[Federal Register: October 20, 1999 (Volume 64, Number 202)]

[Rules and Regulations]               

[Page 56400-56418]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr20oc99-3]                         



-----------------------------------------------------------------------



DEPARTMENT OF AGRICULTURE



Food Safety and Inspection Service



9 CFR Parts 303, 304, 307, 308, 312, 314, 327, 331, 350, 381, and 

416



[Docket No. 96-037F]



 

Sanitation Requirements for Official Meat and Poultry 

Establishments



AGENCY: Food Safety and Inspection Service, USDA.



ACTION: Final rule.



-----------------------------------------------------------------------



SUMMARY: The Food Safety and Inspection Service (FSIS) is revising its 

regulatory requirements concerning sanitation in official meat and 

poultry establishments. Specifically, FSIS is consolidating the 

sanitation regulations into a single part applicable to both official 

meat and poultry establishments, eliminating unnecessary differences 

between the sanitation requirements for meat and poultry processing, 

and converting many of the highly prescriptive sanitation requirements 

to performance standards.



EFFECTIVE DATES: January 25, 2000.



FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director, 

Regulation Development and Analysis Division, Office of Policy, Program 

Development, and Evaluation, Food Safety and Inspection Service, U.S. 

Department of Agriculture (202) 720-5627.



SUPPLEMENTARY INFORMATION:



Background



    As a result of a recent, comprehensive review of its regulatory 

procedures and



[[Page 56401]]



requirements, FSIS identified the need to revise its sanitation 

requirements for official meat and poultry establishments. The Agency's 

tentative view was that a number of the sanitation requirements were 

difficult to understand, redundant, or outdated. Also, the Agency found 

that there were unnecessary differences between the sanitation 

regulations for official meat and poultry establishments. Finally, the 

Agency could not justify the retention of the sanitation regulations 

that were inconsistent with the Agency's recently finalized Hazard 

Analysis and Critical Control Point (HACCP) and Sanitation Standard 

Operating Procedure (Sanitation SOP) regulations. These sanitation 

requirements were unnecessarily prescriptive, impeded innovation, and 

blurred the distinction between establishment and inspection program 

employee responsibilities for maintaining sanitary conditions.

    Therefore, on August 25, 1997, FSIS published in the Federal 

Register a proposal to revise its sanitation requirements for official 

meat and poultry establishments (62 FR 45045). FSIS proposed to 

consolidate the sanitation regulations into a single part applicable to 

both official meat and poultry establishments, eliminate unnecessary 

differences between the meat and poultry sanitation requirements, and 

convert many of the highly prescriptive sanitation requirements into 

performance standards. FSIS initially solicited comment on the proposal 

for a 60-day period ending October 24, 1997.

    Shortly after the comment period for that proposal opened, FSIS 

mistakenly released information that mischaracterized the provisions of 

the proposal concerning the use of nonfood compounds and proprietary 

substances. In order to alleviate any confusion regarding the 

sanitation proposal and to clarify FSIS policy in regard to nonfood 

compounds and proprietary substances, FSIS published a retraction of 

the erroneous information in the Federal Register (FSIS Docket No. 97-

062N; 62 FR 55996). Further, in order to ensure that the public had 

ample opportunity to submit meaningful comments on the sanitation 

proposal and its provisions concerning nonfood compounds and 

proprietary substances, FSIS reopened the comment period for that 

proposal for 15 days, from October 28, 1997, to November 10, 1997 (FSIS 

Docket 96-037R; 62 FR 55997).

    By the close of the second comment period, FSIS had received 51 

comments from meat and poultry establishments, trade and professional 

associations, academia, consumer advocacy groups, State governments, 

and FSIS inspection program employees. Two of these comments included 

requests for a 90-day extension of the original comment period. FSIS 

believed the original 60-day comment period was sufficient and did not 

extend it, except for the 15-day period discussed above.

    About two-thirds of the commenters opposed the proposal in general. 

Many of these commenters characterized the proposal as ``deregulation'' 

that would weaken inspection program employee authority and reduce the 

consumer food safety protections in the existing prescriptive 

regulations. Most of these commenters argued that there should be no, 

or only minimal, change to the existing sanitation regulations.

    The other third of the commenters generally supported the proposal 

to revise the sanitation requirements for official meat and poultry 

establishments. These commenters commended FSIS efforts to streamline 

and consolidate the sanitation requirements, to make the requirements 

consistent with the HACCP and Sanitation SOP regulations, and to grant 

establishments greater flexibility to innovate. Many of these 

commenters, however, did raise objections to and recommend revisions 

for specific provisions in the proposed rule.

    FSIS responses to all of the relevant comments follow.



General Opposition



    Comment: Many of the commenters opposed to the proposal 

characterized the performance standards as ``deregulation'' that would 

weaken FSIS enforcement authority and endanger consumers. Some of these 

commenters maintained that the proposed performance standards are too 

general to be enforceable, as they would allow for multiple 

interpretations of the sanitation standards. Several commenters also 

argued that by replacing with performance standards the existing 

sanitation requirements that contain prohibitions against specific 

activities, such as the prohibition in Sec. 308.8(e) against ``placing 

skewers, tags, or knives in the mouth,'' FSIS would be impairing 

inspection program employees' ability to take action as necessary to 

prevent product adulteration.

    Response: The sanitation performance standards are ``deregulatory'' 

in the sense that they remove obstacles to innovation previously caused 

by overly prescriptive, and in some cases obsolete, sanitation 

regulations. For establishments to fully and successfully meet the 

HACCP and Sanitation SOP requirements, they must be able to innovate, 

or at least customize their operating procedures, to control food 

safety hazards and ensure that product does not become adulterated 

within their unique processing environments. The sanitation performance 

standards established in this rule not only will provide meat and 

poultry establishments with the flexibility to innovate in facility 

design, construction, and operations, but also will articulate the 

standards for good sanitation and for food product safety that must be 

met by establishments.

    The sanitation performance standards are not subject to multiple 

interpretations. Regardless of the area or activity any individual 

performance standard governs, all of the sanitation standards have the 

same intent: An official meat or poultry establishment must operate 

under sanitary conditions, in a manner that ensures that product is not 

adulterated and that does not interfere with FSIS inspection and its 

enforcement of such standards. However, because the sanitation 

performance standards define the results to be achieved by sanitation, 

but not the specific means to achieve those results, the sanitation 

performance standards can be met by establishments in different ways. 

Regardless of the means by which establishments comply with the 

standards, the required results will be the same for all 

establishments.

    The sanitation performance standards do not lessen the authority of 

FSIS inspection program employees nor in any way weaken the statutory 

and regulatory requirements that official meat and poultry 

establishments maintain sanitary conditions and ensure that product is 

not adulterated. Section 8 of the Federal Meat Inspection Act (FMIA) 

states that the ``Secretary shall cause to be made by experts in 

sanitation or other competent inspectors, such inspection * * * as may 

be necessary to inform himself of the sanitary conditions* * * of * * 

*establishments.'' It also provides that ``where the sanitary 

conditions of any such establishment are such that the meat or meat 

food products are rendered adulterated, (the Secretary of Agriculture) 

shall refuse to allow said meat or meat food products to be labeled, 

marked, stamped, or tagged as `inspected and passed.' '' Likewise 

section 7 of the Poultry Products Inspection Act (PPIA) requires that 

every official poultry establishment subject to inspection be operated 

according to sanitary practices ``required by regulations promulgated 

by the Secretary (of Agriculture) for the purpose of preventing the 

entry into * * * commerce * * * of poultry



[[Page 56402]]



products which are adulterated'' and directs the Secretary of 

Agriculture to refuse inspection ``to any establishment whose premises, 

facilities, or equipment, or the operation thereof, fail to meet the 

(sanitation) requirements of this section.''

    FSIS does not need to specifically prohibit every action that could 

possibly lead to product adulteration or insanitary conditions. It 

would, in fact, be impossible to compile such a list of prohibited 

practices. FSIS inspection program employees currently have the 

authority to withhold the mark of inspection if an establishment fails 

to ensure that product is not adulterated or fails to maintain sanitary 

conditions, even if the failure in question is not specifically 

prohibited in the regulations. This authority remains unchanged under 

the new performance standards. For example, were an establishment 

employee to place a knife used on inspected product in his mouth, that 

action would be a violation of Sec. 416.5(a), ``All persons working in 

contact with product, food-contact surfaces, and product-packaging 

materials must adhere to hygienic practices while on duty to prevent 

adulteration of product.''

    Comment: Several commenters objected to the proposed rescission of 

the regulations requiring that various systems (such as plumbing and 

sewage systems) and activities (such as the use of sanitizers, 

pesticides, and other chemicals) be prior-approved by circuit 

supervisors or other FSIS program employees. These commenters claimed 

that many serious sanitation problems can be prevented only through 

prior-approval of such systems and activities by experienced FSIS 

program employees. Further, these commenters maintained that without 

prior approval, establishments will negligently use pesticides and 

other chemicals, adulterating product.

    Response: FSIS disagrees. In regard to the prior approval of 

establishment plumbing, sewage, and other systems, FSIS has made the 

determination that it should afford establishments the flexibility to 

determine what is appropriate and sufficient for maintaining sanitary 

conditions and preventing the adulteration of product. FSIS will verify 

that these systems meet the sanitation performance standards through 

inspection. FSIS already has rescinded the requirements for prior 

approval of establishment drawings, specifications, and equipment used 

in official establishments (62 FR 45015; August 25, 1997).

    In regard to the use of pesticides, sanitizers, and other 

chemicals, FSIS has determined that it is the establishment's 

responsibility to ensure that the chemicals it uses are safe and 

appropriate for use in its particular meat or poultry processing 

environment. Establishments will be required to account for the safety 

and appropriate use of these chemicals in their written HACCP plans, 

Sanitation SOP's, or in other documentation. A full discussion of this 

issue can be found below under the section entitled ``Cleaning 

Compounds and Sanitizers.''

    Comment: Finally, two commenters argued that the proposed 

performance standards could have a deleterious impact on trade. One 

stated that European countries with more stringent sanitation 

requirements would ban imports of U.S. meat and poultry products if the 

proposed performance standards were made final.

    Response: FSIS disagrees. Many of the United States' major 

agricultural trading partners have already implemented or are currently 

developing meat and poultry inspection systems incorporating 

performance standards or food safety objectives, rather than 

prescriptive, ``command-and-control'' regulations. Further, because the 

sanitation performance standards do not lower the existing food safety 

standards for meat and poultry, but instead only allow for increased 

flexibility and innovation to meet the prescribed standards, other 

countries would not be justified in imposing any new restrictions in 

response. Thus, FSIS anticipates that these new regulations will have 

no adverse impact on trade.



General Sanitation: Proposed Sec. 416.1



    Comment: Several commenters questioned the proposed performance 

standard language in Sec. 416.1 and elsewhere requiring that 

establishments be operated in a sanitary manner sufficient to prevent 

product from being ``misbranded.'' These commenters argued that there 

could never be a situation where insanitation by itself could lead to 

misbranding and, therefore, that the requirement is unnecessary.

    Response: FSIS agrees that it would be highly unlikely for any meat 

or poultry product to be misbranded as a result of insanitation and has 

removed the references to misbranding from Secs. 416.1, 416.2(c), and 

416.3. Establishments should keep in mind, however, that the 

misbranding of meat or poultry products is prohibited by the FMIA, the 

PPIA, and the regulations promulgated under those Acts. FSIS will take 

action in accordance with its statutory authority and the regulations 

any time it determines that meat or poultry products have been 

misbranded.

    Comment: Similarly, several commenters questioned the proposed rule 

language requiring that establishments operate in a sanitary manner in 

order to prevent both ``adulteration'' and ``contamination.'' These 

commenters argued that ``contamination'' is a very broad term that can 

describe problems with product quality or composition, as well as those 

associated with product safety. They maintained that a requirement to 

prevent ``adulteration'' would be sufficient, as ``adulteration'' is 

defined by both the FMIA and the PPIA.

    Response: FSIS agrees that the term ``contamination'' may cause 

some confusion and has removed the references to ``contamination'' 

throughout the rule language. FSIS emphasizes, however, that 

establishments must maintain sanitary conditions within their 

processing facilities, as insanitary conditions do lead to the 

adulteration of product. While the references to ``contamination'' have 

been removed, FSIS has added to the regulations the requirement that 

processing activities and the use of chemicals and equipment must not 

create insanitary conditions.



Establishment Grounds and Pest Management: Proposed Sec. 416.2(a)



    Comment: Several commenters objected to the language of proposed 

Sec. 416.2(a) regarding establishment grounds: ``The grounds about an 

establishment must be maintained to prevent conditions that could lead 

to contamination or adulteration of product or that could prevent FSIS 

program employees from performing assigned tasks.'' The commenters 

contended that the phrase ``grounds about an establishment'' is 

inconsistent with recent FSIS policy that establishment management is 

responsible for defining the boundaries of their facilities. 

Specifically, commenters cite recent FSIS Directive 7640.1, 

``Inspection Duties Related to Facilities and Equipment, and Plant 

Operated Quality Control Programs,'' which states that inspection 

program employees are to request from establishment management written 

designation of the official premises' boundaries. Therefore, these 

commenters have suggested that ``grounds about an establishment'' be 

revised to read ``grounds as designated by the establishment.''

