816, 91 Stat. Accommodations and equipment to be furnished by facilities for use of program employees in performing service. In addition to the regulations discussed above, FSIS is proposing to remove the following regulations from 9 CFR part 590 because they will be replaced by proposed 9 CFR 416.2(d) if this rule is finalized: 9 CFR 590.435(d), which states that containers and packing or packaging materials in which shell eggs are received into the official plant shall be free from odors and materials which could contaminate or adulterate the eggs or egg products; § 590.508(b), requiring the removal of containers for trash and inedible eggs at least once daily and their cleaning and treatment in such a manner as to prevent odors or objectionable conditions in the plant; § 590.530(a), which states that liquid egg storage rooms, including surface coolers and holding tank rooms, shall be kept clean and free from odors and objectionable odors and condensation; and § 590.536(a), concerning the conditions in which freezing rooms are to be kept. Consistent with the application of HACCP in meat and poultry operations, plants may determine that the Sanitation SOP or a prerequisite program is an appropriate and suitable means to effectively prevent the occurrence of certain food safety hazards and thus make them not reasonably likely to occur. Several other sections (§§ 590.542(a), 547(a), and 548(a)) require that rooms be kept free of flies, insects, and rodents. An egg products plant's Salmonella testing data continues to be important in monitoring process control. Amend § 590.510 by revising paragraphs (a) introductory text, (c)(1) and (3), and (d) introductory text to read as follows: (a) The eggs must be sorted and classified into the following categories: (c)(1) When presented for breaking, eggs must have an edible interior quality and the shell must be sound and free of adhering dirt and foreign material. All other label types can be generically approved. While prior approval provides assurance that equipment, facilities, and processes, as designed, meet certain requirements that are intended to ensure food safety or quality, it also reflects the emphasis of the current egg products inspection system on dictating the way in which official plants maintain sanitation and produce safe food. Curtis, P., North Carolina State University, Raleigh, NC. Any person receiving inspection service may, if dissatisfied with any decision of an inspector related to any inspection, file an appeal from such decision. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. New Documents The plant number may also be omitted from the official mark if applied on the container's principal display panel or other prominent location and preceded by the letter “G.”. The cost of recordkeeping is dependent on several factors, each of which has to be documented in some manner, such as the number of HACCP plans developed by each plant, the number of shifts operated by each plant, the number of CCPs per HACCP plan, the number of pre-shipment reviews conducted, and any decision-making for hazard analysis that may require documentation. See also 9 CFR 590.552(a). These cost figures were adjusted for inflation using the average CPI-U from 2014 to 2016. Additional Benefits from Generic Labeling: Additional benefits include cost reductions for the Agency and for the egg products plants that submit labels for changes to an existing label or for new label approvals. For the purposes of estimating costs, FSIS simplified the production of egg products into three processes: the breaking of shell eggs, the production of pasteurized liquid egg products (including frozen egg products), and the production of pasteurized dried egg products. Under current 9 CFR 590.300 and proposed 9 CFR 590.310, official plants have the right to appeal inspection decisions. are not part of the published document itself. It is not an official legal edition of the Federal The sanitation requirement in 9 CFR 416.2(h) gives plants the responsibility and flexibility to determine how many dressing rooms, lavatories, and toilets it needs. Should this rule become final, plants would be required to ensure that the design of buildings and equipment is appropriate for sanitary food production and for maintaining good sanitary conditions in accordance with broad sanitation principles. While such equipment may be cleaned by any sanitary means, it is preferable to use water to do so. The sanitation requirement in 9 CFR 416.5(c) is similar to the requirements for employee health in § 590.560(c) to prevent transmission of communicable diseases. Both regulations prohibit the use of tagged equipment, utensils, rooms, or compartments until they have been made acceptable and require the removal of tags by program employees. Plants that have not identified the pathogen as reasonably likely to occur would need to take corrective actions and reassess their HACCP plans in accordance with 9 CFR 417.3(b). 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes. [14 15] As part of its control verification effort, FSIS also will continue to collect and analyze samples from egg product processes for Salmonella and Lm. Finally, proposed 9 CFR 590.910 includes provisions for the public notification of determinations of equivalence made by FSIS of foreign egg products inspection programs. Egg product, Pasteurize, However, FSIS tentatively finds that egg substitutes should no longer be exempt from inspection by FSIS under the EPIA. 17. 1031 et seq.). provide legal notice to the public or judicial notice to the courts. of the issuing agency. Change in Inspector Coverage: Under the proposed rule, FSIS inspectors would no longer provide inspection during all processing operations at each egg products plant, but instead may be provided once per shift. (2) Egg products that are distributed frozen and thawed prior to or during display for sale at retail must bear the statement “Keep Frozen” on the shipping container. (2000). Reported in RTI International. Sanitation SOPs are necessary because they clearly define each plant's responsibility to consistently follow effective sanitation procedures to minimize the risk of direct product contamination and adulteration. [8 9]. Federal Register issue. (a) Operations involving the processing, storing, and handling of eggs, ingredients, and egg products must be strictly in accordance with clean and sanitary methods and must be conducted as rapidly as practicable. (e) As an employer who receives a drug test result indicating that the employee's specimen was dilute, take action as provided in 40.197. 