Source: https://www.federalregister.gov/documents/2001/01/05/01-95/regulations-governing-the-certification-of-sanitary-design-and-fabrication-of-equipment-used-in-the
Timestamp: 2017-09-24 10:41:27
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Matched Legal Cases: ['§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', 'art 58', 'art 1320', '§\u200954', 'art 58', '§\u200954', '§\u200954', 'art 54', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', '§\u200954', 'art 58', '§\u200958']

Federal Register :: Regulations Governing the Certification of Sanitary Design and Fabrication of Equipment Used in the Processing of Livestock and Poultry Products
Regulations Governing the Certification of Sanitary Design and Fabrication of Equipment Used in the Processing of Livestock and Poultry Products
A Rule by the Agricultural Marketing Service on 01/05/2001
1189-1204 (16 pages)
Program Would Become Mandatory Requirement
Comments Referring to AMS Providing the Inspection and Certification Service
Effect of Program on Private Certification Providers
Reexamine Alternatives to Proposed Program
Conformance of Program to ISO and ANSI Standards for Third Party Certification Bodies
Continued Compliance with NSF/3-A Standards
Requiring Samples, Material Lists and On-site Audits
Four Year Certification Review
Comments Referring to the Selection of Standards That AMS Will Inspect and Certify Equipment To
Support for Adoption of NSF/3-A Standards
Incorporation of NSF/3-A Standards
Enforcement of the Worker Safety Provisions of the NSF/3-A Standards
Opposition to Use of Draft Standards
AMS Proposing One or Many Standards
AMS Should Develop Its Own Standards
Use of ISO Standards
Representation of Manufacturers in NSF/3-A Standards Development Process
Suggested Revisions to NSF/3-A Standards
Comments Referring to Administrative Issues
Grandfathering of Equipment Approved Under the Former FSIS Program
AMS Work With Industry Associations
Keep Program Simple and Straightforward
Program Budgeting and Appropriations by Congress
AMS Staffing Levels and Certification Turnaround Times
Acceptance of Program by FSIS
Third-party Appeal of Certification
Concurrent Reviews for Dairy and Meat and Poultry Equipment
AMS Accepted Equipment Symbol Confusing
Size and Format of AMS Accepted Equipment Symbol
Comments Referring to Rulemaking Issues
Extension of Comment Period Accompanying the Proposed Rule
Implement Program on a Trial Basis
1. Equipment Review Request—Form DA-162
2. Application To Use official ID—Form DA-155
3. Request To Display Official ID—Form DA-156
4. Appeal—Equipment Review Request—Form DA-162
5. Letter Requesting Renewal of Acceptance
https://www.federalregister.gov/d/01-95 https://www.federalregister.gov/d/01-95
The Agricultural Marketing Service (AMS) has developed a voluntary, user-fee-funded program under the provisions of the Agricultural Marketing Act of 1946 to inspect and certify equipment and utensils used to process livestock and poultry products. Livestock and poultry processing equipment and utensils inspected and certified by AMS to voluntary consensus standards for sanitary design will provide a third party assurance that they meet minimum requirements for cleanability, suitability of materials used in construction, durability and inspectability.
The information that follows has been divided into three sections. The first one provides background information including a summary of the history of this rulemaking process. The second section provides a summary of the comments received in response to the proposed rule published in the Federal Register on June 6, 2000, and the Agency's responses to these comments including changes made in this final rule as a result of the comments. The last section provides the impact analysis section that addresses various requirements including the Regulatory Flexibility Act, the Paperwork Reduction Act, Civil Rights Review, and the relevant Executive Orders.
Provisions of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001, (Pub. L. 106-387, sec. 729) require AMS to develop a voluntary, user-fee-funded program to inspect and certify equipment and utensils used to process livestock and poultry products. Prior to this amendment, similar language appeared in appropriations acts for fiscal year 1999 (Pub. L. 105-277, sec. 747) and fiscal year 2000 (Pub. L. 106-78, sec. 734). The program will be conducted under the provisions of the Agricultural Marketing Act (AMA) of 1946 (7 U.S.C. 1621 et seq.). From 1975 to 1997, a similar function was carried out by USDA on a mandatory prior approval basis by USDA's Food Safety and Inspection Service (FSIS) as a prerequisite for equipment use in federally inspected meat and poultry packing and processing establishments. The FSIS Equipment Branch formally evaluated equipment and utensils proposed by manufacturers or suppliers before they could be used in official establishments to assure they could be maintained in a sanitary condition. The program focused on identifying and correcting problems during the initial development of equipment and utensils.
At the time FSIS announced that it was discontinuing its prior approval program, equipment and utensil manufacturers and processors of livestock and poultry products expressed their desire to either continue the FSIS program or develop a new program through AMS on a voluntary, user-fee-funded basis to inspect and certify equipment and utensils used to process livestock and poultry products to a sanitary standard. Subsequently, provisions of the fiscal year 1999 appropriations required development of such a program by the Secretary of Agriculture under the authority AMA of 1946.
Through the ANPRM and the public meeting, AMS sought information which would enable the Agency to develop an efficient and cost-effective program for inspecting and certifying equipment and utensils used to process livestock and poultry products. Specifically, AMS requested comments concerning: initiatives underway in the industry to develop a voluntary, consensus sanitary standard for the design and manufacture of equipment and utensils used to process livestock and poultry products; the validity and usability of standards presented to AMS for consideration for adoption; criteria to be used by AMS to select a sanitary standard; and any other information which would aid AMS in administering the program.