    Response: FSIS disagrees. The Agency sees no inconsistency between 

the directive and the performance standard as proposed. Proper 

maintenance of the



[[Page 56403]]



grounds about an establishment is essential for ensuring good 

sanitation. FSIS inspection program employees request written 

designation of establishment boundaries only to facilitate their 

inspection of the establishment. Establishments are responsible for 

preventing adulteration of product even if the sources are outside the 

designated boundaries of the establishment. Revising the performance 

standard to address only areas within the designated boundaries could 

mislead establishments into believing that they are not responsible for 

preventing such adulteration, especially when it originates from areas 

outside of the designated boundaries of the processing operations, but 

under the control of the establishment. Accordingly, FSIS is not making 

any changes to the rule language as proposed.

    Comment: FSIS proposed to require that establishments ``have in 

place an integrated pest management program to prevent the harborage 

and breeding of pests on the grounds and within establishment 

facilities.'' One commenter suggested that FSIS delete the word 

``integrated,'' arguing that it is confusing and unnecessary.

    Response: Integrated pest management (IPM) is a widely recognized 

system of agricultural pest control that takes into account pest 

ecology and the effect of pesticides and other pest control chemicals 

on the environment and on food. For the most part, IPM has been used 

within agricultural production systems. However, IPM also is applicable 

to meat and poultry processing.

    FSIS has rethought its tentative view that meat and poultry 

establishments should implement IPM systems. Although FSIS encourages 

establishments to develop or adopt IPM, FSIS has concluded that IPM is 

not absolutely necessary to ensure the production of unadulterated meat 

or poultry products. In this final rule, FSIS is requiring that any 

pest control system used by an establishment be designed and 

implemented so as to ensure that product is not adulterated either by 

pests or by the products designed to control them and, further, that 

the pest control system does not create insanitary conditions.

    Comment: The remaining comments on pest control addressed the 

proposal to eliminate the requirements that pesticides and rodenticides 

be approved by FSIS prior to their use in official establishments. 

Several commenters argued that without prior approval of pesticides and 

prescriptive requirements concerning their use, establishments will 

adulterate product or create insanitary conditions that could lead to 

adulteration.

    Response: FSIS' review and approval of pesticides and rodenticides 

prior to their intended use provided some assurance to meat and poultry 

processors that proper use of these compounds would not result in the 

adulteration or contamination of food products. However, FSIS has 

concluded after careful consideration of the issue that this prior 

approval program is unnecessary and inconsistent with HACCP. Under the 

HACCP regulations, establishments are responsible for developing and 

implementing HACCP plans incorporating the controls necessary and 

appropriate to produce safe meat and poultry products. Consequently, 

establishments are responsible for ensuring that the pesticides and 

rodenticides they use are safe and effective.

    Further, FSIS prior approval of pesticides and rodenticides has 

been somewhat redundant with the Environmental Protection Agency (EPA) 

requirements and review programs for these compounds. Under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA reviews 

pesticide formulation, intended use, and other information; registers 

all pesticides for use in the United States; and prescribes labeling, 

use, and other regulatory requirements to prevent unreasonable adverse 

effects on the environment, including humans, wildlife, plants, and 

property. Any meat or poultry establishment using a pesticide must 

follow the FIFRA requirements.

    FSIS is requiring that documentation substantiating the safety of 

pesticides and rodenticides be available to FSIS inspection program 

employees for review (Sec. 416.4(c)). The documentation will need to 

include proof of EPA registration and could also include other any 

information, such as letters of guaranty from the manufacturer, labels, 

application instructions, and records of use that establish the safe 

and effective use of these products. FSIS inspection program employees 

will review these records as necessary, as well as observe the 

application and storage of pesticides and rodenticides to ensure the 

maintenance of sanitary conditions and that product is not adulterated. 

(For further discussion of prior approval of pesticides and other 

chemicals, see the section ``Cleaning Compounds and Sanitizers'' 

below.)



Establishment Construction: Proposed Sec. 416.2(b)



    Comment: Several commenters objected to the language of the 

proposed provision: ``Establishment buildings, including their 

structures, rooms, and compartments must be of sound construction, kept 

in good repair, and be of sufficient size to allow for the sanitary 

processing, handling, and storage of product.'' Commenters argued that 

the requirement regarding ``sufficient size'' constitutes a new 

standard for sanitation. Commenters also argued that the phrase 

``sanitary processing, handling, and storage of product'' is too 

general; they suggested that the construction standard be based upon 

preventing adulteration of product.

    Response: FSIS disagrees that the requirement that rooms in an 

official establishment be of ``sufficient size'' constitutes a new 

standard. Although the previous regulations did not explicitly require 

rooms to be any particular size, the requirement that rooms be of 

sufficient size to prevent the adulteration of product was implicit. 

Moreover, this requirement is fully consistent with the FMIA and PPIA. 

An establishment would very likely be in violation of the statutory and 

regulatory prohibitions against product adulteration if its processing 

or storage rooms were so small that adequate separation of raw and 

ready-to-eat product were impossible. FSIS is merely making this 

requirement explicit in this performance standard.

    FSIS agrees that the proposed language regarding ``sanitary 

processing, handling, and storage of product'' should be revised to 

make clear the obligation specified in this regulation. For clarity and 

consistency with the other performance standards, FSIS is revising this 

performance standard to read: ``Establishment buildings, including 

their structures, rooms, and compartments must be of sound 

construction, be kept in good repair, and be of sufficient size to 

allow for processing, handling, and storage of product in a manner that 

does not result in product adulteration or the creation of insanitary 

conditions.''

    Comment: A few commenters stated that while large establishments 

might be able to innovate effectively under the proposed performance 

standards for construction, many small establishments lack the 

expertise to innovate in facility construction and design and need to 

follow specific requirements in order to maintain sanitary operations 

that produce safe meat and poultry products.

    Response: FSIS disagrees. The design or alteration of facility 

construction or layout is well within the capability of most, if not 

all, meat and poultry establishments, regardless of size.



[[Page 56404]]



Moreover, in this rule, FSIS is not requiring establishments to 

innovate in regard to facility construction or layout. Establishments 

currently maintaining sanitary conditions will not need to make any 

changes to their construction or layout as a result of this performance 

standard. Further, FSIS is making available a compliance guide for the 

sanitation performance standards, including the standards for 

construction. Establishments remodeling or undertaking new construction 

may consult this guide or the various national building and 

construction codes, State and local laws and codes, and other relevant 

resources available from trade associations, consultants, and nonprofit 

organizations.

    Comment: One commenter questioned FSIS' recommendation that 

establishments consult the Food Code, as well as national building and 

construction codes, when designing or building facilities. The 

commenter maintained that because these documents have no force of law, 

establishments do not have to follow their guidance, and further, that 

these documents are not always applicable to the unique requirements of 

meat and poultry processing establishments. This commenter concluded 

that specific design and construction requirements are necessary to 

ensure that meat and poultry establishments are built properly.

    Response: FSIS does not agree that specific requirements for 

establishment design and construction are necessary to ensure that meat 

and poultry are not adulterated. FSIS is adopting performance standards 

for construction that provide establishments, regardless of size, the 

flexibility to design facilities and equipment in the manner they deem 

best to maintain the required sanitary environment for food production. 

Further, as stated above, if establishments are maintaining sanitary 

conditions, there is no reason to believe that they will not be in 

compliance with the new performance standards for design and 

construction, as long as their facilities are maintained in good 

repair. Also, as stated above, they may follow the recommendations in 

the Food Code or the national building and construction codes, many of 

which have been adopted as requirements by State and local governments. 

If establishments do so, they should be in compliance with the 

standards.

    Comment: One commenter requested that FSIS delete the examples of 

vermin given in proposed Sec. 416.2(b)(3): ``Walls, floors, ceilings, 

doors, windows, and other outside openings must be constructed and 

maintained to prevent the entrance of vermin, such as flies, rats, and 

mice.'' The commenter argued that these examples are unnecessary.

    Response: These examples are illustrative of the types of vermin 

known to commonly infest meat and poultry establishments and, 

therefore, FSIS is retaining them in the regulations.

    Comment: Finally, although no commenter specifically addressed the 

proposed standard concerning the separation of edible and inedible 

product, FSIS believes that the proposed standard could be 

misunderstood and is making a revision to clarify its intent. FSIS 

proposed to require that ``Rooms or compartments in which edible 

product is processed, handled, or stored must be separate and distinct 

from rooms or compartments in which inedible product is processed, 

handled, or stored.'' FSIS did not intend to imply that rooms where 

edible product is processed, handled, or stored could never be used for 

the processing, handling or storage of inedible product. FSIS has 

allowed, and will continue to allow, establishments to process, handle, 

or store edible and inedible product in the same room as long as they 

are separated by time or space, in a manner sufficient to prevent the 

adulteration of the edible product or the creation of insanitary 

conditions.

    Response: FSIS is adopting a revised standard that states: ``Rooms 

or compartments in which edible product is processed, handled, or 

stored must be separate and distinct from rooms or compartments in 

which inedible product is processed, handled, or stored, to the extent 

necessary to prevent product adulteration and the creation of 

insanitary conditions.''



Light: Proposed Sec. 416.2(c)



    Comment: A few commenters opposed the proposed performance standard 

that establishments provide ``Lighting of good quality and sufficient 

intensity to ensure that sanitary conditions are maintained and that 

product is not adulterated *  *  *'' These commenters maintained that 

by allowing establishments to determine whether light quality and 

intensity is sufficient, FSIS, in fact, would be allowing 

establishments to provide lighting that is not sufficient to ensure 

sanitation. One commenter doubted that establishments would follow the 

recommendations for lighting contained in the Food Code, as suggested 

by FSIS. Another commenter recommended that FSIS maintain the existing 

30-foot candle requirement for light intensity at poultry working 

surfaces and extend the same requirement to meat establishments.

    Response: FSIS disagrees. FSIS does not believe it is necessary to 

prescribe specific light intensities to ensure sanitation in meat and 

poultry processing areas because establishments must determine what 

light intensities are appropriate to ensure sanitation in different 

operational contexts. Importantly, however, as with all of the 

sanitation performance standards, FSIS will continue to verify through 

inspection that the lighting meets the performance standard.

    The previous requirements for lighting in poultry establishments in 

Sec. 381.52 prescribed specific light intensities for different areas 

of the establishment. For example, FSIS required that all rooms in 

which poultry was killed, eviscerated, or otherwise processed have 30-

foot candles of light intensity on all working surfaces. The comparable 

regulations for red meat establishments in Sec. 308.3(b) did not 

contain such specific requirements, but required only that meat 

establishments have ``abundant light, of good quality and well 

distributed.'' However, the intent of these requirements was the same 

for both meat and poultry establishments: there must be enough light of 

adequate quality to monitor sanitary conditions and processing 

operations and to examine product for evidence of adulteration. New 

Sec. 416.2(c) establishes this intent as a single performance standard 

applicable to both meat and poultry establishments, which is wholly 

consistent with the purpose of the current regulations.

    It also is important to note that FSIS is not rescinding the 

specific light intensity requirements for inspection program employee 

and reprocessing stations set out in Secs. 307.2 and 381.36. FSIS has 

determined that these specific requirements are still necessary to 

ensure appropriate conditions for effective inspection.



Ventilation: Proposed Sec. 416.2(d)



    Comment: FSIS proposed that meat and poultry establishments provide 

``ventilation adequate to eliminate odors, vapors, and condensation.'' 

Several commenters maintained that it would be impossible for 

establishments to ``eliminate'' odors, vapors, and condensation. They 

suggested that the standard be revised to require that ventilation be 

adequate to control odors, vapors, and condensation to the extent 

necessary to prevent the adulteration of product.

    Response: FSIS agrees and has revised the standard to require that 

ventilation be adequate to control odors, vapors,



[[Page 56405]]



and condensation to the extent necessary to prevent adulteration of 

product and to prevent the creation of insanitary conditions which can 

lead to product adulteration.



Plumbing and Sewage Disposal: Proposed Secs. 416.2(e) and (f)



    Comment: In the preamble to the proposed rule, FSIS recommended 

that establishments consult the National Plumbing code when designing 

or building a plumbing system and stated that ``a plumbing system in 

compliance with the National Plumbing Code in most instances would meet 

the proposed performance standards for plumbing.'' One commenter 

supported the use of the National Plumbing Code by establishments but 

questioned whether there were certain provisions in the Code that FSIS 

has determined would be inadequate to meet the performance standard.

    Response: FSIS has not determined that any of the provisions of the 

National Plumbing Code are inappropriate or inadequate as models for 

plumbing systems in meat and poultry establishments. However, 

compliance with the National Plumbing Code or any other code does not 

necessarily establish compliance with FSIS regulations. For instance, 

it could be possible to build a plumbing system that meets the 

standards of the National Plumbing Code but also creates insanitary 

conditions that could cause the adulteration of product. FSIS continues 

to recommend that meat and poultry establishments consult the National 

Plumbing Code when designing or building a plumbing system, but also 

encourages establishments to keep in mind the relevant requirements of 

FSIS, other Federal Agencies, and State and local governments.

    Comment: A few commenters opposed the removal of requirements that 

features of plumbing and sewage systems, such as traps and vents, be 

prior-approved by FSIS program employees for safety and efficacy.

