Sanitation Requirements for Official Meat and Poultry Establishments

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.

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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difficult to understand, redundant, or outdated.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