The ANPRM solicited comments on the issue for a 60-day period ending September 14, 1999. The public meeting was held on August 10, 1999, in Room 107-A at the USDA Jamie L. Whitten Building, 12th and Jefferson Drive, SW., Washington, DC.
To assist interested parties in obtaining information on the proposed program and in reviewing comments as AMS received them, the Agency launched a website at www.ams.usda.gov/​lsg/​equip.htm. Contained on this website were electronic versions of the AMS press releases related to the development of Start Printed Page 1191the program, the ANPRM, complete transcripts of the August 10, 1999, public meeting, and all comments received.
The public meeting was attended by 42 representatives of the meat and poultry packing and processing industry, equipment and utensil manufacturing industry, trade and professional associations, standards developers, and other interested parties. Twelve individuals provided prepared remarks at the meeting. AMS received 51 comments during the comment period for the ANPRM.
On June 6, 2000, AMS published in the Federal Register (65 FR 35857), a proposed rule which responded to the ANPRM comments and solicited additional public comment. AMS received 100 comments during the comment period which ended August 7, 2000. The regulatory text of this final rule incorporates changes made in response to these comments and upon further review by AMS.
Summary of Comments: Forty-one commenters expressed general support of the development of the program as presented in the proposed rule which included the standards developed by the NSF/3-A Joint Committee on Food Processing Equipment, the voluntary aspects of the service, and the use of Federal employees to provide the service. Thirty-three of these commenters specifically supported AMS as the certifying agency.
Agency Response: AMS has considered these comments in support of the program as it has contemplated changes from the proposed rule to this final rule.
Summary of Comments: Three commenters expressed concern that this program would become a “de-facto” mandatory requirement and that AMS should clearly state in the final rule that equipment manufacturers remain free to obtain other third party certifications or can “self-certify” that equipment is sanitarily designed and manufactured.
Agency Response: Throughout the development of these regulations and this program, AMS has maintained that the service to be implemented is voluntary and user-fee-funded. Accordingly, no equipment fabricator or user is required to participate in this program. Private certification providers can propose and offer other services to the livestock and poultry industries without restriction by these regulations. Therefore, equipment fabricators and users may use whatever means they desire, including “self certification”, as suggested by commenters, to market or represent their products.
Summary of Comments: Five commenters generally opposed AMS providing the certification service because of concerns over public-private competition. One commenter also asserted that the Office of Management and Budget (OMB), Circular A-76 requires Federal agencies to use private sector services rather than offer duplicative services.
Agency Response: The comments received during the comment periods for the both ANPRM and the proposed rule indicate a clear desire by the livestock and poultry industry that this voluntary certification service be provided by AMS using government employees. These final regulations establish a voluntary, third-party evaluation service administered by AMS which is consistent with other, similar services provided by AMS for the inspection and grading of agricultural products, for laboratory services, for the evaluation of the sanitary design of equipment used in the dairy industry, and for the display of official identification marks. As such, no equipment fabricator or user is required to participate in this AMS service and equipment manufacturers and other users may choose any other voluntary, private certification service available to them. Furthermore, the regulations do not prevent, exclude or limit any private organization from independently offering a certification service of their own design to the livestock and poultry industry. With regard to concerns over the regulation's conformance with OMB Circular A-76, it is our view that this rule is consistent with the provisions of the Circular.
Summary of Comments: One commenter stated that AMS failed to consider the potential effects of the regulation upon private certification providers.
Agency Response: AMS did consider potential effects upon third parties. The service to be implemented by AMS is voluntary and user-fee-funded. As already stated, no equipment fabricator or user is required to participate in this program. Private certification providers may offer their services to the livestock and poultry industries without restriction by these regulations. Therefore, equipment fabricators and users may use whatever means they desire to demonstrate that their products are suitable for use.
Summary of Comments: One commenter asked AMS to reexamine alternatives under the agricultural appropriations act considering programs already implemented or publicly contemplated by AMS and offer an accreditation service for conformity assessment organizations in lieu of a certification service.
Agency Response: The Act provides that USDA develop a voluntary, user-fee-funded program to inspect and certify equipment used to process livestock and poultry products. Accordingly, the Agency examined alternatives, including the alternative suggested by the commenter. Additionally, AMS evaluated comments received in response to the ANPRM and the proposed rule as the alternatives were considered. The alternative option to develop a third-party certifier accreditation service was evaluated and rejected by AMS. The statutory language provides that the Secretary inspect and certify agricultural processing equipment. Further, a significant number of comments during the comment periods for the ANPRM and proposed rule which supported an AMS provided service staffed by Federal employees to conduct the evaluations.
Summary of Comments: Two commenters stated the proposed program did not conform to ISO or American National Standards Institute (ANSI) provisions or standards for third party certification bodies.
Agency Response: It has never been the objective or intent that the certification service provided by AMS would conform to ISO or ANSI provisions or standards for third party certification bodies. AMS intends to operate this program consistent with other voluntary, user-fee-funded inspection and certification services already provided by the Agency. AMS believes that this decision is consistent with the intent of Congress and the expectation of equipment manufacturers and meat and poultry processors who requested AMS develop the service. Start Printed Page 1192
Summary of Comments: Two commenters stated that the proposed program did not provide for continued compliance with the NSF/3-A Standard and that the regulations need to offer interested parties the opportunity to question the appropriateness of an AMS certification of compliance. Additionally, one commenter asked what would happen to those manufacturers who do not report a change in the design of their equipment to AMS, and how would AMS verify if a change had occurred and was not reported.