    Response: As the Agency has stated throughout this document, FSIS 

fundamentally disagrees with those commenters who oppose the 

elimination of prior approval requirements. It is the responsibility of 

the establishment to ensure that plumbing and sewage systems provide an 

adequate supply of potable water for processing and other purposes and 

move waste and sewage from the establishment without adulterating 

product or creating insanitary conditions. There are many ways to 

achieve these goals that are consistent with FSIS regulations, State 

and local laws, and the Food Code. Required prior approval of these 

systems undercuts this objective and would deprive establishments of 

the flexibility to innovate and create sound, effective plumbing and 

sewage systems that ensure sanitary operating conditions. FSIS will 

continue to verify, through inspection, that plumbing and sewage 

systems neither adulterate product nor create insanitary conditions.



Water Supply and Reuse: Proposed Sec. 416.2(g)



    Comment: One commenter believed that FSIS suggested in the preamble 

to the proposal that compliance with the EPA standard for water 

potability might not be sufficient to ensure that water used by meat 

and poultry establishments is potable.

    Response: FSIS proposed a water supply performance standard 

intended to make transparent the current requirement that potable water 

comply with EPA's National Primary Drinking Water regulations. These 

regulations are promulgated under section 1412 of the Public Health 

Service Act, as amended by the Safe Drinking Water Act, and are 

applicable to public water systems. The EPA standard of water 

potability is sufficient and FSIS is adopting the performance standard 

as proposed.

    Comment: Another commenter questioned the proposed requirement that 

establishments make available to FSIS any water reports ``issued under 

the authority of the State health agency, certifying or attesting to 

the quality of the water supply.'' The commenter argued that this 

requirement would be ineffective as an indicator of water potability 

unless FSIS specified the frequency at which an establishment must have 

its water supply tested.

    Response: The EPA National Primary Drinking Water regulations, 

contained in 40 CFR part 141, require testing of drinking water for 

fecal coliforms and other contaminants at specified frequencies. 

Because FSIS is requiring that water used by meat and poultry 

establishments meet the EPA requirements, which include testing 

requirements, FSIS does not need to promulgate separate testing 

requirements. Certifications of water potability provided by State or 

local governments or other responsible entities will show whether water 

meets the EPA requirements.

    Some meat and poultry establishments use private wells for their 

water supply. EPA classifies private wells as ``noncommunity'' water 

sources and does not require testing for potability. It also is 

unlikely that State or local governments would test such wells for 

potability. If an establishment uses a private well, FSIS is requiring 

that the establishment make available to FSIS documentation, renewed at 

least semi-annually, certifying the potability of its private well 

water. Most establishments will obtain this documentation from private 

laboratories.

    FSIS is finalizing this requirement concerning the potability of 

well water in response to the above comment. Although the Agency did 

not specifically propose this approach, it is consistent with the 

proposal, which focused on how to ensure the potability of water used 

in all establishments. Moreover, it is not a new requirement. It is the 

codification of a policy that FSIS has been enforcing under FSIS 

Directive 11,000.1, the ``Sanitation Handbook for Meat and Poultry 

Inspection.'' This Directive was rescinded by FSIS Notice 3-98 on 

January 16, 1998. Another FSIS document concerning this policy, 

entitled ``Approved Water Systems,'' will be rescinded upon the 

effective date of this rule.

    Comment: Several commenters objected to the proposed performance 

standards for water reuse because, they argued, the proposed standards 

would allow establishments to wash raw product, equipment, and utensils 

with non-potable water, and the possibility of product adulteration 

would therefore be greatly increased. One commenter suggested that FSIS 

require water to be ``heat pasteurized'' before reuse on raw or ready-

to-eat product.

    Response: In many circumstances, establishments can reuse water in 

a manner that will neither adulterate product nor create insanitary 

conditions. FSIS already permits certain uses of nonpotable water. For 

example, water is recirculated in tanks to chill raw poultry; water 

treated by an advanced wastewater treatment system can be used to wash 

equipment or raw product, if followed by a potable water rinse; and 

nonpotable, reuse water can be used to wash floors or equipment in 

areas where edible product is not handled. FSIS is making final 

performance standards that will provide for the reuse of water in 

numerous processing contexts, provided that the establishment takes 

actions necessary to ensure that product is not adulterated by the 

water and that sanitation is not compromised. Establishments are 

required to document and monitor water reuse activities either in their 

Sanitation SOP's or HACCP plans.

    Comment: One commenter expressed concern about the proposed 

requirement



[[Page 56406]]



that water used or reused to chill or cook ready-to-eat product be free 

of pathogens. This commenter and others stated that the stated goal of 

the performance standards for water, processing solution, and ice reuse 

should be to prevent meat and poultry products from becoming 

adulterated by pathogens, rather than preventing water, ice, or 

solutions from being contaminated with pathogens, fecal coliforms, and 

other hazardous substances. These commenters maintained that 

establishments will control pathogens in the processing environment, in 

this case water, through HACCP and Sanitation SOP's and recommended 

that the performance standards for water, ice, and solutions reuse be 

revised accordingly.

    Response: FSIS does not agree with the commenters' suggestion. In 

many cases, the presence of fecal coliforms, pathogens, or other 

contaminants in reuse water, ice, or processing solutions indicates 

insanitation that may, in fact, lead to the adulteration of meat and 

poultry products. The control of pathogens in water used in processing, 

therefore, is essential for ensuring that meat and poultry products do 

not become adulterated. The performance standards establish the 

necessary conditions to ensure that water, ice, and solution reuse do 

not compromise sanitation or cause the adulteration of product. 

Establishment Sanitation SOP's and HACCP plans must provide for 

compliance with these sanitation standards.



Ice and Solution Reuse: Proposed Sec. 416.2(h)



    Comment: Several commenters maintained that the hazards inherent in 

ice and solution reuse were identical to those in water reuse and 

suggested, therefore, that the performance standards be combined for 

consistency.

    Response: FSIS agrees and has made final a single set of reuse 

performance standards applicable to water, ice, and solutions. However, 

because of the different physical characteristics and uses of water, 

ice, and solutions, it is expected that establishments will meet the 

performance standards for these substances in different ways. For 

example, an establishment recirculating water in a chill tank for raw 

poultry might add chlorine to the water to reduce the number of 

pathogens. An establishment reusing ice to chill raw poultry might bag 

the ice to prevent it from contacting product.



Dressing Rooms, Lavatories, and Toilets: Proposed Sec. 416.2(i)



    Comment: Numerous commenters opposed the proposed performance 

standard concerning the number of lavatories and toilet facilities in 

official establishments:



    Dressing rooms, toilet rooms, and urinals must be sufficient in 

number, ample in size, conveniently located, and maintained in a 

sanitary condition and in good repair at all times to ensure 

cleanliness of all persons handling any product. They must be 

separate from the rooms and compartments in which products are 

processed, stored, or handled. Where both sexes are employed, 

separate facilities must be provided.



These commenters claimed that many establishments have crowded, 

insanitary conditions now, and, if given this performance standard 

instead of a more prescriptive requirement, establishments would not 

provide a sufficient number of lavatories and toilet facilities. One 

commenter, however, argued that the standard is, in fact, too 

prescriptive in that it requires separate facilities for both sexes. 

This commenter stated that Federal, State, and local labor laws already 

provide for this.

    Response: As the Agency has stated throughout this document, it is 

prudent and reasonable to replace prescriptive sanitation requirements 

with performance standards that articulate the objectives or results 

that establishments must achieve. Thus, FSIS is replacing the 

prescriptive requirements concerning establishment lavatories, toilet 

facilities, and their sanitation with a performance standard. 

Furthermore, other Federal law already does govern lavatories and 

toilet facilities in places of employment.

    The Occupational Safety and Health Administration (OSHA) of the 

Department of Labor has promulgated regulations concerning toilet 

facilities in the workplace in 29 CFR 1910.141, ``Sanitation.'' 

Paragraph (c)(1)(i) of this regulation sets forth requirements for the 

number of toilet facilities in all permanent places of employment. 

Official meat and poultry establishments are governed by these 

requirements. Thus, FSIS has determined that it is not necessary to add 

a more specific provision regarding the number of toilets to the 

performance standard it proposed.

    In regard to the issue of requiring separate toilet facilities for 

men and women, OSHA also has set forth requirements, again in 29 CFR 

1910.141(c)(1)(i): ``toilet facilities, in toilet rooms separate for 

each sex, shall be provided in all places of employment,'' and, 

further, ``Where toilet rooms will be occupied by no more than one 

person at a time, can be locked from the inside, and contain at least 

one water closet, separate toilet rooms for each sex need not be 

provided.'' For consistency with this OSHA requirement, FSIS has 

removed the proposed provision requiring separate lavatories and toilet 

facilities.



Equipment and Utensils: Proposed Sec. 416.3



    Comment: Numerous commenters objected to the proposed elimination 

of the requirement in Secs. 308.3(d)(4) and 308.8 that utensils and 

equipment used to dress diseased meat carcasses be cleaned with either 

180 ( deg.F water or an approved disinfectant. Several commenters 

contended that the use of 180 ( deg.F water has been the method 

``proven'' to be effective for sanitizing implements. These commenters 

submitted no supporting data, however. A few commenters recommended 

that FSIS require a minimum water temperature of at least 155  deg.F to 

160  deg.F, as water in this temperature range is purported to kill E. 

coli O157:H7. Several commenters questioned the studies cited by FSIS 

as support for rescinding the 180  deg.F requirement. These commenters 

recommended that FSIS commission or conduct a new study to determine 

the water temperature that is most effective for controlling bacteria 

in a slaughter environment. Finally, one commenter argued that by 

rescinding the 180  deg.F water requirement, FSIS is contradicting its 

other policy of ``promoting'' the use of steam cabinets as a processing 

step to kill bacteria.

    Response: For HACCP systems to be effective, meat and poultry 

establishments must be afforded the flexibility to take whatever 

actions are necessary to produce safe products. Meat establishments 

must determine what is necessary, in the particular context of their 

processing environment, to clean implements used to dress diseased 

carcasses so that those implements will not adulterate product. Under 

the performance standard, many meat establishments are likely to 

continue using 180  deg.F water for this purpose, but others will use 

different means that they will have determined are more suitable and as 

effective.

    The studies summarized by FSIS in the proposal raise significant 

questions about the efficacy of 180  deg.F water for the cleaning of 

implements used to dress diseased carcasses. FSIS cited these studies 

to emphasize that this prescribed treatment may not be effective in 

every processing



[[Page 56407]]



environment and, therefore, that a performance standard would be more 

appropriate for ensuring that meat establishments maintain proper 

sanitation within their operations. FSIS is not planning to conduct or 

sponsor any additional studies at this time, but certainly will 

evaluate any research developments in this area.

    Finally, FSIS has endorsed the use of steam pasteurization as an 

antimicrobial treatment for the surfaces of meat carcasses. FSIS has 

not prescribed, however, a specific temperature for the steam or a 

specific method for its application. Similarly, FSIS will no longer 

require a specific method for the cleaning of implements used to dress 

diseased carcasses.

    Comment: Several commenters opposed the proposed performance 

standard regarding equipment and FSIS inspection program employees: 

``Equipment and utensils must not interfere with inspection procedures 

or interfere with inspection by FSIS inspection personnel.'' These 

commenters argued that this standard is unnecessary because the general 

requirement that establishments not interfere with FSIS inspection is 

implicit in all of the regulations.

    Response: The FMIA, PPIA, and the regulations specifically prohibit 

the forcible interference with FSIS program employees performing 

inspection or any other duties prescribed by the FMIA, PPIA, or the 

regulations. Moreover, the requirement that establishments not 

interfere with FSIS inspection is implicit throughout FSIS regulations. 

However, it is important to establish a performance standard regarding 

the inspection of the sanitary condition of equipment. Equipment in an 

official establishment must not be constructed or operated in a manner 

that would prevent FSIS inspection program employees from determining 

whether the equipment is in sanitary condition. If meat or poultry 

processing equipment is built, located, or operated in a manner that 

prevents it from being inspected to determine whether it has been 

cleaned or sanitized so as to ensure that it will not be the cause of 

product adulteration, FSIS may withhold the mark of inspection from 

product processed using that equipment. FSIS has revised the proposed 

performance standard, as follows, to clarify this intent: ``Equipment 

and utensils must not be constructed, located, or operated in a manner 

that prevents FSIS inspection program employees from inspecting 

equipment or utensils to determine whether they are in sanitary 

condition.''



Food Contact Surface Cleaning and Sanitation: Proposed Sec. 416.4(a)



    Comment: Numerous commenters objected to the proposed requirement 

that ``all food-contact surfaces, including food-contact surfaces of 

utensils and equipment, must be cleaned daily prior to starting 

operations  *  *  * .'' Commenters stated that many establishments 

currently operate successfully for extended periods (more than 24 

hours), cleaning and sanitizing as necessary. Also, several commenters 

noted that certain types of equipment, such as blast freezers and high 

temperature ovens, can be operated over extended periods without posing 

a significant food safety risk. Finally, a few commenters suggested 

that an establishment's Sanitation SOP or HACCP plan should dictate 

frequency of cleaning food contact surfaces.

    Response: FSIS agrees that it is possible for an official 

establishment to safely operate for an extended period (more than 24 

hours) without re-sanitizing all food contact surfaces. It is also true 

that more frequent sanitizing may be necessary. Accordingly, FSIS is 

finalizing a performance standard for operational sanitation requiring 

that ``All food-contact surfaces, including food-contact surfaces of 

utensils and equipment, must be cleaned and sanitized as frequently as 

necessary to prevent the creation of insanitary conditions and the 

adulteration of product.'' The regulation, as revised, is consistent 

with the Sanitation SOP and HACCP requirements. Establishments must 

comply with the Sanitation SOP requirements regarding food contact 

surfaces in Sec. 416.12(c): ``Procedures in the Sanitation SOP's that 

are to be conducted prior to operations shall be identified as such, 

and shall address, at a minimum, the cleaning of food contact surfaces 

of facilities, equipment, and utensils.''



