1750 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 381 and 441

[Docket No. 97–054F]

RIN 0583–AC26

Retained Water in Raw Meat and

Poultry Products; Poultry Chilling

Requirements

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Final rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is issuing

regulations to limit the amount of water

retained by raw, single-ingredient, meat

and poultry products as a result of postevisceration processing, such as carcass

washing and chilling. Raw livestock and

poultry carcasses and parts will not be

permitted to retain water resulting from

post-evisceration processing unless the

establishment preparing those carcasses

and parts demonstrates to FSIS, with

data collected in accordance with a

written protocol, that any water retained

in the carcasses and parts is an

inevitable consequence of the process

used to meet applicable food safety

requirements. In addition, the

establishment will be required to

disclose on the labeling of the meat or

poultry products the maximum

percentage of retained water in the raw

product. The required labeling

statement will help consumers of raw

meat and poultry products to make

informed purchasing decisions.

Establishments having data

demonstrating that there is no retained

water in their products can choose not

to label the products with the retainedwater statement or to make a noretained-water claim on the product

label.

FSIS is also revising the poultry

chilling regulations to improve

consistency with the Pathogen

Reduction/Hazard Analysis and Critical

Control Points (PR/HACCP) regulations,

eliminate ‘‘command-and-control’’

features, and reflect current

technological capabilities and good

manufacturing practices.

DATES: Effective Date: This rule is

effective on January 9, 2002.

Establishments wishing to implement

the provisions of this final rule prior to

the effective date should contact the

appropriate FSIS District Office. FSIS

will provide instructions to its

inspection program personnel for

facilitating early implementation.

Comments: Comments on the

guidance material published in

Appendix A should be received by

April 9, 2001. Comments responding to

information requested in the preamble

to this final rule should be received by

FSIS by April 9, 2001.

ADDRESSES: Submit one original and

two copies of written comments to

Docket Clerk, U.S. Department of

Agriculture, Food Safety and Inspection

Service, Room 102, 300 12th Street,

SW., Washington, DC 20250–3700.

Please refer to docket number 97–054F

in your comments. All comments

submitted on this rule, as well as the

research and background information

used by FSIS in developing this

document, will be available for public

inspection in the Docket Clerk’s Office

between 8:30 a.m. and 4:30 p.m.,

Monday through Friday. The final

regulatory impact analysis referred to in

this document and summarized in the

section discussing the Agency’s

compliance with Executive Order 12866

is available for viewing on the Agency’s

Internet homepage located at ‘‘http://

www.fsis.usda.gov’’.

FOR FURTHER INFORMATION CONTACT: Ms.

Patricia F. Stolfa, Assistant Deputy

Administrator, Office of Policy, Program

Development and Evaluation, Food

Safety and Inspection Service, U.S.

Department of Agriculture, Washington,

DC 20250–3700; (202) 205–0699.

SUPPLEMENTARY INFORMATION:

Background

FSIS carries out the mandates of the

Federal Meat Inspection Act (FMIA; 21

U.S.C. 601 et seq.), the Poultry Products

Inspection Act (PPIA; 21 U.S.C. 451 et

seq.), and the Egg Products Inspection

Act (21 U.S.C. 1031 to 1056) to ensure

that meat, meat food, poultry, and egg

products prepared for distribution in

commerce are wholesome, not

adulterated, and properly marked,

labeled, and packaged. The FMIA and

PPIA prohibit anyone from selling,

transporting, offering for sale or

transportation, or receiving for

transportation in commerce, of any

adulterated or misbranded meat or

poultry product (21 U.S.C. 610, 458).

Under the Acts (21 U.S.C. 601(m)(8);

453(g)(8)), a product is adulterated if,

among other circumstances in which it

might be adulterated, ‘‘any substance

has been added thereto or mixed or

packed therewith so as to increase its

bulk or weight, or reduce its quality or

strength, or make it appear better or of

greater value than it is.’’ Under the same

Acts (21 U.S.C. 601(n)(1), (12) and 21

U.S.C. 453(h)(1), (12)) a product is

misbranded if, among other

circumstances in which it might be

misbranded, ‘‘its labeling is false or

misleading in any particular.’’

FSIS provides continuous inspection

in meat and poultry slaughtering and

processing establishments and in egg

product processing plants to ensure that

the establishments sell in commerce

only products that are not adulterated or

misbranded. At meat and poultry

slaughtering establishments, FSIS

enforces requirements intended to

prevent the adulteration of carcasses

and parts during post-evisceration

processing, handling, and storage. Some

of these requirements concern the

washing and chilling of the carcasses

and parts.

After evisceration, raw livestock and

poultry carcasses are subject to various

processes, including washing and

chilling, to ensure the safety of the

products. In livestock slaughtering

establishments, air chilling causes

carcass weight loss from evaporation of

the natural water in the carcass during

evaporative cooling. Spraying water on

livestock carcasses during air chilling

either replaces the water that would

have evaporated during air chilling or

prevents the water in the carcass from

evaporating. The result is that livestock

carcasses subjected to a water spray do

not lose weight through evaporation.

Establishments should operate water

spray systems in a manner that does not

result in an increase in the average

weight of a group of livestock carcasses

produced during a scheduled period of

operations over the carcasses’ prechilled weight. FSIS Directive 6330.1,

which describes the Agency’s policies

on the spray-chilling of carcasses,

recognizes that it is technologically

feasible and commercially practical to

chill livestock carcasses in a manner

that, on average, does not result in an

increase in the carcass weight above the

pre-chilled weight.

However, the processing and chilling

methods used for some edible meat

byproducts and organ meats may result

in water retention. For example, cheek

meat, meat from ears and tails, and

organ meats are washed, cleaned, and

chilled to preserve safety and

wholesomeness before being shipped.

Chitterlings (swine intestines) are

washed and chilled before shipment

and are packaged with water. A few

establishments chill beef cheek meats in

water, a process that may result in the

absorption of water. The product is

labeled to indicate the maximum

percentage added water it may contain

to alert buyers to the fact that the

product may weigh more because of the

chilling process.

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1751

Unlike meat packers, poultry

processors have traditionally chilled

poultry using the water-immersion

chilling method. Although air chilling is

permitted, immersion chilling is more

rapid and cost efficient. The use of

water immersion chilling is limited to

whole poultry carcasses or major carcass

portions. Poultry establishments are

required to reduce the internal

temperature of water-chilled poultry

carcasses to 40 °F or less within 4 to 8

hours after slaughter, depending on the

size of the carcass (9 CFR 381.66(b)).

Chilling poultry carcasses in waterimmersion chillers always results in

some absorption and retention of water,

primarily in the skin and the tissue

immediately under the skin. Also, some

water becomes bound to the muscle

tissue.

FSIS has consistently required that

the retention of water in meat and

poultry products be minimized. FSIS is

mandated to prevent the distribution in

commerce of meat, meat food and

poultry products that are adulterated or

misbranded.

Immersion chilling of poultry could

result in a product becoming

misbranded or economically adulterated

through the retention of absorbed water.

Nonetheless, since immersion chilling is

an efficient way to control bacterial

growth in poultry products and to

ensure that establishments consistently

meet applicable chilling time and

temperature requirements, FSIS has

permitted the retention of some water in

poultry products. The Agency requires,

however, that retained water amounts

be minimized (9 CFR 381.66(d)(1)) and

has set limits on the amount of water a

poultry product may retain (9 CFR

381.66(d)(2)–(4)).

The Agency promulgated regulations

limiting water absorption and retention

in poultry products in 1959, 1961, and

1970 (24 FR 9566, December 1, 1959; 26

FR 6471, July 19, 1961; 35 FR 15739,

October 7, 1970). The retained-water

limits were based on carcass weight and

intended use of the product. For

example, higher limits were provided

for birds that were to be cut-up than for

those to be sold as whole birds because,

when the birds are cut up, water

retained at or near those higher limits

declines below the regulatory limits for

whole birds. If water has not been

minimized, the product may be

considered adulterated. Such product

may also be considered misbranded if

its labeling does not disclose the

presence of retained water at levels

higher than the required limits. Until a

Federal court set aside the regulatory

limits on retained water in poultry

products, public knowledge of the limits

obviated the need for a requirement for

retained water to be disclosed on a

product label. Without published limits

on retained water, FSIS cannot

adequately protect consumers from

adulteration and misbranding due to

excessive retained water in whole birds.

FSIS, however, lacks information on

which to decide what level, if any, of

retained water would not constitute

adulteration, or to determine whether

the limits that are in use do not result

in adulteration.

Provisions To Limit Retained Water in

Raw Meat and Poultry Products

On September 11, 1998, FSIS

proposed regulations that would limit

the amount of water retained by raw

carcasses and parts of livestock and

poultry as a result of post-evisceration

processing, such as carcass washing and

chilling. Under the proposal, meat and

poultry carcasses and parts could not

retain water from such processing

unless the establishment preparing the

carcasses and parts demonstrated that

water retention is an unavoidable

consequence of procedures necessary to

meet applicable food safety

requirements. FSIS also proposed to

require that the establishment disclose

on the product labeling the maximum

percentage of retained water in the

product. The labeling statement would

provide information that would be

helpful to consumers in making

purchasing decisions. An establishment

having data demonstrating that there is

no retained water in the products could

choose not to label the products with

the retained-water statement or to make

a no-retained-water claim on the

product label. The proposed

requirements were intended to replace

those set forth in 9 CFR 381.66(d)(2)–(8).

The purpose of the proposed

requirements was to restrict, as much as

feasible, the amount of water absorbed

and retained in raw meat and poultry

products.

The proposed rule was prompted by

longstanding industry petitions and by

the Agency’s need to reform its

regulations to make them more

consistent with its Pathogen Reduction/

Hazard Analysis and Critical Control

Point System (PR/HACCP) regulations,

in accordance with its regulatory reform

agenda. The rulemaking gained further

impetus in the wake of a July 23, 1997,

Federal court decision in Kenney v.

Glickman vacating the regulations in 9

CFR 381.66(d)(2) that contain the waterretention tables for poultry.

As explained above, FSIS has

consistently required that the retention

of water in meat and poultry be

minimized and has considered product

with too much retained water to be

adulterated. FSIS used the retained

water limits specified in § 381.66(d)(2)

to determine whether poultry

establishments were meeting the

requirement to minimize water

absorption and absorption and retention

in whole birds. The decision in Kenney

v. Glickman, however, removed this

regulation because its basis was

inadequate, and left the Agency without

a regulatory limit, greater than zero

percent, at or below which it could

consider retained water in whole

poultry to have been minimized. The

limits for cut-up or ice-pack poultry in

9 CFR 381.66(d)(3)–(6)) were unaffected

by the Court decision. This final rule

replaces retained water limits that have

been set out in the regulations with a

requirement that products not retain

water unless establishments

demonstrate that the retained water is

an unavoidable consequence of meeting

food safety requirements.

FSIS is aware that it may be difficult

to eliminate water retention for poultry

and some meat products while

continuing to meet applicable food

safety requirements. Even in operations

that yield raw product with zero-percent

retained water, there is a certain amount

of process variability. FSIS therefore

proposed an alternative to a zeropercent retained-water requirement.

Establishments would be required to

collect data, in accordance with a

protocol approved by FSIS, and

demonstrate that water retention is an

unavoidable consequence of the process

used to meet a food safety requirement,

such as the Salmonella performance

standards or time/temperature chilling

requirements. FSIS expected that, to

determine that any unavoidable water

retention is the minimum feasible, the

protocol would provide for testing the

process under alternative equipment

settings or other variables.

FSIS said in the proposal that it

would accept data generated from an

approved protocol to support water

retention levels for multiple

establishments using similar postevisceration processing techniques and

equipment. Depending on the design of

the protocol and the adequacy of the

data collected under it, the Agency

stated that the data could be used to

justify an industry-wide water-retention

limit, a limit applying to poultry

products processed by several

establishments, or a limit applying only

to a single establishment’s product.

Establishments using an industry-wide

or multi-establishment limit would have

to be able to demonstrate that the

conditions under which their products

1752 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

are processed match those specified in

the protocol used to justify the limit.

Comments

FSIS received 252 letters commenting

on the proposed rule. Most were from

members of the regulated industry.

Sixty-one were from companies,

company officials, or other individuals

associated with the meat industry, or

trade associations representing the

industry, including both producers and

packers. One hundred and sixty-nine

were from companies, company officials

or other individuals associated with the

poultry industry, or from trade

associations representing the industry,

including both producers and

processors. The rest were sent in by

consumer-advocacy groups and other

consumer-oriented organizations (3),

individual consumers (7), weights and

measures officials (7), a trade

association not exclusively concerned

with meat and poultry (1), technology

firms (3), and the European Union.

Consumers, consumer groups, and

commenters representing livestock

producer and meat packing interests

tended to favor the proposal or to

criticize it for not going far enough in

restricting water retention. Poultry

interests tended to oppose the proposal

or to favor extensive modifications.

Technology firms were divided on the

merits of the proposal and on processes

for improving food safety.

Comment summaries (each termed

‘‘Comment’’) by topic and Agency

responses follow:

Alleged Inequitable Regulatory

Treatment

Comment: Meat industry groups said

that FSIS must eliminate the substantial

inequity in the regulatory treatment of

meat, compared with the treatment of

poultry. They said that requirements for

chilling meat and poultry products must

be the same. The ‘‘equity’’ issue, they

said, remains unresolved by the

proposal, and that FSIS is maintaining

the status quo without offering

compelling food safety reasons for doing

so. Poultry chilling, they said, should be

subject to the same ‘‘rigorous

requirements’’ as those that apply to the

chilling of meat. The rule should be

science-based, equitable, and HACCPconsistent.

On the other side, poultry groups said

that the proposal does not treat poultry

equitably with meat. They said that the

meat industry uses spray chilling and

does not have to adhere to chilling time/

temperature requirements as does the

poultry industry. Moreover, they said,

organ meats are chilled in water without

regulatory limitation.

Poultry groups also suggested that the

proposed regulations may not apply

equally to livestock and poultry parts.

They said that ‘‘parts’’ in the meat

regulations has a connotation different

from that of ‘‘parts’’ in the poultry

regulations. They asserted that there are

few proposed changes that would affect

the chilling and labeling of meats.

Response: FSIS disagrees that it is not

resolving the ‘‘equity’’ issue. This

rulemaking clearly applies to both meat

and poultry products. Both meat and

poultry establishments must abide by

the retained-water minimization

requirements of this final rule. Also, the

retained-water labeling requirement will

make both meat and poultry product

establishments accountable to

consumers for water retention.

The point of the poultry industry

commenters with respect to the spray

chilling of meat carcasses is well taken,

and it is true that meat carcasses do not

have to meet chilling time/temperature

requirements as do poultry carcasses.

FSIS acknowledges the need to

address the issue involving the chilling

time and temperature requirements for

poultry that were raised in both the

American Meat Institute’s 1997 petition

and industry comments on this

rulemaking. However, as the Agency

indicated in the preamble to the

proposed rule (63 FR 48963, 48965),

FSIS did not intend to address this issue

in this but in a future rulemaking.

FSIS does not agree with the poultry

industry statement about the meaning of

‘‘parts’’ in the meat and poultry

regulations, nor does the Agency see the

relevance of the point to this rule. Raw,

single-ingredient meat and poultry

products, including parts of either meat

or poultry carcasses, are covered. Some

products of the meat industry that

previously have not been covered by a

retained-water regulation, e.g. livestock

organs and offal, are now covered by

this rule—a fact to which members of

the meat industry have objected.

If applying ‘‘the same rigorous

requirements’’ to poultry as to meat

means requiring the poultry industry to

adopt non-immersion-chilling methods,

this final rule will not accomplish that

objective. The food safety rationale for

mandating the use of a particular

technology has not been demonstrated.

Comment: FSIS is biased in favor of

the poultry industry when it states that

immersion chilling reduces overall

pathogen levels. There are other ways to

reduce pathogens. The Agency is

particularly biased in stating that

installing air chilling or air-spray

systems in the poultry industry would

be economically infeasible.

Response: FSIS acknowledges that

pre-chill treatments can be

advantageous in controlling bacteria and

in achieving the objectives of the

rulemaking. FSIS has never suggested,

however, that the purpose of immersion

chilling is to remove pathogens, but has

stated that chilling reduces the

temperature of the carcass and thus

inhibits the growth of pathogens and

other bacteria. FSIS stated in the

Preliminary Regulatory Impact Analysis

(PRIA) that requiring the poultry

industry to install air chilling or airspray chilling systems would entail

major construction costs (63 FR 48976).

FSIS does not consider this conclusion

of its analysis to be evidence of bias.

Comment: Poultry has been

immersion-chilled for decades. The

poultry and meat industries are different

and should be regulated differently.

