This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

70809

Vol. 65, No. 229

Tuesday, November 28, 2000

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 309, 310, 311, 314, 318,

320, 325, 327, 331, 381, 416, and 417

[Docket No. 00–043N]

Residue Control in a HACCP

Environment

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Conceptual framework for

program changes; notice of availability

of documents and public meeting.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is publishing

this document to advise the public of its

intent to adapt its approach to the

control of chemical residues in or on

meat and poultry products in light of

the implementation of the regulations in

the Agency’s Pathogen ReductionHazard Analysis and Critical Control

Point Systems (PR/HACCP) final rule.

The Agency is providing an opportunity

for public participation in this effort.

FSIS hopes that a wide variety of

interested members of the public will

consider how HACCP should affect the

Agency’s approach to preventing illegal

chemical residues in or on FSISregulated products and will provide

comments for improving consumer

protection through a well-integrated,

federal farm-to-table food safety

strategy. Therefore, FSIS is providing a

conceptual framework that sets out

issues that the Agency wants to consider

during its program review and in

making decisions about how it should

modify its approach to the control of

chemical residues. FSIS is also making

relevant materials available to the

public. The Agency is soliciting written

comments on the issues raised in this

document, including those raised in the

materials it references, and is seeking

comments that contain additional

information or raise additional issues.

The Agency will hold a public meeting

to discuss the issues presented in this

document and the issues raised by the

comments submitted.

DATES: The public meeting will be held

on December 11, 2000, from 9 a.m. to 5

p.m. Members of the public who wish

to provide information or raise issues

for discussion at the meeting should

submit written comments before

December 4, 2000.

ADDRESSES: Submit one original and

two copies of written comments to FSIS

Docket Clerk, Docket No. 00–43N, U.S.

Department of Agriculture, Food Safety

and Inspection Service, Room 102

Cotton Annex Building, 300 12th Street,

SW, Washington, DC 20250–3700. All

comments submitted and documents

referred to below will be available for

public inspection in the Docket Clerk’s

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

Monday through Friday. The public

meeting will be held at the Washington

Plaza Hotel, 10 Thomas Circle NW,

Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT:

Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations and

Inspection Methods, Food Safety and

Inspection Service, Washington, DC

20250–3700; (202) 205–0699.

SUPPLEMENTARY INFORMATION:

Background

The Food Safety and Inspection

Service (FSIS) administers a regulatory

program under the Federal Meat

Inspection Act (FMIA) (21 U.S.C. 601 et

seq.) and the Poultry Products

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

seq.) to protect the health and welfare of

consumers by, among other things,

preventing the distribution of

adulterated products of livestock and

poultry. Under the FMIA and the PPIA,

it is illegal to sell or transport, offer for

sale or transportation, or receive for

transportation, in commerce, products

that are capable of use as human food

that are adulterated (21 U.S.C.

458(a)(2)(A) and 610(c)(1)).

Both the FMIA and the PPIA include

requirements for federal inspection, and

they prohibit selling or transporting,

offering for sale or transportation, or

receiving for transportation, in

commerce, products required to be

inspected unless they have been

inspected and passed (21 U.S.C.

458(a)(2)(B) and 610(c)(2)). Intrastate

operations and transactions are

effectively subject to the same

requirements and prohibitions, pursuant

to a State inspection program or the

designation of the State for federal

inspection (21 U.S.C. 454(c)(1) and

661(c)(1)).

FSIS laid the foundation for

modernizing its system of food safety

regulation in July 1996, when it issued

the PR/HACCP final rule (61 FR 38806).

The Agency’s regulations (9 CFR

chapter III) now require federally

inspected establishments to take

preventive and corrective measures at

each stage of the food production

process where food safety hazards can

occur. The amended regulations also

establish an approach to food safety

regulation that relies less on after-thefact detection of problems and more on

verification of the effectiveness of an

establishment’s process controls that are

designed to ensure food safety. In

particular, the regulations on HACCP

systems (part 417) require that an

establishment-specific hazard analysis

consider food safety hazards that can

occur before, during, or after entry into

the establishment, and they require the

implementation of a HACCP plan that,

for each production process, addresses

the food safety hazard or hazards that

are reasonably likely to occur

(§ 417.2(a)(1), (b)(1), and (c)).

Under the HACCP system regulations,

a food safety hazard is any biological,

chemical, or physical property that may

cause a food to be unsafe for human

consumption (§ 417.1). The possible

sources from which food safety hazards

might be expected to arise specifically

include chemical contamination,

pesticides, and drug residues

(§ 417.2(a)(3)(iii), (a)(3)(iv), and

(a)(3)(v)).