Non-Food Contact Surface Cleaning and Sanitation: Proposed 

Sec. 416.4(b)



    Comment: Several commenters stated that the language proposed for 

the performance standard for non-food contact surfaces was 

unnecessarily prescriptive and inconsistent with the other performance 

standards because it required that such surfaces be cleaned ``as 

necessary to prevent the physical, chemical, or biological 

contamination or adulteration of product,'' rather than simply to 

prevent adulteration of product.

    Response: FSIS agrees and has revised the standard to be consistent 

with the revised standard in Sec. 416.4(a): ``Non-food-contact surfaces 

of facilities, equipment, and utensils used in the operation of the 

establishment must be cleaned and sanitized as frequently as necessary 

to prevent the creation of insanitary conditions and the adulteration 

of product.'' Obviously, during the normal course of an establishment's 

operations, meat and poultry products should not come in contact with 

``non-food contact surfaces.'' Therefore, as long as such contact did 

not occur, it would be unlikely that these surfaces would ever directly 

adulterate product. However, if non-food contact surfaces are 

insufficiently cleaned or sanitized, insanitary conditions within the 

establishment can result, potentially leading to product adulteration. 

FSIS has revised this performance standard by deleting the specific 

reference to ``physical, chemical, or biological contamination'' and by 

requiring that non-food contact surfaces be cleaned and sanitized as 

necessary to prevent the creation of insanitary conditions and the 

adulteration of product.

    Comment: One commenter claimed that non-food contact surfaces in 

establishments, such as floors, drains, and walls, are highly 

contaminated. This commenter suggested that FSIS revise the performance 

standard to require daily cleaning and sanitizing of non-food contact 

surfaces.

    Response: In many establishments, daily cleaning and sanitizing of 

non-food contact surfaces may not be necessary for the maintenance of 

sanitary conditions or the prevention of product adulteration. FSIS 

will not, therefore, mandate specific time intervals for this 

requirement. If the conditions in an establishment are such that 

floors, drains, walls, and other non-food contact surfaces are highly 

contaminated on a regular basis, the establishment may need to provide 

for the appropriate frequency of cleaning and sanitizing of those 

surfaces in either its HACCP plan or Sanitation SOP's. FSIS is 

confident that insanitary conditions of non-food contact surfaces in 

official establishments will be detected by FSIS inspection program 

employees during verification of an establishment's HACCP plans and 

written Sanitation SOP's.



Cleaning Compounds and Sanitizers: Proposed Sec. 416.4(c)



    FSIS proposed to eliminate the regulatory requirements mandating 

that certain nonfood compounds and proprietary substances be approved 

by the Agency prior to their use. Specifically, FSIS proposed to 

rescind the following regulations:



[[Page 56408]]



    Sec. 308.3(h)--requirements that FSIS approve pesticides, 

rodenticides, and insecticides prior to use in certain areas of meat 

establishments;

    Sec. 308.8(c)--requirements that FSIS approve, prior to use, 

disinfectants used to clean implements that have contacted diseased 

meat carcasses; and

    Sec. 381.60--requirements that germicides, insecticides, 

rodenticides, detergents, wetting agents, and similar compounds be 

approved by FSIS prior to use in poultry establishments.

    FSIS did not propose to discontinue its policy of approving other 

proprietary substances or nonfood compounds prior to their use in 

official establishments. As a matter of policy, FSIS has reviewed and 

approved, prior to use, most other nonfood compounds and proprietary 

substances, including: branding and tattoo inks; poultry and hog scald 

agents; rendering agents; certain cleaning compounds; paint removers; 

antimicrobial agents; hand washing and sanitizing agents; water 

treatments; solvent cleaners; sewer and drain cleaners; and lubricants. 

Following its review, FSIS has listed all approved nonfood compounds 

and proprietary substances in Miscellaneous Publication Number 1419, 

List of Proprietary Substances and Nonfood Compounds.

    Shortly after FSIS published the proposal to revise the sanitation 

regulations, FSIS mistakenly released information that mischaracterized 

the proposal's provisions concerning the prior approval of nonfood 

compounds and proprietary substances. On September 11, 1997, the FSIS 

Compound and Packaging Review Branch mailed a notice to chemical 

manufacturers and other businesses announcing a change of address. 

Included with that notice was a facsimile of the first page of a 

proposed rule, incorrectly identified as the sanitation proposal, FSIS 

Docket No. 96-037P, announcing that the Agency was discontinuing its 

policy of approving all nonfood compounds and proprietary substances 

prior to their use in official meat and poultry establishments.

    In order to clear up any confusion regarding the matter, FSIS 

published a notice in the Federal Register (FSIS Docket No. 97-062N; 62 

FR 55995) explaining the situation and correcting the erroneous 

information. Further, in order to ensure that the public had ample 

opportunity to submit comments on the sanitation proposal and its 

provisions concerning nonfood compounds and proprietary substances, 

FSIS reopened the comment period for that proposal for 15 days, from 

October 28, 1997, to November 10, 1997 (FSIS Docket 96-037R; 62 FR 

55997).

    On February 13, 1998, FSIS announced in a notice (FSIS Docket No. 

97-007N; 63 FR 7319) that it did, in fact, intend to discontinue 

approving all nonfood compounds and proprietary substances prior to 

their use in official meat and poultry products establishments. FSIS 

emphasized that it would continue to require that meat and poultry 

products be neither adulterated nor misbranded through the misuse of 

proprietary additives and nonfood compounds. Further, FSIS also 

explained its plan to maintain a small staff with expertise in nonfood 

compounds and proprietary substances. This staff will keep abreast of 

developments in chemical manufacturing and use, maintain liaison with 

outside organizations that have an interest in this matter, and issue 

technical guidance, particularly to small meat and poultry plants, as 

circumstances warrant. Finally, FSIS requested comment on possible 

alternatives to the FSIS prior approval program, including the option 

of third party review and approval of nonfood compounds and proprietary 

substances.

    The comments FSIS received on this issue, whether in response to 

the sanitation proposal, the letter distributed by the Compounds and 

Packaging Review Branch, or the February 13 notice, do not differ 

substantively. While a few commenters supported the proposed regulatory 

and policy changes, most of the comments were submitted by chemical 

manufacturers, and most were in opposition to ending the prior approval 

program for all nonfood compounds and proprietary substances. In 

response to the letter, FSIS received 68 comments. Because these 

commenters believed that they were responding to an FSIS proposed 

rulemaking, FSIS maintained their comments on file in the FSIS Docket 

Room. In response to the February 13 notice, FSIS received 35 comments. 

Below, FSIS responds to all of the issues raised in all of the comments 

concerning the FSIS plan to eliminate the prior approval program.

    Comment: The majority of commenters opposed to ending the prior 

approval program argued that without prior approval, unscrupulous 

chemical manufacturers will market unsuitable and possibly dangerous 

chemicals to meat and poultry establishments and that the use of such 

chemicals would inevitably lead to the adulteration of product. 

Further, they argued that it would be difficult for FSIS inspection 

program employees to prevent such adulteration since they would not be 

able to consult the List of Proprietary Substances and Nonfood 

Compounds. Several commenters contended that without the List of 

Proprietary Substances and Nonfood Compounds, FSIS inspection program 

employees will make inconsistent or arbitrary decisions in regard to 

what compounds establishments may use.

    Response: FSIS disagrees. The FMIA and PPIA require that meat and 

poultry products be neither adulterated nor misbranded through the use 

of proprietary substances and nonfood compounds. Meat and poultry 

establishments are responsible for ensuring that all proprietary 

substances and nonfood compounds are safe for their intended use and 

used appropriately. In light of these requirements, FSIS anticipates 

that establishments considering purchasing and using nonfood compounds 

or proprietary substances will demand formulation or other information 

from chemical manufacturers before making purchase decisions. 

Manufacturers who fail to provide such information could lose their 

market share.

    FSIS inspection program employees will continue to verify that 

proprietary substances and nonfood compounds do not adulterate meat and 

poultry products. Enforcement activities in this regard will include, 

but will not be limited to, direct observation of establishment 

operations and inspection of an establishment's premises and product, 

as well as sampling of product for chemical residues, as necessary, and 

review of establishment records. Establishments will document the use 

of proprietary substances and nonfood compounds in a variety of 

records, depending on the nature of the compound and its use. FSIS 

inspection program employees will review Sanitation SOP's, HACCP plans, 

use directions, pest control certifications, letters of guarantee, and 

other materials furnished to establishments by chemical manufacturers 

and suppliers.

    In response to comments, FSIS is finalizing an additional 

regulatory requirement in regard to the use of nonfood compounds and 

proprietary substances in Sec. 416.4(c): ``Documentation substantiating 

the safety of a chemical's use in a food processing environment must be 

available to FSIS inspection program employees for review.'' FSIS is 

not requiring that establishments make available any specific type of 

documentation since, as stated above, documentation substantiating the 

safety of a chemical varies with the nature and intended uses of that 

chemical. For example, for a pesticide, an



[[Page 56409]]



establishment should have documentation showing that the compound is 

registered with EPA and the label information for the pesticide. For a 

chemical sanitizer used on food contact surfaces, an establishment 

should have documentation showing that the compound complies with the 

relevant Food and Drug Administration (FDA) regulations in 21 CFR 

178.1010. For an antislip agent, an establishment may satisfy the 

regulations with a letter of guarantee and use instructions from the 

manufacturer certifying that if used in accordance with directions, the 

compound will neither adulterate product nor create insanitary 

conditions. This documentation requirement not only will assist FSIS 

inspection program employees in determining whether the use of given 

compound is proper and safe, but also will ensure that meat and poultry 

establishments have adequately reviewed and evaluated the chemicals 

used in their food processing environments.

    FSIS inspection program employees may, of course, disallow a 

specific use of a chemical in an official establishment if 

documentation is not available or is inadequate, if the establishment 

misuses the nonfood compound or proprietary substance, or if there is 

reason to believe a specific use will lead to insanitation or product 

adulteration. FSIS program employees will be instructed to direct any 

questions or concerns regarding the use of nonfood compounds and 

proprietary substances to the FSIS Technical Services Center. Further, 

FSIS is publishing a new Directive to assist inspection program 

employees in verifying the safety of the use of nonfood compounds and 

proprietary substances in official meat and poultry establishments.

    Comment: Some commenters maintained that small establishments lack 

the resources and technical expertise to determine whether chemical 

compounds are safe and effective and, therefore, would be adversely 

affected by the elimination of FSIS review and approval. Several of 

these commenters urged FSIS to provide guidance material to industry 

concerning the appropriate formulation and use of nonfood compounds and 

proprietary substances.

    Response: FSIS does not anticipate that the elimination of its 

prior approval program will substantially affect small meat and poultry 

establishments. These establishments are or should be already aware of 

which chemicals have been approved by FSIS. Moreover, competition will 

compel chemical manufacturers to provide meat and poultry 

establishments of all sizes with data that establish that their 

compounds are safe and effective. Likewise, FSIS is making available 

guidelines for compliance with the sanitation performance standards 

that explicitly address the appropriate formulation and safe use of 

nonfood compounds and proprietary substances. The guidelines are based 

upon the FSIS's regulatory experience, the requirements of other 

Federal agencies, and the criteria previously used by FSIS for 

reviewing and approving nonfood compounds and proprietary substances. 

Establishments should refer to those guidelines. Furthermore, although 

the guidelines are directed primarily to regulated meat and poultry 

establishments, chemical manufacturers may find them useful in 

developing and marketing their products.

    Comment: A few commenters, including several non-government 

standard-setting organizations, strongly supported third-party review 

and certification of nonfood compounds and proprietary substances.

    Response: FSIS encourages third-party standards organizations and 

independent laboratories to develop systems for testing and certifying 

nonfood compounds and proprietary substances. Such certification would 

encourage the development and marketing of effective, safe, and 

innovative products. Chemical manufacturers whose products meet FSIS 

performance standards and other agency requirements will have ample 

incentive to publicize the fact that their products are approved by 

third party organizations or independent laboratories. It is not likely 

that FSIS will officially sanction any particular organization's 

certification as definitive evidence of compliance with FSIS 

requirements. However, FSIS would obviously give careful consideration 

to valid third-party certifications when questions arise regarding the 

safety of a nonfood compound or proprietary substance.

    Comment: Several commenters noted that some of the nonfood 

compounds and proprietary substances previously approved by FSIS, 

including general cleaners, hand soaps, sewer and drain cleaners, and 

certain water treatments, are not, in fact, reviewed or approved by 

other Federal agencies. These commenters contended that, consequently, 

continued review and approval of these compounds by FSIS is necessary. 

In one comment, FDA raised specific concerns regarding the proposed 

discontinuation of prior approval for hand cleaners and sanitizers. 

Although some hand treatments are considered over-the-counter drug 

products and therefore regulated by FDA, others are not.

    Response: FSIS does not agree that prior approval of these 

chemicals is necessary to ensure the safety of meat and poultry 

products. Meat and poultry establishments have the responsibility of 

ensuring that the nonfood compounds and proprietary substances that 

they use will not adulterate product or create insanitary conditions. 

