at schools. The act of December 29, 2002 (P. L. 1421, No. 179) amended sections 1, 6(c) and 12.1 of the law (35 P. S. §§ 655.1, 655.6(c) and 655.12a) to clarify that school cafeterias are not public eating and drinking places subject to regulation and licensure under that statute. Although the Department must provide inspections of school cafeterias and training for school cafeteria personnel in accordance with the standards applied to public eating and drinking places, school cafeterias are not otherwise subject to the provisions of that statute or this final-form rulemaking.

   Comment: IRRC noted that the proposed rulemaking would repeal existing regulations that are referenced in regulations of other Commonwealth agencies and asked what steps the Department has taken to notify these agencies of the need to update their regulations. As an example, IRRC cited the Department of Environmental Protection regulation in 25 Pa. Code § 171.6 (relating to food service), which requires food services in schools to meet the regulatory standards of the Department's regulation in Chapter 78 (relating to food establishments), a chapter repealed by this final-form rulemaking.

   Response: The Department has had open communication with the Departments of Education, Health, Corrections, Environmental Protection and Public Welfare with respect to the final-form rulemaking and has encouraged these agencies to update their regulations, as necessary.

   Comment: IRRC and the PCC noted that the primary responsibility for issuing licenses to food facilities that are public eating and drinking places lies with county or local health authorities, rather than the Department, and expressed concern that the proposed rulemaking did not make this clear. IRRC recommended the Department consider making use of the term ''licensor,'' which appears in the law and accurately describes entities that have authority to issue licenses.

   Response: The Department has added a definition of ''licensor'' to § 46.3. The definition identifies non-Department entities authorized to issue public eating and drinking place licenses under the law. In addition, references to the ''licensor'' have been added throughout the final-form rulemaking where the subject of the issuance of licenses is addressed.

   Comment: IRRC noted repeated references to the Pennsylvania Construction Code Act throughout the proposed rulemaking and recommended each reference be revised to identify the specific applicable sections of that statute.

   Response: The Department has revised proposed §§ 46.821(a), 46.825(e), 46.862(b) and (d), 46.863, 46.902(b) by inserting a reference to Chapter 3 of the Pennsylvania Construction Code Act (35 P. S. §§ 7210.301--7210.304).

   Comment: IRRC suggested that the definition of ''adulterated'' in proposed § 46.3 be edited into shorter sentences. IRRC also suggested the references to ''the Federal acts'' in subparagraphs (iii), (iv), (viii), (ix) and (xiv) of this definition be more specific.

   Response: The Department is reluctant to edit and redraft this definition, since it is a restatement of section 8 of the act (31 P. S. § 20.8). It has added the same definition of ''Federal acts'' as is contained in section 2 of the act (31 P. S. § 20.2) in § 46.3.

   Comment: IRRC expressed several concerns with respect to the definition of ''approved'' in proposed § 46.3. The commentator was concerned that the section did not specify the process for making the determination of conformity. It also offered that the phrase ''principles, practices and generally recognized standards'' is unclear and suggested the definition include examples, cross references or citations to these practices or standards.

   Response: The Department has added new language in § 46.1102 (relating to obtaining Department or licensor approval) describing a process by which any of the ''approvals'' referenced in the final-form rulemaking can be obtained. The definition of the term ''approved'' was derived directly from the 2001 FDA Model Food Code. There are literally thousands of types of foods and food manufacturing processes and the scientific knowledge surrounding food safety is constantly evolving. For this reason, the principles, practices and generally recognized standards are a ''moving target'' that will vary with food, time and knowledge. The Department believes it has gone as far as it can reasonably go in defining the term ''approved.'' The Department also believe the regulated community is quite familiar with the fact that food safety science is an ever-evolving body of knowledge, and takes the absence of comments from the regulated community on this subject as some indication of familiarity/comfort with the defined term.

   Comment: The PFMA noted that the term ''critical items'' is not defined within the proposed rulemaking, and requested there be ''process or guidance'' to clearly define this term.

   Response: The term ''critical items'' is not used in the final-form rulemaking, so it is not defined. The Department has, historically, used the inspection process and inspection report to indicate to food facilities the critical nature of specific violations encountered in the course of the inspection. The Department intends to continue this in the future.

   Comment: The CCHD commented on the use of the definition of ''Department'' in proposed § 46.3 and requested it be broadened in scope to include local health departments acting under authority of the act or the law.

   Response: The Department has implemented this request by defining a new term--''licensor''--in § 46.3 and making appropriate references to ''the Department or licensor'' throughout the final-form rulemaking.

   Comment: The PFMA commented on the inconsistency of the proposed definition for ''foodborne disease outbreak'' in § 46.3 with that found in the 2001 FDA Model Food Code.

