Mandatory Inspection of Ratites and Squabs

[Federal Register Volume 66, Number 88 (Monday, May 7, 2001)]

[Rules and Regulations]

[Pages 22899-22907]

From the Federal Register Online via the Government Publishing Office [www.gpo.gov]

[FR Doc No: R1-10679]

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Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Rules and

Regulations

[[Page 22899]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 362 and 381

[Docket No. 01-045IF]

RIN 0583-AC84

Mandatory Inspection of Ratites and Squabs

Editorial Note: Federal Register rule document 01-10679

originally appeared in the issue of Tuesday, May 1, 2001 at 66 FR

21631-21639. Due to several errors (repeated text and missing text

on page 21635) the document is being reprinted in its entirety.

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the

Poultry Products Inspection Regulations (Part 381) and the Voluntary

Poultry Inspection Regulations (Part 362) to include ratites and squabs

under the mandatory poultry products inspection regulations. The Agency

is responding to the FY 2001 Agriculture, Rural Development, Food and

Drug Administration and Related Agencies Appropriations Act (the

Appropriations Act), signed by the President on October 28, 2000, which

provides that 180 days after the date of its enactment, U.S.

establishments slaughtering or processing ratites or squabs for

distribution into commerce as human food will be subject to the

requirements of the Poultry Products Inspection Act (PPIA), rather than

the voluntary poultry inspection program under section 203 of the

Agricultural Marketing Act of 1946 (AMA). The provision of the

Appropriations Act specifying that ratites and squabs come under the

Agency's mandatory inspection requirements is effective on April 26,

2001. Interested parties may comment on this interim final rule.

DATES: This interim final rule will be effective April 26, 2001.

Comments must be received on this interim final rule by July 2, 2001.

ADDRESSES: Submit one original and two copies of written comments

within the scope of the rulemaking to FSIS Docket Clerk, Docket #01-

045IF, U.S. Department of Agriculture, Food Safety and Inspection

Service, Room 102, Cotton Annex, 300 12th Street, SW., Washington, DC

20250-3700. All comments submitted in response to this proposal 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.

FOR FURTHER INFORMATION CONTACT: For information about the interim

final rule, contact Dr. Arshad Hussain, Director, Inspection and

Enforcement Standards Development Staff, Office of Policy, Program

Development, and Evaluation, FSIS, U.S. Department of Agriculture, Room

202, Cotton Annex, 300 12th Street, SW, Washington, DC 20250-3700,

(202) 720-3219.

SUPPLEMENTARY INFORMATION:

Background

On October 28, 2000, the President signed the Appropriations Act,

which provides that 180 days after the date of its enactment, U.S.

establishments that slaughter or process ratites (such as ostriches,

emus, and rheas) or squabs for distribution into commerce as human food

will be subject to the requirements of the PPIA (21 U.S.C. 451, et

seq.), rather than the voluntary poultry inspection program under

section 203 of the AMA (7 U.S.C. 1622). This provision of the

Appropriation Act is effective on April 26, 2001.

Ratites are members of a superorder (Ratitae) of flightless birds

that have small or rudimentary wings and flat breastplates, e.g.,

ostriches, emus, and rheas. Squabs are young pigeons that have not yet

flown.

Ratites are currently inspected under the Voluntary Poultry

Inspection Regulations as an experimental program. Operators who wish

to continue to slaughter or process ratites or squabs after April 26,

2001, for transport or sale in commerce must apply to FSIS for a grant

of inspection for mandatory inspection service (Secs. 381.6 and

381.16). As of April 26, 2001, grants of voluntary inspection for

ratites and squabs will no longer be valid. Fees for ratite and squab

inspection services will no longer be charged, except for overtime and

holiday inspection services. Applications for mandatory inspection must

be submitted on an FSIS application form available from any FSIS

District Office or from FSIS Headquarters, Washington, DC 20250. FSIS

will give notice in writing to each applicant granted (or denied)

inspection.

Under the regulations that implement the PPIA, before being granted

Federal inspection, an establishment must have written Sanitation

Standard Operating Procedures (SOPs) (Sec. 381.22(a)) and a Hazard

Analysis and Critical Control Point (HACCP) plan that the establishment

has validated (Sec. 381.22 (b) and (c)). Establishments can receive

conditional grants of inspection for a period of not more than 90 days

while they validate their HACCP plans (Sec. 381.22(b)).

Import Inspection

This interim final rule will be effective on April 26, 2001. Within

18 months of that date, imported ratite or squab products will have to

originate in countries that are eligible to export poultry to the

United States and will have to be processed in establishments certified

by the government of the foreign country as eligible to export to the

United States. Currently, these countries include Canada, France, Great

Britain, and Israel. Hong Kong and Mexico have not yet been approved by

the United States to slaughter poultry; therefore, they are only

eligible to export to the United States processed poultry products that

originate from Canada, France, Great Britain, Israel, or the United

States (Sec. 381.196).

All countries exporting or wanting to export ratite and squabs

products to the United States, regardless of their current eligibility

status regarding meat and poultry product exports to the United States,

may do so for the next 18 months subject to the following. Countries

already eligible to export poultry to the United States will be able to

export ratites and squabs as soon as they certify to FSIS those

establishments eligible to export to the United States. These countries

are Canada, Israel, Great Britain, and France. Animal health

[[Page 22900]]

restrictions continue to apply so there is no change with regard to the

eligibility of specific products based on APHIS regulations.