Response: Different technologies may

be needed to produce safe products

from different species. FSIS is not

banning or discouraging the use of

immersion-chilling technologies to

produce safe poultry products. The

Agency is obligated, however, to take

the same regulatory approach to meat as

to poultry products, unless it finds,

based on the available record, that

different approaches are necessary.

Technology of Chilling and Bacterial

Control

Comment: FSIS should encourage

investment in technology adjustments

that prevent water retention in poultry.

The meat industry uses steam vacuum

and steam-and-hot-water pasteurization

without adding water weight via water

retention in carcasses.

Response: By requiring

establishments to justify unavoidable

retained water in food safety terms and

to apply retained-water labeling to their

products, the final rule will provide an

incentive for technological adjustments

that minimize water retention in

carcasses.

Comment: Consumer groups and meat

industry commenters asserted that FSIS

has failed to consider the most recent

information on the effectiveness of

chilling technologies other than

immersion chilling. They said FSIS

seemed to dismiss air chilling because

it could result in product discoloration.

Some noted that European processors

use air chilling, which does not have the

cross-contamination risks of chiller

baths.

Response: In framing the proposed

regulation, FSIS did not assume that

immersion chilling will be the

technology of choice for either the meat

or the poultry product industry.

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1753

FSIS has taken no position on the

safety or quality of air-chilled product

but has limited data on the effectiveness

of air chilling, especially in large-scale

operations of the kind that supply most

of the poultry products sold in the

United States.

Comment: Immersion chilling is the

best way to prevent potential food safety

problems. Using chilled water is the

most efficient, effective way to remove

carcass heat and is the best way to

achieve the purposes of HACCP. One

company reported data on post-chill

compared with pre-chill carcasses that

show a 73-percent reduction in

pathogenic organisms and an 85-percent

reduction in generic E. coli. After a

trisodium phosphate (TSP) carcass-rinse

treatment, the incidence of Salmonella

and E. coli is 0 percent. (Carcasses not

rinsed with TSP show 96 percent and 30

percent, respectively. Campylobacter

was found in 78 percent of untreated

carcasses, and in 46 percent after TSP

treatment.) The company maintained

that air-chilling methods are not so

effective, but that immersion chilling is

an effective and economical way to meet

the USDA time/temperature

requirement.

Response: FSIS appreciates the food

safety accomplishments of firms using

any post-evisceration processes, but

consumer protections other than food

safety must also be ensured. Although

immersion chilling can be effective in

controlling microbial growth, products

exposed to the process will retain water.

This final rule is intended to address

this problem.

Comment: A poultry processor who

uses air chilling stated that air chilling

is economically feasible. Analysis of

retail prices shows air-chilled poultry

yields 7 to 8 percent more poultry meat

to the consumer than does water-chilled

poultry.

Response: FSIS is not endorsing the

use by the regulated industry of a

particular technology.

Comment: Consumer groups cited

recent studies, including a 1987

conference paper by C.J. Thomas, et al.,

and a 1997 paper by M. Ristic, as

evidence of the advantages of airchilling technology.

Response: The paper by C.J. Thomas

et al. refers only in passing, in a

question-and-answer section, to an

increasing use of air-chilling processes.

The paper is not really about air

chilling.

The Ristic (1997) paper cited by the

commenters and other studies by the

same author have consistently shown

air-spray chilling to have certain

advantages over other methods. The

studies do not compare the feasibility of

air-spray chilling with that of other

chilling technologies in an industry

with a production volume as high as

that in the United States, nor do they

provide a basis for regulatory action

with respect to one or another

technology.

Comment: A European Union official

asked if there are scientific studies that

support immersion chilling, rather than

air-spray chilling, of livestock carcasses.

Response: FSIS is not aware of any

peer-reviewed study on the waterimmersion chilling of whole livestock

carcasses. Among studies on the efficacy

of livestock-carcass spray chilling,

including systems using anti-microbial

solutions, are:

Gill, C.O., and T. Jones, 1992.

Assessment of the hygienic efficiencies

of two commercial processes for cooling

pig carcasses. Food Microbiology

9(4):335–343.

Gill, C.O., and J. Bryant, 1997.

Assessment of the hygienic

performances of two beef carcass

cooling processes from product

temperature history data or enumeration

of bacteria on carcass surfaces, 1997.

Food Microbiology 14(6):593–602.

Gill, C.O., and T. Jones, 1997.

Assessment of the hygienic performance

of an air-cooling process for lamb

carcasses and a spray-cooling process

for pig carcasses. International Journal

of Food Microbiology, 38(2⁄3):85–93.

Grier, G.G., and B.D. Dills, 1988.

Bacteriology and retail case life of spraychilled pork. Canadian Institute of Food

Science and Technology journal 21:295–

299.

Hamby, P.L., J.W. Savell, G.R. Acuff,

C. Vanderzant, and H.R. Cross, 1987.

Spray-chilling and carcass

decontamination systems using lactic

and acetic acid. Meat Science 21:1–14.

Jericho, K.W.F., G. O’Laney, and G.C.

Kozub, 1998. Verification of the

hygienic adequacy of beef carcass

cooling processes by microbiological

culture and the temperature-function

integration technique. Journal of Food

Protection 61(10):1347–1351.

Stevenson, K.E., R.A. Merkel, and

H.C. Lee, 1978. Effects of chilling rate,

carcass fatness, and chlorine spray on

microbiological quality and case-life of

beef. Journal of Food Science 43:849–

852.

Comment: The ozonation process

achieves significant E. coli reductions

on carcasses sampled at post-chill. Any

rule permitting immersion chillers to

use ozonation should be supported.

Response: If it is true that ozonation

reduces generic E. coli populations,

establishments may find the process

useful in meeting requirements of the

PR/HACCP regulations. The FSIS

regulations do not prohibit use of

ozonation equipment with immersion

chillers. However, the Food and Drug

Administration must approve the use of

ozone for food processing purposes

before FSIS can allow it.

Time/Temperature Chilling

Requirement for Poultry

Comment: Some commenters

disputed the FSIS statement that ‘‘for

most poultry establishments, the

inevitable retained-water amount is the

‘minimum’ level that can be reached

with existing immersion chiller

equipment while still meeting the

chilling requirement (for poultry to

reach a temperature 40 °F or below

within a specified number of hours).’’

They stated that the poultry chilling

requirement (9 CFR 381.66(b)(2)) is a

command-and-control regulation that

the final rule should eliminate.

Commenters favoring both the meatindustry and the poultry-industry sides

of the water-retention issue argued for

immediate repeal of the poultry chilling

requirement. Some even thought the

proposal was premature and should be

withdrawn because it did not address

this matter.

Response: FSIS views the poultry

time/temperature 40 °F chilling

requirement as a food safety

performance-standard issue that would

best be addressed in a separate noticeand-comment rulemaking, which the

Agency plans to conduct. The Agency

believes that any performance standard

that might replace the 40 °F requirement

should be science-based, HACCPconsistent, and applicable to all species

subject to mandatory inspection. The

Agency is continuing to study this

matter and hopes to be able to propose

regulatory amendments in the coming

months. In the meantime, FSIS will

permit establishments to vary the

parameters of their chilling or other

processing operations as necessary to

meet the objectives of their data

collection protocols.

Product Quality Argument ‘‘Arbitrary

and Capricious’’

Comment: The product-quality-based

water-weight allowance is arbitrary and

capricious, claimed the plaintiffs in the

Kenney case. Quality is no problem in

Europe, where poultry is air-chilled or

air-spray-chilled. Adding water is

adding an ingredient to make a multiingredient product. The product should

be labeled to show the amount of

retained water that is necessary for food

safety purposes and the amount that is

necessary for food-quality purposes.

Response: The commenters’ criticism

is unwarranted. This rule is primarily

1754 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

intended to limit water retention

resulting from processing to the amount

that is unavoidable to achieve a food

safety objective. However, FSIS has

stated that, in their data collection

protocols, establishments may specify

determining product quality as a

secondary or tertiary purpose of the data

collection activity. This rulemaking

does not provide for an additional

retained-water amount that an

establishment may consider necessary

to maintain product quality.

Ready-to-cook poultry in Europe is

dryer than ready-to-cook poultry in the

United States. Whether United States

consumers will eventually demand

poultry that is similar to the European

product is a question that can be

answered by the market.

FSIS does not agree with the

statement that water should be

considered an ingredient in immersionchilled poultry products. Water is not

added to the products being chilled to

create new products.

Zero Retained Water

Comment: Various commenters

supported a zero-retained-water

standard for both meat and poultry

products. They said FSIS was wrong to

reject, as a reason for a zero-retainedwater standard, the argument that the

information benefit to consumers is

unlikely to exceed costs.

Consumer groups commented that

FSIS’s own figures show consumers pay

almost $1 billion/year for retained water

in poultry. They said FSIS should be

proposing zero retained water, and that

neither meat nor poultry products

should be allowed to gain water. The

proposal falls well short of what is

needed, they said, strongly preferring

Option 2 (zero retained water) in the

regulatory analysis to Option 6 (retained

water limits established by processes

necessary to meet food safety

requirements—the selected option).

They said FSIS should reconsider

Options 2 and 4 (retained water limits

based on best available technology

within traditional production practices).

Response: Mandating zero water

retention for the poultry industry would

be tantamount to requiring the retooling of the industry on an

economically prohibitive scale. FSIS

calculated that the resulting benefit to

consumers, an informational benefit,

would be slight in comparison to the

impact on the national economy. The

Agency calculated that consumers could

receive a desirable informational benefit

at a lower cost to society.

The proposal did not specify any

acceptable amount of retained water,

only that any amount that is retained be

no greater than the unavoidable amount

resulting from post-evisceration

processing to achieve regulatory food

safety requirements.

In the PRIA, FSIS suggested that the

value of poultry production could be

viewed as the production of poultry and

the production of water. The Agency

also said that another view was that the

water has no effect on the price of

poultry meat, but that the consumer is

simply not being informed of the

wholesale-price of poultry or turkey on

a zero-added-water basis. The Agency’s

concern in much of the PRIA was the

effect of full disclosure of retained water

on consumer purchasing. The Agency

concluded that this effect was unclear,

though beneficial. The Agency did not

take the position that water is literally

being sold at poultry prices.

In the FRIA, the Agency has not

attempted to quantify the overall

benefits of the rule. However, FSIS

rejected Option 2 and Option 4 because

the costs to industry would be

substantially disproportionate to

consumer benefits.

This rule will ensure that water

retention is limited to the amount

unavoidable for food safety reasons, and

that consumers are informed about this

water retention. In establishing zero

water retention as the default

requirement, the rule compels the

industry to justify scientifically any

amount of water retention in raw,

single-ingredient, meat or poultry

product. Water in excess of the amount

that is scientifically justified will

adulterate the product.

Comment: Individual commenters

generally supported the proposal on the

ground that consumers would not

purchase meat containing too much

water. Some even thought the Agency

should permit zero-percent retained

water. Commenters said they do not

know the exact water weight of poultry

product because it is not labeled. Some

said that added water in curing or other

processing is a consumer rip-off. One

commenter said immersion-chilling

water is a ‘‘fecal soup’’ in which poultry

are marinated.

Response: FSIS appreciates

commenters’ support for the general

direction of this rulemaking. The

Agency disagrees with the

characterization of poultry chillers

because the chillers efficiently reduce

carcass temperatures and slow microbial

growth. FSIS also disagrees that this

rule should impose an unconditional

limit of zero-percent retained water in

raw meat and poultry products.

Regarding added water in cured

products, curing is outside the scope of

the rulemaking. In any event, if a

product that contains a curing solution

weighs more than it did in the untreated

state, that fact must be reflected on the

product label.

Comment: A commenter with a

veterinary background claimed that

continuous chillers are insanitary

common baths to which there are

economically feasible alternatives.

These alternatives—chilling tunnels,

chill-spray conveyor lines, immersionchilled vacuum-packaged product—

should be explored, said the

commenter. Other alternatives are

unsatisfactory. Radiation treatments are

not wholly effective.

The commenter stated that irradiation

at doses lower than those resulting in

off-odors yields spore formers like C.

botulinum Type C. Irradiation kills

spoilage bacteria that can be indicators

of unwholesomeness.

As for antimicrobial interventions

used with immersion chillers,

chlorination of chiller water is not

entirely effective and forms toxic

organochlorine compounds that have

environmental impacts. Phosphates

used in post-chill dips facilitate water

retention.

Eliminating retained water in poultry

would ‘‘correct a consumer fraud and

[an] advantage poultry has over other

parts of the food industry.’’ The result

of imposing regulatory limits on water

retention after continuous chillers were

introduced was to allow the poultry

industry to sell ‘‘legally adulterated

product.’’

Response: Studies do not bear out the

feasibility of using technologies other

than immersion chilling that would

achieve the same food safety benefit on

the same scale. FSIS is not aware of any

technology other than food irradiation

that is 100-percent effective in

eliminating pathogens on raw meat or

poultry products. Irradiated product

generally is not shelf-stable. Through

proper control, sufficient numbers of

spoilage organisms remain to

successfully compete against outgrowth

of C. botulinum.

Regarding chlorination, FSIS agrees

that organochloride compounds form in

chlorinated poultry chill water.

Nevertheless, FSIS considers the

potential food safety benefits of

chlorination to outweigh the risks.

The adulteration hazard of

phosphates (extra water pick-up) that

are used on raw products is exaggerated

for two reasons. First, some phosphate

compounds, such as orthophosphate

dips, have been approved for use on raw

products but are not in general use.

Second, the treatment of raw products

with such anti-microbial phosphate

solutions as TSP should not be equated

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1755

with the addition of phosphate

compounds to pickle-cured meat

products to reduce the amount of

cooked out juices. Such food additives

become components of the products and

do cause the products to hold water.

On the charge that regulatory water

retention limits constitute legalized

adulteration and a fraud, the Agency

points out that the water retention that

it is allowing would have to be

disclosed on the label. Therefore, there

would be no fraud. The Agency also

believes that in appropriate

circumstances, it could determine that

some water retention is necessary, is

unavoidable, and would not need to be

disclosed. However, those

circumstances have not been established

in this rulemaking.

Data-Collection Protocol Requirement

Comment: Requiring an

establishment-generated data-collection

protocol for determining minimum

unavoidable retained moisture would be

arbitrary and capricious. FSIS has failed

to articulate uniform criteria for such a

protocol or a process for review of

protocols.

Response: FSIS does not have the data

necessary to set a regulatory limit on the

amount of moisture a raw, singleingredient product may retain. FSIS has

put the burden of developing data to

justify a level of retained water other

than zero on official establishments

because they are in the best position to

determine what they have to do

simultaneously to meet food safety

requirements and to minimize retained

water in their products. FSIS published

suggested protocol specifications for

comment on December 9, 1997 (62 FR

64767), and a list of expected elements

of protocols with the proposed rule. The

Agency received few comments on the

expected protocol elements. These

elements of protocol design give

industry flexibility in collecting data

that will be useful in determining waterretention limits on an establishment-byestablishment or industry-wide basis.

Regarding protocol review

procedures, as discussed below, in

response to comments, the Agency has

decided not to pre-approve the data

collection protocols establishments will

use because to do so would contradict

its regulatory policy which is opposed

to command-and-control regulation.

Comment: The proposal, with its

requirement for data-collection

protocols to be pre-approved by FSIS,

represents a return to command-andcontrol regulation.

Response: FSIS proposed that it

review the data-collection protocols

because of the need to ensure a degree

of uniformity in and scientific validity

of data-collection procedures for

establishing the amount of unavoidable

water retention. FSIS agrees with the

commenter, however, that the proposed

pre-approval of protocols would be a

command-and-control requirement. The

Agency, therefore, will not be preapproving such protocols. FSIS is

requiring, however, that an

establishment notify the Agency as soon

as the protocol is available for review.

FSIS will then have 30 days in which

it may object to or require changes in

the protocol.

Comment: A poultry industry

association opposed ‘‘pre-clearance of

retained water after pre-clearance of

data protocols.’’

Response: As stated in the preamble

of the proposal (at 63 FR 48964), the

labels with the retained-water

statements will be generically approved

pursuant to 9 CFR 317.5(b)(2) and

381.133(b)(2). Generically approved

labels may be used without being

submitted to the Agency for approval

provided that they show all mandatory

features and are not false or misleading.

FSIS samples generically approved

labels at establishments to determine

their compliance with labeling

requirements. With respect to labels

with retained-water statements, the

Agency may, from time to time, examine

the data collected by establishments to

ensure that the basis for label statements

is sound. The Agency, however, will not

pre-approve either the data or the waterretention limits the data are purported

to justify.

