This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

21631

Vol. 66, No. 84

Tuesday, May 1, 2001

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

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Interim final rule.

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

(§§ 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) (§ 381.22(a)) and a

Hazard Analysis and Critical Control

Point (HACCP) plan that the

establishment has validated (§ 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

(§ 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 (§ 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

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

21632 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations

1The 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.

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 (§ 381.197) and must be

presented to FSIS for import

reinspection prior to entry (§ 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 § 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 § 381.1(b) to

include ratites and squabs within the

definition of ‘‘Poultry’’ in the Poultry

Products Inspection Regulations.

FSIS is amending § 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 § 381.66 to

exempt ratites from the chilling

requirements of § 381.66 paragraphs (b),

(c), and all of (d), except for (d)(1).

Ratites are air-chilled rather than waterchilled, as is the case with most

amenable poultry.

FSIS is amending § 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 § 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 § 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 § 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 § 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 § 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 § 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

§ 362.1(d) to remove squab from the

definition of poultry in the Voluntary

Poultry Inspection Regulations and will

amend § 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

meat is valued for its flavor and

nutritional characteristics.

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.

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations 21633

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

Species

Federal

establishments

State establishments

Total

inspected Number inspected

% of

total

Number

inspected

% of

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

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

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

21634 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations

2HACCP plans are not required to cover nonamenable species.

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

Costs Per est.

(dollars)

Industry

($thousand)

Start up Cost:

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

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

Recurring Cost: E. coli Sampling (26 samples@$20 per sample per establishment) ............................................ 520 38.5

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

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

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.

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).

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations 21635

TABLE 2.—POTENTIAL COSTS FOR MANDATORY FEDERAL INSPECTION

Costs Per est.

(dollars)

Industry

($thousand)

Start up Cost:

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

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

Recurring Cost: E. coli Sampling (26 samples@$20 per sample per establishment) ............................................ 520 38.5

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

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

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.

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).

21636 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations

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 threeyear 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

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations 21637

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:

§ 362.1 Definitions.

The definitions in § 381.1 are

incorporated in this part except for the

definitions excluded in § 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 § 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.).

§ 362.2 Types and availability of service.

Upon application, in accordance with

§ 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 §§ 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

§§ 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 §§ 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 § 381.36 by revising the

first sentence of paragraph (b) to read as

follows:

§ 381.36 Facilities required.

(b) Facilities for ante mortem

inspection. A suspect pen is required for

adequate ratite inspection. * * *

* * * * *

6. Amend § 381.66 by revising the

headings of paragraphs (b) and (c), and

by revising paragraph (d)(1) to read as

follows:

§ 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 § 381.66(d).

* * * * *

7. Amend § 381.67, by revising the

text preceding the table and the heading

of the table, to read as follows:

21638 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations

§ 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 § 381.70 by designating the

text as paragraph (a) and by adding

paragraph (b) to read as follows:

§ 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 § 381.71 by designating the

text as paragraph (a) and by adding

paragraphs (b), (c), (d), (e), and (f) to

read as follows:

§ 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 § 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 § 381.72 to read as follows:

§ 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 §§ 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 § 381.76 by revising the

introductory text of paragraph (b) (1) to

read as follows:

§ 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 postmortem 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 § 381.96 to read as follows:

§ 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

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Rules and Regulations 21639

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

§ 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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 01–AWP–1]

Establishment of a Class E Enroute

Domestic Airspace Area, El Centro, CA

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final rule; delay of effective

date.

SUMMARY: This document delays the

effective date of a direct final rule which

establishes a Class E enroute domestic

airspace area beginning at 1,200 feet

above ground level (AGL) in the vicinity

of El Centro, CA and replaces existing

Class G uncontrolled airspace within

Restricted Area 2510A (R2510A), the

Kane West Military Operating Area

(MOA), and Kane East MOA.