As stated above, FSIS will verify that these chemicals are being used 

appropriately through inspection, review of documentation 

substantiating the safety of the chemicals, and if necessary, sampling 

and testing. FSIS anticipates that competition will compel chemical 

manufacturers to demonstrate to meat and poultry establishments that 

their products are safe and satisfy the standards established in these 

regulations.

    Specifically in regard to the use of hand treatments and 

sanitizers, FSIS prior approval is unnecessary. Hand care products 

formulated with chlorhexidene gluconate and intended to be used as an 

antimicrobial hand cleaner or hand sanitizer/dip in food handling and 

processing, as well as hand care treatments intended for use as a 

``barrier'' or ``shield'' to prevent or mitigate human disease by 

protecting skin from exposure to toxic chemicals or pathogenic 

microorganisms, are considered ``drugs'' and possibly ``new drugs'' 

under the Federal Food, Drug, and Cosmetic Act (FFDCA). Consequently, 

FDA regulates and registers these hand treatments. Establishments using 

such chemicals should keep registrations on file for review by FSIS 

inspection program employees.

    Other hand treatments, however, are not currently regulated or 

registered by FDA. It is the responsibility of establishments to ensure 

that such treatments do not adulterate product or create insanitary 

conditions. As with other chemicals, FSIS will verify that hand 

treatments are being used appropriately through inspection, review of 

documentation substantiating the safety of the chemicals, and if 

necessary, sampling and testing. FSIS is publishing guidance on the 

appropriate use of hand treatments in the sanitation performance 

standards compliance guide. FSIS also is continuing to consult with FDA 

regarding the appropriate use of hand treatments, and will modify the 

compliance guide in the event of changes in FDA policies.

    Comment: One trade association cited concerns regarding labeling 

and



[[Page 56410]]



marketing claims for nonfood compounds and proprietary substances 

previously approved and listed by FSIS. This commenter requested that 

FSIS explicitly allow manufacturers of previously approved chemicals to 

market them as such.

    Response: FSIS will neither approve nor disapprove marketing claims 

or labeling for the nonfood compounds and proprietary substances used 

in establishments. Chemical manufacturers may market or label their 

products as being previously approved by FSIS, as long as their claims 

are truthful and not misleading, as is required by applicable law. Meat 

and poultry establishments should keep in mind that since FSIS is 

discontinuing its prior approval program for these products, previous 

approval of a product by FSIS does not necessarily mean that it is 

safer or more effective than a new product that has not been reviewed 

and approved.

    Documentation required to be available under the regulation may 

cite that products were previously approved by FSIS for a particular 

use and that the formulation of that product has not changed. This 

information may facilitate decisions by FSIS program employees when 

reviewing documentation that substantiates the safety of a nonfood 

compound or proprietary substance.

    Comment: A few commenters argued that in regard to the proposed 

elimination of its prior approval program, FSIS must perform 

environmental impact analyses pursuant to the requirements of the 

National Environmental Policy Act (NEPA, 42 U.S.C. 4321 et seq.) and 

the Council for Environmental Quality regulations in 40 CFR parts 1500-

1508. These commenters noted that FSIS has been granted a categorical 

exclusion from NEPA requirements by USDA regulation (7 CFR 1b.4), 

unless ``the agency head determines that an action may have a 

significant environmental effect.'' They concluded that the elimination 

of prior approval for nonfood compounds and proprietary substances in 

general, and specifically for pesticides, could have a significant, 

adverse impact on human health and the environment and therefore that 

FSIS should conduct an environmental assessment or impact analysis as 

required by NEPA. Two commenters also claimed that FSIS's planned 

elimination of its prior approval program is inconsistent with the 

intent of E.O. 13045, which encourages Federal agencies to ``identify 

and assess environmental health risks and safety risks that may 

disproportionately affect children'' and result from regulatory action.

    Response: The Administrator of FSIS has determined that the 

elimination of prior approval of nonfood compounds and proprietary 

substances will not have an adverse impact on the environment or human 

health, and therefore, that it is not necessary for FSIS to perform an 

environmental impact assessment for this action. As stated above, FSIS 

is continuing to require that meat and poultry products be neither 

adulterated nor misbranded through the use of proprietary substances 

and nonfood compounds and that the use of these substances and 

compounds must not create insanitary conditions. FSIS inspection 

program employees will verify that these chemicals are being used 

appropriately and are not adulterating product through inspection, 

review of documentation substantiating the safety of the chemicals, and 

if necessary, sampling and testing. Other Federal and state 

requirements concerning the use, storage, or disposal of these 

chemicals will not be affected by this rule. There is no reason to 

believe, therefore, that the discontinuation of the FSIS prior approval 

program for nonfood compounds and proprietary substances will allow 

meat and poultry establishments to use these chemicals in any manner 

that would have an adverse impact on human health and the environment.

    Finally, because FSIS has determined that this action will not have 

any significant impact on the environment or on human health, FSIS has 

similarly determined that this action will not have a 

disproportionately adverse impact on the health of children and is, 

therefore, consistent with the intent of E.O. 13045.



Denaturants



    During the course of reviewing the comments, FSIS discovered that 

it had not proposed to rescind in Secs. 314.3 and 381.95, which require 

establishments to use only prior approved denaturants for condemned 

meat and poultry, even though FSIS has listed approved denaturants in 

the List of Proprietary Substances and Nonfood Compounds. Denaturants 

are chemicals used to color or affect condemned meat and poultry 

products in a manner that readily identifies them as inedible to 

establishment employees and FSIS inspection program employees, so that 

the product will not be processed, shipped, or marketed as edible 

product. In the near future, FSIS will publish a proposal to rescind 

these prior approval requirements for denaturants and replace them with 

a performance standard. The standard that FSIS intends to propose will 

take into account FDA policy regarding denaturants applied to condemned 

meat and poultry products used for animal feed. Until the FSIS proposal 

is published and made final, the requirements regarding prior approval 

of denaturants will remain in effect.



Operational Sanitation: Proposed 416.4(d)



    Comment: Several commenters opposed the proposal to replace with a 

performance standard Sec. 381.47(e), which required that rooms where 

mechanical equipment is operated for the deboning of raw poultry be 

maintained at 50  deg.F or less. FSIS considered this requirement to be 

overly prescriptive and proposed to allow establishments to devise 

their own means for limiting microbial growth in their processing 

operations. Commenters claimed that the prescriptive temperature 

requirement is imperative for preventing microbial growth and contended 

that small establishments lack the resources and expertise to innovate 

in this area.

    Response: As stated in the proposal, in response to requests, FSIS 

has permitted many establishments to use methods other than reducing 

ambient temperature to control microbial growth in raw poultry. Several 

establishments have used heat-exchangers connected to the grinding 

equipment to bring about an immediate reduction in product temperature. 

Use of heat-exchangers on the equipment can more effectively reduce 

product temperature and limit growth of microorganisms than strict 

adherence to the requirement to maintain a specific room temperature. 

The performance standard for operational sanitation will allow 

establishments to devise their own means for limiting microbial growth 

in their processing operations, without requesting special approval 

from the Agency.

    Small establishments will not have to innovate in this area. If 

they choose, small establishments may continue to maintain the 

temperature in poultry deboning rooms at 50  deg.F. Since this measure 

has been proven to adequately control microbial growth in this 

processing situation, it will continue to meet the performance standard 

for operational sanitation, until new or better data suggest otherwise.

    Comment: Also in regard to operational sanitation, FSIS proposed 

the following performance standard: ``Product must be protected from 

contamination or adulteration during processing, handling, storage, 

loading, and unloading at and during



[[Page 56411]]



transportation from official establishments; ready-to-eat product must 

be protected from cross-contamination by pathogenic organisms.'' 

Several commenters argued that the standard regarding cross-

contamination of ready-to-eat product was redundant, unnecessary, and 

only an example of one kind of product adulteration. They requested 

that FSIS make final only the first, more general standard.

    Response: FSIS agrees that the proposed standard concerning cross-

contamination is redundant and thus, for clarity, will not finalize it. 

Establishments already are specifically required to prevent the cross-

contamination of ready-to-eat product by the first half of this 

proposed standard. FSIS also is revising this standard by removing the 

prohibition against product contamination, because, as explained above, 

such a standard is unnecessary.



Employee Hygiene: Proposed Sec. 416.5(a)



    Comment: Several commenters argued that the proposed performance 

standards for employee hygiene were too prescriptive. Specifically, 

these commenters objected to the proposed requirement that ``All 

persons working in contact with * * * product-packaging materials must 

adhere to hygienic practices while on duty to prevent adulteration of 

product.'' They maintained that insanitary contact with certain 

packaging materials, such as canned product shipping containers, could 

never lead to product adulteration. These commenters suggested that 

FSIS clarify that the standard only applies to ``product-contact-

packaging.''

    Response: Although the unhygienic handling of certain packaging 

materials that do not come in contact with product may not lead to 

direct contamination of the product contained therein, such handling 

could contribute to the creation of insanitary conditions within an 

official establishment. FSIS is revising the performance standard to 

reflect this concern. The finalized Sec. 416.5(a) states: ``All persons 

working in contact with product, food-contact surfaces, and product-

packaging materials must adhere to hygienic practices while on duty to 

prevent adulteration of product and the creation of insanitary 

conditions.''

    Comment: Conversely, several commenters opposed rescinding the 

existing regulatory prohibitions against specific, unhygienic employee 

activities and replacing them with performance standards. As discussed 

above in the ``General Opposition'' section, these commenters asserted 

that FSIS inspection program employees' enforcement authority will be 

weakened without specific prohibitions against such actions as 

``placing skewers, tags, or knives in the mouth'' (Sec. 308.8(e)). 

Further, these commenters cited multiple anecdotal examples of employee 

actions that could lead to the adulteration of product.

    Response: FSIS does not need to specifically enumerate every action 

by establishment personnel that could possibly lead to product 

adulteration or insanitary conditions. It would, in fact, be impossible 

to compile such a list of prohibited practices. FSIS program employees 

have always had the authority, and will continue to have the authority, 

to take action whenever establishment personnel fail to ensure that 

product is not adulterated or fail to maintain sanitary conditions, 

even if the problem identified is not specifically delineated in a 

regulation. This authority remains unchanged under the new performance 

standard for employee hygiene in Sec. 416.5(a).



Employee Clothing: Proposed Sec. 416.5(b)



    Comment: FSIS proposed a performance standard requiring that all 

employee outer clothing be readily cleanable. Several commenters from 

industry stated that their employees use disposable clothing, which is 

both sanitary and cost-effective, and requested that FSIS revise the 

standard to specifically allow for the use of disposable clothing.

    Response: FSIS agrees that disposable clothing can be appropriately 

sanitary and has revised the standard to read, in part: ``Aprons, 

frocks, and other outer clothing worn by persons who handle product 

must be of material that is disposable or readily cleaned.''



Employee Disease: Proposed Sec. 416.5(c)



    Comment: FSIS proposed a performance standard requiring that:



    Any person who has or appears to have an illness, open lesion, 

including boils, sores, or infected wounds, or any other abnormal 

source of microbial contamination must be excluded from any 

operations which could result in product contamination or 

adulteration until the condition is corrected.



One commenter requested that the word ``illness'' be replaced with the 

word ``disease.''

    Response: FSIS agrees and has replaced the word ``illness'' with 

the phrase ``infectious disease.'' ``Illness'' is a general term that 

could describe a disease or condition that is not infectious and 

therefore would pose no risk of product adulteration. The phrase 

``contamination or'' also is removed for reasons explained above.



Tagging Insanitary Equipment, Utensils, Rooms or Compartments: Proposed 

Sec. 416.6



    Comment: In regard to tagging insanitary equipment, utensils, rooms 

or compartments, FSIS proposed that its inspection program employees 

take such action when they find ``that any equipment, utensil, room, or 

compartment at an official establishment is unclean or that its use 

would be in violation of any of the regulations in this subchapter.'' 

Several commenters objected to the word ``unclean,'' arguing that it 

constituted a new standard and that its vagueness would lead to highly 

subjective enforcement by FSIS inspection program employees.

    Response: The proposed language is not new and, in fact, is almost 

identical to the previous tagging regulation, Sec. 308.15. 

Nevertheless, FSIS agrees that the regulation can be improved and for 

consistency with the sanitation requirements has replaced the word 

``unclean'' with the word ``insanitary.'' As stated above, under the 

FMIA and PPIA, FSIS must take action when an official establishment 

operates in a manner that leads to insanitary conditions and product 

adulteration. Accordingly, FSIS is revising the requirement to state 

that an FSIS inspection program employee will tag equipment, utensils, 

rooms, or compartments at an official establishment if they are 

``insanitary or [their] use could cause the adulteration of product.''



Custom Slaughter Establishments



    Comment: One commenter suggested that the proposed revisions to 

language exempting custom establishments from certain sanitation 

requirements were too restrictive, as they would apply only to custom 

slaughter operations and not to custom processing operations.

    Response: FSIS agrees. This error was unintentional and the 

exemption in Sec. 303.1(a)(2)(i) has been revised so as to apply to 

establishments ``that conduct custom operations,'' rather than only to 

``establishments conducting custom slaughter operations.''



Miscellaneous Changes



    In the proposal preceding this final rule, FSIS stated that it 

needed ``to revise all of the cross-references in the meat and poultry 

regulations to reflect the proposed deletion of Part 308 and 381 

Subpart H and the proposed addition of new Secs. 416.1 through 416.6.'' 

