Each plant shall provide its employees with adequate, readily accessible toilet facilities. Sec. Plumbing shall be of adequate size and design and adequately installed and maintained to: (1) Carry sufficient quantities of water to required locations throughout the plant. The U.S. Food and Drug Administration (FDA)'s Food Safety Modernization Act (FSMA) regulations aim to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The information on this page is current as of Jun 07, 2023. Your physical plant must have, and you must use, separate or defined areas of adequate size or other control systems, such as computerized inventory controls or automated systems of separation, to prevent contamination and mixups of components and dietary supplements during the following operations: (1) Receiving, identifying, holding, and withholding from use, components, dietary supplements, packaging, and labels that will be used in or during the manufacturing, packaging, labeling, or holding of dietary supplements; (2) Separating, as necessary, components, dietary supplements, packaging, and labels that are to be used in manufacturing from components, dietary supplements, packaging, or labels that are awaiting material review and disposition decision, reprocessing, or are awaiting disposal after rejection; (3) Separating the manufacturing, packaging, labeling, and holding of different product types including different types of dietary supplements and other foods, cosmetics, and pharmaceutical products; (4) Performing laboratory analyses and holding laboratory supplies and samples; (5) Cleaning and sanitizing contact surfaces; (7) Holding components or dietary supplements. copper) effected substantial increases in yield; in 86 (20.5 per cent.) Only the following toxic materials may be used or stored in a plant where food is processed or exposed: (i) Those required to maintain clean and sanitary conditions; (ii) Those necessary for use in laboratory testing procedures; (iii) Those necessary for plant and equipment maintenance and operation; and. (a) Grounds. (d) The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food. Microbial Pest Control Agent: A microorganism that is usually used to infect and kill a target pest or to compete with undesirable microbial pests in the environment. (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. (k) Plant means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food. Pelleted baits no longer are permitted to be used in rodenticide products targeted for consumer markets. Food Industry. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. Compliance with this requirement may be accomplished by: (1) Maintaining the facilities in a sanitary condition. 111.20 What design and construction requirements apply to your physical plant? (e) If you use equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, contact covered produce, you must do so in a manner that minimizes the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards. The following definitions shall also apply: (a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or below. (d) Be designed and constructed in a manner that prevents contamination of components, dietary supplements, or contact surfaces. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. (6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food. The first evidence of weed resistance to triazine herbicides in Bavaria occurred in the period 1975-80 in intensive maize growing areas following continuous treatment with atrazine. 243, 264, 271. (5) Work-in-process shall be handled in a manner that protects against contamination. (4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. The grounds about an establishment must be maintained to prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with inspection by FSIS personnel. (b) Cleanliness. (c) Seams on food contact surfaces of equipment and tools that you use must be either smoothly bonded, or maintained to minimize accumulation of dirt, filth, food particles, and organic material and thus minimize the opportunity for harborage or growth of microorganisms. ( b) For fully-enclosed buildings, you must take measures to exclude pests from your buildings. (c) Education and training. The total combined respondent burden hours from those previously approved . A tool for managing an organization and improving performance, it acts as a quality management system that identifies opportunities for improvement and fulfills the requirements of customers and suppliers, allowing organizations to optimize their processes while reducing costs. (f) Food means food as defined in section 201(f) of the act and includes raw materials and ingredients. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination. (a) You must make and keep records required under this subpart C in accordance with subpart P of this part. Sec. Sec. (a) You must take those measures reasonably necessary to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests in buildings, including routine monitoring for pests as necessary and appropriate. (iv) Those necessary for use in the plant's operations. (a) You must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably foreseeable hazards from domesticated animals by: (1) Excluding domesticated animals from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed; or. (v) Cooling to an adequate temperature during manufacturing. Plant-Incorporated Protectant (PIP) : A pesticidal substance that is intended to be produced and used in living plants, or in the produce thereof, and the genetic material . The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials. Responsibility for assuring compliance by all personnel with all requirements of this part shall be clearly assigned to competent supervisory personnel. (e) Storage and handling of cleaned portable equipment and utensils. (2) Water that is used in a manner such that the water may become a component of the dietary supplement, e.g., when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement. If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a) (1) through (3) of this section, care shall be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination. (6) Frozen raw materials and other ingredients shall be kept frozen. Now, this document with over 170 pages will provide you with guidance on strategies . (10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Note: If you need help accessing information in different file formats, see