Agency Response: After a review of the proposed regulations, AMS believes these comments have merit. Accordingly, § 54.1019 has been modified to require a manufacturer of any equipment or utensil which has been issued a report or certification of compliance to resubmit for evaluation any change in materials of construction, design, or fabrication which may impair the cleanability or hygienic design of the equipment or utensil. Similarly, AMS encourages interested parties to contact AMS if they have any questions regarding the appropriateness of an AMS certification of compliance. AMS can use this feedback as a basis for initiating a review to ensure that equipment marketed as certified through this program comply with the standards.
Summary of Comments: Seventy-two commenters requested AMS clarify or streamline the process for recertification of equipment. The commenters expressed confusion as to AMS' intent behind the wording used in the proposal stating that recertification by AMS was required after “any” change to the design was made. Commenters generally favored AMS only requiring recertification of equipment when a change of design is made that may affect the hygienic, cleanliness, or sanitary aspects of the equipment.
Agency Response: AMS agrees and has revised § 54.1019 in these regulations to clarify that only changes which impair the cleanability or hygienic design of the equipment or utensil need to be submitted for recertification.
Summary of Comments: One commenter stated that the program did not provide for independent audits of the manufacturing facility.
Agency Response: The regulations do not provide for such audits as such audits are not intended to be a part of this service. AMS believes a requirement in these regulations for independent audits of the equipment or utensil manufacturers' facilities is not necessary. The addition of an AMS audit requirement of the manufacturer's facilities would substantially increase the cost of this voluntary program and the Agency believes the marginal benefit of such audits would be unwarranted. Additionally, the FSIS inspection program continues to be responsible for ensuring that equipment and utensils used in federally inspected facilities are of such material and construction as will facilitate their through cleaning and operational cleanliness, and not adulterate edible product. AMS believes the service to be provided by these regulations, particularly those in §§ 54.1019, contain sufficient internal controls to protect the integrity of its evaluations and certifications.
Summary of Comments: One commenter objected to the program not requiring examination of samples, materials lists, or on-site audits. Three additional commenters requested clarification on the issue of when an on-site audit is required.
Agency Response: In order to allow for the greatest flexibility for applicants to apply for this service, AMS does not require blueprints, samples, and materials list be submitted with the application for all pieces of equipment and utensils. However, if sufficient information is unavailable for AMS to accurately evaluate the design of a specific piece of equipment or utensil, which could include the materials used in construction, a report or certification of acceptance will not be granted until such information that is required to perform the inspection is provided.
With respect to on-site audits, the evaluation and certification process includes the fabrication of the equipment or utensil. The only means available to AMS to accurately determine that acceptable fabrication techniques have been accomplished is to evaluate the completed piece of equipment or utensil. Depending upon the size and complexity of the equipment or utensil, this determination can only be accomplished with an on-site evaluation. Once a report or certificate of acceptance has been issued, additional on-site evaluations would be necessary only if the fabricator modified the design and requests a recertification under the provisions of § 54.1019. As appropriate to the review and evaluation process, AMS will conduct on-site reviews of the actual equipment at the point of fabrication or where installed. Section 54.1014 provide the regulatory language outlining the requirements for accessability of the equipment for evaluation.
Because AMS believes that blueprints, material lists and on-site audits will be required in virtually every instance envisioned by the Agency, the cost burden estimates for this program put forward in the Impact Analysis section of this rule assume all applicants will submit such documentation and will receive an on-site audit.
Summary of Comments: Ten commenters requested clarification of how AMS would process equipment which is part of a model line. Specifically, they requested clarification as to whether each member of the model line needed to be submitted for evaluation and certification.
Agency Response: AMS agrees that a clarification is needed. Accordingly, § 54.1006 has been modified by adding the wording, “Equipment or utensils having an identical design, materials of construction, and fabrication, except for scaling up or down in size, may be submitted for evaluation as a model line or series.”
Summary of Comments: Three commenters objected to the requirement that certification must be reviewed every 4 years.
Agency Response: AMS disagrees. Based on experience, AMS believes equipment design and fabrication change frequently to meet the demands and needs of the equipment users. Section 54.1019 provides the requirements for these changes to be accommodated within the evaluation and certification process. For those types of equipment or utensil which change infrequently or not at all, the regulations provide for a simple procedure whereby the fabricator can state that no changes in the design or fabrication have occurred. AMS continues to support the need for these provisions as program integrity safeguards that the certifications issued by AMS are valid and that the four year recertification cycle is appropriate for AMS needs while not being overly restrictive to the livestock and poultry industries. Start Printed Page 1193
Summary of Comments: Twenty-two commenters supported the adoption of the standards developed by the NSF/3-A Joint Committee on Food Processing Equipment.
Agency Response: AMS has adopted these standards as the basis of this certification program.
Summary of Comments: Sixty-nine commenters stated opposition to the way AMS incorporated the NSF/3-A standard in the proposed regulations. Commenters requested any changes to the standards be made through notice and comment in the Federal Register. One of the commenters stated AMS failed to follow OMB Circular A-119 made in the proposed rule.