FSIS is making those revisions



[[Page 56412]]



in this final rule. References to specific sanitation requirements 

contained in sections of previous Part 308 or 381 Subpart H are 

replaced with references to the relevant sanitation performance 

standards in Part 416.

    FSIS also is making a few revisions to the regulations for 

consistency with the new sanitation performance standards. Although 

FSIS did not propose these specific revisions, they are necessary to 

avoid conflict within the meat and poultry inspection regulations. 

These changes will impose no new regulatory burden on establishments.

    First, Section 381.36(c)(1)(viii) of the poultry regulations states 

that ``Online handrinsing facilities with a continuous flow of water 

conforming to section 381.51(f) shall be provided for and within easy 

reach of each inspector and each establishment helper.'' Section 

381.51(f), which will be deleted by this final rule, stated:



    An adequate number of hand washing facilities shall be provided 

in areas where poultry products are prepared. Hand washing 

facilities accepted in accordance with the procedures set forth in 

section 381.53 may be used in such areas, provided that if hand-

activated facilities are used, the hand-contact element must be 

rinsed automatically with a sufficient volume of water to remove all 

fat, tissue, debris, and other extraneous material from the hand 

contact element after each use. Both hot and cold running water 

shall be available at each inspection station on the eviscerating 

line and shall be delivered through a suitable mixing device 

controlled by the inspector. Alternatively, water for hand washing 

shall be delivered to such inspection stations at a minimum 

temperature of 65 degrees F.



    Although FSIS is deleting from Sec. 381.36(c)(1)(viii) the 

reference to the deleted Sec. 381.51(f), it is not rescinding the 

requirements for hand washing facilities at inspection stations in 

official poultry establishments. The specific requirements for hand 

washing equipment and water temperatures previously contained in 

Sec. 381.51(f) are now contained in Sec. 381.36(c)(1)(viii). Similarly, 

in this final rule, although FSIS is replacing with a performance 

standard the prescriptive light intensity requirements for official 

poultry establishments (previous Sec. 381.52), it is not rescinding the 

specific light intensity requirements for inspector and reprocessing 

stations currently contained in Secs. 307.2 and 381.36. FSIS has 

determined that although official establishments are responsible for 

determining what light intensities and types of hand washing equipment 

are necessary to maintain sanitary conditions, the specific 

requirements for light intensities and hand washing facilities at 

inspection stations are still necessary to ensure appropriate 

conditions for effective inspection.

    Second, FSIS is revising the regulations in Secs. 314.2 and 314.4 

regarding the adulteration of edible meat and poultry product by 

inedible meat and poultry products. Specifically, FSIS is removing 

references to Part 308 and converting to performance standards 

prescriptive requirements regarding the prevention of product 

adulteration through contact with inedible product or odors from 

inedible product. These revisions are entirely consistent with the 

performance standards for establishment construction, operations, and 

the suppression of odors.



Elimination of Directives



    Comment: Several commenters objected to the proposed rescission of 

numerous FSIS Directives and Issuances concerning sanitation in 

official establishments, particularly FSIS Directive 11,000.1, the 

``Sanitation Handbook for Meat and Poultry Inspection.'' These 

commenters claimed that these Directives are needed by FSIS inspection 

program employees to ensure that establishments maintain adequate 

sanitation and do not adulterate product.

    Response: The FSIS Issuances and Directives in question are based 

upon the prescriptive sanitation regulations that are being rescinded 

and replaced by this rule. Therefore, retention of these documents 

would only generate conflict and confusion regarding the sanitation 

requirements official establishments must meet and how FSIS inspection 

program employees are to enforce these new requirements. For 

consistency with the HACCP and Sanitation SOP requirements and with the 

recent elimination of prior approval of establishment blueprints and 

equipment, FSIS already has rescinded the following Directives 

concerning sanitation (FSIS Notice 3-98; January 16, 1998):



FSIS Directive 7110.4--Liquid Smoke Re-Use

FSIS Directive 11,100.1--Sanitation Handbook

FSIS Directive 11,000.2--Plant Sanitation

FSIS Directive 11,000.4--Paints and Coatings in Official Establishments

FSIS Directive 11,210.1--Protecting Potable Water Supplies on Official 

Premises

FSIS Directive 11,220.2--Guidelines for Sanitization of Automatic 

Poultry Eviscerating Equipment

FSIS Directive 11,520.2--Exposed Heat-Processed Products; Employee 

Dress



Further, in a forthcoming FSIS Directive concerning the new performance 

standards, FSIS will rescind these remaining Directives:



FSIS Directive 11,240.5--Plastic Cone Deboning Conveyors

FSIS Directive 11,520.4--Strip Doors in Official Establishments

FSIS Directive 11,540.1--Use of Certain Vehicles as Refrigeration or 

Dry Storage Facilities

MPI Bulletin 77-34--Chemical Disinfection in Lieu of 180 deg.  deg.F 

Water

MPI Bulletin 77-129--Water Conservation and Sanitation

MPI Bulletin 79-68--Use of Iodine in Processing Water

MPI Bulletin 81-38--Equipment and Procedure Requirements for Processing 

Gizzards

MPI Bulletin 83-14--Monitoring Chlorine Concentration in Official 

Establishments

MPI Bulletin 83-16--Re-Use of Water or Brine Cooking Solution on 

Product Following a Heat Treatment

    As stated above, FSIS is issuing a new Sanitation Directive to 

accompany this rule. Although the Directive is written for FSIS 

inspector program employees, it will be available to the public. In 

addition, FSIS also will be issuing a compliance guide to assist 

establishments in complying with the new sanitation performance 

standards.



Compliance With Executive Order 12866 and the Regulatory Flexibility 

Act of 1996



    This rule has been determined to be significant for the purposes of 

Executive Order 12866 and, therefore, has been reviewed by the Office 

of Management and Budget.

    FSIS is revising and consolidating the sanitation regulations for 

official meat and poultry establishments, resolving unnecessary 

differences between similar rules for meat and poultry processing, and 

converting prescriptive requirements to performance standards. This 

action affects meat and poultry establishments subject to official 

inspection, custom exempt meat and poultry establishments, and 

consumers. In the proposal preceding this final action, FSIS requested 

comment concerning the potential economic effects of the proposed 

sanitation performance standards. FSIS specifically requested 

information that would allow the Agency to determine the number and 

kind of small entities that may incur benefits or costs resulting from 

issuance of this final rule.

    FSIS received no comments that specifically addressed this issue. 

However, several commenters opposed



[[Page 56413]]



to the proposed sanitation performance standards maintained that small 

meat and poultry establishments do not have the resources to innovate 

in order to take advantage of the flexibility provided by the 

performance standards. Further, these commenters argued that small 

establishments need prescriptive requirements to ensure that they know 

how to maintain sanitary conditions and produce safe, unadulterated 

products. FSIS disagrees. Establishments currently maintaining sanitary 

conditions may choose to continue their current practices and be 

assured that they will be found in compliance with the new performance 

standards. In addition, FSIS will be making available a compliance 

guide that will contain much of the information contained in previous 

sanitation regulations and Directives, to assist establishments of all 

sizes in meeting the new sanitation performance standards.

    In general, the streamlining, clarification, and consolidation of 

the sanitation regulations should benefit FSIS, the regulated industry, 

and consumers. User-friendly regulations employing performance 

standards simplify compliance and, therefore, should bring about food 

safety enhancements in individual establishments. Further, 

consolidation of the separate sanitation requirements for meat and 

poultry establishments and the consequent elimination of unnecessary 

inconsistencies will better ensure that enforcement policies are 

consistent and equitable and that competition is enhanced.

    The performance standards allow individual establishments to 

develop and implement customized sanitation procedures other than those 

currently mandated, as long as those procedures produce and maintain 

sanitary conditions that meet the performance standards. Establishments 

taking advantage of the performance standards to innovate may benefit 

from savings accrued through increased efficiency. Since the previously 

mandated sanitation procedures meet the performance standards 

established by this final rule, establishments may continue employing 

their current procedures. There is no discernable reason that 

establishments would incur any additional expenses as a result of this 

rule. As a matter of fact, FSIS anticipates that the adoption of these 

sanitation performance standards will present numerous opportunities 

for cost savings and believes that this rule will have a favorable 

economic impact on all establishments, regardless of size.

    It is difficult to quantify the potential benefits of the 

sanitation performance standards since it is not possible to predict 

exactly how many establishments will take advantage of the flexibility 

provided and develop innovative processes and how these innovations 

will reduce costs and increase efficiency. However, FSIS sees the 

potential for a more efficient use of resources by official 

establishments. Also, the possibility of subsequently reduced prices of 

meat or poultry products are economic factors that could produce a more 

efficient use of resources in the economy as a whole. These effects 

would be small for individual firms and consumers, but could be 

substantial in the aggregate.

    Finally, FSIS is restructuring inspection activities to focus more 

attention on whether establishments maintain a sanitary environment in 

accordance with the Sanitation SOP requirements and these sanitation 

performance standards. This action should reduce demands on FSIS 

resources which could be redirected to functions more critical to 

improving food safety. FSIS anticipates that this restructuring of 

inspection, along with these performance standards and the HACCP, 

Sanitation SOP, and other food safety initiatives, will produce 

significant economic and societal benefits by reducing the incidence of 

food borne illness.

    In response to comments, FSIS is finalizing a new requirement in 

regard to the use of nonfood compounds and proprietary substances in 

Sec. 416.4(c): ``Documentation substantiating the safety of a 

chemical's use in a food processing environment must be available to 

FSIS inspection program employees for review.'' FSIS is not requiring 

that establishments make available any specific type of documentation 

since the specific documentation substantiating the safety of a 

chemical will almost certainly vary as to the nature and use of that 

chemical. Most, if not all, of the nonfood compounds and proprietary 

substances used by meat and poultry establishments already are sold 

with documentation substantiating their safety and efficacy. 

Pesticides, for example, have labels and documentation demonstrating 

registration with EPA; chemical sanitizers used on food contact 

surfaces often are accompanied by documentation, such as letters of 

guarantee, stating that the compound complies with the relevant FDA 

regulations in 21 CFR 178.1010. Therefore, FSIS has concluded that the 

finalized documentation requirement will place no new economic burden 

on the manufacturers or consumers of most of these compounds.

    FSIS recognizes that certain compounds, such as general cleaners 

and antislip agents, are not currently regulated or reviewed by any 

Federal agency and therefore may not be sold with documentation 

attesting to the safety and efficacy of their use in food processing 

establishments. Manufacturers will be compelled, therefore, to make 

such documentation available to their customers, if they are not doing 

so already. However, FSIS estimates that the economic impact of this 

requirement on these manufacturers will be minimal. Until the recent 

discontinuation of the FSIS prior approval program, these manufacturers 

had been required to supply FSIS with documentation attesting to the 

safety of their products. Now they will instead make this or similar 

documentation available to their customers. The paperwork burden of 

this new documentation requirement is discussed below under the section 

Paperwork Requirements. 

    As an alternative to the proposed sanitation performance standards, 

the Agency considered proposing more comprehensive and prescriptive 

sanitation regulations. The proposed requirements would then have 

included more prescriptive performance standards than those proposed, 

such as microbial criteria for recently cleaned and sanitized food 

contact surfaces; detailed requirements currently contained in Agency 

guidance materials, such as an ambient temperature requirement for 

rooms in which certain types of food processing are conducted; and a 

list of specific regulatory prohibitions, again largely drawn from 

existing regulatory and guidance material.

    The Agency did not choose this more detailed and prescriptive 

alternative, because of the burden it would place on industry. The 

Agency believes that a proliferation of prescriptive standards 

applicable to the establishment environment or its features, like 

ambient temperature or microbial characteristics of cleaned equipment, 

would not be a useful addition to the sanitation performance standards.

    FSIS already has established performance standards applicable to 

meat and poultry products, such as the Salmonella performance standard 

for raw carcasses and ground product established in the Pathogen 

Reduction/HACCP final regulation and the zero tolerance standard for 

fecal material on raw carcasses. Achieving these product-based 

performance standards depends on an establishment doing a number of



[[Page 56414]]



things correctly, including meeting the sanitation performance 

standards set forth in part 416.1 through 416.6. FSIS has concluded 

that because there are many methods and means through which 

establishments can ensure that products are not adulterated, FSIS will 

not prescribe exactly which methods, procedures, or means must be used.

    Finally, on the issue of whether there should be a list of specific 

prohibited practices retained in the regulations, FSIS has concluded 

that this is not necessary and that such a list could be misleading. 

Most of the prohibited practices that are mentioned in the current 

sanitation regulations represent only one or a small fraction of the 

ways in which establishments could fail to meet a performance standard. 

For example, using burlap as a wrap by directly applying it to the 

surface of meat is only one of the means by which an establishment 

could be failing to prevent product adulteration. The Agency believes 

that a partial or outdated list of regulatory prohibitions in the 

regulations could be misconstrued to mean that anything not on the list 

is not prohibited. FSIS has concluded that it is better regulatory 

policy to communicate to industry examples of the types of practices 

that could result in insanitary conditions in guidance material.

    The other alternative available to FSIS was to maintain the 

previous sanitation requirements. However, as explained in detail 

above, these requirements were to an extent inconsistent with the 

principles of HACCP, needlessly reduced flexibility in accomplishing 

good sanitation, and may have substantially impeded innovation.