Protocol Approval Process

Comment: A European Union official

suggested that FSIS clarify the protocol

approval process: Would the

establishment, after it is recognized as

eligible, have to ‘‘submit systematically

a dossier’’ on final treatment of livestock

and poultry carcasses and parts?

Response: Foreign establishments

recognized as eligible to export to the

United States will not have to submit a

dossier to FSIS on water retention.

However, they will have to maintain a

file containing data that demonstrate

either that the product they ship

contains no retained water, or that it

contains no more than the amount that

is stated on the product label and that

such amount is no greater than the

amount that is unavoidable in achieving

food safety objectives. The data must be

collected under a protocol that is

acceptable to the foreign government.

Process for Determining Amount of

Unavoidable Retained Water

Comment: FSIS should more fully

describe the process for demonstrating

that retained water is unavoidable.

Response: FSIS is not prescribing a

method for determining the unavoidable

amount of retained water. Each

establishment should be able to choose

the method that is most appropriate for

its processing situation. However, a

slaughtering establishment should

consider varying its process in whatever

manner seems most likely to reduce

carcass microbial counts and maintain

them at a low level. The establishment

should then measure the water retention

amounts corresponding to the respective

microbial reductions. A series of trials

to achieve pathogen reduction by

running chilling equipment at different

settings, making other process changes,

and plotting the microbial and waterretention data, should show what the

retained water levels in the product

were when any observed increase or

decrease in microbial counts occurred.

The establishment might consider

plotting available E. coli process-control

data, or Salmonella or other microbial

data that it has collected, on a time chart

with water-retention data collected on

the same product on the same dates. It

should then be possible to observe the

retained-water levels corresponding to

microbial counts on the same products.

From this information, an establishment

should be able to determine what is the

unavoidable level of retained water that

corresponds to the lowest microbial

counts.

FSIS is not prescribing any particular

method for establishments to use to

determine the amount of retained water

in their products. A number of chemical

and physical methods are available for

determining the amount of moisture in

foods, such as the method described in

Appendix A of this document.

Retained-Water Limits

Comment: There is no connection

between water retention and HACCP.

Response: Although this rulemaking

is intended to establish a basis for

controlling retained water in raw meat

and poultry products, it is understood

that retained water is an unavoidable

consequence of certain processes

commonly used to achieve food safety

objectives, such as immersing chickens

as a means of lowering the temperature

of carcasses while limiting the

opportunity for pathogen growth. This

objective derives from the need to meet

the pathogen reduction performance

standard, a food safety requirement that

must be met (63 FR 48963). While the

1756 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

Agency does not prescribe the critical

control points or critical limits that

establishments must include in their

HACCP plans, the failure by an

establishment to meet the pathogenreduction performance standards

constitutes failure to maintain an

adequate HACCP plan (9 CFR

310.25(b)(3)(iii), 381.94(b)(3)(iii)). Thus,

there is a relationship between this rule

and HACCP.

Comment: It is difficult to predict

with precision the amount of water that

may be retained. It would be difficult for

the industry to devise protocols and

guidelines necessary to comply with the

proposed rule. Changes in systems

would require changes in protocols,

which would have to be resubmitted for

approval to the Agency. This

requirement would be burdensome to

the industry and the Agency.

Response: Under this final rule, FSIS

may review, but will not pre-approve,

data-collection protocols developed by

establishments. FSIS does not expect

the development and use of a datacollection protocol for determining

unavoidable water retention to be

continuous. In most cases, protocol

development will be largely a one-timeonly expense. FSIS is taking a flexible

approach toward the data-collection

protocols. FSIS understands that there

are many factors that determine water

retention. If variables in the model used

in a protocol changed, FSIS would not

necessarily expect a whole new protocol

to be developed. The Agency is mainly

interested in knowing that the protocols

are scientifically valid, that the data

collected under them will reflect waterretention amounts that are unavoidable,

and that the data support the waterretention statements on product

labeling. For this reason, FSIS is

requiring that an establishment make its

new or revised protocol available for

review by the Agency, but FSIS will not

be pre-approving the protocol.

Comment: The proposed requirements

for limiting water retention and labeling

the amount of retained water are

redundant. If there is a labeling

requirement, there should be no

requirement for industry to limit water

retention. If there is a water-retention

requirement, there is no need for a

labeling requirement.

Response: The retained water

minimization and labeling requirements

are not redundant but address two

different legal prohibitions—

adulteration and misbranding. This rule

is intended to prevent adulteration and

misbranding of raw meat and poultry

products by ensuring that water

retention in the products is minimized

and by improving the availability of

information on water retention. The

retained-water minimization

requirement stems from the Agency’s

long-held view that excessive water

retention is a form of product

adulteration. The labeling requirement

is intended to help prevent

misbranding. It is intended to help

prevent potential buyers from being

misled about a characteristic of the

product—retained water—by providing

them with information about the

characteristic. Product labeling is one of

the most useful ways to provide such

information. The labeling requirement is

especially necessary in the wake of the

U.S. Court decision in Kenney which, by

setting aside the regulations that

prescribed limits for water retention in

ready-to-cook whole poultry, left

consumers without any information that

retained water was being held below a

certain maximum percentage.

Simply imposing a regulation that

limited water retention would not

inform consumers of the retained water

content of products unless specific

water retention limits were clearly

presented in the regulation. For reasons

discussed elsewhere in this document,

FSIS has found that it is not in a

position to impose such a regulation. On

the other hand, simply requiring

labeling would not be consistent with

the adulteration provisions of the FMIA

and PPIA. Unlimited retained water

would constitute economic adulteration

even if identified through labeling.

If an outcome of this rule were that no

raw, single-ingredient meat or poultry

product retained any water from

processing, a labeling requirement

might eventually be unnecessary.

Comment: A weights and measures

official said, regarding FSIS’s view that

‘‘excessive’’ water retention may

constitute adulteration, that the

proposal did not limit water in raw,

single-ingredient products but only

required a more technical justification.

Response: The final rule clearly does

limit water retention. The rule does not

flatly mandate zero-percent water

retention, but requires a demonstration

that any water retention is unavoidable.

Any retained-water percentage greater

than zero percent will be considered

excessive unless the percentage is

justified by data collected under a valid

protocol.

Food Safety Requirements

Comment: FSIS must identify the food

safety requirements to be met in the

post-evisceration or chilling process.

Response: In the PR/HACCP

regulations, FSIS has identified processcontrol criteria and pathogen-reduction

performance standards that

establishments must meet. In the

expected elements published with the

proposed rule on retained water, FSIS

stated its preference concerning the

purpose of a data-collection protocol: To

determine the amount or percentage of

moisture absorption and retention that

is unavoidable using a particular

chilling system while achieving the

pathogen-reduction performance

standard for Salmonella. In conducting

hazard analyses and developing their

HACCP plans, establishments may

identify additional or other food safety

objectives. It has been unnecessary in

this rulemaking to set out further food

safety requirements.

Retained-Water Labeling

Comment: Poultry industry

commenters suggested that the retainedwater labeling requirement was a

punishment for using the most effective

techniques. Some thought the retainedwater labeling provision might decrease

consumer demand for the labeled

products.

Response: FSIS has an obligation to

balance the interests in any situation.

While it is true that any water that will

be declared on the label will be the

unavoidable result of an effective

process, it is also true that the

misbranding and economic adulteration

provisions of the FMIA and PPIA make

clear the obligation of producers raw

meat or poultry products not to mislead

consumers. FSIS thinks that if they

market as meat or poultry a product that

contains something other than meat or

poultry, that fact should be disclosed.

Comments received in response to the

proposal are inconclusive on how

consumers will regard product with

labeled retained-water amounts,

although consumer advocacy groups

and some individual commenters

favored the labeling proposal.

Comment: Plaintiffs in Kenney

opposed the proposed labeling

provision, saying it would only be

sanctioning the reporting of illegal water

retention.

Response: FSIS disagrees. The Court

in the Kenney case held that, under the

PPIA, the Secretary of Agriculture had

the authority to require labeling of the

amount of retained water in and to

define a poultry product. (Kenney v.

Glickman, No. 4–94–CV–10402 (S.D.

Iowa, Jul. 23, 1997) (order granting

plaintiff and respondent motions for

summary judgment) at pp.12, 13.)

Comment: A turkey processor said

that the proposal would create a bagprinting headache for the poultry

industry because turkey processors ship

many products under private-label

brands.

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1757

Response: FSIS does not foresee a

problem in this regard. The purchasing

specifications provided by firms for

which processed birds are prepared

cannot be lower than the minimum

water retention of which the processor’s

technology is capable. The processor

should be able to order or produce bags

labeled with a retained-water statement

that routinely complies with the

regulation.

Comment: Industry groups suggested

that if labeling is needed, a percentretained-water statement could be either

in the product name or in the ingredient

statement, or the retained moisture

could be reflected in nutrition labeling

of the product.

Response: Placing the retained-water

statement in an ingredient statement

would imply that the product is

fabricated of more than one ingredient.

This implication would be misleading,

because the water that would be listed

in the ingredient statement is retained

from processing and not literally added

to the product to create a new meat or

poultry product.

FSIS also does not agree that nutrition

labeling can be used. First, assuming

that retained water could be regarded as

part of the product, and that the

nutrition labeling were accurate, few

consumers would notice changes in the

percentages of protein, fat, or other

nutrients resulting from a change in the

percentage of retained water in the

product. Also, a retained water

statement in a nutrition facts panel

would not be as conspicuous as one on

the principal display panel. Moreover,

because nutrition labeling of singleingredient products is still voluntary,

relatively few consumers of such

products would have the advantage of

even the limited amount of information

on water retention that nutrition labels

could convey.

Comment: A local weights and

measures agency stated that percentretained-water labeling should be

standardized and placed in a uniform

location on the package.

Response: FSIS wants to be as flexible

as possible, consistent with the

objective of informing the consumer of

the amount and presence of retained

water in affected product. The Agency

is requiring that the retained water

statement be contiguous to the product

name or elsewhere on the principal

display panel of the label.

Comment: Several companies and

groups wrote that if FSIS insists on a

labeling requirement, it should apply

only to processor-packaged product

intended for sale to consumers at retail.

The final rule should exempt from the

labeling requirement products intended

for export, products shipped in bulk for

further processing, and product to be

sold to institutions and food-service

operations.

Response: The commenters appear to

be alluding to exemptions in the FSIS

nutrition labeling regulations for

products intended for further

processing, certain products that are not

for sale to consumers, products

intended for export, certain products

sold at retail stores, and items on

restaurant menus (9 CFR 317.400(a)(2),

(3), (6), (7); 381.500(a)(2), (3), (6), (7)).

Those regulations were intended to be

consistent with the aim of the Nutrition

Labeling and Education Act and

regulations implemented by the Food

and Drug Administration, to assist

consumers in maintaining healthy

dietary practices. The preamble to the

FSIS nutrition labeling final rule states

the Agency’s goal of providing

consumers with more accurate and

complete nutritional information (58 FR

635; January 3, 1993). In response to

comments on its nutrition labeling

proposed rule, FSIS did provide

exemptions in the final rule of the sort

the commenter refers to, on the ground

that there was little value in requiring

nutrition information where the

consumer will not see it (58 FR 639).

However, unlike the nutrition labeling

regulations, this final rule is intended to

provide information directly both to

household consumers and to large

purchasers of meat and poultry

products. Product shipped in bulk

should be labeled accurately to ensure

accurate formulation of furtherprocessed products. Also, product

shipped to institutions and food-service

operations should be labeled with the

same accuracy as product shipped to

household consumers.

On the matter of exported product,

the industry does not produce, and FSIS

does not regulate, a separate class of

raw, single-ingredient, meat or poultry

product for export to which this rule

would not appropriately be applicable.

Thus, FSIS disagrees that export

product should be subject to retainedwater labeling requirements different

from those to which product for

domestic sale is subject.

Comment: The proposed retainedwater labeling requirement should be

adopted immediately.

Response: FSIS appreciates the

support for the labeling provision of the

proposal. The Agency, however, is

setting the effective date of the final rule

at 1 year following publication of the

rule in the Federal Register to mitigate

the effects of the rule on

establishments—particularly those that

are considered small businesses under

Small Business Administration

criteria—that may have to consider

changing or updating their chilling

processes and equipment.

This 1-year pre-implementation

period will enable FSIS to prepare

sampling, testing, and document review

procedures; train Agency personnel in

the new procedures; and develop a new

national reference database on the

natural moisture content of raw

products in the various meat and

poultry product classes. However,

establishments can voluntarily

implement the provisions of this rule in

advance of the effective date.

Comment: A local weights and

measures official commented that the

labeled water retention amount on

poultry products should not be based on

an average but should be applicable to

95 percent of individual birds.

Response: FSIS notes that this

comment was based on the analysis in

the PRIA of rulemaking Option 1—to

allow any percentage of retained water

so long as the percentage amount is on

the product label. FSIS will expect

establishment data collection protocols

(see § 441.10(d)) to include the sampling

and testing methods for determining

that food safety requirements (pathogen

reductions) are being met and the

testing methods for determining water

retention. FSIS will also expect the

protocols to explain how water

retention data are to be reported and

evaluated. The data collected by the

establishment should show with

reasonable confidence—i.e., 95-percent

statistical confidence—that a given

package retains no more water than is

unavoidable, and no more than the label

states.

Labeling Format

Comment: Rather than the statement

‘‘up to X% retained water’’ or ‘‘less than

X% retained water,’’ the label of

affected products should state,

‘‘contains X% added water.’’ The ‘‘up to

X%’’ statement prevents the consumer

from calculating the true price per

pound without added water weight. A

‘‘contains X%’’ statement would be

consistent with the ban on qualifying

terms in the Fair Packaging and

Labeling Act.

Response: Current production

practices yield product with varying

levels of water retention. It is therefore

difficult for an establishment to target

an exact water-retention percentage for

all its products of a certain class. FSIS

has taken this fact into consideration

and has framed the labeling

requirements of this final rule in a way

that will minimize inadvertent industry

noncompliance.

1758 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

It is true that a consumer may not be

able to compute the exact percentage of

retained water in a product labeled

‘‘with up to X% retained water.’’ The

establishment that prepared the

product, however, will have had to

determine a water-retention range based

on the data used to determine the

amount of retained water that is

unavoidable in the product. The

establishment will be free to label its

product with the water-retention

amount that reliably represents the

amount that is in the packaged product.

Consumers of the product will have

available more information on water

retention than they have had in the past.

Retained-Water Labeling and Product

Tare

Comment: If FSIS insists on a labeling

requirement, product tare should be

addressed. For example, if product

labeled as having 4-percent retained

water that loses 2 percent of the water

is sold in a wet-tare jurisdiction, how

would the product be labeled? How

would the regulation be applied?

Response: Compliance with netweight regulations is determined by

following the wet-tare and dry-tare

procedures in National Institute of

Standards and Technology (NIST)

Handbook 133, which is incorporated

by reference in the FSIS regulations at

9 CFR 317.19 and 381.121b. The actual

net weight of the product, as determined

on a lot-average basis by these

procedures, is compared with the

labeled net weight of the product.

The commenter did not say whether

the 2-percent moisture loss was

additional to or part of the 4-percent

retained-water amount represented on

the label. FSIS assumes that the 2-

percent loss is from the 4-percent

amount. Thus, in the example presented

by the commenter, the retained-water

statement should reflect that the

product contains at least 2 percent or as

much as 4 percent water from

processing.

Using the 3-pound dry-tare chicken

example presented in the PRIA and

FRIA, the product net weight in a wettare jurisdiction would be as much as

2.94 lb. or as little as 2.88 lb. The

labeled net weight corresponding to a

‘‘2-percent’’ retained-water statement

would be 2.94 lb. The loss to the

product, labeled with this net weight, of

an additional 2 percent in water weight

would raise the issue of short weighting.

The actual net weight of the package

would enter the ‘‘gray area’’ provided in

the NIST Handbook 133 procedures for

determining net-weight compliance in

wet-tare jurisdictions. FSIS and local

weights and measures authorities would

then follow the procedures provided for

gray-area product. Depending on the

wording of the retained-water statement,

this loss of additional moisture could

mean that the statement is inaccurate,

and the product misbranded for that

reason.

If a company has had difficulty in

determining the unavoidable amount of

retained water in the product, the

company should recheck the data on

which its determination of

‘‘unavoidable’’ is based, its datacollection protocol, and its processing

procedures.

If the company knows that the

product will lose 2 percent of net weight

because of water loss while in

distribution channels, the company

should adjust the retained-water

statement to account for the fact. If the

company knows that a retained-water

product will continue to retain a certain

percentage when it is sold in the wettare jurisdiction, the retained water

statement must account for that

percentage of water retention.