Agency Response: As stated in the proposed rule, AMS will inspect and certify equipment and utensils to standards developed by the NSF/3-A Joint Committee on Food Processing Equipment. NSF is an ANSI Designated Audited Certifier. As such, NSF follows all ANSI procedures for standards development and the final published standards will be ANSI/NSF/3-A standards consistent with the provisions of OMB Circular A-119. AMS believes that these ANSI procedures provide for the required participation by all interested parties during all phases of the standards development process to ensure all points of view or concerns are considered before publication of the final standard. However, apart from the ANSI procedures for standards development, AMS encourages public comment on all of its services, and the standards the Agency uses as the basis of its services, including this program. To ensure that public comment is received prior to changes in the standards AMS uses, AMS will provide notice of pending changes in the standards to encourage interested parties to provide AMS with feedback and so they may also comment directly to the NSF/3-A Joint Committee.
Summary of Comments: Seventy-two commenters requested the program not enforce the worker safety provisions of the NSF/3-A standards adopted.
Agency Response: The scope of the NSF/3-A standards apply only to the hygienic requirements of the equipment or utensil design and had not intended to evaluate or comment on worker or occupational safety issues. Similar comments were also made to the NSF/3-A Joint Committee. In August 2000, the Joint Committee published NSF/3-A 14159-1, Draft 7.0 which included modified wording to delete the references to worker and occupational safety from application to livestock and poultry processing equipment and utensils. In view of the changes to the standards effected by the NSF/3-A Joint Committee, AMS believes the concerns raised by the commenters has been resolved and no additional action is needed by AMS.
Summary of Comments: Two commenters objected to the use of the NSF/3-A standard because it is a draft standard.
Agency Response: At the time of the publication of the proposed rule the NSF/3-A standard was a draft standard, however the final ANSI/NSF/3-A standard has now been published and accepted as an American National Standard.
Summary of Comments: One commenter was confused whether AMS was proposing one standard or many standards.
Agency Response: AMS will inspect and certify equipment and utensils to standards developed by the NSF/3-A Joint Committee on Food Processing Equipment. This Joint Committee will develop a wide-range of standards dealing with the hygienic design of equipment. As already stated, one standard has been completed by the Joint Committee and the committee is in the process of developing additional consensus standards. It is the intent of AMS to inspect and certify equipment and utensils to all standards finalized by the Joint Committee that are appropriate to the livestock and poultry industries. As standards are developed, this may result in the application of multiple standards by AMS to the appropriate pieces of equipment and utensils, as well as to the appropriate segments of the industry.
Summary of Comments: One commenter stated that they would have preferred that AMS write its own standards.
Agency Response: AMS disagrees. As already stated, AMS will inspect and certify equipment and utensils to standards developed by the NSF/3-A Joint Committee on Food Processing Equipment. AMS does not believe that the development of a new AMS standards would improve the service or provide users with any benefits.
Summary of Comments: One commenter recommended that any third party certifier should use International Organization for Standardization (ISO) standards.
Agency Response: The primary purpose of the regulations is to provide a third party certification that equipment meet specified standards. The service developed by AMS is intended to meet the needs expressed by the domestic livestock and poultry industries for a third party evaluation of the sanitary design of processing equipment according to specified standards. However, during development of the service, AMS did evaluate and consider international harmonization and compatibility with appropriate ISO standards. The standards developed by the NSF/3-A Joint Committee on Food Processing Equipment, which will be used by AMS, are based on the corresponding ISO standard, ISO/DIS 14159:1997 Safety of Machinery—Hygiene requirements for the design of machinery.
Summary of Comments: Two commenters objected to the use of the NSF/3-A standards because “manufacturers were not represented”.
Agency Response: Equipment manufacturers are represented on the Joint Committee and the technical working groups. Further, the ANSI procedures followed by the Joint Committee for the development of standards requires that all interested parties be included in the development process.
Summary of Comments: One commenter requested AMS adopt the ANSI/UL 2128—Meat and Poultry Plant Equipment Standard developed by the Underwriters Laboratories, Inc., instead of the NSF/3-A standard because the ANSI/UL 2128 standard is the American National Standard.
Agency Response: Since publication of the proposed rule, the NSF/3-A Joint Committee has now finalized their deliberation and published the draft standard that was proposed in final form. Accordingly, the NSF/3-A standard is now an American National Standard. Start Printed Page 1194
Summary of Comments: Thirteen commenters provided specific revisions that they would like made to the hygienic portions of the NSF/3-A draft standards.
Agency Response: AMS appreciates this feedback and will use it as it evaluates revisions that may need to be made to the NSF/3-A standards. AMS also recommends the commenters direct their specific revision changes to the NSF/3-A Joint Committee, NSF International, P. O. Box 130140, 789 N. Dixboro Rd., Ann Arbor, MI 48105.
As already stated, AMS encourages public comment on all of its services, and the standards the Agency uses as the basis of its services, including this program. To ensure that public comment is received prior to changes in the standards AMS uses, AMS will provide notice of pending changes in the standards to encourage interested parties to provide AMS with feedback and so they may also comment directly to the NSF/3-A Joint Committee.
Summary of Comments: Two commenters requested that equipment approved under the former FSIS prior-approval program be “grandfathered” under this program.
Agency Response: AMS disagrees. The standards applicable under the two programs are different. It would be inappropriate for AMS to “grandfather” equipment that did not meet the standards proposed under this service that would then compete in the market place with equipment fabricators complying with the new standards.
Summary of Comments: One commenter requested we inform the industry associations about what we are doing.
Agency Response: AMS agrees. AMS has participated in a number of informational meetings with all of the major industry trade associations whose members use AMS programs and services.
Summary of Comments: One commenter requested we keep the program as “simple and straightforward” as possible.