Countries eligible to export meat to the United States will be

permitted to export ratites to the United States provided the animals

are slaughtered in an establishment certified to export to the Unites

States and provided the countries submit a request for establishing

equivalency. Certified establishments are required to meet FSIS HACCP

and Pathogen Reduction requirements. At this point, Australia and New

Zealand, which are both eligible to export meat to the United States,

have indicated that they want to export ratites.

Countries not eligible to export meat or poultry to the United

States will need to submit a request for equivalency and FSIS will need

to make an equivalency determination according to 9 CFR Part 327.

As indicated above, however, each country desiring to begin or

continue exporting such products to the United States will have to

apply for an equivalence determination of its ratite and squab

inspection system. Countries' ratite and squab export inspection

systems must be found to be equivalent with the U.S. domestic

inspection system within 18 months of the effective date of the

Agency's new mandatory ratite and squab inspection requirements (April

26, 2001).

After the 18 month period has ended, all shipments of ratites and

squabs from eligible countries must be accompanied with the appropriate

veterinary health certificate (Sec. 381.197) and must be presented to

FSIS for import reinspection prior to entry (Sec. 381.199).

Countries wanting to export ratites and squab to the United States

should make a written request to export poultry to FSIS through the

United States Embassy located in the country. FSIS will conduct both a

document review and an on-site audit to determine if the country

operates an equivalent poultry inspection system.

During the review, FSIS will work cooperatively with the Animal and

Plant Health Inspection Service, which approves the entry of poultry

products according to the disease status of the exporting country.

If the country's export inspection system is found to be equivalent

with the U.S. domestic inspection system, FSIS will publish a proposal

in the Federal Register to list the country as eligible to export

poultry products to the United States. After the public has had 60 days

to comment on this proposed rule, FSIS will review all of the public

comments and make a final determination of equivalence. The

determination to list a country as equivalent, and, therefore, eligible

to export poultry products to the United States, is published as a

final rule in the Federal Register, along with FSIS's responses to the

public comments. At that time, the country's inspection service may

certify establishments for export of poultry products, including

ratites and squabs, to the United States.

Summary of Interim Final Rule

FSIS is making a number of technical changes in its regulations,

which it believes are noncontroversial, to provide for the inspection

of ratites and squabs. The Agency is amending 9 CFR 362.1(d) to remove

squab from the definition of ``Poultry'' in the Voluntary Poultry

Inspection Regulations. FSIS is also amending Sec. 362.1(e) to include

ratites and squabs with chickens, turkeys, ducks, geese, and guineas in

the definition of ``Poultry Product.'' The Agency is also amending

Sec. 381.1(b) to include ratites and squabs within the definition of

``Poultry'' in the Poultry Products Inspection Regulations.

FSIS is amending Sec. 381.36(b) to require a pen for the ante

mortem inspection of ratites. It is necessary to specify that a pen be

available for ratites because ante mortem inspection of ratites is done

on an individual bird basis, rather than a lot basis as is done for

other amenable poultry.

The Agency is amending Sec. 381.66 to exempt ratites from the

chilling requirements of Sec. 381.66 paragraphs (b), (c), and all of

(d), except for (d)(1). Ratites are air-chilled rather than water-

chilled, as is the case with most amenable poultry.

FSIS is amending Sec. 381.67 to include squabs with young chickens

under traditional inspection procedures. The two types of birds are of

similar size and weight and thus can be inspected in a similar manner.

The Agency is amending Sec. 381.70 to permit an exception to

examining and inspecting ratites on the day of slaughter for humane

reasons or, for low volume establishments, under certain conditions.

This amendment allows the humane handling of ratites to be the same as

that for livestock.

FSIS is amending Sec. 381.71 to provide information on how suspect

and condemned ratites are to be handled. This amendment is necessary

because the treatment of suspect and condemned ratites is different

than the treatment of suspect and condemned birds of other amenable

species.

FSIS is amending Sec. 381.72 to reflect the fact that ratites

showing disease symptoms at ante mortem will be handled differently

than other diseased poultry.

The Agency is amending Sec. 381.76 to add Ratite Inspection as the

fifth post mortem poultry inspection system. This amendment is

necessary because inspection of ratites must be done in a different

manner than inspection of other amenable poultry species. Thus,

inspection of ratites cannot be done under the existing four inspection

systems.

FSIS is amending Sec. 381.96 to provide that ratite carcasses and

parts that are shipped unpacked must bear the official brand. This

addition is necessary because ratites are the only species of amenable

species that are likely to be shipped unpacked.

Finally, FSIS is proposing to make some editorial changes to

Sec. 362.1 to correct inaccuracies and to provide for greater clarity.

Regulatory Impact Analysis

Basis for Regulatory Action

Currently, ratites and squabs are inspected on a voluntary, fee-

for-service basis under section 203 of the AMA. The interim final rule

will amend Sec. 362.1(d) to remove squab from the definition of poultry

in the Voluntary Poultry Inspection Regulations and will amend

Sec. 381.1 to include ratites and squabs under the Agency's mandatory

poultry inspection requirements.

Congress mandated, in the FY 2001 Agriculture Appropriation Act,

that 180 days from the date of enactment (April 26, 2001) U.S.

establishments that slaughter or process ratites or squabs will come

under mandatory inspection by FSIS.