Executive Order 12898



    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 

``Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations,'' FSIS has considered potential 

impacts of this final rule on environmental and health conditions in 

low-income and minority communities.

    This rule consolidates the sanitation regulations for official meat 

and poultry establishments into a single part, eliminates unnecessary 

differences between the meat and poultry sanitation requirements, and 

converts many highly prescriptive requirements to sanitation 

performance standards. As explained in the economic impact analysis 

above, the new regulations should generally benefit FSIS, the regulated 

industry, and consumers. The regulations do not require or compel meat 

or poultry establishments to relocate or significantly alter their 

operations in ways that could adversely affect the public health or 

environment in low-income and minority communities. Further, this rule 

does not exclude any persons or populations from participation in FSIS 

programs, deny any persons or populations the benefits of FSIS 

programs, or subject any persons or populations to discrimination 

because of their race, color, or national origin.



Executive Order 12988



    This final rule has been reviewed under Executive Order 12988, 

Civil Justice Reform. States and local jurisdictions are preempted by 

the Federal Meat Inspection Act (FMIA) and the Poultry Products 

Inspection Act (PPIA) from imposing any marking, labeling, packaging, 

or ingredient requirements on federally inspected meat and poultry 

products that are in addition to, or different than, those imposed 

under the FMIA and the PPIA. States and local jurisdictions may, 

however, exercise concurrent jurisdiction over meat and poultry 

products that are within their jurisdiction and outside official 

establishments for the purpose of preventing the distribution of meat 

and poultry products that are misbranded or adulterated under the FMIA 

and PPIA, or, in the case of imported articles, that are not at such an 

establishment, after their entry into the United States.

    This rule is not intended to have retroactive effect.

    Under this rule, administrative proceedings will not be required 

before parties may file suit in court challenging this rule. However, 

the administrative procedures specified in 9 CFR 306.5 and 381.35 must 

be exhausted prior to any judicial challenge of the application of the 

provisions of this rule, if the challenge involves any decision of an 

FSIS employee relating to any matters under the FMIA and the PPIA.



Paperwork Requirements



    Abstract: FSIS has reviewed the paperwork and recordkeeping 

requirements in this proposed rule in accordance with the Paperwork 

Reduction Act.

    Under the previous regulations, if meat and poultry establishments 

were cited for rodent or vermin infestation, FSIS required them to 

develop a written corrective action report. The Office of Management 

and Budget (OMB) under control number O583-0082, ``Meat and Poultry 

Inspection and Application for Inspection,'' had approved 351 burden 

hours for this activity.

    This final rule eliminates the requirement that establishments 

develop rodent and vermin infestation corrective action reports. 

Corrective action measures for rodent and vermin infestation will be 

part of establishments' Sanitation SOP's. The burden hours reported for 

Sanitation SOP's includes the development of these corrective actions. 

Therefore, FSIS is requesting OMB to remove the 351 burden hours 

approved for the development of rodent and vermin infestation 

corrective action reports.

    Also, Sec. 416.2(g)(1) requires that establishments, upon request, 

make available to FSIS ``water reports issued under the authority of 

the State or local health agency certifying or attesting to the quality 

of the water supply.'' This paperwork collection requirement already is 

in place under the current regulations and is approved under OMB 

control number O583-0082, ``Meat and Poultry Inspection and Application 

for Inspection.''

    Finally, the Agency is adding a new information collection 

requirement in Sec. 416.4(c): ``Documentation substantiating the safety 

of a chemical's use in a food processing environment must be available 

to FSIS inspection program employees for review.'' FSIS is not 

requiring that establishments make available any specific type of 

documentation since documentation substantiating the safety of a 

chemical varies as to the nature and use of that chemical. Further, 

most, if not all, of the nonfood compounds and proprietary substances 

used by meat and poultry establishments already are sold with 

documentation substantiating their safety and efficacy. Nevertheless, 

manufacturers will be compelled to make such documentation available to 

their customers, if they are not doing so already. FSIS estimates that 

the impact of this requirement on these manufacturers will be quite 

minimal, since until the recent discontinuation of the FSIS prior 

approval program, these manufacturers had been required to supply FSIS 

with documentation attesting to the safety of their products.

    FSIS estimates that there are approximately 8,000 chemical 

manufacturers selling about 115,000 compound and substances to official 

meat and poultry establishments. There are approximately 6,186 official 

meat and poultry establishments. The following calculations were based 

upon the assumption that each chemical manufacturer sells, and each 

official establishment uses, an average of 14 compounds and substances.

    Estimate of Burden: The public reporting burden for this collection 

of



[[Page 56415]]



information is estimated to average 30 minutes for chemical 

manufacturers to provide documentation and 10 minutes for 

establishments to file the information.

    Respondents: Meat and poultry establishments and chemical 

manufacturers.

    Estimated Number of Respondents: 14,186.

    Estimated Number of Responses per Respondent: 14.

    Estimated Total Annual Burden on Respondents: 132,403 hours.

    Copies of this information collection assessment can be obtained 

from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 

Service, USDA, Cotton Annex Building, Room 109, Washington, DC 20250.

    Comments are invited on: (a) Whether the collection of information 

is necessary for the proper performance of the functions of the Agency, 

including whether the information will have practical utility; (b) the 

accuracy of the Agency's estimate of the burden of the proposed 

collection of information including the validity of the methodology and 

assumptions used; (c) ways to enhance the quality, utility, and clarity 

of the information to be collected; and (d) ways to minimize the burden 

of the collection of information on those who are to respond, including 

through the use of appropriate automated, electronic, mechanical, or 

other technological collection techniques or other forms of information 

technology. Comments may be sent to Lee Puricelli, Paperwork Specialist 

(see address above) or the Desk Officer for Agriculture, Office of 

Information and Regulatory Affairs, Office of Management and Budget, 

Washington, DC 20253.

    Comments are requested by December 20, 1999. To be most effective, 

comments should be sent to OMB within 30 days of the publication date 

of this final rule.



List of Subjects



9 CFR Parts 303, 304, and 307



    Meat inspection, Reporting and record keeping requirements.



9 CFR Part 308, 312, 314, 327,, 331, and 350



    Meat inspection.



9 CFR Part 381



    Poultry and poultry products inspection, Reporting and record 

keeping requirements.



9 CFR Part 416



    Sanitation.



    Accordingly, title 9, chapter III, of the Code of Federal 

Regulations is amended as follows:



PART 303--EXEMPTIONS



    1. The authority citation for part 303 continues to read as 

follows:



    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



    2. Section 303.1 is amended by revising paragraph (a)(2)(i) to read 

as follows:





Sec. 303.1   Exemptions.



    (a) * * *

    (2) * * *

    (i) Establishments that conduct custom operations must be 

maintained and operated in accordance with the provisions of 

Secs. 416.1 through 416.6, except for: Sec. 416.2(g) (2) through (6) of 

this chapter, regarding water reuse and any provisions of part 416 of 

this chapter relating to inspection or supervision of specified 

activities or other action by a Program employee. If custom operations 

are conducted in an official establishment, however, all of the 

provisions of Part 416 of this chapter of shall apply to those 

operations.

* * * * *





Sec. 303.1  [Amended]



    3. In Sec. 303.1, paragraph (c), the second sentence is amended by 

removing the phrase ``in part 308 of this subchapter, except 

Secs. 308.1, 308.2, and 308.15'' and adding the phrase ``in part 416, 

Secs. 416.1 through 416.5 of this chapter'' in its place.



PART 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF 

INSPECTION



    4. The authority citation for part 304 continues to read as 

follows:



    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.





Sec. 304.2  [Amended]



    5. In Sec. 304.2(b), the first sentence is amended by removing the 

phrase ``308'' and adding the phrase ``Part 416, Secs. 416.1 through 

416.6 of this chapter'' in its place.



Part 307--FACILITIES FOR INSPECTION



    6. The authority citation for part 307 continues to read as 

follows:



    Authority: 7 U.S.C 394, 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



    7. Section 307.2 is amended by revising paragraph (l) to read as 

follows:





Sec. 307.2   Other facilities and conditions to be provided by the 

establishment.



* * * * *

    (l) Sanitary facilities and accommodations as prescribed by 

Secs. 416.2(c), (d), (e), (f), and (h) of this chapter.

* * * * *

    8. Section 307.3 is revised to read as follows:





Sec. 307.3  Inspectors to furnish and maintain implements in a sanitary 

condition.



    Inspectors shall furnish their own work clothing and implements, 

such as flashlights and triers, for conducting inspection and shall 

maintain their implements in sanitary condition as prescribed by 

Sec. 416.3(a) of this chapter.

    9. Section 307.7, paragraph (a), is revised to read as follows:





Sec. 307.7  Safety requirements for electrical stimulating (EST) 

equipment.



    (a) General. Electrical stimulating (EST) equipment is equipment 

that provides electric shock treatment to carcasses for the purpose of 

accelerating rigor mortis of facilitating blood removal. These 

provisions do not apply to electrical equipment used to stun and/or 

slaughter animals or to facilitate hide removal. Electrical stimulating 

equipment consists of two separate pieces--the control system and the 

applicator. The EST control system contains the circuitry to generate 

pulsed DC or AC voltage for stimulation and is separate from the 

equipment used to apply the voltage to the carcass. The voltage is 

applied by inserting a probe that penetrates the carcass or is inserted 

in the rectum, placing a clamp in the nose, a carcass rub-bar, a 

conveyor with energized surfaces traveling with the carcass, or any 

other acceptable method.

* * * * *



PART 308--[REMOVED AND RESERVED]



    10-11. Remove and reserve part 308, consisting of Secs. 308.1-

308.16.



PART 312--OFFICIAL MARKS, DEVICES AND CERTIFICATES



    12. The authority citation for part 312 continues to read as 

follows:



    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



    13. In Sec. 312.6, paragraphs (a), and introductory text and (a)(3) 

are revised to read as follows:



[[Page 56416]]



Sec. 312.6  Official marks and devices in connection with post-mortem 

inspection and identification of adulterated products and insanitary 

equipment and facilities.



    (a) The official marks required by parts 310 and 416 of this 

chapter for use in post-mortem inspection and identification of 

adulterated products and insanitary equipment and facilities are:

* * * * *

    (3) The ``U.S. Rejected'' mark which is used to identify insanitary 

buildings, rooms, or equipment as prescribed in part 416, Sec. 416 of 

this chapter and is applied by means of a paper tag (Form MP-35) 

bearing the legend ``U.S. Rejected.''

* * * * *



PART 314--HANDLING AND DISPOSAL OF CONDEMNED OR OTHER INEDIBLE 

PRODUCTS AT OFFICIAL ESTABLISHMENTS



    14. The authority citation for part 314 continues to read as 

follows:



    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



    15. Section 314.2 is revised to read as follows:





Sec. 314.2  Tanking and other facilities for inedible products to be 

separate from edible product facilities.



    All tanks and equipment used for rendering, otherwise preparing, or 

storing inedible products must be in rooms or compartments separate 

from those used for preparing or storing edible products. There may be 

a connection between rooms or compartments containing inedible products 

and those containing edible products as long as it does not cause the 

adulteration of edible product or create insanitary conditions.

    16. Section 314.4 is revised to read as follows:





Sec. 314.4  Suppression of odors in preparing inedible products.



    Tanks, fertilizer driers, and other equipment used in the 

preparation of inedible product must be operated in a manner that will 

suppress odors incident to such preparation which could adulterate 

edible product or create insanitary conditions.



PART 327--IMPORTED PRODUCTS



    17. The authority citation for part 327 continues to read as 

follows:



    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.





Sec. 327.6  [Amended]



    18. In Sec. 327.6, paragraph (e) is amended by removing the phrase 

`` 308.3, 308.4, 308.5, 308.6, 308.7, 308.8, 308.9, 308.11, 308.13, 

308.14, 308.15'' and adding the phrase ``416.1 through 416.6 of this 

chapter'' in its place.



PART 331--SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; 

AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH 

AND FOR SUCH DESIGNATED ESTABLISHMENTS



    19. The authority citation for part 331 continues to read as 

follows:



    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.



    20. Section 331.3, paragraph (c), is revised to read as follows:





Sec. 331.3  States designated under paragraph Sec. 301(c) of the Act; 

application of regulations.



* * * * *

    (c) Sections 416.2(c), (d), (e), (f), and (h) of this chapter shall 

apply to such establishments.

* * * * *



PART 350--SPECIAL SERVICES RELATING TO MEAT AND OTHER PRODUCTS



    21. The authority citation for part 350 continues to read as 

follows:



    Authority: 21 U.S.C. 1622, 1624; 7 CFR 2.17, 2.55.





Sec. 350.3  [Amended]



    22. Section 350.3, paragraph (a)(2) is amended by removing the 

phrase ``part 308'' and adding the phrase ``part 416, Secs. 416.1 

though 416.6 of this chapter'' in its place.



PART 362--VOLUNTARY POULTRY INSPECTION REGULATIONS



    23. The authority citation for part 362 continues to read as 

follows:



    Authority: 21 U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), 2.55.





Sec. 362.2  [Amended]



    24. The second sentence of Sec. 362.2(a) is amended by removing the 

phrase ``subchapter C of this chapter'' and adding the phrase 

``subchapter A and subchapter E, part 416, Secs. 416.1 through 416.6 of 

this chapter'' in its place.



PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS



    25. The authority citation for part 381 continues to read as 

follows:



    Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 21 U.S.C. 451-470; 7 

U.S.C. 2.18, 2.53.



    26. In Sec. 381.1, paragraph (b)(39) is removed.

    27. Section 381.36, is amended as follows:

    a. Paragraph (c)(1)(iv) is revised,

    b. Paragraph (c)(1)(vi), is amended by removing the phrase 

``complying with Sec. 381.53(g)(4) of this part'',

    c. Paragraphs (c)(1)(vii), (viii) and (x) are revised,

    d. In Paragraph (d)(1)(vi), the first sentence is amended by 

removing the phrase ``complying with Sec. 381.53(g)(4) of this part'',

    e. In paragraph (d)(1)(viii), the first sentence is amended by 

removing the phrase ``, notwithstanding the requirement of 

Sec. 381.52(b)'',

    f. Paragraph (d)(1)(xi) is revised,

    g. In paragraph (e)(1)(v), the first sentence is amended by 

removing the phrase ``complying with Sec. 381.53(g)(4)'', and

    h. Paragraph (e)(1)(ix) is revised.

    These revisions to Sec. 381.36 read as follows:





Sec. 381.36  Facilities required.



* * * * *

    (c) * * *

    (1) * * *

    (iv) Each inspector's station shall have a platform that is slip-

resistant and can be safely accessed by the inspector. The platform 

shall be designed so that it can be easily and rapidly adjusted for a 

minimum of 14 inches vertically while standing on the platform. The 

platform shall be a minimum length of 4 feet and have a minimum width 

of 2 feet; the platform shall be designed with a 42-inch high rail on 

the back side and with \1/2\-inch foot bumpers on both sides and front 

to allow safe working conditions. The platform must have a safe lift 

mechanism and be large enough for the inspector to sit on a stool and 

to change stations during breaks or station rotation.

* * * * *

    (vii) A minimum of 200-footcandles of shadow-free lighting with a 

minimum color rendering index value of 85 where the birds are inspected 

to facilitate inspection.

    (viii) Online handrinsing facilities with a continuous flow of 

water must be provided for and within easy reach of each inspector and 

each establishment helper. The hand-contact element must be rinsed 

automatically with a sufficient volume of water to remove all fat, 

tissue, debris, and other extraneous material from the hand contact 

element after each use. Both hot and cold running water shall be 

available at each inspection station on the eviscerating line and shall 

be delivered through a suitable mixing device controlled by the 

inspector. Alternatively, water for hand washing shall be delivered to 

such



[[Page 56417]]



inspection stations at a minimum temperature of 65 degrees F.

    (ix) * * *

    (x) Each inspection station shall be provided with receptacles for 

condemned carcasses and parts. Such receptacles shall comply with the 

performance standards in Sec. 416.3(c) of this chapter.

* * * * *

    (d) * * *

    (1) * * *

    (xi) Each inspection station shall be provided with receptacle for 

condemned carcasses and parts. Such receptacles shall comply with the 

performance standards in Sec. 416.3(c) of this chapter.

* * * * *

    (e) * * *

    (1) * * *

    (ix) Each inspection station shall be provided with receptacles for 

condemned carcasses and parts. Such receptacles shall comply with the 

performance standards in Sec. 416.3(c) of this chapter.

* * * * *





Secs. 381.45-381.61   (Subpart H)--Sanitation  [Removed and reserved]



    28. Remove and reserve Subpart H, consisting of Secs. 381.45--

381.61.

    29. Section 381.99 is revised to read as follows:





Sec. 381.99  Official retention and rejection tags.



    The official marks for use in post-mortem inspection and 

identification of adulterated products, insanitary equipment and 

facilities are:

    (a) A paper tag (a portion of Form MP-35) bearing the legend ``U.S. 

Retained'' for use on poultry or poultry products under this section.

    (b) A paper tag (another portion of Form C&MS 510) bearing the 

legend ``U.S. Rejected'' for use on equipment, utensils, rooms and 

compartments under this section.



PART 416--SANITATION



    30. The authority citation for part 416 continues to read as 

follows:



    Authority: 21 U.S.C. 451-470, 601-680; 7 U.S.C. 450; 7 CFR 2.18, 

2.53.



    31. Part 416 is amended by adding new Secs. 416.1 through 416.6, as 

follows:





Sec. 416.1  General rules.



    Each official establishment must be operated and maintained in a 

manner sufficient to prevent the creation of insanitary conditions and 

to ensure that product is not adulterated.





Sec. 416.2  Establishment grounds and facilities.



    (a) Grounds and pest control. 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 program employees. Establishments must have in place a pest 

management program to prevent the harborage and breeding of pests on 

the grounds and within establishment facilities. Pest control 

substances used must be safe and effective under the conditions of use 

and not be applied or stored in a manner that will result in the 

adulteration of product or the creation of insanitary conditions.

    (b) Construction. (1) Establishment buildings, including their 

structures, rooms, and compartments must be of sound construction, be 

kept in good repair, and be of sufficient size to allow for processing, 

handling, and storage of product in a manner that does not result in 

product adulteration or the creation of insanitary conditions.

    (2) Walls, floors, and ceilings within establishments must be built 

of durable materials impervious to moisture and be cleaned and 

sanitized as necessary to prevent adulteration of product or the 

creation of insanitary conditions.

    (3) Walls, floors, ceilings, doors, windows, and other outside 

openings must be constructed and maintained to prevent the entrance of 

vermin, such as flies, rats, and mice.

    (4) Rooms or compartments in which edible product is processed, 

handled, or stored must be separate and distinct from rooms or 

compartments in which inedible product is processed, handled, or 

stored, to the extent necessary to prevent product adulteration and the 

creation of insanitary conditions.

    (c) Light. Lighting of good quality and sufficient intensity to 

ensure that sanitary conditions are maintained and that product is not 

adulterated must be provided in areas where food is processed, handled, 

stored, or examined; where equipment and utensils are cleaned; and in 

hand-washing areas, dressing and locker rooms, and toilets.

    (d) Ventilation. Ventilation adequate to control odors, vapors, and 

condensation to the extent necessary to prevent adulteration of product 

and the creation of insanitary conditions must be provided.

    (e) Plumbing. Plumbing systems must be installed and maintained to:

    (1) Carry sufficient quantities of water to required locations 

throughout the establishment;

    (2) Properly convey sewage and liquid disposable waste from the 

establishment;

    (3) Prevent adulteration of product, water supplies, equipment, and 

utensils and prevent the creation of insanitary conditions throughout 

the establishment;

    (4) Provide adequate floor drainage in all areas where floors are 

subject to flooding-type cleaning or where normal operations release or 

discharge water or other liquid waste on the floor;

    (5) Prevent back-flow conditions in and cross-connection between 

piping systems that discharge waste water or sewage and piping systems 

that carry water for product manufacturing; and

    (6) Prevent the backup of sewer gases.

    (f) Sewage disposal. Sewage must be disposed into a sewage system 

separate from all other drainage lines or disposed of through other 

means sufficient to prevent backup of sewage into areas where product 

is processed, handled, or stored. When the sewage disposal system is a 

private system requiring approval by a State or local health authority, 

the establishment must furnish FSIS with the letter of approval from 

that authority upon request.

    (g) Water supply and water, ice, and solution reuse. (1) A supply 

of running water that complies with the National Primary Drinking Water 

regulations (40 CFR part 141), at a suitable temperature and under 

pressure as needed, must be provided in all areas where required (for 

processing product, for cleaning rooms and equipment, utensils, and 

packaging materials, for employee sanitary facilities, etc.). If an 

establishment uses a municipal water supply, it must make available to 

FSIS, upon request, a water report, issued under the authority of the 

State or local health agency, certifying or attesting to the potability 

of the water supply. If an establishment uses a private well for its 

water supply, it must make available to FSIS, upon request, 

documentation certifying the potability of the water supply that has 

been renewed at least semi-annually.

    (2) Water, ice, and solutions (such as brine, liquid smoke, or 

propylene glycol) used to chill or cook ready-to-eat product may be 

reused for the same purpose, provided that they are maintained free of 

pathogenic organisms and fecal coliform organisms and that other 

physical, chemical, and microbiological contamination have been reduced 

to prevent adulteration of product.

    (3) Water, ice, and solutions used to chill or wash raw product may 

be reused for the same purpose provided that measures are taken to 

reduce physical, chemical, and microbiological



[[Page 56418]]



contamination so as to prevent contamination or adulteration of 

product. Reuse that which has come into contact with raw product may 

not be used on ready-to-eat product.

    (4) Reconditioned water that has never contained human waste and 

that has been treated by an onsite advanced wastewater treatment 

facility may be used on raw product, except in product formulation, and 

throughout the facility in edible and inedible production areas, 

provided that measures are taken to ensure that this water meets the 

criteria prescribed in paragraph (g)(1) of this section. Product, 

facilities, equipment, and utensils coming in contact with this water 

must undergo a separate final rinse with non-reconditioned water that 

meets the criteria prescribed in paragraph (g)(1) of this section.

    (5) Any water that has never contained human waste and that is free 

of pathogenic organisms may be used in edible and inedible product 

areas, provided it does not contact edible product. For example, such 

reuse water may be used to move heavy solids, to flush the bottom of 

open evisceration troughs, or to wash antemortem areas, livestock pens, 

trucks, poultry cages, picker aprons, picking room floors, and similar 

areas within the establishment.

    (6) Water that does not meet the use conditions of paragraphs 

(g)(1) through (g)(5) of this section may not be used in areas where 

edible product is handled or prepared or in any manner that would allow 

it to adulterate edible product or create insanitary conditions.

    (h) Dressing rooms, lavatories, and toilets. (1) Dressing rooms, 

toilet rooms, and urinals must be sufficient in number, ample in size, 

conveniently located, and maintained in a sanitary condition and in 

good repair at all times to ensure cleanliness of all persons handling 

any product. They must be separate from the rooms and compartments in 

which products are processed, stored, or handled.

    (2) Lavatories with running hot and cold water, soap, and towels, 

must be placed in or near toilet and urinal rooms and at such other 

places in the establishment as necessary to ensure cleanliness of all 

persons handling any product.

    (3) Refuse receptacles must be constructed and maintained in a 

manner that protects against the creation of insanitary conditions and 

the adulteration of product.





Sec. 416.3  Equipment and utensils.



    (a) Equipment and utensils used for processing or otherwise 

handling edible product or ingredients must be of such material and 

construction to facilitate thorough cleaning and to ensure that their 

use will not cause the adulteration of product during processing, 

handling, or storage. Equipment and utensils must be maintained in 

sanitary condition so as not to adulterate product.

    (b) Equipment and utensils must not be constructed, located, or 

operated in a manner that prevents FSIS inspection program employees 

from inspecting the equipment or utensils to determine whether they are 

in sanitary condition.

    (c) Receptacles used for storing inedible material must be of such 

material and construction that their use will not result in the 

adulteration of any edible product or in the creation of insanitary 

conditions. Such receptacles must not be used for storing any edible 

product and must bear conspicuous and distinctive marking to identify 

permitted uses.





Sec. 416.4  Sanitary operations.



    (a) All food-contact surfaces, including food-contact surfaces of 

utensils and equipment, must be cleaned and sanitized as frequently as 

necessary to prevent the creation of insanitary conditions and the 

adulteration of product.

    (b) Non-food-contact surfaces of facilities, equipment, and 

utensils used in the operation of the establishment must be cleaned and 

sanitized as frequently as necessary to prevent the creation of 

insanitary conditions and the adulteration of product.

    (c) Cleaning compounds, sanitizing agents, processing aids, and 

other chemicals used by an establishment must be safe and effective 

under the conditions of use. Such chemicals must be used, handled, and 

stored in a manner that will not adulterate product or create 

insanitary conditions. Documentation substantiating the safety of a 

chemical's use in a food processing environment must be available to 

FSIS inspection program employees for review.

    (d) Product must be protected from adulteration during processing, 

handling, storage, loading, and unloading at and during transportation 

from official establishments.





Sec. 416.5  Employee hygiene.



    (a) Cleanliness. All persons working in contact with product, food-

contact surfaces, and product-packaging materials must adhere to 

hygienic practices while on duty to prevent adulteration of product and 

the creation of insanitary conditions.

    (b) Clothing. Aprons, frocks, and other outer clothing worn by 

persons who handle product must be of material that is disposable or 

readily cleaned. Clean garments must be worn at the start of each 

working day and garments must be changed during the day as often as 

necessary to prevent adulteration of product and the creation of 

insanitary conditions.

    (c) Disease control. Any person who has or appears to have an 

infectious disease, open lesion, including boils, sores, or infected 

wounds, or any other abnormal source of microbial contamination, must 

be excluded from any operations which could result in product 

adulteration and the creation of insanitary conditions until the 

condition is corrected.





Sec. 416.6  Tagging insanitary equipment, utensils, rooms or 

compartments.



    When an FSIS program employee finds that any equipment, utensil, 

room, or compartment at an official establishment is insanitary or that 

its use could cause the adulteration of product, he will attach to it a 

``U.S. Rejected'' tag. Equipment, utensils, rooms, or compartments so 

tagged cannot be used until made acceptable. Only an FSIS program 

employee may remove a ``U.S. Rejected'' tag.



    Done in Washington, DC on October 6, 1999.

Thomas J. Billy,

Administrator.

[FR Doc. 99-26983 Filed 10-19-99; 8:45 am]

BILLING CODE 3410-DM-P