105 CMR, § 500.005 - Additional Requirements for Good Manufacturing Practices Applicable to All Licensees and Permit Holders[1]

All licensees and permit holders shall comply with the following requirements.

(A) Person in Charge. There shall be a person in charge present in the facility during all hours of operation. The person in charge shall be responsible for the facility's compliance with all relevant requirements of 105 CMR 500.000.

(B) Source of Food; Ingredients.

(1) All food shall be obtained from approved sources that comply with law.

(2) Food and ingredients for use in any food product shall not bear or contain any pesticide chemical or other residues in excess of levels permitted pursuant to state or federal law.

(C) Non-food Uses: Prohibition. No food or food ingredient, including water intended for bottling, shall be stored, transported, processed, or bottled through equipment or lines used for any non-food product.

(D) Source of Water and Ice. All water and ice used in the manufacture of food products, whether used in facility or equipment operations or as an ingredient in any product, shall be from an approved source of water as follows:

(1) Water from a Massachusetts public water supply source shall meet the quality standards of 310 CMR 22.00: Drinking Water, promulgated by the Massachusetts Department of Environmental Protection (DEP), and of any additional maximum contaminant levels promulgated by the U.S. Environmental Protection Agency (EPA) and in effect.

(2) Water from a private source of water in Massachusetts, if used:

(a) As an ingredient in any product, shall meet the standard in 105 CMR 500.005(D)(1), and

(b) Solely in facility or equipment operations, shall meet standards established by the Department.

(3) Water from a source outside Massachusetts shall meet the quality standards of 40 CFR Parts 141 and 143: National Primary and Secondary Drinking Water Regulations, promulgated by the EPA, and any additional maximum contaminant levels promulgated by EPA and in effect.

(4) Sea water may be used to deliver, chill, or hold live or unprocessed seafood, except as otherwise determined by the Department.

(E) Major Food Allergens. Whenever a facility uses the same equipment for processing multiple products and makes a transition from processing a product containing a major food allergen to a product containing no major food allergen or a different major food allergen, it shall:

(1) Ensure that all of the product-contact surfaces of the equipment are fully washed and rinsed in a manner sufficient to clear the equipment of any residual allergen before the second product is processed, or

(2) Process products containing a particular major food allergen on dedicated processing equipment.

(F) Ready-to-eat Foods. Food handlers shall not contact exposed, ready-to-eat food with their bare hands but shall use suitable utensils such as deli tissue, spatulas, tongs, single-use non-latex gloves, or dispensing equipment.

(G) Cooling of Potentially Hazardous Foods.

(1) Food manufacturing shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms and for the contamination of food. The licensee or permit holder shall use processes that are adequate to prevent adulteration of food and growth of harmful microorganisms.

(2) Specific processes outlined in the Sanitation Standard Operating Procedure, as required by 105 CMR 500.005(H)(4), shall be validated by means of laboratory testing or monitoring of specific control factors such as pH, water activity, temperature, time/temperature, acidification, flow rate, and similar factors.

(H) Sanitation Standard Operating Procedure (SSOP). Each licensee and permit holder shall develop and implement a Sanitation Standard Operating Procedure (SSOP). The SSOP shall be modified as necessary and shall adequately address the following areas:

(1) Safety of the operations water in the facility;

(2) Construction, condition, maintenance of, and cleaning procedures for the facility, holding tanks, piping and all related equipment, utensils, washing equipment, and food transportation vehicles under the control of the licensee or permit holder;

(3) Prevention of cross-contamination;

(4) Manufacturing processes, including thermal processing and product cooling;

(5) When a major food allergen is an ingredient of any product, procedures for the use of all equipment that comes in contact with the allergen, including procedures for cleaning and flushing/rinsing the equipment in a manner sufficient to clear the equipment of any residual allergen;

(6) Production records for each production run, including information on cleaning and sanitizing the equipment;

(7) Maintenance of hand washing, hand sanitizing, and toilet facilities;

(8) Protection of packaging and product contact surfaces from contamination;

(9) Proper labeling, storage, and handling of all toxic substances in the facility;

(10) Sanitization procedures;

(11) Employee health and hygiene;

(12) Employee training;

(13) Exclusion of pests;

(14) Food transportation defense as provided in 105 CMR 500.007(D); and

(15) Procedures for daily monitoring and recording compliance with the SSOP.

(I) Records. At all times, the facility shall maintain, and make available to inspectors, records sufficient to conduct trace-back and trace-forward of food products in the distribution system.

(J) Emergency Action Plan.

(1) Each facility shall develop, maintain on file, and follow a written emergency action plan. Appropriate personnel shall be trained in the implementation of the plan. The plan shall contain, but need not be limited to:

(a) Contact information for, and procedures for notification of, local emergency services, the board of health, the Department, and FDA or USDA as appropriate;

(b) Procedures to be followed in the case of foreseeable emergency events, including but not limited to loss of water or power, flood, fire, and intentional or accidental contamination of food;

(c) Procedures to implement a product recall; and

(d) Names and contact information for the primary suppliers of ingredients to the facility (to enable trace-back) and for the facility's primary customers (to enable trace-forward).

(2) A licensee or permit holder shall notify the Department immediately when an imminent danger to the public health is present in the facility or its products.

(3) Any licensee or permit holder may present for advance review and approval by the regulatory agency a plan to continue operations during an emergency and/or to respond to an emergency due to natural or man-made causes.

(K) Product Recall.

(1) A facility operator who knows or has reason to believe that circumstances exist that may adversely affect the safety of products, including but not limited to major spills, serious accidents, introduction of toxins or contaminants, natural disasters, or major breakdowns in production, shall notify the Program immediately.

(2) Each facility operator shall develop and maintain on file a current written contingency plan for use in initiating and accomplishing a product trace and recall, and shall follow the plan as appropriate. The plan shall include procedures for the notification of the Program, consumer notification, and recall of the product.

(a) Recalls of meat or poultry products shall conform to the procedures and policies established by USDA.

(b) Recalls of products other than meat or poultry products shall conform to the procedures and policies of 21 CFR Part 7 : Enforcement Policy.

(3) The facility shall use sufficient coding of products to make possible positive lot identification and to facilitate effective recall of all violative lots. The code shall be designed to remain affixed to the container during retail distribution and consumer use.

(4) The facility shall maintain such product distribution records as are necessary to enable location of products if a recall is initiated. These records shall be maintained for two years after December 31^st of the year in which the product was processed.

(5) The facility shall implement the recall procedures as necessary with respect to any product which the facility or the Department knows or has reason to believe may adversely affect its safety for the consumer.

(6) If the Department determines that the circumstances present an imminent danger to the public health and that a form of consumer notice and/or product recall can effectively avoid or significantly minimize the threat to public health, the Department may advise the facility:

(a) To initiate a level of product recall approved by the Department, and/or

(b) If appropriate, to issue a form of notification to consumers.

1. The facility shall be responsible for disseminating the notice in a manner designed to inform consumers who may be affected.

2. The facility shall, where appropriate, provide the notice to the news media serving the affected public, and/or shall directly notify affected consumers when doing so effectively avoids or minimizes the risk to health.

(L) Maintenance of Records. All records required to be kept by 105 CMR 500.000 shall be maintained on file for at least two years, or for the time required by another specific record-keeping requirement in 105 CMR 500.000, and shall be made available to agents of the regulatory agency for inspection and copying upon request.

¹ The requirements in 105 CMR 500.005 apply to all facilities that are not subject to USDA inspection, and are recommended for all facilities that are subject to USDA inspection

Notes

105 CMR, § 500.005

Amended by Mass Register Issue 1322, eff. 9/23/2016.