Baseline

Ratites and squabs are considered non-amenable species and are

currently inspected by the Agency on a voluntary, fee-for-service

basis.\1\ These species are also inspected on a mandatory or voluntary

basis under State programs. Ratites are an order of flightless birds

that includes ostriches, emus, rheas, cassowaries, and kiwis. The most

economically important species of ratites are the ostrich and the emu.

Squabs are young domesticated pigeons that have never flown. Ratite and

squab

[[Page 22901]]

meat is valued for its flavor and nutritional characteristics.

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\1\ The FMIA and PPIA do not mandate the inspection of ratites

and squabs. FSIS provides, on a fee-for-service basis, voluntary

inspection services under the Argicultural Marketing Act of 1946 for

these species and others such as reindeer, elk, deer, antelope,

water buffalo, bison, migratory water fowl, game birds, and rabbits.

The Food and Drug Administration has primary statutory authority

over all food animals and birds not covered by the FMIA and the

PPIA.

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Since 1992, when FSIS first granted a request for voluntary

inspection for ostriches, approximately 166 establishments have been

issued a grant of inspection for ratite operations. Currently 99

establishments possess a grant of inspection. In 1999, there were a

total of 48,286 (76%) ratites inspected in Federal establishments and

14,427 (24%) ratites inspected in State establishments, or a total of

62,713 ratites inspected (Table 1). Ostriches made up the largest share

(69%) of the ratites inspected under the Federal program, whereas emus

made up the largest share (56%) of the ratites inspected under State

programs.

Table 1.--Ratites and Squab Inspection Volume and Establishments, FY 1999

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

Federal State establishments

establishments ----------------------

Species ---------------------- Total

Number % of Number % of inspected

inspected total inspected total

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

Ratites

Ostrich............................................ 33,521 86 5,254 14 38,775

Emu................................................ 14,745 64 8,068 36 22,813

Other.............................................. 20 2 1,105 98 1,125

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

Ratites Total.................................... 48,286 76 14,427 24 62,713

Squabs................................................. 175,496 14 1,122,131 86 1,297,627

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

Totals............................................. 223,782 16 1,136,558 84 1,360,240

========================================================

Ests. Number Number

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

Squabs............................................. 2 2

Ratites............................................ 99 95

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In 1999, states with a large share of ratites inspected under the

Federal program were California, Georgia, Illinois, Louisiana,

Oklahoma, and Texas. Alabama, California, Mississippi, North Carolina,

Ohio, and Texas inspected a large share of ratites under State

programs. There were almost an equal number of establishments involved

in slaughter of ratites under the Federal (99) and State (95)

inspection programs.

Ostriches

Ostrich is the largest bird in the world, standing about seven to

eight feet tall and weighing 300-400 pounds when fully grown. Industry

representatives indicate that there were about 600 ostrich growers

1998, down from 1000 growers in 1996. There is significant uncertainty

about the annual production of ostriches and other ratites at this

time. The Agency requests reliable information on the annual number of

ratites and squab produced and the number of producers.

Ostriches are slaughtered at an average age of 12 months. The

average weight at slaughter is 350 pounds. Ostrich meat is sold as

steaks, fillets, medallions, roasts, and ground meat. Currently,

ostriches are processed in establishments that are equipped to process

other red meat species such as cattle, sheep, goats, and swine.

Emus

A mature emu reaches a height of 5 to 6 feet tall, weighing 90 to

120 pounds. In 1999, 22,813 emus were inspected under Federal and State

programs (Table 1). There are a number of valuable products derived

from emus in addition to their meat.

There is also significant uncertainty about the annual production

of emus. Some source indicate that there may be as many as 500,000

birds on 5,000 to 6,000 farms in the U.S., with the majority of them in

Texas, Oklahoma, and elsewhere in the Southwest.

Squabs

Squabs are young domesticated pigeons that have never flown. Squabs

usually weigh 1 pound or less at the time of slaughter (about 4 weeks

old). In 1999, California and Oregon were the only two states that

inspected squabs under the Federal voluntary inspection program. In

that year, 175,496 squabs were inspected (Table 1). During that same

period 1,122,131 squabs were inspected under the inspection programs of

California and South Carolina.

Regulatory Alternatives

FSIS considered two options in developing its interim final rule.

The first option the Agency considered was to only change the

definition of poultry in the Poultry Products Inspection Regulations to

include ratites and squabs. This approach may have caused confusion in

the industry because it would be difficult to apply some of the current

poultry regulations to ratites and squabs, e.g., chilling and certain

handling requirements.

The Agency's second option was to make the changes required by

statute and other changes as noted above. FSIS selected this option

because it will provide a more orderly transition from voluntary

inspection to mandatory inspection of ratites and squabs than the first

option at little or no additional cost.

Benefits

There are three primary benefits that may result from extending

mandatory inspection services to ratites and squabs: industry growth,

public health, and industry cost savings.

Having the inspection mark on the ratite and squab products could

lead to greater consumer confidence and acceptability of the products.

Demand could be expected to increase as a result. Establishments that

are able to capitalize on the change in consumer preference may realize

increased sales of these products. To the extent that inspection

promotes growth in the ratite and squab industry, society could benefit

also from the increased employment and earnings of workers in these

establishments. Studies are not available to identify the potential

growth in the industry that may occur.

The public health benefits of inspection are related to the

reduction

[[Page 22902]]

in risk associated with consumption of all ratite and squab meat that

must be inspected using the same procedures employed in the meat and

poultry industries. HACCP systems, Sanitation SOPs, and process control

practices have been shown to reduce contamination by harmful foodborne

pathogens.