The standard for determining whether

a food safety hazard is reasonably likely

to occur in the production process is if

either (1) the hazard historically has

occurred, or (2) there is a reasonable

possibility that the hazard will occur in

the particular type of product being

produced in the absence of preventive

measures to control it (§ 417.2(a)(1)). For

each hazard that is reasonably likely to

occur, a HACCP plan must identify the

preventive measures that the

establishment will apply to control the

hazard. These include critical control

points (CCPs), the critical limits to be

met at each CCP, procedures for (and

documentation of) the monitoring of

CCPs, corrective actions to be followed

in response to any deviation from a

70810 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

2Reference 1 is a list of FSIS regulations,

directives, and notices.

1Reference 2 describes the interagency

infrastructure.

3NRP results indicate that, over time, the

majority of residue violations have involved illegal

levels of animal drugs, particularly sulfonamides

and antibiotics, apparently due to the failure of

producers of a relatively small percentage of

livestock and poultry to follow prescribed

withdrawal times—that is, to use these drugs in

accordance with the FDA regulations.

critical limit at a CCP, and verification

procedures (§§ 417.2(c), 417.3(a), and

417.4(a)).

A HACCP plan’s CCPs are the points,

steps, and procedures in a food process

at which the establishment can apply

control and, as a result, prevent,

eliminate, or reduce to acceptable levels

food safety hazards that could be

introduced in the establishment and

food safety hazards introduced outside

the establishment (including hazards

that occur before, during, and after entry

into the establishment) (§§ 417.1 and

417.2(c)(2)). A plan’s critical limits must

be designed, at a minimum, to ensure

that applicable targets or performance

standards established by FSIS, and any

other requirement in the Agency’s

regulations pertaining to the specific

process or product, are met

(§ 417.2(c)(3)).

FSIS phased in the applicability of

part 417 requirements over a two year

period, based on establishment size,

beginning with large establishments

(those with 500 or more employees) on

January 26, 1998, and ending with very

small establishments (those with fewer

than 10 employees or annual sales of

less than $2.5 million) on January 25,

2000. The Agency is evaluating the

results of HACCP implementation to

date and is considering what further

steps to take to increase the

effectiveness of the HACCP approach to

food safety—including steps that would

better ensure the adequacy of industry

members’ HACCP plans and advance

the ongoing transformation of the

Agency’s regulatory system (see ‘‘

417.8). One focus of the Agency during

this process will be its consideration of

what approach should be taken to

control chemical residues in light of the

PR/HACCP final rule.

Residue Control

FSIS-regulated products may be

adulterated because they bear or contain

residues of drugs, pesticides, and other

chemicals used in animal production or

present in the animals’ environment

(see 21 U.S.C. 453(g)(1), (g)(2), and (g)(3)

and 601(m)(1), (m)(2), and (m)(3)). FSIS

has not yet modified its regulatory

requirements and program activities

dealing with residues to reflect the

implementation of HACCP plans at

official establishments. Some companies

have had difficulty understanding their

responsibilities under the HACCP

system regulations and integrating their

residue control responsibilities with

other regulatory requirements.

Since the 1960’s, the public and

private sectors have tried to meet the

challenges presented by various types of

adulteration that organoleptic

examination generally cannot detect.

Residue control is a particularly

appropriate candidate for an improved

approach that involves a well-integrated

and seamless, prevention-oriented farmto-table strategy.

At the federal regulatory level, efforts

to prevent residue-related food safety

problems principally involve, in

addition to FSIS, the Food and Drug

Administration (FDA), acting under the

Federal Food, Drug, and Cosmetic Act

(FFDCA) (21 U.S.C. 321 et seq.), and the

Environmental Protection Agency

(EPA), acting under the FFDCA, the

Federal Insecticide, Fungicide, and

Rodenticide Act (7 U.S.C. 135 et seq.),

and the Toxic Substances Control Act

(15 U.S.C. 2601 et seq.). In their

premarket approval programs, FDA and

EPA consider what, if any, levels of

drug and pesticide residues should be

viewed as safe, and they evaluate

potential exposure to toxic substances

that may contaminate food. FDA also

has federal regulatory responsibility for

animal feeds and food producing

animals.

At slaughter, FSIS looks for

indications of illegal chemical use or

exposure and collects carcass samples

for residue analysis. The analytical

components of the Agency’s residue

control activities are collectively known

as the ‘‘National Residue Program’’

(NRP). The most recent NRP reports are

the ‘‘1999 FSIS National Residue

Program’’ and the ‘‘Domestic Residue

Data Book National Residue Program

1998’’ (referred to informally as the

‘‘Blue Book’’ and the ‘‘Red Book’’,

respectively.)