   Response: The proposed definition has been supplanted by the 2001 FDA Model Food Code definition.

   Comment: IRRC requested a typographical correction to the definition of ''food employee'' in proposed § 46.3.

   Response: The Department has made the correction.

   Comment: IRRC suggested that the definition of ''hazard'' in proposed § 46.3 include examples of what might constitute an ''unacceptable consumer health risk.''

   Response: The Department has modified the definition to include examples such as pathogens, pesticides, natural toxins, rodent contamination or foreign materials.

   Comment: IRRC noted the use of the term ''honestly presented'' in several sections of the proposed rulemaking and suggested that the term be defined. IRRC recommended the Department consider language from proposed § 46.421(b)(1) (relating to accurate representation).

   Response: The Department has implemented the suggestion by defining the term in § 46.3.

   Comment: IRRC noted that the term ''package'' is defined in section 2 of the act and that § 46.3 of the proposed rulemaking did not contain that definition but, instead, a definition of the term ''packaged.'' IRRC further noted that the definition of ''packaged'' in the proposed rulemaking is not similar to the definition of ''package'' in section 2 of the act. IRRC suggested the Department review the regulation and determine the most appropriate term.

   Response: The Department has reviewed the use of the term ''packaged'' in the proposed rulemaking and intends to continue to use that term, rather than ''package.'' The definition of ''packaged'' is consistent with the 2001 FDA Model Food Code.

   Comment: The PFMA commented on the inconsistency of the proposed definition for ''potentially hazardous food'' with that found in the 2001 FDA Model Food Code.

   Response: The Department agrees the definitions are not identical, but the term is defined in section 2 of the act and the Department must use that statutory definition for the term.

   Comment: IRRC and the CCHD noted that although the proposed rulemaking defined the term ''private water system'' in § 46.3, the remainder of that document made reference to a ''nonpublic water supply.'' The commentators requested that this be resolved by using one term or the other exclusively.

   Response: The Department has implemented this request by deleting the term ''private water system'' and adding the term ''nonpublic water supply.''

   Comment: The PCHD and IRRC commented on the misspelling of the word ''ingredient'' in the definition of ''potentially hazardous food'' in proposed § 46.3

   Response: The Department has corrected this error.

   Comment: The CCHD noted the defined term ''bed and breakfast homestead or inn'' in proposed § 46.3 and did not believe the term was used anywhere else in the body of the proposed rulemaking.

   Response: The term ''bed and breakfast homestead or inn'' is used in the definition of a ''public eating and drinking place'' in § 46.3, where it is identified as an exception with respect to which the regulation is not applicable. The definition itself is from section 1 of the law.

   Comment: Both IRRC and the PCHD noted an error in the definition of ''public eating and drinking place'' in proposed § 46.3, which included dining cars and bed and breakfast homestead inns within that term.

   Response: The Department has corrected this error.

   Comment: IRRC commented that the definition of the term ''substance'' in proposed § 46.3 contained the word ''substance'' and noted this was inconsistent with the Pennsylvania Code and Bulletin Style Manual.

   Response: The Department changed the word ''substance'' in the referenced definition to ''material.''

   Comment: IRRC reviewed proposed § 46.112 (relating to diseases or medical conditions that must be reported) and suggested that paragraphs (5)--(8) be rewritten to identify the persons to whom the provision applies and to ''. . . more closely reflect the 1999 Federal Recommended Food Code at Section 2-201.11.''

   Response: The Department has implemented this suggestion. The phrase ''food employee or food employee applicant'' was added to the referenced section, making it more consistent with the 2001 FDA Model Food Code (the successor to the 1999 version of the model code).

   Comment: IRRC and the CCHD both suggested that proposed § 46.112 and proposed § 46.113(a)(2)(ii) (relating to duty to impose exclusions and restrictions) be amended to replace the phrase ''Escherichia coli O157:H7'' with ''Shiga toxin-producing E. coli.''

   Response: The term ''Eshcherichia coli O157:H7'' was replaced by ''Shiga toxin-producing Eshcherichia coli'' in §§ 46.112 and 46.113, as well as when used in other sections throughout the chapter. The replacement is consistent with the 2001 FDA Model Food Code.

   Comment: IRRC and the CCHD suggested that proposed § 46.132 (relating to duty of food employees to wash) be revised to include a requirement that employees wash their hands before donning gloves, as stated in the 2001 FDA Model Food Code.

   Response: The suggestion has been implemented in the final-form rulemaking.