A shift to the mandatory inspection system will eliminate the

payment of fees for inspection services. This is not a benefit from an

economic perspective as the costs of inspection are transferred

elsewhere in the economy. Since FSIS will recover these costs through

appropriated funds, the change to a mandatory inspection system results

in an income transfer from the public to the ratite and squab industry.

The total cost savings to the industry would be about $2 million in

2001, with the possibility of increasing over time with the expansion

of the industry.

Industry Costs

The compliance cost of extending mandatory inspection to ratite and

squab species will be negligible. All establishments involved in

slaughtering amenable species, as of January 25, 2000, must be in

compliance with the provisions of Pathogen Reduction/Hazard Analysis

Critical Control Point (PR/HACCP) final rule. Under the provisions of

the rule, all slaughter establishments under mandatory inspection are

required to have HACCP plans and meet process control requirements.

Nearly all establishments that slaughter and process ratites and squabs

because they also slaughter other species under mandatory inspection

have already implemented HACCP, Sanitation SOPs, and other measures

consistent with the requirements of this rule. These establishments

will still be required to make changes to their HACCP or sanitation

procedures to include ratites and squabs. Establishments that have not

included ratites and squabs in their HACCP plans \2\ would incur

minimal costs associated with HACCP plan modification.

As poultry is subject to mandatory Federal inspection, ratites and

squabs will be subject to E. coli testing requirements. Establishments

that slaughter more than one kind of poultry and livestock are required

to test the kind of species slaughtered in the greatest number. The

number of establishments where ratites and squabs will be the species

being slaughtered in the greatest number is very low. Consequently,

very few establishments will be required to perform additional E. coli

testing for process control verification. The costs per establishment

for E. coli testing are shown in Table 2. The Agency is requesting

information on the number of establishments where ratites or squabs

are, or would become, the major species for slaughter.

For those establishments slaughtering and processing ratites and

squabs under voluntary inspection, the transition to mandatory

inspection will not require changes in equipment and processing

methods. Ratites are currently being slaughtered and processed in

establishments that are equipped to process cattle, sheep, goats, and

swine. Squabs are processed using the same equipment and procedures as

those used for young chickens.

The Agency estimates that 50% of the Federal establishments (50

establishments) and 25% of the State establishments (24 establishments)

may be required to make minor changes in their HACCP plan to

accommodate mandatory inspection requirements for ratites.

Table 2.--Potential Costs for Mandatory Federal Inspection

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

Per est. Industry

Costs (dollars) ($thousand)

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

Start up Cost:

HACCP Plan Modification............. 500 37.0

SSOP Modification................... 100 7.4

Recurring Cost: E. coli Sampling (26 520 38.5

samples@$20 per sample per

establishment).........................

Recordkeeping........................... 300 22.2

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

Total............................. 1,420 105.1

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The Agency seeks comment or further information pertaining to its

cost figures for mandatory inspection.

Other additional costs that would apply to all establishments

applying for Federal mandatory inspection will be the application cost.

This cost will be negligible, as it is limited to a one-time cost for

filling out an application, about $10. The total compliance cost to the

establishments identified above are estimated to be $105,100.

FSIS is aware that some State inspected ratite product may contain

sodium nitrite and/or sodium nitrate even though the Food and Drug

Administration (FDA) regulations do not authorize such use of these

substances for ratite products. However, once ratites are officially

defined as poultry under PPIA regulations, such use will not be allowed

in FSIS inspected products. FSIS does not have information on the types

or amounts of product affected by this change, but is seeking

information.

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\2\ HACCP plans are not required to cover non-amenable species.

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FSIS Costs

The Agency anticipates the need to conduct baseline microbiological

and chemical residue studies. These studies constitute the major costs

to the Agency totaling $600,000.

Microbiological Testing

The microbiological studies would help the Agency determine the

prevalence of harmful bacteria or pathogens in ratites and squabs.

These studies can also be used to develop performance standards for

pathogen reduction. The costs of a microbiological baseline testing for

ratites are $110,000 and for squabs, $95,000 (Tables 3 and 4).

Chemical Residue Testing

Chemical residue studies would help the Agency determine the

presence of violative chemical and drug residues in ratites and squabs.

Chemical residue testing would be necessary to determine how these

additional species would be incorporated in the Agency's annual residue

testing program. FSIS' one-time costs for chemical residue studies for

ratites and squabs are $210,000 and $185,000, respectively (Tables 3

and 4).

[[Page 22903]]

Table 3.--Cost to FSIS of a Mandatory Ratite Inspection Program

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

Inspection Thousands of

One-time costs hours dollars

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

Chemical Residue Study.................. .............. 210.0

Microbiological Baseline................ .............. 110.0

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

Total............................... .............. 320.0

Transfer Payment:\1\ Federally-Inspected 38,524 1,959.0

Ests...................................

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

\1\ The hourly rate for Federal inspection in FY 2000 is estimated to be

$38.44 per hour.

Table 4.--FSIS Mandatory Squab Inspection Program Costs

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

Inspection Thousands of

One-time costs hours dollars

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

Chemical Residue Study.................. .............. 185.0

Microbiological Baseline................ .............. 95.0

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

Total............................... .............. 280.0

Transfer Payment:\1\ Federally-Inspected 322 16.4

Ests...................................

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

\1\ The hourly rate for Federal inspection in FY 2000 is estimated to be

$38.44 per hour.