2018-00425 Filed 2-12-18; 8:45 am], updated on 8:45 AM on Wednesday, December 2, 2020. 453, 21 U.S.C. 37. As part of its effort to make the egg products inspection regulations as consistent as possible with the Agency's meat and poultry products regulations, FSIS is proposing to modify the prior label approval program for egg products labeling. When reading the drug test result, you will find a line at the very top of every testing window and that is the control region (C). Remove §§ 590.112, 590.114 and 590.116. The plant would have to establish critical limits for the preventive measures associated with each identified CCP. If your children are important to you, a drug test shouldn't be an issue. Validation also encompasses reviews of the records, routinely generated by the HACCP system, in the context of other validation activities. (a)(1) No substance may be used in the processing of egg products, for any purpose, unless its use is authorized under 21 CFR as a direct food additive (part 172), a secondary direct food additive (part 173), an indirect food additive (parts 174-178), a source of radiation (part 179), an interim-listed direct food additive (part 180), a prior-sanctioned substance (part 181), a Generally Recognized As Safe (GRAS) substance (parts 182 or 184), or by 21 CFR 160.185, or by regulation in this chapter. Eggs used in processed egg products must be broken in a sanitary manner and examined to ensure that the contents are acceptable for human consumption. showed that 93 percent of egg products plants use a written HACCP plan to address at least one production step in their process. FSIS is proposing that imported egg products bear the same mark of inspection that is applied to imported meat and poultry products. To meet the proposed regulation's sanitation requirements, each processor will develop and maintain a Sanitation SOP. 1251 et seq.  However, FSIS has developed a Sanitation Performance Standards Compliance Guide (Compliance Guide) that presents or references methods already proven to be effective in maintaining sanitary conditions in meat and poultry products establishments, which is posted on the Agency's web page: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index/sanitation-performance-standards. Information about this document as published in the Federal Register. (b) Any food manufacturing establishment or institution which uses any eggs that do not meet the requirements of 21 U.S.C. (a) Except as provided in § 590.960, each consignment imported into the United States must have an electronic foreign inspection certification or a paper foreign inspection certificate issued by an official of the foreign government agency responsible for the inspection and certification of the product. Once a plant has established critical limits for the measures associated with each identified CCP, it will need to monitor the identified CCPs to assess whether the CCP is within the established critical limit (9 CFR 417.2(c)(4)). For example, corrective action plans must be in place to identify and correct the cause of a deviation and to determine the disposition of potentially adulterated product. As required by 9 CFR 412, the Labeling and Program Delivery Staff (LPDS) evaluates certain sketch applications and all temporary applications for meat and poultry products. Such products are not required to be inspected upon arrival in the United States and may be shipped to the importer without further restriction under this part, except as provided in 9 CFR 590.925(b), provided that the Department may, with respect to any specific importation, require that the importer certify that such product is exclusively for said importer's personal use, display, or laboratory analysis and not for sale or distribution. Q.5.11 What was the approximate value of egg product sales during the past year? A sanitation recordkeeping task would be performed daily, unless the plant reported performing a task more than daily, in which case FSIS assumed there would be one task per shift (an average of 1.7 shifts per plant based on the results of the Industry Survey). The rule provides a net cost savings of between $1.3 million and $1.4 million annualized over 10 years at the 7 percent and 3 percent rates. As a result, FSIS is proposing to amend or replace many of the current sanitary requirements contained in 9 CFR 590.500-575. § 590.548(b)(4), which includes prescriptive requirements for maintaining sanitary conditions in drying, blending, packaging, and heat treatment rooms and facilities. 1036(a) requires that egg products inspected at an official plant and found to be not adulterated be pasteurized before they leave the official plant, except as otherwise permitted by the regulations of the Secretary. The egg products industry's documentation of its processes, first in a plan and thereafter in a continuous record of process performance, will be a more effective food safety approach than the sporadic generating of information by inspection program personnel. Periodic inspections will be made at any plant processing egg products which are not intended for use as human food of its operations and records to ensure compliance with the Act and the regulations in this part. Egg product means any dried, frozen, or liquid eggs, with or without added ingredients, excepting products which contain eggs only in a relatively small proportion or historically have not been, in the judgment of the Secretary, considered by consumers as products of the egg food industry, and which may be exempted by the Secretary under such conditions as the Secretary may prescribe to assure that the egg ingredients are not adulterated and such products are not represented as egg products. The best kept secret in determining an egg's freshness is to see if it sinks in water. FSIS is proposing to amend 9 CFR 590.965 to permit the re-entry of inspected and passed egg products from foreign countries if they are not adulterated or misbranded at the time of such return. Water and water based (aqueous) solutions are widely used for prewetting, washing, and rinsing eggs, product formulation, and cleaning and sanitizing equipment. may appeal a regulatory control action. (6) No egg product that has been refused entry and exported to another country pursuant to paragraph (a)(3) of this section may be returned to the United States under any circumstances.  