   Comment: IRRC and the PCHD reviewed proposed § 46.133 (relating to required washing locations) and commented on the need to define the term ''utility sink'' and to provide clarification regarding the allowance for utilizing the utility sink as a handwash location in small food establishments with limited space. The PCHD also suggested the section be renamed ''approved hand washing locations.''

   Response: A definition of ''utility sink'' has been added to § 46.3. As a general food safety practice, a utility sink used for disposal of mop water or other liquid waste should not be used as a handwash sink. However, § 46.1103 (relating to variances) permits variances to allow this practice (when justifiable).

   Comment: IRRC suggested that the Department provide a definition of the acronym ''OTC,'' used in proposed § 46.134 (relating to hand sanitizers).

   Response: The suggested definition has been added.

   Comment: IRRC noted numerous references to other authority in proposed § 46.213 (relating to packaged food) and suggested these references be replaced by a single reference to § 46.422 (relating to labeling), which contains the same references and greater detail regarding labeling requirements. IRRC also suggested the term ''Food Act'' be changed to ''act'' throughout the final-form rulemaking.

   Response: The referenced section has been revised as recommended by IRRC. With respect to the use of the term ''act'' or ''Food Act,'' the Department has deleted the definition of ''act'' from § 46.3 and defined ''Food Act'' and ''Public Eating and Drinking Places Law'' to clearly distinguish between the two statutes upon which the final-form rulemaking is premised.

   Comment: IRRC noted references to the act in proposed §§ 46.213, 46.421 and 46.422 and suggested these references be to the specific applicable sections of the act.

   Response: The reference to the act in § 46.213 has been deleted. The references to the act in §§ 46.421 and 46.422 have been made more specific.

   Comment: IRRC requested that the references to the act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §§ 645--660g), known as the Milk Sanitation Law, in proposed §§ 46.217 and 46.244 (relating to milk and milk products; and receiving eggs and milk products) be revised to provide references to specific sections of that statute.

   Response: The recommended revision has been made in § 46.217. The Department believes it appropriate to leave the reference to the Milk Sanitation Law in § 46.244 general, though.

   Comment: IRRC commented that the reference to ''the act and this chapter'' in proposed § 46.219(a) (relating to molluscan shellfish) should be made more specific.

   Response: The references have been clarified to reflect section 14 of the act and Subchapter C (relating to food). In addition, a reference to Chapter 49 (relating to shellfish) has also been added. The proposed rulemaking reflected the Department's intention to rescind Chapter 49, but during the comment review process, the Department decided to leave Chapter 49 intact and pursue revisions of Chapter 49 as a separate regulatory promulgation effort.

   Comment: Both the PFMA and IRRC noted the use of the term ''mushroom identification expert'' in proposed § 46.220 (relating to wild mushrooms) and recommended the rulemaking establish required qualifications and training for mushroom identification experts. The PFMA acknowledged an ongoing debate between ''state public health agencies and the food industry'' as to appropriate qualifications and training and that the 2001 FDA Model Food Code does not address this subject.

   Response: The Department declines to implement this recommendation. It has revised the section to show it will not ''approve'' mushroom identification experts. The mushroom production industry and individuals will remain responsible for mushroom identification safety. The Department will continue to monitor this area and will consider any subsequent FDA opinions on what is relevant to qualifications of a wild mushroom expert in its determination as to whether it is necessary to regulate in this area.

   Comment: IRRC reviewed proposed §§ 46.220 and 46.221 (relating to game animals) and requested that the Department explain what other regulatory agencies would have jurisdiction over food and food establishments.

   Response: A definition of ''other food regulatory authority'' has been added to § 46.3. Food sold or used in food preparation in this Commonwealth is not always processed, manufactured or commercially prepared under the statutory authority of the Department.

   Comment: IRRC noted that proposed § 46.221(b)(2)(i) contains broad references to laws governing meat and poultry and other unspecified regulatory agencies. The commentator requested the final-form rulemaking identify these laws more specifically.

   Response: The Department has defined ''other food regulatory agency'' in § 46.3 and has used that term in the referenced subparagraph and at other appropriate places in the final-form rulemaking. It is difficult to specifically identify each agency that might have authority with respect to food in this Commonwealth. Federal agencies and the food safety authorities of other states and nations might have a role, depending upon the point of origin of the food or its ingredients.

   Comment: The PFMA recommended that proposed §§ 46.241 and 46.385 (relating to receiving temperature of food; and potentially hazardous food: hot and cold holding) be revised by changing the minimum holding temperature for hot potentially hazardous foods from ''60°C (140°F)'' to ''54°C (130°F).''