Transfer Payments

Under voluntary inspection, establishments pay for inspection

services. The funds for mandatory inspection activities are

appropriated from Federal tax revenues. The transition from voluntary

to mandatory inspection changes the source of inspection program

funding. The Agency estimates that the industry cost of inspection of

ratites and squabs for 1999 in Federal establishments was $1,975,000,

of which ratites accounted for $1,959,000 and squabs, $16,400,

including overhead (Tables 3 and 4).

When ratite and squab inspection becomes mandatory, it is possible

that the volume of ratites and squabs inspected at Federally inspected

establishments will increase beyond what is currently being inspected.

First, there may be significant volumes of ratites and squabs that are

currently slaughtered and consumed without inspection that would be

brought under inspection. Second, an establishment currently under a

State inspection program that is shipping ratites and squabs in

interstate commerce would have to shift to Federal inspection to

maintain its markets. It is expected that 25% of the establishments

under State voluntary inspection would migrate to the Federal mandatory

program. The analysis does not take into account the potential increase

in the demand for inspection services. Both species currently account

for an extremely small share of meat and poultry inspection. Changes in

the required level of inspection program personnel are not expected to

be significant in the near-term.

The estimated total cost of inspection in State establishments is

$554,400 for 14,427 ratites and 1,122,131 squabs for FY 1999. Under the

current agreement the Agency has with state having a voluntary

inspection program, the Agency pays half of the inspection program

costs, or $277,191 (Table 5).

Under a mandatory program, states would no longer be able to

collect fees for inspection services. States may decide to terminate

their ratite and squab inspection program. If this occurs, FSIS will

take over inspection at the facilities operating under a State program

and thereby absorb the total costs of inspection at these

establishments. For those states that do not have a State voluntary

program for ratites and squabs, the impact of a Federal mandatory

inspection program will be minimal. The payment of these costs at

previously State inspected establishments is an income transfer similar

to that occurring for Federally inspected establishments.

The total transfer payment to Federal and State establishments is

$2,252,000 (1,975,000 plus 277,000).

Table 5.--Ratites and Squabs Inspection Cost at State Establishments--FY 1999

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

Total

Number inspection Total cost of

Species inspected hours inspections

required \1\

----------------------------------------------------------------------------------------------------($thousand)-

Ratites......................................................... 14,427 11,510 442.4

Squabs.......................................................... 1,122,131 2,912 111.9

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

Total....................................................... 1,136,558 14,422 554.4

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

\1\ FSIS hourly base rate of $38.44 times inspection hours required.

Consumer Cost

In large part, the costs of ratite and squab inspection are

transferred from producers to taxpayers. As the burden of paying for

inspection service is eliminated, establishments may transfer these

cost savings to consumers through lower prices.

Economic Impact on International Trade Assessment

Countries that previously had little interest in export

certification may petition FSIS if additional species come under

mandatory inspection. Foreign

[[Page 22904]]

establishments that specialize in exotic species may seek to broaden

their markets by exporting to the United States. The Agency may need to

evaluate the equivalence of a greater number of foreign food regulatory

inspection systems.

Executive Order 12866 and Regulatory Flexibility Act

Because this interim final rule has been determined to be

significant, the Office of Management and Budget (OMB) has reviewed it

under Executive Order 12866.

The Administrator, FSIS, has determined that this interim final

rule would not have a significant economic impact, as defined by the

Regulatory Flexibility Act (5 U.S.C. 601), on a substantial number of

small entities.

Small establishments will not be adversely affected by this interim

final rule. Few establishments slaughter and process ratites or squabs

exclusively. They usually slaughter and process both amenable and non-

amenable species. For small slaughtering establishments as well as

large ones, ratites and squabs do not comprise all or even most of

their business. Of the 100 establishments that slaughter or process

ratites and squabs, only two slaughter over 90% of the squabs consumed

in the market. There are no establishments that dominate the

slaughtering of ratites. Small entities will benefit along with the

rest of the industry with the increased marketability of their product

and the cost savings realized because they will no longer have to pay

fees to either FSIS or the state for voluntary inspection service.

Executive Order 12988

This interim final rule has been reviewed under Executive Order

12988, Civil Justice Reform. This interim final rule: (1) Preempts

State and local laws and regulations that are inconsistent with this

rule; (2) has no retroactive effect; and (3) does not require

administrative proceedings before parties may file suit in court

challenging this rule. However, the administrative procedures specified

in 9 CFR 306.5, 381.35, and 590.320 through 590.370, respectively, must

be exhausted before any judicial challenge of the application of the

provisions of this proposed rule, if the challenge involves any

decision of an FSIS employee relating to inspection services provided

under the PPIA.

Executive Order 13132

Executive Order 13132, ``Federalism,'' requires that Agencies

assess the federalism implications of their policy statements and

actions, i.e., the effects of those statements and actions on the

States, on the relationship between the national government and the

States, or on the distribution of power and responsibilities among the

various levels of government. The Federal Meat Inspection Act (FMIA)

and the Poultry Products Inspection Act (PPIA) preempt State and local

laws in regard to the manufacture and distribution of meat and poultry

products. Therefore, FSIS policy statements and actions impact

federalism within the context of these statutory preemptions.

States and local jurisdictions are preempted by the FMIA and PPIA

from imposing any marking, labeling, packaging, or ingredient

requirements on federally inspected meat and poultry products that are

in addition to, or different than, those imposed under the FMIA and the

PPIA. States and local jurisdictions may, however, exercise concurrent

jurisdiction over meat and poultry products that are within their

jurisdiction and outside official establishments for the purpose of

preventing the distribution of meat and poultry products that are

misbranded or adulterated under the FMIA and PPIA, or, in the case of

imported articles, that are not at such an establishment, after their

entry into the United States.