National Standard for Retained Water

Comment: Several commenters said

that if FSIS proceeds with the

rulemaking, the Agency should develop

national standards for ‘‘unavoidable

moisture retention.’’ Products should be

able to exceed the national standard if

labeled. Some argued that, based on

information in the PRIA at 63 FR 48978,

water retention could be held to 2–5%

with appropriate technology. Others

suggested that the Agency could simply

justify scientifically the water retention

limits in the regulations that were set

aside.

Response: To be valid, a national

standard such as envisioned by the

commenters would have to be

applicable to homogeneous products

produced under similar conditions.

The currently available data on water

retention provide an inadequate basis

for setting any retained-water standard

because the data that could be applied

to the industry are based on industry

practices that conformed to the

regulations that the U.S. District Court

set aside in Kenney v. Glickman. The

Court set the regulations aside, in part,

because USDA had not adequately

explained how the particular water

retention limits in the regulations were

determined or why water retention

could not be reduced below those

levels.

FSIS would have to have new data,

collected under new protocols and

criteria that meet the concerns

expressed in the Court decision in

Kenney to be able to revive the previous

regulations, including updated tables

listing the water retention limits for

poultry. In other words, the Agency

would have to be able adequately to

explain how the particular water

retention limits were determined and

why they could not be further reduced.

Moreover, the Agency would have to be

able to explain adequately how such

regulations would apply to meat and

poultry. Commenters did not state how

this could be done.

FSIS agrees with the commenter who

cited the analysis in the PRIA of

available water retention data. This

analysis indicates that water retention

can be held at substantially below the

regulatory limits that were set aside by

the United States District Court in

Kenney v. Glickman. It thus seems

unlikely that new data would support

the limits in the regulations that were

set aside.

Comment: Even with supporting data,

an industry-wide water-retention

standard could still be ‘‘arbitrary and

capricious.’’

Response: Depending on the design of

the protocol and the adequacy of the

data collected, a limit applying to the

products of one or more establishments

could be scientifically justified and not

be arbitrary and capricious.

Costs of Rule

Comment: Compliance to ensure

labeling accuracy should not result in

added costs.

Response: The data-collection and

labeling requirements will be minimal

for meat establishments whose products

do not gain water. Poultry

establishments will have to collect data

to determine the minimum waterretention levels in their products and

will have to be able to verify on a

continuing basis the accuracy of their

product labels. Establishments will not

necessarily have to conduct more tests

or collect more data than they have been

collecting under the regulations that this

rule replaces. Thus, day-to-day costs of

complying with the requirements for

labeling accuracy will not be greater

than past costs of complying with waterretention requirements.

Measuring Retained Water

Comment: The water retention

amount should be measured as the

difference between the ‘‘hot carcass

weight’’ and finished package weight of

the product. The second amount should

be measured at the point of packaging.

Response: Establishments may use inplant methods, such as weighing

carcasses before and after washing or

chilling procedures, as a means of

controlling water retention. However,

FSIS emphasizes that compliance with

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1759

this final rule will primarily depend on

whether the retained-water amount of

the product in distribution channels, i.e.

the retained water weight of the product

at the time it enters commerce, is no

greater than the amount that is

demonstrably unavoidable. FSIS intends

to subject product samples collected indistribution to an oven-drying test

(described in Appendix A of this

document) to determine the amount of

water in the samples. Those amounts

will be compared with the amount of

naturally occurring water in the

products to determine compliance with

labeling and the retained-waterminimization provisions of the final

rule. FSIS will, however, conduct inplant verification of establishment

process controls, and this verification

may occasionally involve comparing hot

carcasses weights with the weights of

carcasses after spray chilling.

Compliance, Oversight and Control

Comment: FSIS must explain how

compliance with the regulation is to be

determined. A European Union official

requested information on methods

currently used to detect water content.

One company suggested that moisture

gain be determined at the last possible

point before consumer packaging.

Another observed that the poultry

industry views retained water as the

amount in the product to be lost over

time as the product is en route to the

consumer.

Response: Until now, FSIS and

official establishments have measured

water content by sampling and weighing

carcasses before the carcass wash and

after chilling. In poultry slaughtering

establishments, carcasses are sampled

and weighed before and after immersion

chilling. In livestock slaughtering

establishments, sampled carcasses are

weighed after slaughter before and after

being subject to spray-chilling

processes. These traditional in-plant

methods for determining the

effectiveness of retained water controls

continue to be available to the Agency

and industry.

Under this final rule, though, FSIS

will be verifying compliance with the

retained-water limitation and labeling

requirements primarily by reviewing

establishment water-retention data

collected under the required datacollection protocol. The Agency also

plans to conduct in-plant and indistribution tests of the moisture

content of products using the ovendrying method described in the

Agency’s Chemistry Laboratory

Guidebook and in Appendix A of this

document. FSIS will not be dictating to

industry the in-plant sites for measuring

and controlling retained water.

Establishments must be aware that the

Agency will be most concerned with the

amount of retained water in product

that has entered commerce.

Comment: The proposed rule has no

provision for compliance oversight in

distribution channels and at retail or

food-service operations.

Response: The regulation clearly

applies to products in distribution

channels, although it does not specify

how the Agency will enforce regulatory

requirements outside official

establishments. Official slaughtering

establishments will be primarily

responsible for minimizing water

retention, subject to meeting the food

safety objectives of their HACCP plans

and of the PR/HACCP and other

regulations. FSIS will conduct in-plant

and in-distribution activities to verify

labeling accuracy and retained-water

minimization.

Comment: Correction of the wateradulteration problem at retail would

trigger costly recalls and reduce

consumer confidence in regulatory

bodies.

Response: If a recall is necessary to

prevent the sale of adulterated product,

the Agency will expect the industry to

take the necessary action.

Weights and Measures Checks

Comment: ‘‘Weights and Measures

officials generally inspect prepackaged

meat and poultry at the retail level. Any

changes * * * should either have no

effect on point-of-sale package weight

inspection procedures or, even better,

simplify them.’’

Response: Net-weight compliance

procedures will be largely unaffected by

this rulemaking. FSIS will be following

NIST Handbook 133 procedures for

determining whether or not product is

misbranded with respect to net weight.

These procedures are used by State and

local weights and measures officials, so

there will be no difference between the

procedures followed by the Federal

Government and the States with respect

to net weight.

Offal Products

Comment: From companies and

associations representing the meat

industry: Offal products should be

exempt from the rule because they are

not considered meat products.

Moreover, FSIS Standards and Labeling

Division policy covers ‘‘purge’’ from

organ products.

Response: In the interests of equitable

regulation, offal products and other

products of the meat industry and any

poultry products with which there is a

water-retention issue are subject to the

present rule. This final rule supersedes

current policy notices and directives

affecting water retention; as appropriate,

the Agency will revise or cancel those

documents.

FSIS Priorities

Comment: The proposal is a

misapplication of FSIS resources, which

should be focused on food safety

concerns. Consumers are more

interested in knowing about product

safety than retained water.

Response: While the Agency’s

primary concern is food safety, the

FMIA and PPIA provide other consumer

protections as well, including that

consumers have the right to be apprised

of what they are buying.

Consumer Situation

Comment: Some commenters asserted

that FSIS offered no data showing

consumers are misled about retained

water in poultry products.

Response: It is true that FSIS has not

gathered survey data showing that

consumers are being misled about

retained water, but from inquiries it has

received over the years, the Agency is

aware of consumer concerns about

water in packaged poultry. Although

consumers did not petition the Agency

for a retained-water-labeling

requirement, a number of individuals

and consumer advocates who

commented on the proposal regarded

informing consumers about retained

water as an important purpose of the

rule. Some requested immediate

implementation of the labeling

requirement.

Comment: The proposed rule could

adversely affect industry and

consumers. Product quality could be

adversely affected. The proposal itself

(at 63 FR 48980) suggests that retainedwater labeling, by inducing a reduction

in retained water in raw products,

would actually be harmful to consumers

who may prefer a moist product.

Response: The information on

consumer receptiveness to poultry

products that might be less moist is

inconclusive. The Agency

acknowledged in the PRIA, to which the

commenter refers, that consumers in the

United States have become accustomed

to purchasing fresh poultry that is very

moist. FSIS requested comment on

whether consumers would be more or

less likely to purchase a package of meat

or poultry that appeared less moist but

received little information on this

matter in response.

1760 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

FSIS Response to Kenney Case Decision

Comment: The proposal is not

justified by the limited scope of the

decision in Kenney. FSIS misinterpreted

the decision, in which the Court found

poultry with retained water not to be

adulterated and recommended sciencebased limits.

Also, the decision in the Kenney case

does not require the Agency to mandate

retained-water labeling.

Response: The Agency does not agree

with the commenter’s view that the

Agency misinterpreted the District

Court decision in the Kenney case, nor

does the Agency infer from the decision

that it is not warranted to proceed with

this rulemaking. The Court affirmed the

Agency’s right to define a poultry

product to include poultry product with

retained water. Although the Court did

not specifically instruct the Agency to

revise the retained water regulations

that the Court set aside, the Court

clearly affirmed the Agency’s authority

to regulate the amount of retained water

in poultry products. This final rule will

limit the amount of retained water in

raw meat and poultry products and FSIS

believes the retained water limitation

will be scientifically based.

Regarding the labeling requirement in

the final rule, it will prevent

misbranding of products subject to the

rule.

Comment: Poultry industry

commenters argued that FSIS is

responding to competitive, not

consumer, concerns and to lobbying by

the meat industry. The Agency is

responding to ‘‘perceived inequity’’

rather than to food safety concerns.

Response: FSIS took seriously the

determination by the Court that the

basis for its regulation of retained water

in poultry was inadequate. As a result

of the decision, the Agency believed it

was necessary to re-examine the basis

for regulation and determine the most

appropriate, science-based approach for

regulating retained water in poultry.

The Agency’s response on this issue was

grounded in its obligation to ensure that

consumers are protected from

adulterated and misbranded product.

Comment: According to some poultry

industry commenters, the rule is

arbitrary and capricious in that it makes

unjustified sweeping changes to the

Agency’s long-established policy of not

requiring that meat or poultry be labeled

to show retained-water content. The

rule could be invalidated under the

‘‘arbitrary and capricious’’ standard

applied by the Supreme Court (in

Automobile Manufacturers Assn. v.

State Farm) to the Department of

Transportation’s rescission of a rule

requiring the installation of passive

restraints in new cars. Simply requiring

that meat and poultry establishments

justify retained water in their products

would fully satisfy the mandate of the

U.S. District Court in Kenney v.

Glickman.

Response: FSIS disagrees that, in

requiring labeling of raw, singleingredient meat and poultry products to

state the retained-water content of the

products, it is making ‘‘arbitrary and

capricious’’ sweeping policy changes.

Rather, FSIS is attempting to carry out

its statutory obligation to prevent the

distribution of products that are

adulterated or misbranded under

circumstances in which a regulation

intended to prevent adulteration or

misbranding of poultry products has

been invalidated.

With respect to the labeling issue,

FSIS thinks that the State Farm case is

inapposite. FSIS is willing to concede

that it had a policy not to require

labeling of poultry products for retained

water. However, the Kenney decision

represents a change in circumstances

that requires that the Agency rethink its

policies and change them if it is unable

to justify them within the legal context

established by the Court’s decision. The

case has left the Agency without a

published, regulatory limit on retained

water to prevent adulteration. Because

there is no longer such a limit, the case

has also left the public without access

to information about the characteristics

of poultry products. In the absence of a

specific level of retained water that is

unavoidable in the production of a safe

product, FSIS finds that the level of

retained water is a fact that is material

in that the product is being represented

as meat or poultry. Failure to disclose

this fact would misbrand the product.

Therefore, FSIS is requiring that meat

and poultry products be labeled to show

the maximum amount of water they may

retain. In the absence of data, the

Agency is taking the most logical and

reasonable course of action available to

it.

Regarding the U.S. District Court

decision in the Kenney case, the Court

agreed with the Department’s

contention that the PPIA (21 U.S.C.

457(b)(2)) gives the Secretary the

authority to determine that the

composition of a poultry product

includes a limited amount of water

retained from processing. The Court also

stated that, given the deference that

must be shown the Secretary on this

matter, ‘‘the Secretary did not abuse his

discretion or act contrary to law by

failing to conclude that a label that does

not disclose the retained water in a

poultry product was false or

misleading.’’ The Court further held

that, notwithstanding the quantity-ofcontents labeling provisions of the

PPIA, the Secretary was within his

discretion in not finding poultry with

retained water to be misbranded.

However, the Court found that the

Secretary acted arbitrarily and

capriciously in not adequately

explaining the reasons for the water

retention limits for poultry products and

in not explaining why water retention

could not be further reduced. In other

words, the Secretary did not provide a

basis for determining whether and what

amount of water retention should be

permitted or could be considered nonadulterative, or what amount of water

retention is unavoidable in a poultry

product. Put another way, the Secretary

did not provide a basis for

distinguishing a poultry product with

permissible retained water from such a

product adulterated by excessive

retained water. The Court also found the

Secretary to have acted arbitrarily and

capriciously in not according the same

regulatory treatment to meat and to

poultry. The Court therefore set aside

the regulation that provided the water

retention limits for poultry products (9

CFR 381.66(d)(2)).

Thus, this situation is distinguishable

from that in State Farm. FSIS is not

simply abandoning a long-held, welljustified position. When asked to justify

its position on retained water in poultry,

the Agency could find no basis for it in

the record compiled when the position

was adopted. Thus, the Court in Kenney

found that FSIS water retention levels

for poultry were not sustainable. When

FSIS sought a reliable basis for arriving

at a new level, it could find no evidence

that would justify any water retention in

poultry. In view of this, and the

Agency’s obligation, in the absence of

evidence that justifies a contrary

approach, to treat meat and poultry

products the same way in its

regulations, FSIS is left with little

choice but to insist that meat and

poultry products contain no retained

water unless there is a substantial

justification for permitting some water

retention.

FSIS is not stating in this final rule

what the justification for retained water

should be beyond stating that it must be

an unavoidable consequence of

processing to meet food safety

requirements. This is the only

justification FSIS can find for the

presence of retained water in a livestock

or poultry carcass.

As stated previously in this

document, the Agency has consistently

required that establishments minimize

retained water in meat and poultry

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1761

products, but the Agency no longer has

a quantitative limit or measure other

than zero-percent retained water by

which to determine that retained water

has been minimized. For this reason,

and because the Court found that the

Agency did not have a basis for

determining unavoidable retained water

in a product, the Agency must insist

that, in addition to justifying the

presence of retained water,

establishments also substantiate the

amount of retained water that is

unavoidable.

In order to determine whether or not

a poultry product is economically

adulterated by retained water, the

Agency must have available to it data

that show what the amount of

unavoidable retained water is and the

amount that the product retains. Hence,

the requirement that establishments

collect such data according to written

protocols.

Effect on Pathogens

Comment: Increasing water retention

in achieving non-required Salmonella

levels (i.e., reducing Salmonella levels

below the pathogen reduction

performance standards) would defeat

the purpose and goal of the rule.

Response: FSIS encourages

establishment efforts to improve the

safety of meat and poultry products by

reducing the incidence of Salmonella

below the prescribed performance

standards. We recognize that achieving

such results may cause the product to

have increased retained water that

would be required to be labeled on the

package. However, we feel that the

requirement to label a product to

indicate the maximum amount of water

that may be retained in the product is

necessary to reflect the material fact that

water has been retained.

Comment: The proposal (at 63 FR

48977) suggested the possibility that

pathogens on product could increase

with decreased retained water, and that

efforts to reduce the retained-water level

would harm consumers.

Response: The commenter

misinterpreted the proposal. The

commenter took out of context a step in

the Agency’s reasoning on the potential

costs of a rejected option: that of

establishing retained water limits based

solely on the capabilities of existing

equipment. In fact, this rule is based on

the chosen option of limiting water

retention to the amount that is

unavoidable in meeting food safety

requirements.

Comment: A consumer group

commented that FSIS has paid

insufficient attention to Lillard (1990),

who reports a significant increase in the

incidence of Salmonella on post-chill

poultry carcasses.

Response: The Lillard (1990) paper

cited by the commenter did indeed

show that Salmonella incidence

increased on post-chill as compared

with pre-chill poultry. The study

identified immersion chilling as the

most significant point of cross

contamination in modern commercial

poultry processing. However, the study

also confirmed that the immersion

chilling process has a washing effect,

and that even though Salmonella

incidence may have increased on the

birds, the microbiological quality of the

poultry carcasses, as determined by

enumeration of aerobic bacteria and

Enterobacteriaceae, improved. In other

words, though bacteria might be spread

from bird to bird during the process, the

overall level of bacteria on the birds

decreased.