   Response: The Department has implemented this recommendation. In consideration of this comment, the Department reviewed the recommendations resulting from the 2002 Conference for Food Protection to be forwarded to the FDA for inclusion in the next Model Food Code publication. The conference forwarded a resolution to the FDA to modify the hot holding temperature from 60°C (140°F) to 58°C (135°F) and the Department has modified all references in this chapter to reflect this change.

   Comment: The PCHD and IRRC requested proposed § 46.241(d) be revised to include examples of visible evidence of previous temperature abuse.

   Response: The Department has added examples to the referenced subsection. These include ''dehydration, ice crystals, discoloration or damaged packaging.''

   Comment: The PCHD reviewed proposed § 46.242 (relating to additives) and offered that sulfiting agents may be used as an additive in a number of commercial foods. When the foods are offered to the consumer for immediate consumption there is no direct notice to the consumer of the presence of sulfites. The commentator requested that a new subparagraph be added to require that consumers be notified of the presence of sulfiting agents in food.

   Response: The Department considered this comment carefully and declines to add the requested language. The Department does not have the scientific expertise to evaluate the extent of the food safety risk of sulfite in relation to any other known food allergen, such as MSG or red food coloring. The Department will continue to follow the Federal requirements as written with respect to food additives and labeling. The specific Federal regulatory references in this section will reflect any changes in the Federal standards which may occur in the future.

   Comment: IRRC noted that proposed § 46.242 contained two citations to the Code of Federal Regulations (9  CFR 318.7 and 40 CFR 185) that appeared to be inaccurate.

   Response: The Department has corrected these citations and checked citations elsewhere in the final-form rulemaking to ensure they are accurate.

   Comment: IRRC requested that proposed § 46.243 (relating to receiving shell eggs) be revised to identify the specific applicable sections of the Egg Refrigeration Law (31 P. S. §§ 300.1--300.9) and Chapter 87 (relating to standards for grading and marketing eggs).

   Response: The Department has revised the referenced section by inserting the requested reference. The reference to Chapter 87 in subsection (a) has been changed to ''§ 87.41 (relating to standards)'' and the same reference in subsection (c) was revised to refer to ''§§ 87.51 and 87.2 (relating to receptacles; and marketing).'' The reference to the Egg Refrigeration Law in subsection (b) has also been made more specific.

   Comment: The CCHD commented on the provision for detention of shellfish in § 46.246 (relating to receiving shucked shellfish: packaging and identification) and suggested that detention provisions provided for in the act should be delineated in this chapter.

   Response: The Department declines to implement this suggestion, as it believes that section 6 of the act (31 P. S. § 20.6) is sufficiently clear.

   Comment: IRRC, the PFMA and the CCHD suggested the Department revise proposed § 46.261 (relating to preventing contamination from food employees' hands) to more clearly describe the circumstances under which food employees may contact food with their bare hands. The PFMA offered language for this revision.

   Response: The Department has implemented this suggestion in the final-form rulemaking and has used language from the 2001 FDA Model Food Code that is quite similar to the language proposed by the PFMA. The additional language is an adaptation of that found in the annex of the 2001 FDA Model Food Code.

   Comment: The PCHD and IRRC offered comment with respect to proposed § 46.303 (relating to linens and napkins: use limitations). The commentators noted the section did not allow for use of clean linens in retail displays of dry nonpotentially hazardous foods, such as rolls in a bakery. The commentators recommend adding the term ''approved retail display'' to this section to provide for the use of linens in contact with food on display.

   Response: The Department has revised the referenced section to allow for linens to be in contact with nonpotentially hazardous food for the purposes of retail display, but requires that the linens and napkins be replaced upon restocking of the retail display.

   Comment: IRRC suggested that the Department should clarify the safe distance between food and a source of contamination in proposed § 46.321 (relating to food storage).

   Response: The Department cannot adequately define the safe distance between food and a source of contamination. The safe distance can vary widely--depending upon the circumstances. A professional evaluation with consideration of the type of contamination (such as airborne or wet), the environmental conditions (such as air currents or amount of usage) and other conditions would be necessary.

   Comment: IRRC reviewed proposed § 46.345 (relating to miscellaneous sources of contamination) and expressed concern that the Department would be unable to measure or observe compliance with this provision and the regulated community would not be able to know whether it was in compliance. The commentator suggested that the Department outline procedures staff or public health officials will follow when notifying regulated facilities of a previously-unidentified source of contamination.

   Response: The Department deleted § 46.345.

   Comment: IRRC noted a typographical omission in the first sentence of proposed § 46.362 (relating to microwave cooking).

   Response: The Department corrected the error.

   Comment: The PCHD and IRRC noted that proposed § 46.385 contained no provisions regarding date marking, tracking or use of foods within a specified time frame. The PCHD requested that the Department consider adding language on this subject consistent with the 2001 FDA Model Food Code.