Initiated more than 30 years ago, the

NRP has generally been a success. It has

been instrumental in reducing the

incidence of such residue violations as

sulfamethazine in market hogs and in

improving analytical capabilities for

detecting chemical residues, including

significantly increasing the number of

compounds for which analyses can be

performed. Additionally, FSIS has been

instrumental in the development of

screening tests that make more efficient

use of resources and that facilitate

residue detection. Other improvements

include the development of

sophisticated information exchange

systems that aid communication both

within the public sector and with

interested private sector parties, and the

development of collaborative

educational efforts with producers that

are supported by other USDA agencies.

In recent years, FSIS’ Animal

Production Food Safety Staff has

worked with States, producer groups,

and others to develop and enhance

producers’ residue avoidance activities

and to help ensure that only

nonviolative animals are presented for

slaughter.

FSIS regulations directed at residue

control and the Agency’s implementing

directives have grown more pointed

during the past 30 years. In general, the

regulations have become more detailed,

have reflected a growing dependence on

residue testing as the preferred means of

control, and have increased FSIS’

responsibility for this control function.1

At the same time, communication and

coordination among the agencies

involved in residue control have

improved, with multiple interagency

committees and contacts.2

Despite these arrangements, more

testing, and more government control,

the outcome has not been optimal.

Significant residue control issues have

persisted. For example, certain market

classes of domestic animals continue to

have unacceptably high rates of residue

violations.3

Discussed below is additional

information about the basic design of

the NRP, the relationship between

residue control and HACCP, and

practical considerations that need to be

taken into account when reconsidering

the approach to residue control. The

document then discusses the resolution

of a practical problem that arose during

HACCP implementation that FSIS

believes can serve as a first step in

rethinking what ought to be the

approach to residue control in a HACCP

environment. Finally, other issues that

FSIS believes need to be considered in

order to determine what approach will

best lead to optimal residue control in

a HACCP environment are discussed.

FSIS hopes that a wide variety of

interested members of the public will

consider how developments described

in this document should affect the

Agency’s approach to preventing illegal

chemical residues in or on FSISregulated products and the approach to

providing improved consumer

protection through a well-integrated,

federal farm-to-table food safety

strategy. The Agency is soliciting

written comments, including the

submission of additional information,

and it will hold a public meeting to

discuss broad policy and program

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70811

concerns, including the issues raised in

this document and in the comments

submitted.

FSIS intends to organize the public

meeting so that a number of groups that

include a variety of constituents

consider one or more of the issues

identified in this document. The

materials referenced in this document

(see footnotes) are available in the

Docket Clerk’s office, and they also will

be available at the meeting. A variety of

people with knowledge and experience

about the particular topics to be

considered will facilitate the groups. At

the end of the day, the facilitator will

report to the attendees at the general

meeting on the comments of the

participants in each group. This

information will be considered in the

development of policy and program

activities for residue controls.

Basic Program Design

Although NRP testing is planned and

conducted using several sampling

schemes, there are essentially two broad

purposes for all NRP residue sampling.

They are:

(1) Prevalence sampling: sampling to

estimate the prevalence of residues of

certain chemical compounds in the

tissues of specific market classes of

livestock and birds after they have been

inspected and passed at slaughter; and

(2) Verification sampling: sampling to

determine whether one or more

processes to control residues have been

successful.

Prevalence sampling has

encompassed national, annual testing of

specific market class/compound pairs of

livestock and birds (e.g., market hogs/

sulfonamides) to determine whether a

compound is a problem in that market

class of animals; regional, seasonal, or

market class specific testing, often in

response to suspected problems of a

more limited nature; and special testing

programs initiated to meet the concerns

of non-USDA entities, often

international groups or countries that

receive meat or poultry products.

Prevalence sampling programs generally

occur at one of four levels: 460 samples/

year; 300 samples/year; 230 samples/

year; or 90 samples/year. The 300

samples/year scheme provides a 95

percent confidence level that a problem

occurring in 1 percent of the market

class will be detected. The assumption

that a greater than 1 percent violation

rate will be discovered 95 percent of the

time rests on the premise that normalappearing inspected and passed

carcasses constitute a sufficiently

homogeneous population that this size

sample can provide a national picture.