They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. (e) Storage and handling of cleaned portable equipment and utensils. (2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. 211.80 - 211.94. (2) Keeping the facilities in good repair at all times. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. (h) Use adequate screening or other protection against pests, where necessary. (6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces. The term "undesirable microorganisms" includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. The reuse water to be used in inedible areas under FDA jurisdiction, such as pet food areas, must also meet FDA requirements. (3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. (b) Plant construction and design. (d) Sanitation of food-contact surfaces. The Food and Drug Administration establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action. Proper pest management is a critical component in preventing contamination. (5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. Food-contact surfaces shall be corrosion-resistant when in contact with food. (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. (iii) Using materials for food containers and food- packaging materials that are safe and suitable, as defined in 130.3(d) of this chapter. If you believe you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration. (4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands. (ii) Controlling the amount of acid or acidified food added to low-acid food. GUIDANCE DOCUMENT Guidance for Industry: Food Security Preventive Measures Guidance for Food Producers, Processors, and Transporters October 2007 Final Docket Number: FDA-2020-D-1929 Issued by:. (2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means. (1) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. 111.15 What sanitation requirements apply to your physical plant and grounds? (b) Your hand-washing facilities must be furnished with: (1) Soap (or other effective surfactant); (2) Running water that satisfies the requirements of 112.44(a) for water used to wash hands; and. (p) Shall is used to state mandatory requirements. (5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. (3) Sanitary towel service or suitable drying devices. (m) Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food. 110.37 Sanitary facilities and controls. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means. 321, 331, 342, 350h, 371; 42 U.S.C. PART 117 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD. Resistance was shown by Stellaria media, Solanum nigrum, Chenopodium album and Galinsoga ciliata, with Atriplex patula and C. ficifolium being largely unaffected. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices. Fapon Biotech Inc. Fapon Biotech Inc., founded in 2001, adheres to the mission of "Empowering Timely, Accurate and Affordable Diagnosis for All", while focusing on the future needs and trends of biotechnology development, and committed to providing global diagnostic companies with high-performance IVD reagent raw materials, such as antigens, antibodies, and enzymes, as well as reagent . All of the following requirements apply to the control and disposal of trash, litter, and waste in areas used for covered activities: (a) You must convey, store, and dispose of trash, litter and waste to: (1) Minimize the potential for trash, litter, or waste to attract or harbor pests; and. All of the following requirements apply for the control and disposal of sewage: (a) You must dispose of sewage into an adequate sewage or septic system or through other adequate means. 112.129 What requirements apply to toilet facilities? The maximum safe moisture level for a food is based on its water activity (aw). Sec. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. (ii) Employing adequate heat processes where applicable. Guidance and Regulation. (g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives. (4) Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against such contamination (such as double doors or positive air-flow systems). (b) Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing materials. (3) You must not use insecticides, fumigants, fungicides, or rodenticides, unless you take precautions to protect against the contamination of components, dietary supplements, or contact surfaces. 110.110 Natural or unavoidable defects in food for human use that present no health hazard. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. General requirements. The potential for contamination must be reduced by effective design including the separation of operations in which contamination is likely to occur, by one or more of the following means: Location, time, partition, enclosed systems, or other effective means; and. (c) For partially-enclosed buildings, you must take measures to prevent pests from becoming established in your buildings (such as by use of screens or by monitoring for the presence of pests and removing them when present). You must keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step. 111.23 Under this subpart C, what records must you make and keep. (iv) Those necessary for use in the plant's operations. (5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing. Total estimated cost: $183,517,210 (per year), which includes $0 annualized capital or operation & maintenance costs.