Agency Response: AMS agrees. It is the goal of AMS in these regulations to provide a voluntary, user-fee-funded evaluation and certification program that meets the needs of the livestock and poultry industries, and is carried out in a manner as simple, straightforward, efficiently and cost effective as possible.
Summary of Comments: Nine commenters expressed concern over language in the proposed rule restricting the use of marketing claims on promotional literature for equipment not approved by this program. Additionally, commenters requested that approval letters from the former FSIS prior-approval program be allowed to be used and that such equipment be allowed to be marketed with the claim “USDA accepted equipment” and “USDA approved.”
Agency Response: AMS disagrees. The standards and procedures provided for in these regulations are different than those implemented by the FSIS prior-approval program. As such, it would be unfair to participants in the this new program to have to compete with claims of manufacturers sanctioned under the former FSIS program which have not participated in this new AMS service. FSIS discontinued the mandatory prior approval program for equipment and utensils on September 24, 1997 (62 FR 45016). Since that time, there has been no procedure available to assure that the equipment or utensils covered by letters issued during the former FSIS program accurately represent the current equipment design or that such equipment even still meet current FSIS requirements.
Summary of Comments: One commenter stated their belief that the new service would be subject to congressional budgeting and appropriations.
Agency Response: The commenter is not correct. This service is fully user-fee supported.
Summary of Comments: Four commenters expressed concern over AMS staffing levels and turnaround times on certifications. Two of the commenters specifically asked that AMS include a maximum certification turnaround time in the regulations (30 and 60 days).
Agency Response: AMS will staff the program with sufficient personnel to accomplish the goals of the program using the best estimates available to AMS while still operating the program in an efficient and cost effective manner. AMS disagrees with the suggestion of commenters to include a maximum turnaround time in the regulations. Due to the complexity and sophistication of many of the designs eligible for evaluation and certification, turnaround time restrictions could be unrealistic and ultimately detrimental to the evaluation process.
Summary of Comments: One commenter objected to AMS being able to reject an application based on “administrative reasons such as the non-availability of personnel to perform the service.”
Agency Response: AMS disagrees. While AMS intends to provide service to applicants consistent with this subpart, there may be instances where such service may not be provided. Accordingly, the provision will remain unchanged.
Summary of Comments: One commenter requested AMS work to ensure this program is accepted by FSIS.
Agency Response: AMS has worked to ensure FSIS is fully aware of the services being developed by AMS. Additionally, AMS has informed FSIS of our availability to provide information about this service to their management or employees.
Summary of Comments: One commenter requested that a section be added to the final rule allowing for users or other third-parties to question AMS certifications.
Agency Response: As already stated, AMS encourages interested parties to contact AMS if they have any questions regarding the appropriateness of an AMS certification of compliance. AMS can use this feedback as a basis for initiating a review to ensure that equipment marketed as certified through this program comply with the standards. The Agency believes this addresses the concern of the commenter sufficiently without the need for the insertion of a new section in the regulations. Accordingly, the regulations will remain unchanged.
Summary of Comments: One commenter requested that to improve efficiency, dairy and meat and poultry equipment reviews be done concurrently. Start Printed Page 1195
Agency Response: Although these regulations do not specifically provide for a “concurrent” review of equipment to be accepted for use under both this and the dairy equipment acceptance program, reviews will be conducted concurrently to all applicable standards upon the request of an applicant using the joint form used for both programs, DA-162, Equipment Review Request.
Summary of Comments: One commenter objected to the AMS symbol as confusing and leading observers to believe that the equipment bearing the symbol has the endorsement of FSIS.
Agency Response: AMS disagrees. These regulations are intended to meet the needs expressed by the domestic livestock and poultry industries for a third party evaluation of the sanitary design of processing equipment according to specified standards. These regulations and the services they provide for do not obligate or require any action on the part of FSIS. AMS believes these regulations can be used by the livestock and poultry industries to demonstrate they have had a third party evaluation of the hygienic design and fabrication of processing equipment according to specified standards. The symbol clearly references only AMS as the agency within USDA certifying acceptance. There is no reference, intended or implied, in these regulations of FSIS sanction of the symbol or the acceptance it represents. FSIS regulations specifically identify their responsibility for ensuring all Federally inspected meat and poultry establishments produce safe and wholesome products, regardless of whether the equipment and utensils used to process the products were certified by AMS under the provisions of this regulation.
Summary of Comments: Four commenters expressed concern over the size and format of the USDA “Accepted Equipment” symbol.
Agency Response: AMS agrees that the regulations were not sufficiently clear on the intended size of the symbol. Section 54.1018 has been revised to include subsection (c) recommending at least a 3/4 by 3/4 inch size for the official AMS symbol, but also allowing for smaller sizes to be used provided they are sufficiently large to be identifiable and legible. Accordingly, symbols of varying size could be used to be compatible with the use and location of the symbol on either the equipment or promotional materials. The use of the official AMS symbol for this program is consistent with the use of other official identification marks used within other AMS programs.
Summary of Comments: One commenter requested the comment period be extended.
Agency Response: AMS disagrees. The 60 day comment period which accompanied the ANPRM and the 60 day comment period which accompanied the proposed rule were sufficient to obtain the public comment required to develop the program.
Summary of Comments: One commenter requested the program be implemented as a 3-year pilot program.
Agency Response: AMS disagrees. Because this is a voluntary, user-fee-funded service there is no benefit to the program being implemented on a trial basis.
Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), AMS has considered the economic impact of this proposed rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses would not be disproportionally burdened. Accordingly, we have prepared this regulatory flexibility analysis.