Comment: A consumer group said

that FSIS should determine the

pathogen levels in poultry package

liquid and the relationship between

these levels and the risk of crosscontamination in the kitchen. FSIS

should compare the benefits in lower

social and medical costs from

contaminated poultry, compared with

increased costs to the poultry industry

and consumers from eliminating all

retained water.

Response: As explained in the FRIA,

FSIS has assumed as an indirect benefit

of the final rule the possible health

effects from reducing retained water.

However, to determine the relationship

between pathogen levels in poultry and

the risk of cross contamination in the

consumer’s home, and to compare the

increased costs to the poultry industry

of this rule with the possible health

benefits to society from reducing

retained water, would require a lengthy

study. If such a study were a

prerequisite for this final rule, the rule

and its beneficial effects would be

delayed.

Apparent Inconsistency in Proposed

Rule

Comment: There is, apparently, an

inconsistency between the preamble use

of the term ‘‘raw, single-ingredient,

meat, meat products, and poultry

products’’ and the term ‘‘carcasses and

parts’’ in the proposed regulation

concerning products to be covered by

the labeling requirement.

Response: ‘‘Raw, single-ingredient

meat, meat products and poultry

products’’ are broadly comprised of

‘‘carcasses and parts,’’ whether of

livestock or of poultry. The term

‘‘carcass’’ in the FSIS regulations

denotes ‘‘all parts, including viscera, of

any slaughtered livestock’’ (9 CFR

301.2(p)) and in the poultry products

regulations ‘‘all parts, including viscera,

of any slaughtered poultry’’ (9 CFR

381.1(b)(9). By the term ‘‘carcasses and

parts,’’ FSIS means a class of product

included in the terms ‘‘meat and meat

food product’’ and ‘‘poultry product,’’

namely, raw, single-ingredient products

that have been subject to no more than

minimal processing, such as cutting or

grinding, before being sold in

commerce. The current regulatory

definitions for ‘‘meat food product’’ and

for ‘‘poultry product’’ include product

made partly or wholly from carcasses

and parts of livestock or poultry for use

as human food. Thus, FSIS finds no

inconsistency between the use of terms

in the preamble of the proposed rule

and the proposed regulatory text.

Time and Flexibility for Final Rule

Implementation

Comment: If FSIS proceeds to a final

rule, the Agency should give industry

time and flexibility to minimize cost

impacts. The industry should have

flexibility similar to that provided in the

sausage casings notice (FSIS Docket No.

96–020N: 61 FR 39853; July 31, 1996).

Response: FSIS believes that the

commenter is referring to the labeling

options that would be available to

establishments subject to the proposed

rule on sausage casings, ‘‘Labeling of

Natural or Regenerated Collagen

Sausage Casings’’ (FSIS Docket No. 96–

020N: 62 FR 38220; July 17, 1997).

Under that proposal, the labels of

sausages in natural casings made from

livestock or poultry viscera or

regenerated collagen casings would

have to identify the type of livestock or

poultry from which the casings are

derived, if different from the livestock

or poultry meat component of the

sausage. The casing identification could

be on the principal display panel or in

the ingredient statement. Establishments

producing, manufacturing, or using

natural or regenerated collagen casings

would have to keep records on the

livestock or poultry source of the

casings.

FSIS is trying to minimize the cost

impacts of the labeling requirements of

this final rule by providing ample time

for implementation and allowing the

industry to use existing stocks of labels

until they are exhausted. FSIS also is

providing a degree of flexibility by

permitting establishments to place the

required retained water statement either

contiguous to the product name or

elsewhere on the principal display

panel of the label.

1762 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

Recommendations for Various

Technical Changes

Comment: The qualifier ‘‘mature’’

should be restored to the term

‘‘reproductive organs’’ in § 381.1(b)(44).

Response: As discussed in the

proposal, FSIS is revising the definition

of ‘‘ready-to-cook poultry’’ to account

for the elimination of the requirement to

remove kidneys from mature birds. The

qualifier ‘‘mature’’ was inadvertently

dropped from the term ‘‘mature

reproductive organs’’ in the proposed

regulatory text and is restored in this

final rule. The verb phrase expressing

the action taken with respect to mature

reproductive organs and kidneys is

changed from ‘‘have been removed’’ to

‘‘may have been removed’’ (in

§ 381.1(b)(44)) to reflect the fact that the

decision to remove these organs is

HACCP-based. Some establishments, in

operating their HACCP systems, have

shown that they can determine when

poultry kidneys constitute a hazard

(e.g., when they contain cadmium) and

when they do not.

Comment: The phrase ‘‘feet, crop and

oil glands’’ appears twice in proposed

§ 381.1(b)(44).

Response: FSIS is correcting this

typographical error.

Comment: Remove § 381.65(a) and (b).

These are covered by HACCP or

Sanitation SOP.

Response: FSIS agrees that sanitary

handling and processing of poultry and

the protection of poultry products from

adulterants ought to be covered by

establishment Sanitation SOP’s and

HACCP plans. FSIS is removing

paragraph (b) of 9 CFR 381.65 for that

reason, as proposed, but retaining

paragraph (a). The paragraph requires

establishments to conduct operations

and procedures in a manner that will

ensure sanitary processing, proper

inspection, and products that are not

adulterated. These are basic

performance objectives for any official

establishment. The requirement to

ensure proper inspection is especially

pertinent to poultry processing and is

not duplicated by the SSOP and HACCP

regulations. Paragraph (c) is being redesignated as paragraph (b). FSIS will

review the requirements in these and

other paragraphs for further

streamlining.

Comment: Remove § 381.65(d)

because it is redundant with proposed

§ 441.10.

Response: Proposed § 381.65(d) is a

re-designation of § 381.65(k), which

requires ready-to-cook poultry to be

adequately drained after chilling to

remove ice and free water before

packaging or packing. FSIS agrees that

it is redundant with the new 9 CFR

441.10 and is removing it.

Comment: Paragraph (d)(8) in § 381.66

requiring the plant to notify the

inspector of changes in washing,

chilling, and draining procedures

should be removed.

Response: FSIS is removing 9 CFR

381.66(d)(8) as proposed.

Comment: Proposed § 381.66(c)(2)(i),

restricting how plants operate chillers,

should be revised to eliminate

prescriptive requirements for the

continuous overflow of water between

chiller sections and references to the

design of multi-section chillers. The

paragraph should only require that the

chiller be operated in a manner

consistent with meeting pathogen

reduction performance standards.

Response: FSIS agrees in principle

with the suggested change and is

revising the paragraph. The Agency is

removing the prescriptive design

requirements for chillers and replacing

them with a performance standard

requirement that is consistent with the

PR/HACCP regulations.

Comment: Proposed § 381.66(c)(2)(ii)

should be revised to refer to split

carcasses as defined in § 381.170(b)(22).

FSIS should revise the second sentence,

the chilling method to be applied to

individual poultry parts, because it is

not consistent with HACCP.

Response: FSIS agrees that the

wording of proposed § 381.66(c)(2)(ii)

should be modified as suggested by the

commenter.

FSIS is removing the second sentence

of the paragraph, which prohibits the

chilling in water and ice of individual

parts from salvage operations. While the

purpose of this prohibition, to prevent

the marketing of parts that retain too

much water, coincides with some of the

objectives of this final rule, it is a

command-and-control requirement that

is inconsistent both with HACCP and

with the basic thrust of this final rule.

FSIS published the retained-water

proposal in the same issue of the

Federal Register as the final rule

permitting the continuous chilling of

transversely split carcasses (63 FR

48957; September 11, 1998). The splitcarcass-chilling final rule left

unchanged the prohibition against the

chilling in water and ice of individual

parts.

This final rule, however, applies to

transversely split carcasses and other

portions and parts of poultry. It applies

to all raw, single-ingredient, poultry

products. This final rule makes

redundant the requirements concerning

the specific chilling method applied to

these parts or portions of poultry.

Therefore, the Agency is removing these

requirements.

Comment: Delete the proposed

§ 381.66(d)(1) and (2) as redundant with

§ 441.10.

Response: While 9 CFR 381.66(d)(1),

which requires that poultry washing,

chilling, and draining practices

minimize water absorption and

retention, may appear to some to be

redundant with 9 CFR 441.10, it

articulates a general principle with

which the Agency agrees irrespective of

the present rulemaking: Retained water

should be minimized. 9 CFR

381.66(d)(1) does not, however, present

a measurable criterion for judging

minimization, as 9 CFR 441.10 does.

Therefore, FSIS finds it appropriate to

adopt both provisions.

FSIS finds that the proposed 9 CFR

381.66(d)(2), requiring the

establishment to supply measuring

devices or scales for use in measuring

retained water, should be retained to

ensure that both the establishment and

the Agency can conduct in-plant checks

for compliance with this final rule.

Comment: Delete 9 CFR 381.66(f)(3), a

prior-approval requirement for FSIS

approval for off-premises freezing of

ready-to-cook poultry. This prescriptive

requirement is inconsistent with

HACCP.

Response: The commenter’s

suggestion is beyond the scope of the

present rulemaking. FSIS regards the

procedures for freezing poultry as

encompassing a separate set of issues

that are peripheral to the concerns of

this rulemaking, which are focused on

the chilling of poultry.

Effect on International Trade

Comment: The proposal could distort

international trade because the only

establishments that will be considered

eligible to export to the United States

will be those that are able to

demonstrate that ‘‘residual water

content is due to the final

decontamination of the products and

not to the chilling process.’’

Response: The final rule does not

identify any specific post-evisceration

process that an establishment must use

for any purpose. Further, the rule is not

expected to have significant impacts on

international trade. Any imports

containing retained water will have to

be appropriately labeled, and poultry

products are likely to be more affected

than meats. Only six countries,

however, Canada, France, Great Britain,

Hong Kong, Israel, and Mexico, are

listed as eligible to ship poultry

products to the United States. Currently,

about 5 million pounds of poultry

imports enter the United States

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1763

annually. This is a relatively small

amount of trade.

Provisions of the Final Rule

Under § 441.10(a), raw livestock and

poultry carcasses and parts may not

retain any amount of water resulting

from post-evisceration processing,

absent a demonstration, with data, by

the establishment preparing them that

such water is the unavoidable

consequence of a process used to meet

applicable food safety requirements.

The data must have been collected

according to a written protocol.

Under § 441.10(c)(1), the

establishment must keep this protocol

on file and available to FSIS personnel.

The protocol must explain how the data

will be collected and used in making the

required demonstration for the product

the protocol covers. Under

§ 441.10(c)(2), the establishment must

notify FSIS as soon as its data-collection

protocol—whether new or revised—is

available to the Agency. Within 30 days

after receipt of this notification, FSIS

may object to or require the

establishment to make specified changes

in the protocol. FSIS will take this

action if it determines that the protocol

is not valid, or that the data collected

under it will not be sufficient to

demonstrate that the amount of water

retained in the product is an

unavoidable consequence of the process

used to meet applicable food safety

requirements.

FSIS is including in § 441.10(d) the

expected elements of a protocol for

gathering water retention data. These

protocol elements were published for

comment as Appendix A of the

September 11, 1998, proposal.

Under § 441.10(b), meat or poultry

products will have to bear a label

statement of the maximum percentage of

water absorbed and retained as a result

of post-evisceration processes. A

qualifying statement accompanying the

product name could read, ‘‘may contain

up to ll percent absorbed water.’’ The

percentage must reflect the maximum

percentage of water that may be retained

in the product. Alternatively, the label

may simply bear an accurate statement

of the percentage of retained water in

the product. Establishments having data

or information to demonstrate that their

products do not contain retained water

will not have to label the products and

could include a no retained water claim

on the product label. The labels will be

generically approved pursuant to 9 CFR

317.5(b)(2) or 381.133(b)(2).

This requirement, which is

responsive, in part, to the AMI petition

discussed above, would ensure that

accurate information concerning the

product is conveyed to the consumer in

accordance with the misbranding

provisions of the FMIA and the PPIA

(especially 21 U.S.C. 601(n)(1), (6);

453(h)(1), (6)). It will ensure that the

product labeling is not misleading with

respect to water retained by the product.

FSIS had proposed that the retainedwater statement be contiguous to the

product name on the product label. In

response to comments, the Agency is

providing some flexibility in this matter

by also permitting the statement to

appear either contiguous to the product

name or elsewhere on the principal

display panel of the label. The

placement of the required information

on the label will ensure that the

information will be likely to be read and

understood by the ordinary individual

under customary conditions of purchase

and use.

With the required labeling

information, consumers will be in a

better position to compare packaged raw

meat or poultry products containing

retained water with alternatives in the

meat case. The market will provide

incentives to plants to adopt new, costeffective technologies for reducing

retained water. The rule will not affect

raw products that now bear complete

labeling or nutrition labeling, such as

pre-basted frozen turkeys, or further

processed products, such as deli meats.

This final rule also will not cover

cooked and cured pork products, such

as those subject to protein-fat-free

requirements (9 CFR 318.19(a)(5),

319.104–.105, 327.23).

As stated elsewhere in this document,

the Agency’s concern in this rule is to

ensure that products in commerce will

not be adulterated or misbranded. To

alleviate some confusion on this point

that was expressed in a number of the

comments received, the labeling

provision in new § 441.10(b) has been

more precisely phrased than in the

proposal.

Changes in Poultry Chilling Regulations

FSIS is amending the chilling

requirements for poultry by removing

various prescriptive requirements and

specifications, such as the minimum

amount of fresh water intake by

continuous chillers for each poultry

carcass. The removal of those

requirements should encourage

processors to use the most efficient and

effective methods of controlling

microorganisms. Establishments will

have the flexibility to take advantage of

the latest technologies and procedures.

This final rule amends 9 CFR 381.65,

which concerns general operating

procedures, by removing provisions that

are redundant, excessively detailed, or

inconsistent with the PR/HACCP final

rule. The final rule eliminates current

paragraph (b), the prohibition on

handling and storing materials that

could cause adulteration of poultry

products in any room where poultry

products are processed, handled, or

stored. This provision is unnecessary

because HACCP plans have been

implemented in every affected

establishment and because each HACCP

plan must specify the measures to be

taken to protect poultry products from

physical, chemical, or biological

contamination. The requirements in

paragraphs (a) and (c) of 9 CFR 381.65

will be retained as paragraph (a) and (b)

because they set out general principles

of sanitation and commercial practice to

which all establishments must adhere.

The requirements in paragraphs (h)

and (j) of 9 CFR 381.65, relating to

poultry thawing and dressing

techniques, are being replaced with two

performance standards. The first

requires simply that establishments use

thawing procedures that will prevent

adulteration of, or net weight gain by,

the product. The second requires that

water used in washing ready-to-cook

poultry be permitted to drain freely

from the carcass. A new paragraph (c),

which replaces paragraph (h), requires

that frozen poultry be thawed for further

processing in a manner that will prevent

product adulteration but would not

require that any specific thawing

method be used.

The thawing regulation that is being

replaced does not prevent practices that

may constitute hazards to food safety.

For example, it does not prevent reexposure of thawed, or partially thawed,

product to a thawing medium that may

have become contaminated by previous

use and that may be too warm to

prevent microbial growth. Paragraph

(h)(1)(i) specifies a maximum permitted

thawing medium temperature of 70 °F,

which is too high to prevent microbial

growth in product that is re-exposed to

or held in the medium. The regulation

conflicts with HACCP because

establishments should assess thawing

processes when conducting their hazard

analyses. Establishments must be given

the responsibility and flexibility to

choose thawing measures that are

effective and that do not create food

safety hazards.

A new paragraph (d) replaces

paragraph (j), which specifies the

manner in which carcass wash water is

to be drained, with a performance

standard requiring simply that the wash

water be permitted to drain freely from

the carcass.

Paragraph (d), which contains a

requirement to remove kidneys from

1764 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

mature chickens and turkeys, is being

eliminated. The kidneys of mature

chickens and turkeys are a source of

cadmium, which can accumulate in the

human liver and kidneys and cause

acute or chronic health problems.

Kidneys with excess cadmium are a

‘‘food safety hazard reasonably likely to

occur’’ that establishments will identify

in their hazard analyses and control

through their HACCP systems. Thus,

paragraph (d) is redundant with the

HACCP regulations. The requirement to

remove kidneys is referenced in the

definition of ‘‘ready-to-cook poultry’’ at

9 CFR 381.1(b)(44). Therefore, the

Agency is amending that definition.

Paragraph (i), which specifies how

poultry carcasses are to be cut open for

evisceration, is being removed. The

regulation is outdated and prescriptive

and may be an obstacle to improved

product safety. The regulation is

intended to ensure that opening cuts are

made without cutting the intestinal tract

and without contaminating the carcass.

Unnecessary cuts are prohibited because

they may result in carcass

contamination during evisceration or

excessive water absorption during

chilling. The regulation is also intended

to maximize the viewing of the interior

and viscera of the carcass during the

postmortem inspection.