Specifically, under section 301 of the FMIA and section 5 of the

PPIA, a State may administer State meat and poultry inspection programs

provided that it has developed and is effectively enforcing State meat

and poultry inspection requirements at least equal to those imposed

under titles I and IV of the FMIA and sections 1-4, 6-10, and 12-22 of

the PPIA. These titles contemplate continuous ongoing programs. When

States can no longer effectively enforce meat and poultry inspection

requirements at least equal to Federal requirements, they must be

``designated'' by the Secretary to receive Federal inspection.

When FSIS revises its meat and poultry inspection requirements,

States that administer their own inspection programs may be impacted,

since they must continue to enforce requirements equal to those of

FSIS. To minimize any additional costs States must incur to modify

their inspection programs, FSIS grants the States significant

flexibility under the ``equal to'' provisions of the FMIA and PPIA.

Further, States are eligible to receive up to 50 percent Federal

matching funds to cover the costs of their inspection programs.

Paperwork Reduction Act Requirements

Title: Mandatory Inspection of Ratites and Squabs.

Type of Collection: New.

The paperwork and recordkeeping requirements in this final rule

will be approved on an emergency basis by OMB under control number

0583-01120. FSIS is seeking comments on the paperwork and recordkeeping

requirements in this interim final rule so that the Agency may receive

a three-year approval for these requirements.

Abstract: FSIS has reviewed the paperwork and record keeping

requirements in this interim final rule in accordance with the

Paperwork Reduction Act. Under this proposed rule, FSIS is requiring

several information collection and record keeping activities. FSIS is

requiring that establishments slaughtering and processing ratites and

squabs apply for Federal Inspection. Also, these establishments will

need to develop and maintain Sanitation SOPs, HACCP plans, and perform

testing for E. coli.

Estimate of Burden: FSIS estimates that the time to apply for

inspection would be two hours. The time to develop a Sanitation SOP

will be two days (16 hours) and five minutes to file. FSIS estimates

that an establishment will spend about 5 minutes a day developing an

average of eight monitoring records, per Sanitation SOP, and two

minutes a day filing each record. The time to develop a HACCP plan or

process schedule would take an average of two days (16 hours) and five

minutes to file. FSIS estimates that an establishment will spend about

five minutes a day developing an average of eight monitoring records,

per HACCP plan or process schedule, and two minutes a day filing each

record. The time to record E. coli testing results would be five

minutes a day.

Respondents: Meat and poultry product establishments and

irradiation facilities.

Estimated Number of Respondents: 105 (100 ratite and 5 squab

establishments).

Estimated Number of Responses per Respondent: 8,252.

Estimated Total Annual Burden on Respondents: 54,758 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 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 collection of

information including the validity of the methodology and

[[Page 22905]]

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

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

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

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

other technological collection techniques or other forms of information

technology.

Comments are requested by July 2, 2001. To be most effective,

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

List of Subjects

9 CFR Part 362

Poultry and poultry products.

9 CFR Part 381

Poultry and poultry products.

PART 362--VOLUNTARY POULTRY INSPECTION REGULATIONS

For the reasons stated in the preamble, FSIS is amending 9 CFR

chapter III as follows:

1. The authority citation for part 362 is revised to read as

follows:

Authority: 7 U.S.C. 1622; 7 CFR 2.18 (g) and (i) and 2.53.

2. Sections 362.1 and 362.2 are revised to read as follows:

Sec. 362.1 Definitions.

The definitions in Sec. 381.1 are incorporated in this part except

for the definitions excluded in Sec. 362.2(a). In addition to those

definitions, the following definitions will be applicable to the

regulations in this part.

(a) Act. ``Act'' means the Agricultural Marketing Act of 1946, as

amended (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.).

(b) Inspector. ``Inspector'' means any officer or employee of the

Department authorized to perform any duties under the regulations in

this part.

(c) Person. ``Person'' means any individual, corporation, company,

association, firm, partnership, society, or joint stock company, or

other organized business unit.

(d) Poultry. ``Poultry'' means any migratory water fowl or game

bird, whether dead or alive.

(e) Poultry Product. ``Poultry product'' means any poultry carcass

or part thereof; or any human food product which is made wholly or in

part from the carcass of any domesticated bird (as defined in

Sec. 381.1(b) of this chapter) and is excepted from the inspection

requirements of the Poultry Products Inspection Act (21 U.S.C. 451 et

seq.).

Sec. 362.2 Types and availability of service.

Upon application, in accordance with Sec. 362.3, the following

types of service may be furnished under the regulations in this part:

(a) Inspection service. An inspection and certification service for

wholesomeness relating to the slaughter and processing of poultry and

the processing of poultry products. All provisions of Part 381 and

Secs. 416.1 through 416.6 of this chapter shall apply to the slaughter

of poultry, and the preparation, labeling, and certification of the

poultry and poultry products processed under this poultry inspection

service except for the following provisions: the definitions of

``Act,'' ``animal food manufacturer,'' ``Inspection Service,''

``inspector,'' ``Inspector in Charge,'' ``poultry,'' ``poultry

product,'' ``poultry food product,'' ``poultry products broker,''

``renderer,'' and ``U.S. Refused Entry'' in Secs. 381.1 (b), 381.3 (a),

381.6, 381.10, 381.13-381.17, 381.21, 381.29, 381.39-381.42, 381.175

(a)(2), 381.175 (a)(3), 381.179, 381.185-381.187, 381.192, and 381.195-

381.225.