EFFECTIVE DATE: The effective date of the

direct final rule published on February

26, 2001 (66 FR 11531) is delayed until

0901 UTC July 12, 2001.

ADDRESSES: The official docket may be

examined in the Office of the Assistant

Chief Counsel, Western-Pacific Region,

Federal Aviation Administration, Room

6007, 15000 Aviation Boulevard,

Lawndale, California 90261.

An informal docket may also be

examined during normal business hours

at the Office of the Manager, Airspace

Branch, Air Traffic Division at the above

address.

FOR FURTHER INFORMATION CONTACT:

Debra Trindle, Air Traffic Division,

Airspace Specialist, AWP–520.10,

Western-Pacific Region, Federal

Aviation Administration, 15000

Aviation Boulevard, Lawndale,

California 90261, telephone (310) 725–

6613.

SUPPLEMENTARY INFORMATION: On

February 26, 2001, the FAA published

in the Federal Register a direct final

rule; request for comments, which

established a Class E enroute domestic

airspace area beginning at 1,200 feet

above ground level in the vicinity of El

Centro, CA (FR Document 01–4680, 66

FR 11531, Airspace Docket No. 01–

AWP–1). Please note that when

accessing this document it was

published incorrectly by the Federal

Register as 00–AWP–1. The FAA uses

the direct final rulemaking procedure

for a non-controversial rule where the

FAA believes that there will be no

adverse public comment. This direct

final rule advised the public that no

adverse comments were anticipated,

and that unless a written adverse

comment, or a written notice of intent

to submit such an adverse comment,

were received within the comment

period, the regulation would become

effective on June 15, 2001. No adverse

comments were received; therefore this

document confirms that this direct final

rule will become effective, but on a

delayed date of July 12, 2001. The delay

in the effective date is so the change

will be in conjunction with established

aeronautical charting cycles.

Issued in Los Angeles, California, on April

4, 2001.

Leonard A. Mobley,

Acting Manager, Air Traffic Division,

Western-Pacific Region.

[FR Doc. 01–10841 Filed 4–30–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

15 CFR Part 902

50 CFR Part 648

[Docket No. 010410087–1087–01; I.D.

031401B]

RIN 0648–AO07

Fisheries of the Northeastern United

States; Atlantic Sea Scallop Fishery;

Framework Adjustment 14

AGENCY: National Marine Fisheries

Service (NMFS), National Oceanic and

Atmospheric Administration (NOAA),

Commerce.

ACTION: Final rule.

SUMMARY: NMFS issues this final rule to

implement measures contained in

Framework Adjustment 14 to the

Atlantic Sea Scallop Fishery

Management Plan (FMP). This final rule

implements management measures for

the 2001 and 2002 fishing years,

including a days-at-sea (DAS)

adjustment, a Sea Scallop Area Access

Program (Area Access Program) for two

areas that have been closed to scallop

fishing in the Mid-Atlantic, and a 50–bu

(17.62 hectoliters (hl)) possession

restriction of in-shell scallops on vessels

shoreward of the vessel monitoring

system (VMS) demarcation line. The

intent of this action is to achieve the

goals and objectives of the FMP and to

achieve optimum yield in the scallop

fishery. In addition, NMFS publishes

the Office of Management and Budget

(OMB) control numbers for collectionof-information requirements contained

in this final rule.

DATES: Effective April 26, 2001.

ADDRESSES: Copies of Framework

Adjustment 14, its Final Supplemental

Environmental Impact Statement

(FSEIS), and Regulatory Impact Review

(RIR) are available on request from Paul

J. Howard, Executive Director, New

England Fishery Management Council,

50 Water Street, Newburyport, MA

01950. These documents are also

available online at http://

www.nefmc.org.

Comments regarding the collection-ofinformation requirements contained in

this final rule should be sent to Patricia

A. Kurkul, Regional Administrator,

Northeast Regional Office, NMFS, One

Blackburn Drive, Gloucester, MA

01930–2298; and to the Office of

Information and Regulatory Affairs,

Office of Management and Budget,