Currently, verification sampling of

domestic products occurs after there has

been a violation detected in carcasses

from a particular producer. Typically, in

such a case, subsequent livestock from

the same producer are subjected to

verification sampling until findings

demonstrate that the production

problem has been corrected. Verification

sampling can also be generated by

inspector observations, either antemortem or post-mortem, that suggest

that a violative residue may be present.

Verification sampling is also done on

imports. FSIS samples products shipped

to the United States from countries

whose inspection systems, including

their residue control programs, have

been determined by FSIS to be

equivalent.

Relationship Between Residue Control

and HACCP

The PR/HACCP final rule established

various requirements for inspected

facilities producing meat and poultry

products. These requirements include

the following: (1) That establishments

develop, implement, maintain, and keep

records of their standard operating

procedures for sanitation (Sanitation

SOPs) (part 416), (2) that slaughter

establishments implement generic E.

coli testing and record and analyze

results as a means of verifying the

effectiveness of their slaughter and

sanitary dressing process in preventing

and removing fecal contamination from

carcasses (§§ 310.25(a) and 381.94(a)),

and (3) that establishments develop and

implement HACCP plans to prevent,

eliminate, or reduce to an acceptable

level the food safety hazards reasonably

likely to occur in their meat and poultry

product production processes (part 417).

These requirements were designed to

improve the safety of meat and poultry

products, thereby reducing the

incidence of foodborne illness

attributable to these products. These

requirements also assist the Agency in

meeting one of its other regulatory

objectives: to separate and clarify the

roles of the government inspection force

and the regulated industry.

Sanitation SOP implementation was a

vitally important first step in getting the

inspection force out of the role of

functioning as the quality control

department for plants. Key features of

part 417 requirements reinforced this

objective: the requirement that

establishments, not FSIS, conduct (or

have conducted for them) a hazard

analysis (§ 417.2(a)(1)), the absence of

HACCP plan approval by FSIS, the lack

of FSIS-specified CCPs, the requirement

that establishments validate the

adequacy of their HACCP plans

(§§ 417.4(a)), and the specification of

consequences for incomplete corrective

actions (§§ 417.2(e) and 417.6). All of

these emphasize the distinctly different

roles of FSIS and the establishment.

These regulations underscore the

companies’ responsibility for producing

meat and poultry products that are safe,

and make clear that the Agency will

hold them accountable for failing to do

so.

The preamble to the PR/HACCP final

rule discussed other important features

of the Agency’s overall food safety

strategy, including regulatory reform,

that provide flexibility and encourage

company innovation and a farm-to-table

approach that extends beyond the

slaughter and processing establishments

where most FSIS activities have

occurred (61 FR 38810–11). FSIS is

aware that the command-and-control

nature of many of its regulations may

discourage or impede establishments

from taking full responsibility for the

production of safe, complying products.

In some cases, these regulations dictate

to establishments exactly how

something must be done; in other cases,

FSIS carries out the activity itself and

does not accept results from other

sources. To address this problem, FSIS

is converting many of its regulatory

requirements into performance

standards that allow an establishment to

determine how it will meet a

requirement, while still ensuring that

appropriate requirements are in place.

FSIS is also aware that food safety

problems may arise at many points

along the farm-to-table continuum, not

just in inspected establishments.

Invisible hazards may be introduced at

the production, distribution, or

consumption levels. Therefore, FSIS has

committed itself to working

cooperatively with others concerned

with food safety to encourage hazard

prevention and control at every step in

the process where a problem could

arise.

As explained above, part 417 makes

clear that violative residues present food

safety hazards that may be reasonably

likely to occur, and, therefore, slaughter

establishments must consider the

likelihood of their occurrence in

developing HACCP plans. Nevertheless,

some companies have found it difficult

to integrate part 417 requirements with

other FSIS regulations, including those

that address residue control, even

though § 417.2(c)(3) directly addresses

the need to design critical limits to

ensure that regulatory requirements are

met. Part 417 also addresses FSIS

activities with respect to establishments’

HACCP systems and makes clear that

FSIS will conduct activities to verify the

70812 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

4Reference 3 is ‘‘Trends in the United States:

Consumer Attitudes and the Supermarket,’’ 2000,

Food Marketing Institute.

adequacy of HACCP plans, including

records review, direct observation or

measurement at a CCP, and sample

collection and analysis (§ 417.8).

FSIS believes that it is appropriate

now to rethink the current approach to

residue control. On the one hand,

industry must develop more effective

systems of residue control. On the other,

FSIS will need to shift its focus to

verification testing to ensure residue

requirements are met, so that only safe

meat and poultry products reach the

public. The Agency believes that this

will result in a more effective residue

control program and a more efficient use

of its resources.