(b) Export certification service. At the request of any person

intending to export any slaughtered poultry or poultry product,

inspectors may make certification regarding products for human food

purposes, to be exported, as meeting conditions or standards that are

not imposed or are in addition to those imposed by the regulations in

this chapter and the laws under which such regulations were issued.

(c) Identification Service. (1) Poultry or other product that is

federally inspected and passed at an official establishment, or upon

importation, under the Poultry Products Inspection Act, is officially

marked to identify it as federally inspected and passed. In order to

facilitate the division of such poultry or other product into smaller

portions or its combination into larger units and still maintain its

identify as product which has been federally inspected and passed and

so marked, inspectors may supervise the handling and weighing of the

product and mark such portions and units with the official mark of

inspection when they determine that identify has been maintained.

(2) At the time service is furnished, product must be sound,

wholesome, and fit for human food. The service will be available only

on premises other than those of an official establishment. The

sanitation of the place or area where service is furnished must comply

with provisions of Secs. 416.1 through 416.6 of this chapter.

(3) The mark of inspection shall be applied only under the

immediate supervision of an inspector.

(4) This service does not cover further cutting and processing of

products. These activities must take place at an official

establishment.

(5) The registration and recordkeeping requirements enumerated in

Part 381, subpart Q, of this chapter shall apply to persons requesting

voluntary identification service under this paragraph (c).

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

3. The authority citation for Part 381 continues to read as

follows:

Authority: 7 U.S.C. 138f, 450; 21 USC 451-470; 7 CFR 2.18, 2.53.

4. Section 381.1 (b) is amended by revising the definition of

poultry to read as follows:

Poultry. ``Poultry'' means any domesticated bird (chickens,

turkeys, ducks, geese, guineas, ratites, or squabs, also termed young

flightless pigeons), whether live or dead.

* * * * *

5. Amend Sec. 381.36 by revising the first sentence of paragraph

(b) to read as follows:

Sec. 381.36 Facilities required.

(b) Facilities for ante mortem inspection. A suspect pen is

required for adequate ratite inspection. * * *

* * * * *

6. Amend Sec. 381.66 by revising the headings of paragraphs (b) and

(c), and by revising paragraph (d)(1) to read as follows:

Sec. 381.66 Temperatures and chilling and freezing procedures.

* * * * *

(b) General chilling requirements, except for ratites. * * *

(c) Ice and water chilling requirements, except for ratites. * * *

(d) (1) Moisture absorption and retention limits.

(1) Poultry washing, chilling, and draining practices and

procedures shall be such as will minimize moisture absorption and

retention at time of packaging. Ratites must meet the requirements of

this paragraph but are exempt from the rest of Sec. 381.66(d).

* * * * *

7. Amend Sec. 381.67, by revising the text preceding the table and

the heading of the table, to read as follows:

[[Page 22906]]

Sec. 381.67 Young chicken and squab slaughter inspection rate maximums

under traditional inspection procedure under traditional inspection

procedure.

The maximum number of birds to be inspected by each inspector per

minute under the traditional inspection procedure for the different

young chicken and squab slaughter line configurations are specified in

the following table. These maximum rates will not be exceeded. The

inspector in charge will be responsible for reducing production line

rates where in the inspector's judgment the prescribed inspection

procedure cannot be adequately performed within the time available,

either because the birds are not presented by the official

establishment in such a manner that the carcasses, including both

internal and external surfaces and all organs, are readily accessible

for inspection, or because the health conditions of a particular flock

dictate a need for a more extended inspection procedure. The standards

in 381.170(a) of this part specify which classes of birds constitute

young chickens and squabs. Section 381.76(b) specifies when either the

traditional inspection procedure or the modified traditional inspection

procedure can or must be used.

Maximum Production Line Rates--Chickens and Squabs-Traditional

Inspection Procedures

* * * * *

8. Amend Sec. 381.70 by designating the text as paragraph (a) and

by adding paragraph (b) to read as follows:

Sec. 381.70 Ante mortem inspection; when required; extent.

* * * * *

(b) The examination and inspection of ratites will be on the day of

slaughter, except:

(1) When it is necessary for humane reasons to slaughter an injured

animal at night or on a Sunday or holiday, and the FSIS veterinary

medical officer cannot be obtained; or

(2) In low volume establishments, when ante mortem inspection

cannot be done on the day of slaughter, and the birds to be slaughtered

have received ante mortem inspection in the last 24 hours, provided the

establishment has an identification and control system over birds that

have received ante mortem inspection.

9. Amend Sec. 381.71 by designating the text as paragraph (a) and

by adding paragraphs (b), (c), (d), (e), and (f) to read as follows:

Sec. 381.71 Condemnation on ante mortem inspection.

* * * * *

(b) Dead-on-arrival ratite carcasses and ratites condemned on ante

mortem inspection will be tagged ``U.S. Condemned'' by an establishment

employee under FSIS supervision and disposed of by one of the methods

prescribed in Sec. 381.95.

(c) All seriously crippled ratites and non-ambulatory ratites,

commonly termed ``downers,'' shall be identified as ``U.S. Suspects.''