In recent years, the poultry industry

has developed new methods of poultry

evisceration that do not result in

adulteration. For example, ultrasound

techniques are available for use as a

diagnostic aid to detect malformities or

other defects before carcasses are

opened. Also, equipment is available

that can remove the viscera intact, using

vacuum suction, without breakage or

spillage of intestinal contents, and other

available evisceration systems require

that the carcass be opened by a

longitudinal cut. The regulation

generally limits the opening cut to the

area around the vent (cloaca) to prevent

birds from carrying excess water under

the skin that could cause water-control

test failures. Because of this limitation,

the new technologies, which can

improve efficiency and product

wholesomeness, are not likely to be

implemented. Establishments, however,

should have the flexibility to innovate

and to implement promising new

technologies, consistent with their

HACCP plans.

Paragraph (k), a requirement to

adequately drain ready-to-cook poultry

after chilling to remove ice and water

before packaging, is redundant because

of new part 441, and FSIS is removing

it.

Paragraphs (l) through (p) are also

being removed. These paragraphs

include requirements concerning the

chilling of poultry parts, the removal

from establishments of offal resulting

from evisceration, the cleanliness of

containers, the sturdiness of packaging

materials, and the use of protective

coverings. These are all matters that are

to be addressed by establishments in

their Sanitation SOP’s and HACCP plan.

Finally, paragraph (q), concerning the

harvesting of detached ova for human

food, is being re-designated as

paragraph (e) and revised to reduce

duplication with requirements in

§ 590.440 for handling ova and to

eliminate a command-and-control

requirement to identify the ova past the

point of inspection. Also, the reference

to a section of the egg products

inspection regulations has been

amended to account for the recent

redesignation (63 FR 72353) of those

regulations to Title 9, CFR.

In 9 CFR 381.66, paragraph (a) is

being revised. This paragraph requires

poultry to be chilled or frozen in a

manner that promptly removes animal

heat from the carcasses and does not

adulterate the product. The second

sentence of the paragraph, a commandand-control requirement to file a

description of the chilling or freezing

procedures with the inspector in charge,

is being removed.

The general chilling requirements for

poultry, paragraph (b), remain the same.

FSIS has long regarded the chilling of

poultry to a safe internal temperature

within a minimum number of hours as

a useful food safety precaution.

However, as mentioned above, the

Agency intends to undertake

rulemaking on this matter. The table of

maximum times and temperatures in

paragraph (b) is based on the duration

of the lag phase of bacterial growth on

the surfaces of dressed, ready-to-cook

poultry carcasses under plant

conditions. Although interested persons

are encouraged to submit data that

would justify a change in this provision,

amending the paragraph is outside the

scope of the present rulemaking.

The numerous detailed, prescriptive,

command-and-control requirements in

paragraph (c) are being removed. For

example, the amended paragraph

(c)(2)(i) does not specify chilling media

temperatures or the use of recording

thermometers. New paragraph (c)(1)

requires that potable water be used, and

new paragraph (c)(2)(i) requires that

sufficient water be used to maintain the

sanitation of chilling media. However,

specific requirements (paragraphs

(c)(2)(ii)–(iii) and (c)(2)(v)) concerning

the operation of continuous chilling

systems, including the minimum

amount of fresh water intake per bird,

are being removed.

Paragraph (c)(2)(iv) is being redesignated as (c)(2)(ii) and revised as

discussed above in the response to

comments. This paragraph, which

concerns the chilling of major portions

of poultry carcasses, was the subject of

a September 18, 1999, final rule (63 FR

48958; proposed at 62 FR 31017; June 6,

1997).

Paragraph (c)(2)(vi), the highly

detailed and prescriptive requirements

concerning water-reconditioning

systems for poultry chillers, including

the requirement for prior approval of

such systems by FSIS, is being removed.

Establishments subject to the poultry

product inspection regulations are not

using these systems because none have

proven feasible in commercial

operations.

The requirements in paragraphs

(c)(4)(i) and (c)(4)(ii), concerning the

holding of poultry in chilling tanks, are

being removed, and in paragraph (c)(5),

the highly specific requirements

concerning the use of continuous

chillers to chill giblets are also being

removed. Establishments will address

the food safety hazards associated with

these procedures in their HACCP plans.

However, the requirement to chill

giblets to less than 40 °F in under 2

hours will remain at this time.

Paragraph (d) of § 381.66 is being

completely revised. The general

requirement to minimize water

absorption by raw poultry, and the

requirement to furnish equipment

necessary for water tests, will remain.

The tables setting water absorption and

retention limits for the various kinds

and weight classes of poultry are being

eliminated, as are the requirements for

daily water testing by FSIS inspectors.

The requirement to notify FSIS of any

adjustments in washing, chilling, and

draining methods is also being removed.

FSIS is removing paragraph (d)(10),

which specifies how poultry may be icepacked in barrels and requires FSIS

approval for the use of alternative types

of containers. Establishments will

ordinarily have procedures for

determining appropriate containers for a

product. If, in their hazard analyses,

they determine that there are food safety

hazards reasonably likely to occur that

are associated with containers, they will

address these hazards in their HACCP

plans.

The Agency is likewise removing

paragraph (d)(11), which requires

establishments to prevent free water

from being included in giblet packages.

Among other things, paragraph (d)(11)

requires use of a specific type of giblet

wrapping material and incorporates by

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1765

reference the testing standards that must

be met in evaluating the material. This

kind of detailed specification is no

longer necessary under the Agency’s

new regulatory approach. Also,

establishments must comply with the

regulations on net quantity of contents

and net weight (9 CFR 317.18–.19,

381.121–121b). This provision will give

establishments flexibility in choosing

giblet packaging materials, but also the

responsibility to ensure that their choice

is suitable, as well as safe, for this use.

By complying with the retained-water

limitation requirements (discussed

below) and by appropriately labeling

product, establishments will be

ensuring that water absorption is

controlled as well as ensuring that

consumers are appropriately informed.

Finally, paragraph (e), on air chilling,

and paragraph (f), governing the freezing

of poultry, are being retained

substantially in their present form.

Paragraph (f)(6), concerning immersion

or spray freezing compounds and

equipment, will be removed because it

is a prior-approval requirement

inconsistent with the HACCP

regulations and is duplicative of other

inspection regulations.

Implementation of the Final Rule

FSIS foresees little difficulty in

implementing the revised poultry

chilling regulations, which relieve

poultry establishments of certain

burdens without raising misbranding or

adulteration issues. FSIS will ensure

compliance with the revised regulations

through normal inspection.

To implement the retained-water

provisions of this final rule, on the other

hand, both the Agency and the regulated

industry will have to adopt new

procedures. FSIS personnel will verify

an establishment’s control of water

retention by checking establishment

records or by conducting in-plant or indistribution tests of sampled products.

FSIS intends to sample product in

distribution channels and in official

establishments, using the oven-drying

method described in Appendix A to

determine the amount of moisture in

product samples. At poultry processing

establishments, the traditional method

of weighing birds before and after

chilling to determine moisture pick-up

will continue to be available to both the

Agency and the establishments as a

process control check.

FSIS also will conduct independent

tests of the establishment’s retainedwater control as part of investigations of

suspected problems or in the course of

special studies. The overall focus of the

Agency’s activities will be to ensure that

raw products that enter commerce do

not contain water in excess of the

amount that is unavoidable in achieving

food safety objectives.

FSIS is providing a full year from the

publication date for implementation of

this final rule to mitigate the effects of

the rule on establishments that may

have to consider changing or updating

their chilling processes and equipment.

The extended implementation period

should be especially helpful to

establishments that meet the smallbusiness-entity size criteria defined by

the Small Business Administration.

During the period before the effective

date, FSIS will provide its field

inspection personnel with the

instructions they will need to carry out

their review of protocols and verify that

establishment data demonstrate the

amount of water retention that is

unavoidable and support product

labeling statements. The Agency will

prepare sampling, testing, and

document review procedures for Agency

use; train Agency personnel in the new

procedures; and develop a new national

reference database on the natural

moisture content of raw products in the

various meat and poultry product

classes with which this rule is

concerned.

To develop this national database on

natural moisture content, FSIS will test

product samples drawn at official

establishments. The Agency will use a

common, analogous point of reference

in livestock carcass and poultry product

preparation at which to determine the

naturally occurring percentage of

moisture in meat products and poultry

products, namely, the point at which

the calculated yield weight is

determined. (Calculated yield weight of

a carcass is its predicted ‘‘green

weight’’—the weight of the carcass after

dressing and before any additional inplant processing.) In poultry plants, this

point is at the re-hanging operation

(after de-feathering and hock removal).

The analogous point in livestock

slaughtering establishments is before the

pre-evisceration carcass wash. FSIS has

chosen these common reference points

to reduce the possibility of

measurement errors caused by various

carcass-washing procedures.

To determine the moisture content of

a product sample, the Agency plans to

rely on the oven-drying method

described in its Chemistry Laboratory

Guidebook and in Appendix A of this

document. This method involves

weighing, before and after drying, a dish

containing a homogenized meat or

poultry product sample. The method

can be applied to products at any point

in processing or distribution. Similar

oven-drying methods for determining

the amount of moisture in meat, meat

products, and poultry products are

described in the Official Analytical

Methods of the Association of Official

Analytical Chemists and in ISO 1442,

published by the International

Organization for Standardization.

After developing sufficient

information on the natural water

content of raw meat or poultry products,

FSIS will be in a better position to verify

that the establishment is complying

with the requirement to minimize

retained-water amounts when the final

rule becomes effective. To determine

whether an establishment is complying

with the regulations, the Agency will

verify the establishment’s protocol

documentation and the data collected

under the protocol, including data on

retained-water minimization and

pathogen reduction. FSIS also will

verify compliance with the requirement

that product labels display retainedwater amounts, and that the actual

retained water in the products

corresponds to the labeled amount.

Usually, the verification will consist

only of a document check. However, the

Agency will occasionally test products

for moisture content to verify the

establishment’s findings.

FSIS will randomly sample raw meat

and poultry products both in-plant and

in-distribution and will test the

products for retained water content.

FSIS will collect and run tests on

product samples and statistically

analyze the results of the tests.

The Agency will directly measure the

moisture content of the raw products

sampled in-plant at pre-shipment using

its oven-drying method. The Agency

will compare the results of these tests

with the naturally occurring amounts of

water in the national reference database

and with the retained-water statements

on the product labels to determine

whether the products are in compliance

with the requirement to minimize

retained water, and whether they are

correctly labeled with a retained-water

statement.

To measure the amount of retained

water and determine compliance with

the final rule in in-plant situations

when using the weighing method, FSIS

will compare product weights taken

after chilling, but before the product

leaves the establishment, to the prefinal-wash weight or (in poultry plants)

the calculated yield weight. In livestock

slaughtering plants, the Agency expects

to be comparing pre-final wash or ‘‘hot’’

carcass weights with the ‘‘cold weights’’

taken after spray chilling in

establishments using the spray-chill

process.

1766 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

The Agency does not expect to use

calculated yield weight data as a basis

for comparing hot and cold livestock

carcass weights because such data are

not available for most livestock

establishments. The great majority of

such establishments do not weigh

carcasses after de-hiding or de-hairing

and before the pre-evisceration wash.

FSIS is aware that there may be a slight,

measurable gain in carcass weight

immediately after the pre-evisceration

wash. However, this gain is usually

more than offset by moisture loss on the

kill floor. Thus, the ‘‘hot’’ carcass

weight does not include a moisture gain

resulting from the pre-evisceration

wash.

FSIS is not prescribing any particular

method that official establishments

must use to measure the amount of

retained water in their products.

Establishments are free to use any

scientifically valid method for this

purpose. Establishments may want to

use the food chemistry method

described in Appendix A and used by

FSIS to determine the moisture content

of their products. Because of the

destructive nature of the method and

the delay in getting results,

establishments may find it more

convenient on a day-to-day basis to

compare the weights of carcasses and

parts before and after they are exposed

to washes, sprays, or immersion

chilling. The data from such checks

would have to be available to FSIS to

verify. As mentioned, poultry

establishments will continue to be able

to use the traditional method involving

the weighing of birds before and after

chilling as a check on water retention

controls.

FSIS also will conduct surveys of

products in plants and in distribution

channels to obtain an overview of

national compliance with the

regulations and to update the national

reference database on the moisture

content of meat and poultry products.

The Agency will compare the results of

these surveys with the information in its

database to determine whether any

adjustments in its enforcement of the

regulations are necessary. Comments are

requested on sampling and survey

methods that the Agency should

consider using both for initially

building the national reference database

and for the on-going compliance

overview.

FSIS will continue to verify that

products are in compliance with the

net-weight requirements for meat and

poultry products. As stated elsewhere in

this document, neither the net-weight

requirements nor the obligation of an

establishment to comply with them is

affected by this final rule.

FSIS expects there to be requests for

adding water solutions to meat and

poultry manufacturing trimmings in an

effort to reduce the pathogen levels on

product. Such applications may or may

not result in retained water, as well as

chemical residues. FSIS expects such

applications to adhere to the same

criteria as other applications resulting in

retained water. FSIS will allow

establishments to implement the

provisions of this final rule in advance

of the effective date provided the

establishment informs the appropriate

District Office in order that inspection

program personnel are provided with

the necessary instructional materials.

FSIS expects to provide instructions

regarding early implementation of the

final rule.

Executive Order 12866 and Regulatory

Flexibility Act

Current Practices in the Poultry Industry

The regulations controlling retained

water in poultry carcasses have

consisted of three major components: (1)

A performance standard requiring

washing, chilling, and draining

practices that will minimize water

absorption and retention at time of

packaging; (2) limits for maximum

retained water in birds that will be

packaged as whole carcasses; and (3)

limits for maximum retained water in

birds that will be ice-packed or cut up

prior to packaging. The performance

standard is to minimize the water that

is absorbed and subsequently retained,

i.e., it is not interpreted as requiring

minimization of both water absorption

and water retention. In implementing

the standard, FSIS concludes that the

performance standard is met when

retained water is under the maximum

limits.

Until the Kenney case, argued in U.S.

District Court and referred to earlier in

this document, various limits on

maximum retained water applied to the

various weight classes of whole

chickens and turkeys. For example, the

maximum retained water for most

whole chickens weighing 4.25 pounds

or less was 8 percent. The maximum

retained water for chicken that is icepacked or subsequently cut up into

parts has been 12 percent. In its July

1997 decision, the U.S. District Court

found that the regulation specifying

water absorption and retention limits for

ready-to-cook poultry that is to be

frozen, cooked, or consumer-packaged

as whole poultry was arbitrary and

capricious because the Secretary of

Agriculture did not explain in the

rulemaking record how he determined

the particular water retention levels,

why water retention cannot be reduced

below those levels, or why meat and

poultry should be treated differently

with respect to water retention. The

Court therefore set aside the water

retention limits for poultry to be

consumer packaged, frozen, or cooked

as whole poultry. In the wake of the

decision, there have been no regulatory

criteria by which to determine whether

retained water has been minimized in

chilled or frozen whole birds.

As discussed previously, FSIS is

mandated by the FMIA and PPIA to

prevent the distribution in commerce of

meat or poultry products that are

adulterated or misbranded. Without

limits on retained water, FSIS cannot

adequately protect consumers from

adulteration and misbranding due to

excessive retained water in whole birds.

Hence, the Agency is establishing a new

regulatory basis for minimizing retained

water.

FSIS is replacing the regulations

under which poultry establishment was

considered to be ‘‘minimizing’’ retained

water when it was operating within the

regulatory limits. FSIS is aware that not

all establishments have really been

minimizing retained water. Data

analyzed for this FRIA show that some

poultry establishments have been

controlling their processes to retain the

maximum allowed amount of water.

While this is considered acceptable in

the sense that product is not

adulterated, it is not consistent with a

regulatory intent to minimize. However,

it may be consistent with food safety

objectives to reduce pathogens.

The existence of the 12-percent limit

for cut-up chicken is in itself

inconsistent with the concept of

minimization. Many establishments

pack both whole-and cut-up chicken. In

meeting the 8-percent limit for whole

birds, they demonstrate that their

minimum is below 8 percent. The 12

percent limit serves as an opportunity to

maintain water levels in cut-up poultry.

The 12-percent limit is also available as

default when the 8-percent limit is not

achieved. An establishment can divert

birds to cut-up operations when they

fail the whole bird limit.

With this final rule, FSIS also is

addressing the issue of inconsistent

treatment of meat and poultry in its

regulations because, under the final

rule, both meat and poultry products

will be subject to the same

requirements.