Full HACCP implementation gives

FSIS and its constituents the

opportunity to consider what approach

is best to resolve problems of residue

control by plants and what approach is

best to accomplish effective integration

of HACCP and residue control

requirements.

Practical Considerations

(1) Historically, residue control

programs have engendered

controversies. There may be several

underlying reasons, including persistent

consumer concerns about the hazards

they cannot see and cannot readily

manage themselves. Obviously,

chemical hazards in meat and poultry

products cannot be managed by the

individual consumer through usual

techniques such as cooking or careful

handling. The Food Marketing Institute

(FMI) has conducted surveys of

consumer attitudes and actions with

regard to food safety. Even after many

years of documented improvement of

residue control in domestic meat and

poultry products, and even with the

increasing availability of data about the

success of residue control, annual FMI

surveys reveal that consumers continue

to be concerned about residues.4

(2) Management of the hazards

presented by chemical residues depends

on persons with several different, but

highly technical, scientific

qualifications: toxicologists, chemists,

epidemiologists, veterinarians,

microbiologists, statisticians, and others

who sometimes have not regarded open

communication with the less expert

public as a critical task. Additionally, in

the United States and most countries,

the scientists who are involved in the

management of the hazards presented

by chemical residues are not all

employed by the same government

agency and naturally develop different

perspectives and concerns. Thus, a

program that encompasses the kind of

coordination and communication that is

included in the United States’ system is

necessary. Communication about that

system, and public involvement in

shaping it, however, can be improved.

FSIS does not contemplate changes to

residue control that would significantly

alter the involvement in it of different

types of highly skilled professionals or

the close coordination that exists among

food safety agencies in regard to it. FSIS

does, however, contemplate changes

that would make it even clearer that

inspected establishments are

responsible for analyzing the hazards

from chemical residues and for taking

measures to control those hazards that

are reasonably likely to occur.

(3) The public health hazards

presented by violative residues may be

underestimated by the public whose

attention is currently drawn to health

hazards associated with pathogens in

meat and poultry products. Two

possible reasons for this may be a sense

of security about the effectiveness of the

current residue program and the usually

longer-term consequences of residue

control failures when compared to the

immediate consequences of failures to

control pathogenic organisms.

Although there is competition for

finite resources, FSIS does not

contemplate changes to its residue

control program that would reduce its

effectiveness or its importance. In fact,

FSIS expects that the environment

established by full HACCP

implementation should lead to more

efficient and effective residue control.

(4) Residue control activities have

been the subject of well-publicized

international controversies. The United

States is a major exporter and importer

of meat and poultry products. In

addition, its agricultural production

systems for meat and poultry products

are substantially different from those of

the many countries with which it trades.

Determining whether such different

systems impose equivalent requirements

has not been an easy task.

FSIS does not contemplate changes

that would undermine the exportation

of meat and poultry products, but it is

likely to ask that producers and

processors take more responsibility for

ensuring that residue violations are

prevented. If producers and processors

do so, FSIS will be able to assume a true

verification role, as contemplated by

HACCP.

Rethinking the Approach to Residue

Control—Best Available Practices

FSIS believes that efforts to solve a

practical problem that arose during

HACCP implementation provide the

initial steps for rethinking the approach

to residue control in a HACCP

environment. An establishment that

slaughters principally cull dairy cows, a

market class of livestock with an

historically high incidence of drug

residue violations, had not included any

residue controls in its HACCP plan

because it assumed that FSIS would

continue to take the lead responsibility

in this area. Findings of violative levels

of drug residues in carcasses of animals

slaughtered at the establishment

resulted in the issuance of FSIS

Noncompliance Records (NRs). (The

NR, FSIS Form 5400.5–4, is the

Agency’s official record of

noncompliance and serves as

notification to an establishment of its

failure to comply with one or more

regulatory requirements. See FSIS

Directive 5400.5.)

In response to this situation, a

coalition of industry members and trade

associations and other interested parties

met with the Agency. They expressed a

number of concerns. They were

concerned about the high number of

NRs issued at some establishments

because of repeated violations in cull

dairy cows. They also were concerned

about the lack of consistency regarding

the taking of screening samples for

residues of certain antibiotics in similar

types of establishments. They requested

that the Agency clarify its instructions

to its supervisory veterinary medical

officers (SVMOs) regarding the taking of

screening samples for residues of certain

antibiotics. They also requested

assistance in obtaining rapid laboratory

results so that the appropriate

disposition of carcasses could be

determined quickly.