documents in the last year, 647  Therefore, FSIS now intends to require inspection in egg products plants at least once per shift, instead of during all processing operations. Such substances must be safe and effective under conditions of use and not result in the adulteration of product. The documents posted on this site are XML renditions of published Federal FSIS is also announcing that it is seeking public comment on draft guidance designed to help small and very small plants producing egg products to meet the new regulatory requirements being proposed in this rulemaking. The Agency would save approximately $58,498 annually discounted over 10 years at the 7 percent rate. The water must comply with Environmental Protection Agency (EPA) National Primary Drinking Water regulations. The full-scale data collection took place over a 16-week period from February 17, 2014, to June 9, 2014. The Secretary has also been authorized to make inspections, as appropriate, of the facilities of egg handlers (including transport vehicles) to determine whether shell eggs destined for the ultimate consumer are being held under refrigeration at an ambient temperature of no greater than 45 degrees Fahrenheit after packing and contain labeling that indicates that refrigeration is required (21 U.S.C. 2. 32. Academic literature (please see next section) has also shown that an egg products plant's choice to process under a HACCP system as a management tool can also be internally driven by efficiency gains. Table 19 summarizes the quantified costs and cost savings to industry and the Agency if the proposed rule is implemented. 18. It is a quality, not a food safety, indicator. • Additional travel costs for inspection personnel on patrol assignments in egg products plants. FSIS used the training estimates from Section 1 and assumed that any plant which did not provide training for Sanitation SOPs did not have a written plan. 50. However, while the risk assessment showed that pasteurization resulting in a 6-log10 reduction of Salmonella was predicted to be effective for reducing illnesses from Salmonella spp. A patient fails a drug test, but stays in this doctor’s practice. A critical limit is the maximum or minimum value to which a hazard must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard. Plan Development: For the most part, plants already have plans for sanitation insofar as FSIS already requires certain sanitation procedures. Table 12—Total Sanitation SOPs-Related Industry Costs. In my case I was told I tested + for "oxycontin"-a drug I have never even seen, nor been prescribed. 9 CFR 411(c)(5) requires that containers of product bearing official identification display that identification and the plant number. having a total compensation of $94.20. This repetition of headings to form internal navigation links FSIS included recurring training costs to account for labor separation and the need to train new employees. Authority: 55. The pasteurization time and temperature compliance guidelines specifically will assist small and very small businesses in identifying validated procedures. Section 416.2(b) of 9 CFR sets out construction sanitation requirements that will allow for increased flexibility in regard to facility operation construction and maintenance if adopted by reference through proposed 9 CFR 591.1. On September 19, 2014, FSIS published a final rule amending 9 CFR 590.915 and 590.920 to provide an electronic alternative to the paper-based import inspection application and the foreign inspection and foreign plant certificate processes (79 FR 56220). An appeal inspection or review of a program employee's decision, as requested in § 590.310, must be performed by a program employee of FSIS other than the one who made the initial decision. Large volume producers would acquire benefits from implementing HACCP. For these plants, there will be a cost savings and reduction in recordkeeping costs, because they are keeping records for both a HACCP system and the current regulations. Use of these procedures can usually return water to a level of quality appropriate to its intended use. This accounts for approximately 91 percent of all egg products plants. of two to the hourly wage rate to estimate a total compensation rate for a Quality Control (QC) manager at $102.94 per hour; and for Supervisors or QC technicians at $68.52 per hour; and for Production workers at $26.00 per hour. § 590.500(n), requiring suitable facilities for cleaning and sanitizing utensils and equipment at convenient locations throughout the plant, § 590.504(f) and (n), requiring personnel handling utensils or containers which may come into contact with egg products to wash their hands and maintain them in a clean condition and requiring most utensils and equipment to be clean and sanitized at the beginning of processing operations and kept clean and sanitary during all processing operations, § 590.506(a), which states that the equipment shall be arranged to facilitate cleaning and the removal of refuse and excess packing material from the candling and transfer room, § 590.508(c) and (d), requiring the handling of shell eggs in a manner to minimize sweating prior to breaking and placing shell eggs with extensively damaged shells, unless otherwise prohibited, into leaker trays, § 590.515(a)(1) and (b), requiring that shell egg cleaning equipment be kept in good