Need for the Rule

The FMIA and PPIA, which the

Agency administers, make clear the

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1767

obligation of producers of raw meat or

poultry products not to mislead

consumers. FSIS thinks that if they

market as meat or poultry a product that

contains something other than meat or

poultry, that fact should be disclosed. It

has been the consistent policy of FSIS

to ensure that information that

accurately discloses the contents of

meat or poultry products is made

available to consumers of those

products.

As noted earlier in this document, a

1997 U.S. District Court decision set

aside the regulatory limits on retained

water in poultry products. The District

Court found that the Agency had not

presented the basis for its retained water

levels, why water retention could not be

reduced below those levels, or why

meat and poultry should be regulated

differently with respect to water

retention.

The District Court ruling left FSIS

without regulatory criteria for

determining whether retained water had

been minimized or what levels

constituted adulteration. The Agency

also no longer had available published

retained water limits that it could

enforce in an effort to protect consumers

from misbranded product.

Analysis of Alternatives

This rule resulted from an analysis of

six alternative regulatory approaches for

addressing retained water in raw meat

and poultry products. The six

alternatives are as follows:

1. No limit on retained water but

mandatory labeling that identifies the

percentage of retained water in the product.

FSIS did not recommend this alternative for

adoption because it would not reduce

retained water so that economic adulteration

would continue to persist. It would, however,

be advantageous to consumers because it

would enable them to compare alternative

packages of poultry with varying quantities

of retained water and prices and select the

package to suit their budgets.

2. A requirement that all establishments

meet a water limit based on best available

technology, with mandatory labeling to

indicate any retained water. FSIS did not

propose this option because the adoption of

the best available technology would be a step

backward into a regime of command and

control. It would also impose considerable

costs on plants that are currently not

employing such a technology without a

corresponding improvement in food safety.

For example, if the best available technology

is determined to be the continuous chillers,

there are several small and medium size

plants that do not employ this technology.

The economic impact of such an option

would be significant on these plants. In the

current environment of regulatory reform,

FSIS is moving away from command and

control to incentive-based performance

standards. Such standards permit plants to

reduce their retained water levels

irrespective of the technology they employ. A

moisture limit based on the best performance

achievable with existing equipment, with

mandatory labeling to show any retained

water. FSIS did not adopt this option

because, beyond stating that water retention

should be minimized consistent with

maximizing the safety of the product, it

would be difficult, if not impossible, for FSIS

to define the best performance achievable.

This option would also encourage

establishments to continue to use existing

equipment, perhaps beyond the economic

life of the equipment.

3. A standard of zero retained moisture.

FSIS did not recommend this option because

the costs of this option might exceed the

benefits. Finally, some minimum amount of

retained water might be necessary for

reducing pathogens.

4. A requirement that no retained water

could be included in net weight. FSIS did not

recommend this option for adoption because

it would require establishments to adjust

their scales to account for retained water. The

costs of adjusting these scales could be

excessive. Moreover, enforcement of net

weight requirements is an area where

Federal, State and local authorities share

responsibility and must cooperate. The

enforcement procedure, as adopted by the

National Conference on Weights and

Measures, are published in NIST Handbook

133, Third Edition, Supplement, ‘‘Checking

the Net Contents of Packaged Goods’’. The

National Institute of Standards and

Technology (NIST) has a statutory

responsibility for ‘‘cooperation with the

states in securing uniformity of weights and

measures laws and methods of inspection.

5. A requirement of zero retained water

unless the water retention is unavoidable in

processes necessary to meet food safety

requirements, e.g., to reduce pathogens, with

product labeling to indicate the presence of

retained moisture, where applicable. FSIS

recommended this option because it

prioritizes food safety above retained water.

It also includes the provision of labeling the

retained water to help consumers decide

amongst alternative packages with different

levels of retained water and prices.

FSIS chose the last alternative. The

selected option does not allow retained

water in an affected product unless it is

an unavoidable consequence of the

process or processes used to meet

applicable food safety requirements. By

‘‘unavoidable consequence’’ the Agency

means an unavoidable and irreducible

side effect. Under this option, inspected

establishments, associations, or other

groups, using acceptable protocols must

establish levels of unavoidable retained

water. Also, the maximum amount of

retained water that can be present must

be stated on the product label. FSIS has

found that this option is likely to

provide greater benefits than other

options because it is more flexible and

likely to prove less costly than some of

the proposed alternatives. A food safety

requirement can be a regulatory

prescription, such as the temperature to

which a product must be chilled and

held. It can also be a preventive measure

taken at a CCP or a critical limit in the

establishment’s HACCP plan. For

example, the proposed rule might

increase human handling for

transferring products from the chillers

to the freezer, thereby increasing cross

contamination. A critical control point

at such handling could reduce, if not

eliminate, cross contamination. Given a

food safety requirement, an

establishment must choose a method for

satisfying the requirement.

The method selected for meeting food

safety requirements may have

unintended consequences that cannot

be eliminated. A consequence of an

antimicrobial treatment of carcasses or a

carcass chilling method may be an

increase in the water content of

carcasses and parts. FSIS is requiring

that the amount of water that might be

retained in carcasses and parts as a

result of using such an anti-microbial or

chilling method be an unavoidable and

irreducible effect of using that method.

To be applicable to the raw products

of an inspected establishment, a nonzero retained-water limit would have to

be based on supporting data collected in

accordance with a written protocol that

has been subject to review by FSIS. This

final rule will allow an individual

establishment or industry trade

association or other group using the

same or similar processing techniques to

develop a protocol and carry out datagenerating studies according to the

protocol. Depending on the design of

the protocol, the data gathered could

justify water-retention limits for a single

establishment, a group of establishments

with similar equipment processing

similar classes of raw product, or all

such establishments in an industry. To

establish a non-zero retained water

limit, an inspected establishment,

industry trade association, or other

group would have to generate the

necessary supporting data. The labels of

products would have to state the

presence of retained water in the

products.

Cost Estimates

The analysis estimates a range of costs

the poultry industry will incur to meet

this new regulatory requirement. If

establishments are able to demonstrate

that current levels of retained water are

unavoidable in achieving applicable

food safety standards, establishments

will not incur additional costs for

reducing retained water. These

establishments would only incur costs

for establishing limits and costs for

labeling the product. The costs of

1768 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

establishing limits for the poultry

industry are estimated to be $1.5 million

(in 1998 dollars). This estimate is based

on each establishment conducting its

own tests. The cost should be lower if

associations or other groups establish

limits for different types of chiller

systems. Labeling costs are estimated to

be $18.4 million (in 1998 dollars) if all

raw, single-ingredient poultry continues

to retain water.

To the extent that establishments

cannot demonstrate that current

retained water levels are unavoidable in

achieving applicable food safety

standards, significant costs could be

incurred as establishments modify

processes to minimize retained water

levels. FSIS estimates that the average

retained water for chicken, as a

percentage of net weight is currently in

the 5.0 to 6.5 percent range. The

corresponding level for turkey is 4.0 to

4.5 percent. Reducing retained water

could entail a wide range of process

modifications, depending on the type of

chilling equipment currently used and

amount of retained water that would

have to be removed. FSIS estimates that,

if extensive modifications to chilling

systems were needed throughout the

industry, the fixed costs associated with

removing a substantial portion of the

existing retained water could run to

well over $100 million. The substantial

portion was defined in the PRIA, viz.,

that it would take 12 hours to drain

substantial portion of the retained water

in chickens. The 12-hour drain would

reduce the existing level range from 5–

6.5 percent, by 4 to 5 percentage points,

i.e., to 1–1.5 percentage range, or by

about 80 percent. The fixed costs

estimates of these extensive

modifications were taken from USDA/

ERS study, discussed in the PRIA, and

are summarized below.

The drip-dry process for chicken

requires production workers to remove

chickens from a production line, place

the chickens in vats, place the vats in a

cool room for 12 hours, and return the

chickens to the poultry line. Besides

labor, this process requires cooling

space, stainless steel vats that hold up

to 500 chickens, and a forklift to transfer

chickens from a production line to a

storage room and then back to the line

after the drip-dry process is complete.

To extend draining or dripping time,

many establishments would have to add

refrigerated facilities, purchase vats for

storing birds being drained, hire

additional personnel, and purchase

additional stock handling equipment.

There would be inventory costs due to

holding birds off the market for a longer

time before shipment. Holding birds at

inspected establishments would also

reduce the corresponding retail shelf

life.

The ERS staff developed some cost

estimates for holding poultry based on

the following industry input:

1. One common method of draining

uses stainless steel vats at a cost of

$1,000 each.

2. Vats hold approximately 500

chickens or 100 turkeys.

3. Cooler space costs $125 per square

foot.

4. Vats can be stacked two high.

5. Stacked vats with aisles require 12

square feet of space per vat.

6. Forklifts to move vats cost $24,000

each.

The Daily Moisture Records

sometimes include a record of the

additional drain time required. The time

varies with the initial water level, the

drain configuration and the location of

the excess water, i.e., under skin versus

between muscle tissues or within

muscle tissues. Based on the violations

data, it was determined that a 12-hour

drain would be the minimum time

required to remove most of the retained

water from chickens.

Most of the drain time for turkeys

ranged from 1⁄2 to 1 hour on an ‘‘hour

per percentage reduction’’ basis. All of

the turkey violations noted were less

than 1 percent above the existing limit

whereas some of the chickens started at

water levels 4 to 5 percentage points

above the existing limits.

To drain chickens for 12 hours is

equivalent to saying the industry would

need to add extra capacity to drain half

a day’s production, since most chicken

is processed in establishments running

two shifts.

Since average chicken production is

29.5 million birds per day (assuming a

260-day work year), half a day’s

production is 14.75 million birds. Using

the above factors, this would require

29,510 vats at $29.5 million; 354.12

square feet of cooler space at $44.3

million’ and $4.8 million of forklifts

assuming the largest 200 chicken

establishments would each require an

additional forklift. In this 12-hour case,

the total fixed costs would be $78.6

million ($29.5 + 44.3 + 4.8).

In addition, half a day’s turkey

production at 557,000 birds requiring

5,570 vats would cost $5.57 million and

cooler space would cost $8.36 million.

Assuming that the largest 70 turkey

establishments would require an

additional forklift at a cost of $1.68

million, the total fixed costs for draining

all turkeys for 12 hours would be $15.61

million ($5.57 + 8.36 + 1.68).

In short, the total fixed costs for a 12-

hour draining of chickens and turkeys

would be $94.2 million ($$78.6 +

$15.61). Since these costs were

estimated in 1997, updating them with

to the year 2000 would amount to about

$100 million.

Variable costs of holding poultry to

drain would include increased labor

costs, higher utility costs, increased

overheads, and the cost of carrying

additional inventory. Holding half a

day’s production is equivalent to

continually storing a wholesale value of

$37 million poultry ($19.2 billion

divided by 520 shifts/year). At a 5

percent interest rate, the annual cost of

draining poultry for 12 hours would be

$1.85 million.

It would be conservative to assume a

minimum average of one additional

employee per establishment. Since there

are 300 establishments, the cost at

$21,500 per employee per year would

result in an annual labor cost of $6.4

million ($21,500 x 300). The total

variable costs of $8.25 million ($1.85 +

$6.4) would increase to about $10

million in the year 2000 when updated

by an increase in Employment Cost

Index.

To sum up, the first year costs of

draining poultry would amount to $110

million ($100 m + $10 m). These are the

costs of reducing retained water in the

range of 1–11⁄2 percent. Since the

retained water is not reduced to zero,

these are merely the lower bounds. The

upper bound costs would be the costs of

reducing retained water to zero percent.

However, if extensive modifications

were not needed, the industry would

only incur the costs of establishing

retained water limits and meeting the

labeling requirements of the final rule.

Benefits of Final Rule

Because of longstanding industry

petitions and the decision in the Kenney

case, FSIS has had to develop new

regulatory requirements to carry out its

responsibilities for protecting the public

from economic adulteration. Prevention

of economic adulteration is a consumer

benefit. Consumers also will benefit

from the additional information on

retained water that will be provided as

a result of the labeling requirement. The

information on retained water should

contribute to a sounder basis for

purchasing decisions. Consumers are

currently not being informed about the

amount of retained water. Consumers

will benefit from having improved

knowledge of product quantity in terms

of meat or poultry meat content.

The final rule will provide the meat

industry with additional flexibility for

meeting the pathogen reduction

performance standards. Meat processors

will be able to use pathogen reduction

techniques without having to be

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1769

concerned about meeting the existing

zero retained water requirement. Of

course, if their single-ingredient raw

products retain water, the products will

have to be labeled to indicate how much

water may be retained.

This final rule also will provide

affected establishments with increased

flexibility to choose the most

appropriate means for implementing

HACCP plans for protecting the safety or

raw product while minimizing the

potential for economic adulteration. By

removing certain command-and-control

requirements and providing increased

flexibility for HACCP implementation,

this final rule may reduce the costs of

HACCP implementation.

As discussed in the preamble, this

final rule eliminates many

requirements, including the following:

1. The requirement that poultry

establishments provide FSIS with a

description of all chilling and freezing

procedures.

2. The requirement that poultry

establishments notify FSIS before any

changes in chilling procedures are

implemented and provide FSIS with test

results demonstrating the effectiveness

of the changes.

3. The requirements that meat

carcasses cannot show any weight gain

resulting from the use of carcass spray

systems.

4. Elimination of minimum water

intake requirements for immersion

chillers.

Finally, the rule will also provide all

affected establishments with the

flexibility and market incentives to

implement new procedures for meeting

pathogen reduction performance

standards. In addition, by replacing

command-and-control requirements

with HACCP-consistent performance

standards, the final rule will eliminate

some recordkeeping and reporting

burdens, provide for increased

flexibility, and reduce the costs of

HACCP implementation.

Impact on Small Entities

The final rule should not have a

significant impact on a large number of

small businesses. Almost half of all

federally inspected poultry slaughter

establishments are large business

entities, based on the Small Business

Administration size criterion of more

than 500 employees.

These establishments, and indeed

most poultry establishments, use

immersion chilling to meet the existing

chilling requirements for poultry, e.g., 9

CFR 381.66(b)(2) requires that poultry

carcasses under 4 pounds must be

chilled to 40 °F within 4 hours

following evisceration. It follows that,

for most poultry establishments, the

unavoidable retained water amount is

the minimum level that can be reached

with existing immersion chiller

equipment while still meeting the

chilling requirement. FSIS recognizes

that this minimum must be established

within practical limits for operating

parameters such as drip time and chiller

water temperature. The industry already

has information concerning the chiller

variable settings that minimize water

retention. Therefore, the poultry

industry can establish water retention

limits for various chiller systems with

minimal costs. FSIS also recognizes the

possibility that some poultry

establishments may have to use antimicrobial interventions that result in

higher levels of retained water to meet

the Salmonella standards than they do

to meet the existing chilling

requirements.

Fifty to 60 poultry slaughter

establishments process under a million

birds annually. Many of these smaller

operations do not use continuous

immersion chillers. They use ice or

slush to meet the existing chilling

requirements. Few, if any, would have

to reduce the current level of retained

water. The establishments most affected

by this final rule are the firms operating

immersion chillers in a manner that

targets the maximum allowable retained

water.

This final rule should not have a

significant impact on the meat industry

because that industry is already

achieving zero-percent retained water.

This final rule, however, provides an

alternative for establishments that are

having or will have trouble meeting the

Salmonella performance standards.

These establishments could use a full

range of anti-microbial rinses or hotwater rinses without having to worry

about meeting a zero-percent retainedwater limit. If they can demonstrate that

they need a non-zero limit to meet the

Salmonella standards, they can use the

flexibility provided by the final rule and

establish a new water limit as long as

they state the maximum percentage of

water absorbed and retained on product

labels. Of the meat products affected by

this final rule, edible organs prepared in

slaughtering plants are most likely to

retain water. Of the 1,200

establishments that prepare these

products, about 85 percent are small.

Most of these establishments will have

to label their products to indicate the

maximum retained-water percentage in

the products.

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 or

packaging requirements on federally

inspected meat and meat products or

poultry products that are in addition to,

or different than, those imposed under

the FMIA and PPIA. States and local

jurisdictions may, however, exercise

concurrent jurisdiction over meat and

poultry products that are outside official

establishments for the purpose of

preventing the distribution of meat or

poultry products that are misbranded or

adulterated under the FMIA or PPIA.

States and local jurisdictions also may

exercise concurrent jurisdiction, for the

same purpose, over imported meat and

poultry products that are not at an

official establishment after the entry of

such imported articles into the United

States.

This final rule is not intended to have

retroactive effect.

There are no applicable

administrative procedures that must be

exhausted prior to any judicial

challenge to the provisions of this final

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 final rule, if the

challenge involves any decision of an

FSIS employee relating to inspection

services provided under the FMIA or

PPIA.