(d) Ratites exhibiting signs of drug or chemical poisoning shall be

withheld from slaughter.

(e) Ratites identified as ``U.S. Suspects'' or ``U.S. Condemned''

may be set aside for treatment. The ``U.S. Suspect'' or ``U.S.

Condemned'' identification device will be removed by an establishment

employee under FSIS supervision following treatment if the bird is

found to be free of disease. Such a bird found to have recovered from

the condition for which it was treated may be released for slaughter or

for purposes other than slaughter, provided that in the latter instance

permission is first obtained from the local, State, or Federal sanitary

official having jurisdiction over movement of such birds.

(f) When it is necessary for humane reasons to slaughter an injured

ratite at night or Sunday or a holiday, and the Agency veterinary

medical officer cannot be obtained, the carcass and all parts shall be

kept for inspection, with the head and all viscera except the

gastrointestinal tract held by the natural attachment. If all parts are

not so kept for inspection, the carcass shall be condemned. If on

inspection of a carcass slaughtered in the absence of an inspector, any

lesion or other evidence is found indicating that the bird was sick or

diseased, or affected with any other condition requiring condemnation

of the animal on ante mortem inspection, or if there is lacking

evidence of the condition that rendered emergency slaughter necessary,

the carcass shall be condemned. Ratites that are sick, dying, or that

have been treated with a drug or chemical and presented for slaughter

before the required withdrawal period, are not covered by emergency

slaughter provisions.

10. Revise Sec. 381.72 to read as follows:

Sec. 381.72 Segregation of suspects on ante mortem inspection.

(a) All birds, except ratites, that on ante mortem inspection do

not plainly show, but are suspected of being affected with, any disease

or condition that under Secs. 381.80 to 381.93 of this Part may cause

condemnation in whole or in part on post mortem inspection, shall be

segregated from the other poultry and held for separate slaughter,

evisceration, and post mortem inspection. The inspector shall be

notified when such segregated lots are presented for post mortem

inspection, and inspection of such birds shall be conducted separately.

Such procedure for the correlation of ante mortem and post mortem

findings by the inspector, as may be prescribed or approved by the

Administrator, shall be carried out.

(b) All ratites showing symptoms of disease will be segregated,

individually tagged as ``U.S. Suspects'' by establishment personnel

under FSIS supervision with a serially numbered metal or plastic leg

band or tag bearing the term ``U.S. Suspect,'' and held for further

examination by an FSIS veterinarian. Depending upon the findings of the

veterinarian's examination, these birds will either be passed for

regular slaughter, slaughtered as suspects, withheld from slaughter, or

condemned on ante mortem. Those ratites affected with conditions that

would be readily detected on post mortem inspection need not be

individually tagged on ante mortem inspection with the ``U.S. Suspect''

tag provided that such ratites are segregated and otherwise handled as

``U.S. Suspects.'' All ratites identified as ``U.S. Condemned'' shall

be tagged by establishment personnel, under FSIS supervision, with a

serially numbered metal or plastic leg band or tag bearing the term

``U.S. Condemned.''

11. Amend Sec. 381.76 by revising the introductory text of

paragraph (b) (1) to read as follows:

Sec. 381.76 Post-mortem inspection, when required; extent;

traditional, Streamlined Inspection System (SIS), New Line Speed (NELS)

Inspection System and the New Turkey Inspection (NTI) System; rate of

inspection.

* * * * *

(b)(1) There are five systems of post-mortem inspection:

Streamlined Inspection System (SIS) and the New Line Speed (NELS)

Inspection System, both of which shall be used only for broilers and

cornish game hens; the New Turkey Inspection (NTI) System, which shall

be used only for turkeys; Traditional Inspection; and Ratite

Inspection.

* * * * *

12. Revise Sec. 381.96 to read as follows:

Sec. 381.96 Wording and form of the official inspection legend.

Except as otherwise provided in this subpart, the official

inspection legend required to be used with respect to inspected and

passed poultry products

[[Page 22907]]

shall include wording as follows: ``Inspected for wholesomeness by U.S.

Department of Agriculture.'' This wording shall be contained within a

circle. The form and arrangement of such wording shall be exactly as

indicated in the example in Figure 1, except that the appropriate

official establishment number shall be shown, and if the establishment

number appears elsewhere on the labeling material in the manner

prescribed in Sec. 381.123(b), it may be omitted from the inspection

mark. The administrator may approve the use of abbreviations of such

inspection mark; and such approved abbreviations shall have the same

force and effect as the inspection mark. The official inspection

legend, or the approved abbreviation thereof, shall be printed on

consumer packages and other immediate containers of inspected and

passed poultry products, or on labels to be securely affixed to such

containers of such products and may be printed or stenciled thereon,

but shall not be applied by rubber stamping. When applied by a stencil,

the legend shall not be less than 4 inches in diameter. An official

brand must be applied to inspected and passed carcasses and parts of

ratites that are shipped unpacked.

Done at Washington, DC, on: April 25, 2001.

Thomas J. Billy,

Administrator.

[FR Doc. 01-10679 Filed 4-26-01; 1:36 pm]

billing code 3410-dm-p

Editorial Note: Federal Register rule document 01-10679

originally appeared in the issue of Tuesday, May 1, 2001 at 66 FR

21631-21639. Due to several errors (repeated text and missing text

on page 21635) the document is being reprinted in its entirety.

[FR Doc. R1-10679 Filed 5-4-01; 8:45 am]

BILLING CODE 1505-01-D