   Response: The Department added date marking language to § 46.385(b). The language is not directly from the 2001 FDA Model Food Code but, instead, is a compromise found acceptable by both the Department and the PFMA, the entity representing the retail food industry.

   Comment: The PFMA suggested proposed § 46.422 be revised to clarify alternative options with respect to ''unpackaged foods portioned to consumer specifications.''

   Response: The Department believes proposed § 46.422(c) was sufficiently specific, but has added an example.

   Comment: IRRC suggested that proposed § 46.422(e)(1) be revised to include citations to the law referenced in that provision.

   Response: The referenced paragraph has been deleted.

   Comment: The PFMA suggested the addition of a ''pizza peel'' to the examples provided in § 46.521(i)(1)(i) (relating to materials in multiuse utensils and food-contact surfaces).

   Response: The suggestion has been implemented.

   Comment: The PFMA asked the Department to clarify § 46.591(d) (relating to warewashing machines) with respect to audible or visual alarms that indicate when the sanitizer reservoir of a warewashing machine is empty.

   Response: The Department modified the subsection to use the specific language on this subject in the 2001 FDA Model Food Code. The section now requires ''. . . a visual means to verify that detergents and sanitizers are delivered or a visual or audible alarm to signal if the detergents and sanitizer are not delivered to the respective washing and sanitizing cycles.''

   Comment: IRRC suggested the Department either delete the word ''equipment'' or add a clarifying term such as ''equipment that requires cleaning by immersion'' to proposed § 46.612(b) (relating to manual warewashing: sink compartment requirements).

   Response: The Department has revised the referenced subsection to describe equipment and utensils that require cleaning by immersion.

   Comment: IRRC suggested that the Department add examples to the ''other task-specific cleaning equipment'' described in proposed § 46.612(c)(3) and (4).

   Response: The Department has implemented this suggestion.

   Comment: The PFMA offered the opinion that proposed § 46.633 (relating to temperature measuring devices for manual warewashing) is intended for mechanical warewashing machines, rather than manual warewashing.

   Response: The section is intended to address temperature measuring devices for manual warewashing. Section 46.591(c) addresses temperature measuring devices for mechanical warewashing machines.

   Comment: The PCHD reviewed proposed § 46.676(b) (relating to manual warewashing equipment), permitting the use of a warewashing sink for food washing, food thawing and for washing of soiled wiping cloths and suggested that separate equipment should be provided to limit cross-contamination of foods.

   Response: Section 46.676(a) was amended to prohibit the use of a warewashing sink for food preparation. The Department could ascertain no food safety hazard, however, in the washing of linens in a warewashing sink. Soiled linens would create no further food safety hazard than dirty dishes, if properly washed, rinsed and sanitized.

   Comment: The PFMA suggested proposed § 46.712(d)(2)(ii) (relating to frequency of cleaning equipment food-contact surfaces and utensils) be revised to require cleaning frequency to be ''monitored,'' rather than ''documented.''

   Response: The Department declines to implement this suggestion. The required frequency for food equipment cleaning is in subsection (c). Since subsection (d)(2) describes an exception to the general cleaning frequency requirement, the Department believes it reasonable to require an entity cleaning in accordance with the requirements of that paragraph to be able to prove compliance through documentation.

   Comment: The BCHD noted that proposed § 46.801 (relating to sources of drinking water) does not prohibit cross-connections between a public and nonpublic water supply and that the section makes no mention of disinfection facilities (such as ultraviolet light treatment) or whether the facilities are required.

   Response: The referenced section states that water must comply with the regulations of the Department of Environmental Protection in 25 Pa. Code Chapter 109 (relating to safe drinking water). That chapter requires back-flow prevention to protect the public water system. In the event of a cross-connection between a public and nonpublic water supply, adherence to this requirement protects the public water system. Chapter 109 of 25 Pa. Code does not require disinfection facilities in all cases, but requires them when necessary for safe drinking water and requires that these disinfection facilities be maintained and operated appropriately.

   Comment: The BCHD and IRRC noted that proposed § 46.802 (relating to drinking water system flushing and disinfection) does not mention the requirement for obtaining ''. . . check samples on a water supply prior to placing back in service after an emergency situation.''

   Response: The Department has revised the section by adding language requiring that the water meet the quality standards for public drinking water set forth in the regulations of the Department of Environmental Protection in 25 Pa. Code Chapter 109 before a drinking water system is placed back into service after construction, repair, modification or emergency.

   Comment: IRRC reviewed proposed § 46.804 (relating to quality of water) and recommended the section include a procedure (or a cross reference or citation) for obtaining the Department's approval for a ''nondrinking water supply.''