Development of this program is required by the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001, (Pub. L. 106-387, sec. 729). The program will be conducted under the provisions of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.).
AMS is establishing these regulations to conduct a voluntary, user-fee-funded inspection and certification program for equipment and utensils that are used to process livestock and poultry products. Under this proposed program, manufacturers of new, modified, or reconditioned equipment and utensils designed to process livestock and poultry products who want to have the equipment and utensils they manufacture officially inspected and accepted by AMS as meeting the NSF/3-A standards which outline minimum requirements for cleanability, suitability of materials used in construction, inspectability and durability would apply to AMS.
Under this equipment and utensil acceptance program, equipment and utensil manufacturers seeking AMS acceptance and certification may apply to AMS for an evaluation of their equipment and utensils. Although AMS does not require the drawings, blueprints and a material list for all pieces of equipment or utensils upon application, such blueprints and lists must be submitted as will facilitate the inspection and certification process. Additionally, some equipment and utensils will require AMS to conduct an on-site review at the point of fabrication or where installed and operating in an establishment to fully evaluate the design and construction and execute final acceptance.
To maintain acceptance and certification, these regulations require any manufacturer whose equipment or utensil has been accepted to resubmit the design and fabrication details of the accepted equipment or utensils whenever a change of design or fabrication which may impair the cleanability or hygienic design of the equipment or utensil occurs. Barring changes in equipment or utensil design and fabrication, acceptance is granted for a four year period. When equipment or utensil acceptance nears expiration at the end of the four year period, manufacturers may send a letter stating that no design changes have been made to receive an additional four year acceptance renewal.
This equipment and utensil inspection and certification program affects manufacturers or other vendors of equipment and utensils. The Start Printed Page 1196equipment and utensil manufacturers range in size from small to large concerns. According to the Standard Industrial Classification (SIC) (13 CFR 121.201) which are used by the Small Business Administration to identify small businesses, a small business equipment and utensil manufacturer is defined as a firm with less than 500 employees (SIC Division D. Major Group 20). According to the most complete data available to AMS, it is estimated that there are about 2000 equipment and utensil manufacturers, about 90 percent of these can be classified as small entities.
Previously, FSIS maintained a mandatory prior approval program for equipment and utensil inspection as a prerequisite for use in Federally inspected meat and poultry packing and processing establishments that affected these same entities. Under FSIS' former mandatory prior approval program for equipment, an estimated 2,500 applications for equipment approval were received each year. Evaluation and certification of equipment and utensils is based on the complexity and sophistication of the design and fabrication of the equipment or utensil being evaluated.
Provisions of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001, require AMS to develop a voluntary, user-fee-funded program to inspect and certify equipment and utensils used to process livestock and poultry products. Prior to this amendment, similar language appeared in the appropriations acts for fiscal year 1999 (Pub. L. 105-277, sec. 747) and fiscal year 2000 (Pub. L. 106-78, sec. 734). The program will be conducted under the provisions of the Agricultural Marketing Act (AMA) of 1946. Under the AMA of 1946, AMS is required to collect reasonable fees for providing official services provided under this proposed equipment and utensil certification program, to cover as nearly as practicable AMS costs for performing the service, including related administrative and supervisory costs. Since the procedures used to inspect and certify equipment and utensils used to process livestock and poultry products are similar to those used to inspect and certify dairy processing equipment, AMS has decided to charge the same hourly fees for inspecting and certifying equipment used to process livestock and poultry products. Inspection and certification services are based on the hourly rate for applicants who request services on an hourly basis and appear at 7 CFR Part 58 as published in the Federal Register at 62 FR 66258 on December 18, 1997. The current base hourly rate for such service is $56 per hour for service performed between 6 a.m. and 6 p.m. and $61.60 for service performed between 6 p.m. and 6 a.m., for the time required to perform the service calculated to the nearest 15-minute period, including the time required for preparation of certificates and reports and the travel time of the equipment review specialist in connection with the performance of the service. A minimum charge of one-half hour will be made for the service pursuant to each request or certificate issued. If an applicant requests that certification service be performed on a holiday, Saturday, or Sunday or in excess of each 8-hour shift Monday through Friday, the applicant would be charged such service at a rate of 11/2 times the rate which would be applicable for such service if performed during normal working hours.
AMS estimates that the time required to review and accept an initial submission for simple designs would be 1 hour. For complex designs, AMS estimates that the time required to review and accept an initial submission would be 8 hours. Based on the proposed AMS base hourly fee for service of $56 per hour, an initial submission of assembly type drawings and corresponding parts and material lists should range from $56 to $448. However, the final cost for equipment or utensil inspection and certification would be contingent on a final on-site review of the equipment or utensil at the point of fabrication or under conditions of actual use. The cost of this on-site review would include associated travel and per diem costs in addition to the hourly fee for service. AMS estimates the average time to perform a on-site review for a piece of equipment or utensil to be 12 hours.
As stated in the previous section pertaining to the comments received in response to the proposed rule and the Agency's responses to them, the Act provides that USDA develop a voluntary, user-fee-funded program to inspect and certify equipment used to process livestock and poultry products. Accordingly, the Agency examined alternatives in developing such a program, including an alternative that would have allowed AMS to accredit third-party certifiers to act as agents of AMS, as well as the alternative to allow equipment and utensil manufacturers to self certify their equipment to AMS standards.