The coalition offered to share

information that the large majority of

establishments had that slaughter cull

dairy cows, including the identification

of suppliers of residue-violative

animals, and notifications issued by a

slaughtering establishment to such

suppliers of a violative residue finding

that might indicate that future

purchases would be restricted. Coalition

members suggested that, over time, such

an approach might result in an actual

decrease in violative residue findings in

cull dairy cows.

Since the initial discussions, there

have been several important

developments:

—FSIS reviewed its instructions to

SVMOs about the post-mortem

observations that should trigger

performance of a screening test for

residues of certain antibiotics, and it

found that there was a discrepancy

between the Agency’s training of

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70813

5Reference 4 is FSIS Notice 24–00.

6Reference 5 is Council Directive 96/23/EC.

7Reference 6 is a list of live animal test methods.

8Reference 7 is general information describing

the AOAC Institute and its activities.

9Reference 8 is the chapter of the 1985 NAS

report (Chapter 4) that addressed control of

chemical hazards.

10Reference 9 is extra residue requirements for

the EU.

SVMOs and the instructions they

received on the job for this matter.

FSIS remedied this situation by

issuing a new notice that is consistent

with the training given to SVMOs.5

The notice is expected to result in

more screening tests being performed.

—FSIS determined that it could

accomplish its laboratory

confirmation analyses of screening

positive results within a short

timeframe.

—FSIS has told establishments that if

their HACCP plans include residue

controls that constitute the best

available preventive practices for

slaughter establishments, if they

implement those controls effectively,

and if they supply FSIS with

information about violators, then the

Agency will not treat violative residue

findings by the establishment that are

followed by appropriate corrective

actions as noncompliance (see

§ 417.3(a)).

In response to these modest shifts in

the Agency’s approach, several

establishments are exploring what might

be considered to be the best preventive

practices available to slaughterers.

These include:

• ensuring that all animals brought

into an establishment for slaughter are

identified, so that they can be traced

back to the producers of them, with

receiving as a CCP;

• Notifying animal producers in

writing of both violative and high, but

not violative, residue findings, with

such notification including a discussion

of the issues involved, the company’s

future expectations, and an indication

that repeat violators will not be future

suppliers;

• Exploring the possibilities for the

establishment of state-certified, and

possibly USDA Cooperative State

Research, Education, and Extension

Service-verified, voluntary residue

avoidance programs comparable to

those developed by major producer

trade organizations, so that slaughter

establishments could add to their

purchase specifications a requirement

that suppliers participate in such

programs and supply certifications to

that effect; and

• Exploring the possibilities for live

animal testing, so that slaughter

establishments could have a rapid,

convenient verification tool.

FSIS notes that there is a considerable

methods development agenda that must

be accomplished before the potential for

live animal testing can be fully realized,

but some existing efforts may aid this

process. For example, the European

Union (EU) expects testing at the

producer level,6 and thereby has created

a demand for such methods.7 In

addition, there are efforts underway to

facilitate the timely recognition and

acceptance of test kit methods by

providing independent, third-party

scientific validation and accreditation of

test kit performance claims.8

There may be models in Europe for

other forms of public-private

cooperation in residue control. In the

Netherlands, there is a National Plan for

Residues implemented by two

ministries. Analyses for drug and

pesticide residues in meat, poultry, and

eggs are performed on a variety of

sample types (muscle, fat, liver, kidney,

and urine) taken from animals at

slaughterhouses and on farms. There is

also a private sector quality assurance

group that provides support to producer

groups that use its seal in marketing.

The laboratory for the quality assurance

group uses the same analytical methods

as the government laboratories, and its

results are considered to be equivalent

to those of the government laboratories,

including as a basis for action against

producers of violative animals.

It is likely that additional models in

use in other countries could provide

concepts for the United States to

consider as it reviews residue control in

a HACCP environment.

Residue Control in a HACCP

Environment—Issues To Be Considered

Almost fifteen years ago, the National

Academy of Sciences (NAS) issued the

first of several reports commissioned by

FSIS that analyzed and commented

upon the status and future of the

nation’s meat and poultry inspection

system. The July 1985 report, titled

‘‘Meat and Poultry Inspection System,

The Scientific Basis of the Nation’s

Program,’’ paid particular attention to

the NRP because it was a principal

means through which chemical hazards

were addressed.9 The report provides a

useful framework for reconsidering the

management of chemical hazards

because it is HACCP oriented, and

because most of the elements on which

it focused still appear relevant today.