   Response: The Department has added § 46.1102 (relating to obtaining Department or License approval) clarifying the procedure for obtaining approval of the Department.

   Comment: IRRC recommended proposed § 46.805(b) (relating to quantity and availability of water: capacity and pressure) be rewritten for clarity.

   Response: The Department has implemented this recommendation.

   Comment: The BCHD noted that proposed § 46.806 (relating to distribution, delivery and retention of water) does not have a provision for having a chlorine residual for emergency or alternative water supplies for food facilities.

   Response: All emergency or alternative water supplies must meet the requirements in § 46.802. This section was revised to require these water supplies to comply with 25 Pa. Code Chapter 109.

   Comment: IRRC noted a typographical error in proposed § 46.822(a)(2) (relating to design, construction and installation of plumbing systems).

   Response: The error has been corrected in the final-form rulemaking.

   Comment: The BCHD and the CCHD opined that proposed § 46.823(a)(1) (relating to numbers and capacities of plumbing facilities) does not provide for any type of handwashing facilities for the general public. The commentators recommended that in public eating and drinking places or where self-service foods are available for the consumer (such as at salad bars), public health concerns should dictate that facilities should be provided for patron handwashing prior to food handling or consumption.

   Response: The Department accepts the recommendation and has implemented it by adding § 46.823(a)(4).

   Comment: IRRC asked for clarification of the process by which the Departmental approvals referenced in proposed § 46.823(a)(2) and (3) can be obtained.

   Response: The Department has added § 46.1102, clarifying the procedure for obtaining approval of the Department.

   Comment: IRRC reviewed § 46.823(b) and asked whether the Department planned to impose toilet requirements that differed from those established by the Department of Labor and Industry. If not, IRRC recommended the phrase ''the Department or'' be deleted from that subsection.

   Response: The referenced phrase has been deleted. The Department's intention is to require a minimum of one toilet, and the subsection accomplishes this objective.

   Comment: IRRC reviewed proposed §§ 46.841(1) and 46.842(f)(1) (relating to materials used in construction of water tanks and mobile food facility water tanks; and design and construction of water tanks and mobile food facility water tanks), and recommended the Department use the defined term ''safe materials'' instead of the term ''safe.''

   Response: The recommendation has been implemented.

   Comment: IRRC commented on the provision in proposed § 46.843(c)(2) (relating to numbers and capacities of water tanks and mobile food facility water tanks) requiring a hose connection that cannot possibly be used for another purpose.

   Response: The fresh water supply of a mobile food unit must be protected from cross-contamination. Although the hose connection may be of a type commonly found, the intent is that the hose connection must be unique on each mobile unit so that it is not vulnerable to environmental contaminants, such as a sewage hose connected to the fresh water tank.

   Comment: The BCHD reviewed proposed § 46.922(d) (relating to functionality of various physical facilities of a food facility) and opined that toilet room doors in shopping malls should not be mentioned in that subsection, as ''most of the large malls across the State have bathroom facilities with self-closing doors.''

   Response: The Department feels that although most malls may have self-closing doors, the situation does not require self-closing doors to protect food safety where the toilet room does not open directly into the food facility.

   Comment: The BCHD reviewed proposed § 46.922(e) and noted it makes no mention of the use of air-curtain doorways into food facilities.

   Response: The provision allows for air curtains in § 46.922(e)(4)(ii).

   Comment: IRRC offered several comments with respect to proposed § 46.922. It opined that proposed § 46.922(e)(3)(ii) and (iii) appears to be different ways of saying the same thing and one should be deleted. IRRC also offered that proposed § 46.922(e)(4)(iii) should give examples of ''other effective means.'' IRRC also suggested that proposed § 46.922(e)(4) and (5) should use consistent language concerning insects, rodents, flying insects and other pests.

   Response: The Department has revised the section by combining § 46.922(e)(3)(ii) and (iii). The Department cannot provide examples of ''other effective means'' in § 46.922(e)(4)(iii). That subparagraph was inserted to allow for the use of devices developed in the future that perform satisfactorily to be used, although the Department is not aware of any currently-existing devices it can cite as examples. Section 46.922(e)(5) has been revised to make it consistent with § 46.922(e)(4).

   Comment: The PCHD requested that proposed § 46.982(b)(1) (relating to limitations on animals) be revised to more-clearly state that animals that do not meet the exceptions set forth in that section may not be brought onto the premises of a food facility.

   Response: The Department agrees the recommended change will add clarity, and has implemented it.