AMS considered these alternatives as it evaluated comments received in response to the ANPRM and the proposed rule as the alternatives were considered. The alternative options were rejected by AMS. The statutory language provides that the Secretary inspect and certify agricultural processing equipment. Further, a significant number of comments during the comment periods for the ANPRM and proposed rule which supported an AMS provided service staffed by Federal employees to conduct the evaluations.
In assessing alternatives to the scheme provided for in these regulations, we believe that the provisions contained herein will best accomplish the purpose of the program and at the same time minimize any burden that might be placed upon affected parties.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform and is not intended to have a retroactive effect. This rule would not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. Further, section 729 of the Start Printed Page 1197Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001, (Pub. L. 106-387) states that the provision does not affect the authority of the Secretary to carry out the Federal Meat Inspection Act (21 U.S.C. 601 et seq.); the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.). There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this final rule.
The proposed rule (65 FR 35857) contained paperwork submission requirements that were subject to public comment and to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. Chapter 35). In accordance with 5 CFR Part 1320, we included the description of the reporting requirements and an estimate of the annual burden on manufacturers of equipment and utensils used to process livestock and poultry products. As identified in § 54.1004 of these final regulations, the Certification of Sanitary Design and Fabrication of Equipment Used in the Slaughter, Processing, and Packaging of Livestock and Poultry Products service would be administered by AMS. During the administration of the service, AMS will expand the use of existing forms currently used by AMS and approved by OMB under 7 CFR part 58, subpart A, Regulations Governing the Inspection and Grading of Manufactured or Processed Dairy Products. The Agency published a Federal Register Notice 65 FR 2370, dated January 14, 2000, that expanded the use of these forms and allowed for a 60-day comment period. Additionally, the proposed rule for this action published in the Federal Register, 65 FR 35857, dated June 6, 2000, solicited comments from all interested parties concerning the information collection requirements contained in this proposed rule. Comments were specifically invited on the following: (1) The accuracy of the agency's burden estimate of the proposed collection of information including the validity of the methodology and assumptions used; (2) ways to minimize the burden of the collection of information on those who would respond, including through the use of appropriate electronic collection methods; (3) whether the proposed collection of information is sufficient or necessary for the proper performance of the functions of the agency to perform this program; and (4) ways to enhance the quality, utility, and clarity of the information to be collected.
Of the one hundred comments received for the proposed rule only one comment referenced the Paperwork Reduction Act requirements. This one commenter stated AMS substantially underestimated the number of applications per respondent. The commenter based the comment on the history of their company's applications under the former FSIS prior approval program. The AMS published estimates are based on the expected average number of respondents. Any one applicant may exceed the number of applications submitted based on their voluntary participation in the service provided. However, AMS believes that the published average number of applications is accurate for the program and has not revised its estimates.
Abstract: The dairy grading program is a voluntary, user-fee-funded program. In order for a voluntary inspection program to perform satisfactorily with a minimum of confusion, there must be written requirements and rules for both Government and industry. The information collections are essential to carry out and administer the inspection and grading program. The information requested is used to identify the product offered for grading, to identify a request from an equipment manufacturer of equipment used in the dairy, meat or poultry industries for evaluation for sanitary design and construction, to identify and contact the party responsible for payment of the inspection, grading or equipment evaluation fee and expense, to identify applicants who wish to be authorized for the display of official identification on product packaging materials, equipment, utensils, or on descriptive or promotional materials.
For the purposes of the burden estimate, AMS estimated that the hourly wage for those submitting information would be $20 per hour. To have equipment and utensils accepted under this program, equipment and utensil manufacturers would submit an application to AMS requesting evaluation of equipment or utensils (Form DA-162). AMS estimates that of the 2000 livestock and poultry equipment and utensil manufacturers, AMS will receive approximately 2500 applications per year or, on average, 1.25 applications from each manufacturer. Form DA-162 requires 0.038 hours to complete. The total annual burden on the industry for this proposed collection of information would be 95 hours or $1,900 annually. Since AMS does not require the drawings, blueprints and a material list to be submitted, they have not been included in this burden estimate.
Manufacturers whose equipment or utensil receives AMS acceptance may, upon request, be issued an official certificate as proof that the equipment or utensil meets NSF/3-A standards and is therefore accepted. Since completion of this certificate is performed by AMS, it has also not been included in this burden estimate. Upon written application (Form DA-155 and Form DA-156), manufacturers of accepted equipment or utensils may receive permission to display the official mark of acceptance on equipment and utensils, or in promotional literature as illustrated in the regulatory text (Figure 1). Form DA-155 is a one-time application from each manufacturer and, therefore, has been estimated to only be sent by a respondent once in every four-year cycle of equipment and utensil approval. The estimate of the total annual burden of this collection of information is 10.5 hours or $210 annually. Form DA-156 is submitted by a manufacturer each time there is a request to use the symbol on a piece of equipment or utensil, or in promotional literature. AMS estimates that it would receive one request each year to use the symbol on equipment or utensils, or in promotional material for each piece of equipment or utensil accepted. Therefore, AMS estimates that the total annual burden for this collection of information would be 42.5 hours or $850 annually.
Manufacturers whose equipment or utensil does not meet the design and fabrication requirements of the NSF/3-A standards and does not receive acceptance by AMS may appeal AMS' determination. The manufacturers would make a request for appeal service with the Chief, Dairy Grading Branch by completing and submitting a request for service (Form DA-162) to have Start Printed Page 1198equipment or utensils reevaluated. The appeal process is set forth in sections § 54.1020 through § 54.1027 of the proposed regulations. As the AMS Dairy Program has never received an appeal for service under its current equipment acceptance program, AMS has estimated that 1% of applicants will appeal service in this estimate of the burden of the collection of information. Accordingly, with 2500 applications per year and Form DA-162 requiring 0.038 hours to complete and an estimate of only 1 percent of applicants requiring an appeal, the total annual burden on the industry for this proposed collection of information would be 0.95 hours or $19 annually.