repair and be cleaned after each day's use or more frequently, if necessary, and requiring that the temperature of wash water be maintained at 90 degrees F or higher, and shall be at least 20 degrees F warmer than the temperature of the eggs to be washed, throughout the cleaning cycle, § 590.520(g), states that a suitable container conspicuously identified shall be provided for the disposal of rejected liquid, § 590.522(d), (h), (s), (t), (u), (v), (y), (aa)(1)-(3), containing prescriptive requirements for the cleaning of breaking machines and equipment, including mechanical breaking machines, as well as other equipment used in the processing of egg products, such as cups, knives, racks, etc., dump tanks, drawoff tanks, and churns, strainers, filtering devices, etc., and containers used for transporting liquid eggs products, § 590.538, concerning the construction and cleaning of defrosting facilities, § 590.539(f), concerning the cleaning of crushers and other equipment used in defrosting operations, § 590.540(h), requiring the construction of powder conveying equipment as will facilitate thorough cleaning, § 590.542(b)(2) and (c)(1), requiring the sanitizing of spray process drying equipment within 2 hours prior to resuming spray drying operations and the clearing of sifters and conveyers used for other than dried albumen powder when such equipment is not to be used for 24 hours or longer, § 590.548(b)(3)-(5), which requires that equipment and utensils used in dried eggs be kept off the floor and be kept clean at all times and whenever contaminated be cleaned and sanitized. Conditional inspection may be provided for a period not to exceed 90 days, during which period the plant will have to validate its HACCP plan. Instead, equipment and utensils used for processing or otherwise handling edible product or ingredients will only have to be of such material and construction as to facilitate thorough cleaning and be durable and suitable for its intended use. As with official meat and poultry products establishments, FSIS will verify that the plant's HACCP plans comply with the requirements of proposed 9 CFR 590.149(b) and 591.1 and 9 CFR part 417; that these plans have been validated by the facility; and that plants are producing egg products to be edible without additional preparation to achieve food safety. in Egg Products. A copy of each document referenced in this notice of proposed rulemaking is available for viewing in the FSIS Docket Room, on the FSIS website as a related document associated with this docket, and on www.regulations.gov, unless otherwise noted. (b) The following are exempt, to the extent prescribed, from the continuous inspection of egg products processing operations in section 5(a) of the Act (21 U.S.C. The egg products regulations are the same. FSIS will provide additional guidance to plants on how to validate their HACCP systems. Procedures for rescinding or refusing approval of marks, labels, and containers. Section 590.100 provides exemptions from continuous inspection under certain circumstances, provided that the conditions for exemption and the provisions of the regulations are met. Plants that choose not to develop new or modified procedures will be able to continue to follow a set of pasteurization time and temperature combinations for products that have been validated as achieving the intended pathogen reduction, such as those in the current regulations. FSIS is seeking comment on this guidance document, which is posted on the Agency's web page: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. Section 590.504(q) states that all liquid and solid material in the official plant shall be disposed of in a manner approved by the Administrator to prevent product contamination and in accordance with acceptable environmental protection practices. Remove §§ 590.536, 590.538 through 590.540, 590.542, 590.544, 590.546 through 590.550, 590.552 and 590.560. Recordkeeping: Under the proposed rule, plants would be required to maintain daily records sufficient to document the implementation and monitoring of sanitation SOPs. QC Managers would be trained initially at a cost of $2,756 ($1,378 to $4,134) with an annual refresher at a cost of $205.98 ($102.94 to $308.82). (d) Liquid or frozen egg products identified as whole eggs and processed in other than natural proportions as broken from the shell must have a total egg solids content of 24.20 percent or greater. Objectionable odors or condensation are to be reduced to the extent possible or eliminated because they can adulterate product. Process records documenting that the temperature and labeling requirements in § 590.50(a) have been met must also be kept; (2) The date of packaging, ambient air temperature surrounding product stored after processing, quantity and quality of eggs delivered or sold, and to whom (including a complete address, unless a master list is maintained); (3) If a consecutive lot numbering system is not employed to identify individual eggs, containers of eggs, or egg products, record the alternative code system used, in accordance with § 590.411(c)(3); (4) The date of disposal and quantity of restricted eggs, including inedible egg product or incubator reject product, sold or given away for animal food or other uses or otherwise disposed of, and to whom (including a complete address, unless a master list is maintained); (5) The individual or composite (running tally) record of restricted egg sales to household consumers. Edible dried egg powder may be reconstituted, repasteurized, and redried when accomplished in a clean, sanitary manner. FSIS has determined that some of the products on the list of specific products that have been exempted as not being “egg products” are incorrectly categorized as such. Box 12194 Research Triangle Park, NC 27709-2194. FSIS used initial and recurring annual refresher training cost estimates (updated using the CPI for Urban Consumers from 2014 to 2016 dollars and the assumed benefit factor of two) and the number of hours of training from the Cost of Food Safety Interventions 
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