Executive Order 12898

Pursuant to Executive Order 12898

(59 FR 7629; February 16, 1994),

‘‘Federal Actions to Address

Environmental Justice in Minority 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 final rule will provide new,

uniform regulations limiting the amount

of water retained by raw, singleingredient, meat and poultry products

as a result of post-evisceration

processing, such as carcass chilling,

considered necessary to minimize

pathogen growth on the products. As

explained in the economic impact

analysis, the regulations should

generally benefit consumers of meat,

meat products, and poultry products.

The regulations will not require or

compel meat or poultry establishments

to relocate or alter their operations in

ways that could adversely affect the

public health or environment in lowincome and minority communities.

Further, this final rule will not exclude

1770 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

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.

FSIS estimates that as many as 4

percent of meat and poultry

establishments under Federal and State

inspection are owned by women or

members of non-white minority groups.

Therefore, of the establishments affected

by this rule, as many as 4 percent of the

establishments may be under female or

minority ownership. FSIS has no reason

for supposing, however, that the effects

of this rule, whether adverse or

beneficial, on such establishments

would be disproportionate.

Additional Public Notification

Public awareness of all stages of

rulemaking and policy development is

important. Consequently, in an effort to

better ensure that minorities, women,

and persons with disabilities are aware

of this final rule, FSIS will announce it

and provide copies of this Federal

Register publication of this final rule in

the weekly FSIS Constituent Update.

The FSIS Constituent Update is

communicated via fax to over 300

organizations and individuals. In

addition, the update is available on line

through the FSIS web page located at

‘‘http://www.fsis.usda.gov’’. The update

is used to provide information regarding

FSIS policies, procedures, regulations,

Federal Register notices, FSIS public

meetings, recalls, and any other types of

information that could affect or would

be of interest to the Agency’s

constituents/stakeholders. The

constituent fax list consists of industry,

trade, and farm groups, consumer

interest groups, allied health

professionals, scientific professionals,

and other individuals who have

requested to be included. Through these

various channels, FSIS is able to

provide information to a much broader,

more diverse audience. For more

information and to be added to the

constituent fax list, readers of this

document may fax their requests to the

Congressional and Public Affairs Office,

at (202) 720–5704.

Paperwork Requirements

Title: Retained Water in Raw Meat

and Poultry Products; Poultry Chilling.

Type of Collection: Labels and

labeling records; data or information

supporting labeling statements.

Abstract: Slaughtering establishments

would have to have data to support

percent-absorbed-water statements on

product labels and to demonstrate that

the amount of absorbed water in the

product is unavoidable under the

establishments’ HACCP plans. The data

would have to have been collected

under written protocols.

This final rule will require an

estimated 210,000 hours to develop the

data to support retained water levels

above zero. All 300 federally inspected

poultry establishments will need to

conduct studies to establish minimum

retained water levels. The FRIA

assumed that the average establishment

would conduct studies for two product

categories. The FRIA assumed that a

reasonable study would examine 10

alternative chiller settings with four 50-

bird water tests conducted for each

setting. Each test would require 2.5

hours. Thus, it would take an estimated

200 hours for each of 300 poultry

establishments, or more than 30,000

hours.

The FRIA assumed that at most 500

meat establishments need to develop

non-zero water levels to meet the

existing pathogen-reduction

performance standards. With larger

carcasses, the recording time is doubled

to 200 hours per establishment. These

500 meat establishments would also

require 100 hours to collect microbial

samples. Thus, the information

collection would be 300 hours for each

of 500 establishments, or 150,000 hours.

All 800 establishments with non-zero

levels would also have to develop new,

generically approved labels.

Estimate of Burden: Protocols for

determining minimum feasible water

retention in product classes (3,000

hours); data supporting absorbed-water

label statements or the lack thereof

(210,000 hours). Changes to product

labels would be generically approved

and, therefore, establishments would

not incur a burden from label

submission.

Respondents: Meat and poultry

product establishments or trade

associations.

Estimated Number of Respondents:

800.

Estimated Number of Responses per

Respondent: 1.

Estimated Total Annual Burden on

Respondents: 213,000 hours.

Copies of this information collection

assessment can be obtained from Lee

Puricelli, Paperwork Specialist, Food

Safety and Inspection Service, USDA,

112 Annex, 300 12th SW., Washington

DC 20250.

Comments are invited on: (a) Whether

the proposed 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.

Specifically, FSIS is interested in

comments regarding the label

requirements. Some commenters

expressed concern about the usefulness,

or ‘‘practical utility,’’ of the information

on the maximum percentage of retained

water that must be disclosed on the

label. FSIS welcomes any information

and data to support this requirement or

that presents alternatives. FSIS will

fully address any comments in its

information collection request that it

will submit to the Office of Management

Budget 60 days after publication of this

rule.

Comments may be sent to Lee

Puricelli, see address above, and the

Desk Officer for Agriculture, Office of

Information and Regulatory Affairs,

Office of Management and Budget,

Washington DC 20253.

Comments are requested by March 12,

2001. To be most effective, comments

should be sent to OMB within 30 days

of the publication date.

List of Subjects

9 CFR Part 381

Food labeling, Poultry and poultry

products.

9 CFR Part 441

Consumer protection standards, Meat

and meat products, Poultry products.

For the reasons discussed in the

preamble, FSIS is amending 9 CFR

Chapter III, as follows:

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

1. 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 CFR 2.18, 2.53.

2. Paragraph (b) of § 381.1 is amended

by revising the definition of Ready-tocook poultry to read as follows:

§ 381.1 Definitions.

* * * * *

(b) * * *

(44) Ready-to-cook poultry. ‘‘Readyto-cook poultry’’ means any slaughtered

Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations 1771

poultry free from protruding pinfeathers

and vestigial feathers (hair or down),

from which the head, feet, crop, oil

gland, trachea, esophagus, entrails, and

lungs have been removed, and from

which the mature reproductive organs

and kidneys may have been removed,

and with or without the giblets, and

which is suitable for cooking without

need of further processing. Ready-tocook poultry also means any cut-up or

disjointed portion of poultry or other

parts of poultry, such as reproductive

organs, head, or feet that are suitable for

cooking without need of further

processing.

* * * * *

3. Section 381.65 is revised to read as

follows:

§ 381.65 Operations and procedures,

generally.

(a) Operations and procedures

involving the processing, other

handling, or storing of any poultry

product must be strictly in accord with

clean and sanitary practices and must be

conducted in a manner that will result

in sanitary processing, proper

inspection, and the production of

poultry and poultry products that are

not adulterated.

(b) Poultry must be slaughtered in

accordance with good commercial

practices in a manner that will result in

thorough bleeding of the carcasses and

ensure that breathing has stopped prior

to scalding. Blood from the killing

operation must be confined to a

relatively small area.

(c) When thawing frozen ready-tocook poultry in water, the establishment

must use methods that prevent

adulteration of, or net weight gain by,

the poultry.

(d) The water used in washing the

poultry must be permitted to drain

freely from the body cavity.

(e) Detached ova may be collected for

human food and handled only in

accordance with 9 CFR 590.440 and

may leave the establishment only to be

moved to an official egg product

processing plant for processing. Ova

from condemned carcasses must be

condemned and treated as required in

§ 381.95.

4. Section 381.66 is amended by

revising paragraphs (a), (c), and (d) and

removing paragraph (f)(6), to read as

follows:

§ 381.66 Temperatures and chilling and

freezing procedures.

(a) General. Temperatures and

procedures that are necessary for

chilling and freezing ready-to-cook

poultry, including all edible portions

thereof, must be in accordance with

operating procedures that ensure the

prompt removal of the animal heat,

preserve the condition and

wholesomeness of the poultry, and

assure that the products are not

adulterated.

* * * * *

(c) Ice and water chilling. (1) Only ice

produced from potable water may be

used for ice and water chilling. The ice

must be handled and stored in a

sanitary manner.

(2)(i) Poultry chilling equipment must

be operated in a manner consistent with

meeting the applicable pathogen

reduction performance standards for

raw poultry products as set forth in

§ 381.94 and the provisions of the

establishment’s HACCP plan.

(ii) Major portions of poultry

carcasses, as defined in § 381.170(b)(22),

may be chilled in water and ice.

(3) Previously chilled poultry

carcasses and major portions must be

maintained constantly at 40 °F or below

until removed from the vats or tanks for

immediate packaging. Such products

may be removed from the vats or tanks

prior to being cooled to 40 °F or below,

for freezing or cooling in the official

establishment. Such products must not

be packed until after they have been

chilled to 40 °F or below, except when

the packaging will be followed

immediately by freezing at the official

establishment.

(4) Giblets must be chilled to 40 °F or

below within 2 hours from the time they

are removed from the inedible viscera,

except that when they are cooled with

the carcass, the requirements of

paragraph (b)(2) of this section must

apply. Any of the acceptable methods of

chilling the poultry carcass may be

followed in cooling giblets.

(d) Water absorption and retention.

(1) Poultry washing, chilling, and

draining practices and procedures must

be such as will minimize water

absorption and retention at time of

packaging.

(2) The establishment must provide

scales, weights, identification devices,

and other supplies necessary to conduct

water tests.

* * * * *

(f) * * *

(6) [Removed]

5. A new Part 441 is added to

subchapter E to read as follows:

PART 441—CONSUMER PROTECTION

STANDARDS: RAW PRODUCTS

Authority: 21 U.S.C. 451–470, 601–695; 7

U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53.

§ 441.10 Retained water.

(a) Raw livestock and poultry

carcasses and parts will not be

permitted to retain water resulting from

post-evisceration processing unless the

establishment preparing those carcasses

and parts demonstrates to FSIS, with

data collected in accordance with a

written protocol, that any water retained

in the carcasses or parts is an

unavoidable consequence of the process

used to meet applicable food safety

requirements.

(b) Raw livestock and poultry

carcasses and parts that retain water

from post-evisceration processing and

that are sold, transported, offered for

sale or transportation, or received for

transportation, in commerce, must bear

a statement on the label in prominent

letters and contiguous to the product

name or elsewhere on the principal

display panel of the label stating the

maximum percentage of water that may

be retained (e.g., ‘‘up to X% retained

water,’’ ‘‘less than X% retained water,’’

‘‘up to X% water added from

processing’’). The percent water

statement need not accompany the

product name on other parts of the

label. Raw livestock and poultry

carcasses and parts that retain no water

may bear a statement that no water is

retained.

(c)(1) An establishment subject to

paragraph (a) of this section must

maintain on file and available to FSIS

its written data-collection protocol. The

protocol must explain how data will be

collected and used to demonstrate the

amount of retained water in the product

covered by the protocol that is an

unavoidable consequence of the process

used to meet specified food safety

requirements.

(2) The establishment must notify

FSIS as soon as it has a new or revised

protocol available for review by the

Agency. Within 30 days after receipt of

this notification, FSIS may object to or

require the establishment to make

changes in the protocol.

(d) Expected elements of a protocol

for gathering water retention data:

(1) Purpose statement. The primary

purpose of the protocol should be to

determine the amount or percentage of

water absorption and retention that is

unavoidable using a particular chilling

system while achieving the regulatory

pathogen reduction performance

standard for Salmonella as set forth in

the PR/HACCP regulations (9 CFR

310.25(b), 381.94(b)) and the time/

temperature requirements set forth in 9

CFR 381.66. Additional purposes that

could be included are determining

chilling system efficiency and

evaluating product quality.

1772 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Rules and Regulations

(2) Type of washing and chilling

system used by the establishment. Any

post-evisceration washing or chilling

processes that affect water retention

levels in and microbial loads on raw

products should be described. For

poultry establishments, the main chiller

types, identified by the mechanism used

to transport the birds through the chiller

or to agitate the water in the chiller, are

the drag-through, the screw type, and

the rocker-arm type.

(3) Configuration and any

modifications of the chiller system

components. A description of chillersystem configurations and modifications

should be provided. The description

should include the number and type of

chillers in a series and arrangements of

chilling system components, and the

number of evisceration lines feeding

into a chiller system. If there is a prechilling step in the process, its purpose

and the type of equipment used should

be accurately described. Any

mechanical or design changes made to

the chilling equipment should be

described.

(4) Special features in the chilling

process. Any special features in the

chilling process, such as antimicrobial

treatments, should be described. Also,

the length and velocity of the dripping

line should be described, as well as the

total time allowed for dripping. Any

special apparatus, such as a mechanism

for squeezing excessive water from

chilled birds, should be explained.

(5) Description of variable factors in

the chilling system. The protocol should

describe variable factors that affect

water absorption and retention. In

poultry processing, such factors are

typically considered to be the time in

chiller water, the water temperature,

and agitation. The protocol should

consider air agitation, where applicable.

Additional factors that may affect water

absorption and retention are scalding

temperature and the pressure or amount

of buffeting applied to birds by feather

removal machinery, and the resultant

loosening of the skin. Another factor

that should be considered is the method

used to open the bird for evisceration.

(6) Standards to be met by the chilling

system. For example, the chilling system

may be designed simply to achieve a

reduction in temperature of ready-tocook poultry to less than 40 °F within

the time limit specified by the

regulations, or in less time. As to the

standard for pathogen minimization, the

Salmonella pathogen reduction

standards, as set forth in the PR/HACCP

final rule, have been suggested.

Although there is not yet an applicable

Salmonella standard for turkeys,

establishments are free to adopt

practicable criteria for use in gathering

data on turkeys under the protocols here

suggested. Additional microbiological

targets, such as E. coli or Campylobacter

levels, or reductions in numbers of other

microorganisms, may also be used.

(7) Testing methods to be employed.

The protocol should detail the testing

methods to be used both for measuring

water absorption and retention and for

sampling and testing product for

pathogen reductions. The protocol

should call for water retention and

pathogen reduction tests at various

chilling equipment settings and chilling

time-and-temperature combinations.

The method to be used in calculating

water absorption and retention should

be reproducible and statistically

verifiable. With respect to the pathogenreduction aspect of the testing, FSIS

recommends the methods used for E.

coli and Salmonella testing under the

PR/HACCP regulations. The number of

samples, the type of samples, the

sampling time period, and the type of

testing or measurement should be

included in the protocol.

(8) Reporting of data and evaluation

of results. The protocol should explain

how data obtained are to be reported

and summarized. The criteria for

evaluating the results and the basis for

conclusions to be drawn should be

explained.

(9) Conclusions. The protocol should

provide for a statement of what the data

obtained demonstrate and what

conclusions were reached.

Done at Washington, DC: January 3, 2001.

Thomas J. Billy,

Administrator.

Note: Appendix A will not be codified in

Title 9 of the Code of Federal Regulations.

Appendix A—Method for Determining

Moisture in Meat and Meat Products

and Poultry Products

A. Introduction

Theory: In this determination, a weighed

sample is heated, cooled, and then reweighed. The loss in weight is calculated as

moisture content.

B. Equipment

Apparatus:

a. Covered aluminum dish. At least 50 mm.

diameter and not greater than 40 mm. deep,

containing a paddle.

b. Mechanical convection oven, preferably

one equipped with a booster heater.

c. Food chopper with plate openings ≤ 1⁄8′′

(3 mm.), or Robot Coupe or equivalent food

processor.

C. [Reserved.]

D. [Reserved.]

E. Sample Preparation Procedure for Fresh

Meat or Poultry

For accurate and reliable measurement, the

raw meat or poultry sample should be finely

ground to a homogeneous consistency.

F. Analytical Procedure

a. Accurately weigh sample (representing

approximately 2 g. of dry material) into an

aluminum dish.

i. Weigh the sample as rapidly as possible

to minimize loss of moisture.

ii. The weight of the pan should include

the paddle, which is used in spreading the

sample across the bottom of the pan, thereby

presenting a greater sample surface area,

which is beneficial to moisture removal.

iii. If the sample is relatively dry when

received, a small quantity of distilled water

may be added to the pan only after the

sample weight is obtained. This quantity of

water will be helpful in spreading the sample

across the bottom of the pan, and will

introduce no error since it will be evaporated

when the sample is oven-dried.

b. Dry, with cover removed, for 16–18

hours at 100–102 °C, or for 4 hours at 125

°C in mechanical convection oven.

Do not overload the drying oven or sample

may be insufficiently dried and give low

results. Drying time will start when the

original temperature has been reached. Use

the oven’s booster heater, if the oven is so

equipped, to minimize this recovery time.

G. Calculations

1. Procedure

Percent C

A = 100 (B ) −

A = sample weight

B = weight of dish + sample before drying

C = weight of dish + sample after drying

Note: If laboratory is not air-conditioned,

and humidity is high, dishes should be

desiccated before the initial and final

weighings.

Reference: Official Methods of Analysis of

the Association of Official Analytical

Chemists, 16th Edition, 950.46.

[FR Doc. 01–460 Filed 1–4–01; 10:35 am]

BILLING CODE 3410–DM–P