The areas addressed by NAS include

the 10 discussed below. They are

addressed here in order to raise issues

that need consideration in the course of

reconsidering the Agency’s approach to

residue control.

(1) Public Protection as the Primary

Objective

The 1985 report determined that

public protection was the primary

objective of the NRP, and it remains the

primary objective today. One issue that

needs to be considered now is what full

HACCP implementation adds to the

potential for public health protection

against chemical hazards. The Agency

believes that it explicitly adds

responsibility for establishments,

through the hazard analysis, to

determine whether chemical

contamination, pesticides, or drug

residues are food safety hazards

reasonably likely to occur, and if so, it

adds the responsibility for the

establishment to control them through

the HACCP system. Industry’s enhanced

role in this area will enable FSIS to

optimize its effectiveness by allowing it

to focus upon verifying that safe and

wholesome product enters commerce.

If public protection is to be the

primary focus of the Agency’s residue

control program, a question remains as

to how the Agency should respond to

requests by receiving countries to test

for compounds that this country’s risk

analysis has not determined to be of

public health significance. Where

additional testing is requested, current

FSIS policy is to not use federal funds

for it; rather, the expense is borne by the

exporter. For example, meat and poultry

products exported from the United

States to the EU are subjected to

additional residue testing for some

compounds that are banned in the EU

but that may be used, in accordance

with FDA regulations, in the United

States. They also are tested for

compounds that are approved for use in

both the EU and the United States, but

for which the EU mandates testing and

for which the current U.S. program does

not conduct tests. Only product eligible

for export to the EU is being sampled for

these compounds, and the analyses are

performed in independent laboratories

at industry expense.10 In light of

HACCP, an issue that needs to be

considered is what other possible

approaches might be developed for this

matter.

(2) Focus on Prevention

The July 1985 NAS report indicated

that the NRP was improved, but that it

was nevertheless still deficient in its

focus on prevention. An issue that

needs to be examined in this area is

what full implementation of HACCP has

added to the capacity of the government

70814 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules

11Reference 10 summarizes recent FSIS data that

could serve as the basis for performance standards. 12Reference 11, sections 5 and 6 of the current

Blue Book, describes the new approach.

to enhance residue control programs’

focus on prevention.

As articulated in the preamble to the

PR/HACCP final rule (61 FR 38807–08),

HACCP is a science-based system of

process control, designed to prevent

food safety problems during the

processing of food rather than to detect

them after they have occurred. This

raises the question of what producers

and processors should be doing to

identify and promote the acceptance of

validated preventive measures.

In 1985, NAS suggested that the NRP

was handicapped by the lack of

traceback capabilities as well as by the

low numbers of samples for residue

testing. NAS also suggested that analysis

of test results needed to produce a better

characterization of the hazards, rather

than just an enumeration of them across

market class/compound dimensions.

This raises the issue of how full HACCP

implementation contributes to

addressing these deficiencies.

(3) Clear Tolerance Levels Available on

All Important Substances

In 1985, NAS identified this feature as

improved, but still needing more

progress. The process of setting

tolerances has changed significantly

since 1985. Tolerance setting is a

function performed by FDA and EPA

and, thus, minimally affected by FSIS

program changes. Therefore, FSIS

considers this issue to be minimally

affected by full HACCP implementation.

(4) Sampling Scheme Adequate for

Prevention

In 1985, NAS was critical of the NRP’s

monolithic sampling strategy. NAS

suggested that the strategy ought to be

revised to provide for more sampling,

true probability sampling, and sampling

designed to adequately characterize the

nature and distribution of contaminants.

NAS also suggested that random

sampling schemes other than simple

random sampling should be considered

and that substantial technical advice

from experts on sample surveys should

be obtained.

There are certainly alternative

sampling strategies that could be used

in the residue control effort. FSIS might

choose to sample certain historically

problematic market classes intensively

to define baseline conditions; from

those baseline conditions, the Agency

could consider promulgating

performance standards for some market

class/compound combinations that have

been historically troublesome.

Alternatively, FSIS could propose

performance standards based on

historical results from its own

program.11 In either case,

establishments would be responsible for

achieving these standards. FSIS would

verify whether they were meeting the

standards, and failure to meet the

standards would have HACCP system

consequences.

The Agency could also consider an

approach that takes into account the

amount of establishment sampling being

done in determining the amount of FSIS

testing that is appropriate. In fact, if

FSIS verifies that an establishment has

included residue control in its HACCP

plan and is following corrective action

procedures after any violative finding,

with records available for Agency

personnel to review, it would logically

be expected that FSIS would consider

limiting its residue testing.