   Comment: IRRC recommended that proposed § 46.1022(b)(3) (relating to poisonous or toxic substances: limitations on presence and use) either be deleted or revised to establish the parameters within which the Department would establish the ''additional conditions'' referenced in that section.

   Response: The Department reworded the section to read ''approved by the Department,'' and requirements for obtaining approval are outlined in § 46.1102.

   Comment: IRRC noted that proposed § 46.1026(a)(1) (relating to pesticides) contains an inaccurate citation to the United States Code Annotated.

   Response: This error has been corrected.

   Comment: IRRC recommended that proposed § 46.1101 (relating to application for intended purpose: public health protection) be deleted, since it repeats the substance of proposed § 46.1 (relating to purpose).

   Response: The Department accepts the recommendation and has deleted the proposed section.

   Comment: IRRC reviewed proposed § 46.1102 (relating to access to food facilities), and suggested the word ''credentials'' be replaced by ''identification'' and that the Department provide examples of ''other reasonable times'' when an inspection might occur. IRRC also suggested the phrase ''any other relevant statutory or regulatory authority'' be deleted.

   Response: The substance of proposed § 46.1102 has been moved to § 46.1101 (relating to access to food facilities) and the Department has implemented IRRC's recommendations.

   Comment: The PFMA offered that proposed § 46.1121(b) (relating to facility and operating plans) seems to imply that hazard analysis critical control point (HACCP) plans would be required for facility plan reviews.

   Response: The referenced section has been revised and clarifies that an HACCP plan is not required of all food facilities, just those specified under § 46.1122(a) (relating to HACCP plans).

   Comment: IRRC raised several concerns with respect to proposed § 46.1121. IRRC recommended that proposed § 46.1121(b)(5) be revised to require any Department-issued request for ''other information'' to be in writing. IRRC also recommended the referenced section describe how plans and specifications are to be communicated to the Department.

   Response: The Department accepts the commentator's recommendation that Department-issued requests for additional information be in writing. Section 46.1121(b)(7) now requires the referenced requests for ''other information'' to be in writing. The Department also added a cross-reference to § 46.1142 (relating to application procedure for appropriate license or registration) in § 46.1121(a). Section 46.1142 requires an applicant (operator of a food facility) to obtain appropriate application forms from the Department or licensor. The location to which these forms are to be submitted may vary. Different licensors have different addresses and different applications received by the Department might be processed at different regional offices of the Department. The application materials will contain specific instructions regarding the application process.

   Comment: The PFMA noted that the reference in proposed § 46.1122(a)(1)(ii) to § 46.345(d)(3) is incorrect.

   Response: The Department agrees, and has made the correction.

   Comment: The PCC reviewed proposed § 46.1142 and expressed concern that the rulemaking does not ''. . . adequately explain the distinctions among permits, licenses or registrations.'' The commentator expressed concern that food facilities would be subjected to arbitrary standards.

   Response: The Department has added language to the referenced section to clarify that a food facility that is a public eating and drinking place must have a license, while a food facility that is a food establishment must have a registration. These requirements are not new, but are imposed by the act and the law. The final-form rulemaking has deleted the reference to a ''permit'' that appeared throughout the proposed rulemaking.

   Comment: The PFMA requested clarification that the use of the term ''variance'' in proposed § 46.1144(9) (relating to conditions or retention: responsibilities of the food facility operator) ''is not intended to mean an HACCP plan would be required.''

   Response: The Department believes the referenced provision does not impose an HACCP plan requirement. The term ''variance'' is defined in § 46.3 and does not require an HACCP plan. The Department believes § 46.1122 clearly described the circumstances under which an HACCP plan is required.

   Fiscal Impact

   Commonwealth. The final-form rulemaking does not impose costs and has no fiscal impact on the Commonwealth. The Department currently registers and inspects food establishments under the act and issues licenses allowing the operation of public eating and drinking places under the law. It will merge the Department's regulatory functions into a single set of standards applicable to all ''food facilities'' in this Commonwealth.

   Political Subdivisions: The final-form rulemaking does not impose costs and has no fiscal impact upon political subdivisions.

   Private Sector: The final-form rulemaking might impose some initial cost on the private sector, although this cannot be readily quantified. Since the food safety standards prescribed by the final-form rulemaking reflect rather widely-known food safety concerns, the Department expects most food facilities in operation in this Commonwealth are currently meeting these standards or would have relatively little difficulty meeting them. In addition, the final-form rulemaking is likely to result in a decrease in the number of lawsuits relating to foodborne illness originating from food facilities, with a resultant savings in costs attributable to litigation and awards of damages. These savings are not readily quantifiable.

   General Public: The final-form rulemaking will enhance public health and safety. It is expected to reduce the number of cases of foodborne illness attributable to food originating from food facilities in this Commonwealth. This should result in some indeterminate cost savings to the general public.