Collectively, AMS estimated that the total annual burden for the collection of information would be 200.95 hours or $4019 annually.
It is found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register (5 U.S.C. 553) because this (1) is a voluntary, user-fee-funded program; (2) equipment manufacturers are aware of the provisions of this rule, which a 60-day comment period was provided for in the proposed rule; and (3) have already begun to request this service.
Authority: 7 U.S.C. 1621-1627; Pub. L. 106-387, sec. 729.
2. In Part 54 a new Subpart C consisting of §§ 54.1001 through 54.1034 is added to read as follows.
54.1001 54.1002 54.1003 54.1004 54.1005 54.1006 54.1007 54.1008 54.1009 54.1010 54.1011 54.1012 54.1013 54.1014 54.1015 54.1016 54.1017 54.1018 54.1019 54.1020 54.1021 54.1022 54.1023 54.1024 54.1025 54.1026 54.1027 54.1028 54.1029 54.1030 54.1031 54.1032 54.1033 54.1034
Designation of official certificates, memoranda, marks, and other identifications, for purposes of the Agricultural Marketing Act.
(c) “Official mark” or “other official identification” means any form of mark or other identification, including those prescribed in § 54.1018; used under the regulations in marking any equipment or utensils or displayed as an indication that the equipment or utensils has been evaluated by AMS (including the compliance of the equipment or utensils with applicable standards).
(b) Copies of standards developed by NSF/3-A that AMS will inspect and certify to are available, for a nominal fee, from NSF International at www.nsf.org or contact Techstreet, 310 Miller Avenue, Ann Arbor, MI 48103; Phone (800) 699-9277. Copies of all other instructions and guidelines can be obtained from, and copies of standards developed by NSF/3-A may be inspected at, the U.S. Department of Agriculture, Agricultural Marketing Service, Dairy Programs, Dairy Grading Branch; Room 2746-S; 1400 Start Printed Page 1200Independence Ave., SW., Washington, DC 20250-6456.
Service under the regulations shall be furnished to applicants, insofar as practicable and subject to the availability of a qualified design review specialist, in the order in which requests therefor are received, insofar as consistent with good management, efficiency and economy. Precedence will be given, when necessary, to requests made by any government agency and to requests for appeal service under § 54.1021.
An application or a request for service under the regulations may be withdrawn by the applicant at any time before the application is approved or prior to performance of service. The applicant shall be responsible for payment, in accordance with § 54.1028 and § 54.1029, of any expenses already incurred by the Agricultural Marketing Service in connection therewith.
(2) The application or request relates to equipment or utensils which are not eligible for service under § 54.1006;
(a) Report. The design review specialist shall prepare, sign, and issue Start Printed Page 1201a narrative report covering the observations, comments and recommendations based on the evaluation for conformance with standards of equipment and utensils as provided for in § 54.1005 and indicate the fees and other charges incurred for the services rendered.
(c) Distribution. The original report and official certificate (if requested) shall be delivered or mailed to the applicant or other persons designated by the applicant. Other copies shall be forwarded as required by agency, program, and branch instructions. Additional copies will be furnished to any person financially interested in the equipment or utensil involved with the concurrence of the applicant and upon payment of fees, as provided in § 54.1028 and § 54.1029.
(c) The official identification symbol is recommended to be at least 3/4 inch by 3/4 inch in size. Symbols which are smaller in size will be considered provided they are sufficiently large to be identifiable and legible.
(a) Except as otherwise provided in § 54.1020, an applicant or their representative may request appeal service when the applicant or their representative disagree with the determination as to compliance with the standard of the piece of equipment, portion of a piece of equipment, or utensil as documented in the applicable report.
A request for appeal service may be rejected or such service may be otherwise denied to or withdrawn from any person in accordance with the procedure set forth in § 54.1013(a), if it appears that the person or product involved is not eligible for appeal service under § 54.1020, or that the identity of the piece of equipment, portion of a piece of equipment, or utensil has been lost; or for any of the causes set forth in § 54.1032.
Fees and other charges equal as nearly as may be to the cost of the services rendered shall be assessed and collected from applicants in accordance with the provisions for Fees and Charges set forth in 7 CFR part 58, Subpart A, Regulations Governing the Inspection and Grading Services of Manufactured or Processed Dairy Products, sections §§ 58.38, 58.39, 58.41, 58.42, and 58.43, as appropriate.
When a design review specialist, supervisor, or other responsible employee of the Branch has evidence of inaccurate evaluation, or of incorrect certification or other incorrect determination or identification as to the compliance of a piece of equipment or utensil, such person shall report the matter to the Chief. The Chief will investigate the matter and, if deemed advisable, will report any material errors to the owner or the owner's agent. The Chief shall take appropriate action Start Printed Page 1204to correct errors found in the determination of compliance of equipment or utensils, and the Chief shall take adequate measures to prevent the recurrence of such errors.
(a) (1) Bases for denial or withdrawal. An application or a request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, any person who, or whose employee or agent in the scope of the person's employment or agency:
[FR Doc. 01-95 Filed 1-4-01; 8:45 am]