Paperwork Requirements

   The final-form rulemaking is not likely to appreciably impact upon the paperwork generated by the Department or food facilities.

Sunset Date

   There is no sunset date for the final-form rulemaking. The Department will review the efficacy of the final-form rulemaking on an ongoing basis.

Contact Person

   Further information is available by contacting the Sheri Dove, Department of Agriculture, Bureau of Food Safety and Laboratory Services, 2301 North Cameron Street, Harrisburg, PA 17110-9408, (717) 787-4315.

Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 8, 2002, the Department submitted a copy of the notice of proposed rulemaking, published at 32 Pa.B. 1046, to IRRC and the Chairpersons of the House and Senate Standing Committees on Agriculture and Rural Affairs for review and comment.

   Under section 5(b.1) of the Regulatory Review Act, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.

   Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on October 7, 2003, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on October 23, 2003, and approved the final-form rulemaking.

Findings

   The Department finds that:

   (1)  Public notice of its intention to adopt the regulations encompassed by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.

   (2)  A public comment period was provided as required by law and all comments received were considered.

   (3)  The modifications that were made to this final-form rulemaking in response to comments received do not enlarge the purpose of the proposed rulemaking published at 32 Pa.B. 1046.

   (4)  The adoption of this final-form rulemaking in the manner provided in this order is necessary and appropriate for the administration of the authorizing statute.

Order

   The Department, acting under authority of the authorizing statute, orders the following:

   (a)  The regulations of the Department, 7 Pa. Code Chapters 31, 35, 41, 43, 45--47, 53, 55, 61, 63, 79, 80 and 81, by adding §§ 46.1--46.3, 46.101, 46.102, 46.111--46.115, 46.131--46.137, 46.151--46.153, 46.201, 46.211--46.222, 46.241--46.251, 46.261, 46.262, 46.281--46.286, 46.301--46.307, 46.321--46.344, 46.361--46.366, 46.381--46.385, 46.401, 46.402, 46.421--46.483, 46.441, 46.461, 46.501, 46.521--46.523, 46.541--46.544, 46.561--46.563, 46.581--46.595, 46.611--46.615, 46.631--46.634, 46.651, 46.652, 46.671--46.676, 46.691--46.693, 46.711--46.719, 46.731, 46.751--46.753, 46.771--46.775, 46.801--46.806, 46.821--46.825, 46.841--46.844, 46.861--46.863, 46.881--46.886, 46.901, 46.902, 46.921, 46.922, 46.941--46.946, 46.961--46.965, 46.981, 46.982, 46.1001, 46.1002, 46.1021--46.1029, 46.1041, 46.1101--46.1103, 46.1121--46.1124 and 46.1141--46.1144; and by deleting §§ 31.1, 31.11--31.23, 31.31--31.39, 35.1--35.11, 41.1--41.4, 41.11--41.14, 41.21--41.24, 43.1--43.8, 45.1--45.7, 45.21--45.24, 45.31--45.33, 45.41--45.44, 45.51--45.54, 45.61--45.64, 45.71, 47.72, 45.81--45.87, 45.91--45.93, 47.1--47.3, 53.1--53.7, 53.11--53.19, 53.21, 53.22, 55.1--55.5, 61.1--61.7, 61.11--61.13, 61.21, 61.22, 61.31--61.34, 61.41--61.43, 61.51--61.53, 61.61--61.65, 61.71, 61.72, 63.1--63.4, 78.1--78.3, 78.11--78.14, 78.21--78.24, 78.31, 78.32, 78.41--78.43, 78.51--78.53, 78.61--78.65, 78.71--78.78, 78.91--78.97, 78.101, 78.111--78.114, 78.121, 78.122, 78.131--78.133, 78.141--78.147, 78.151--78.155, 78.161, 78.171--78.173, 78.181, 78.191, 78.192, 78.201--78.204, 78.211, 78.212, 78.221, 79.1, 80.1, 80.11--80.13, 80.21--80.23, 80.31, 80.32, 80.41--80.48, 80.51, 80.52, 80.61--80.63, 80.71, 80.72, 80.81--80.84, 81.1, 81.11, 81.12 and 81.21, to read as set forth in Annex A.

   (b)  The Secretary shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General for approval as required by law.

   (c)  The Secretary shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

   (d)  This order shall take effect upon publication in the Pennsylvania Bulletin.

DENNIS C WOLFF,   
Secretary

   (Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 33 Pa.B. 5579 (November 8, 2002).)

   Fiscal Note: Fiscal Note 2-137 remains valid for the final adoption of the subject regulation.

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