Another alternative sampling strategy

could involve adding marketbasket

testing to FSIS activities and combining

all FSIS results with any available test

results from industry—animal

producers as well as processors.

Analysis of such a body of data might

be possible and might provide a more

comprehensive picture of residue

control. Other countries may have

experience with approaches that

combine public and private testing.

Other issues that need to be

considered here are what new

approaches that combine producer,

processor, and government activities

into a multifaceted and more

comprehensive residue control

approach can and should be

implemented now that HACCP has been

fully implemented, and what needs to

be done to accomplish this.

(5) Risk Assessment

NAS recommended that risk

assessment play a prominent role in

each of the first four areas discussed

above. FSIS experience with risk

assessment in the realm of microbial

hazards is somewhat limited, although

growing. FSIS has completed a risk

assessment for Salmonella enteritidis in

shell eggs and egg products, and it soon

will complete a risk assessment for E.

coli O157:H7 in ground beef and a

Listeria monocytogenes risk ranking

with FDA. Some people believe that risk

assessment is less difficult in the realm

of chemical hazards. The interagency

Surveillance Advisory Team recently

completed a significant change in the

way compounds are selected for

analysis any given year.12

FSIS believes the following issues

need to be considered in this area: How

should the Agency establish an agenda

for risk assessment in the realm of

controlling chemical hazards; how

should the Agency allocate resources for

its growing risk assessment needs; is the

Animal and Plant Health Inspection

Service’s approach—which involves

setting standards for risk assessments,

and then permitting outside parties who

meet those standards to perform risk

assessments—useful; and what does full

HACCP implementation bring in terms

of these risk assessments?

(6) Adequate Analytical Tools and

Testing Capacity

The Agency and its partners, such as

FDA, have made great strides in the

development of methods for residue

testing and in the capability of

laboratories to conduct analyses for

residues (which even in 1985 were

recognized as greatly improved).

However, full implementation of

HACCP may bring opportunities for

greater progress, because it could create

new markets for high quality laboratory

work or new analytical methods.

Issues that need to be considered

include the following: What are the

needs for laboratory capacity, and what

new analytical methods are needed;

should the Agency consider recognizing

test results for residues from State and

private laboratories that have

appropriate accreditation; and how can

the Agency facilitate the development of

new testing methods, particularly for

live animals?

(7) A Trained Inspection Force

Issues that need to be considered in

this area include the following: What

training does the FSIS inspection force

need regarding residue control in a full

HACCP implementation situation; and

what training do those in the regulated

industries and others need regarding

residue control in a full HACCP

implementation situation?

(8) Close Links to Regulatory

Enforcement

Much has changed since 1985,

including a major FSIS reorganization

and implementation of the PR/HACCP

final rule. An issue that needs to be

considered is what opportunities do the

Agency’s realignment and other

activities in support of full HACCP

implementation create for linkage

between residue control and

enforcement.

FSIS intends to proceed with its

regulatory reform agenda and to apply

the principles that guide it to complete

its agenda, which includes residue

control reform. (See the Agency’s

advance notice of proposed rulemaking,

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Proposed Rules 70815

‘‘FSIS Agenda for Change: Regulatory

Review’’ (60 FR 67469, December 29,

1995), and Reference 1.) In this regard,

issues that need to be considered

include the following: What

amendments to the regulations and

other materials that cover residue

control are needed; are additional efforts

at interagency coordination regarding

residue control necessary, and if so,

what should they be?

FSIS has adopted the practice of

supplementing its regulations with

guidance material for industry. Issues

that need to be considered include the

following: What new or improved

guidance materials are needed regarding

residue control; what improvements in

these materials can be made to ensure

that industry members obtain the

greatest benefit possible from them?

(9) Useful Information Systems

Implementation of HACCP has

significantly modified most of the

Agency’s information system needs.

Considering residue control alone, what

are the critical information system

needs in this area?

FSIS knows that EPA and FDA both

need information regarding residues.

The following issues need to be

considered here: Who else needs

information regarding residues, and

who has the needed information; what

are the constraints on sharing

information regarding residues; how can

obstacles to the sharing of information

be overcome; and what resources are

available for obtaining and sharing

information?

(10) Priorities Are Set Through an Open

Process

The NAS strongly suggested that an

open process, readily available to a wide

spectrum of constituents, be used to

establish priorities for the control of

chemical hazards in the meat and

poultry supply. The upcoming public

meeting is a first step in an effort to

meet that goal. FSIS would like to know

what other efforts might be useful in

opening up the process.

Additional Public Notification

Public awareness of all segments of

rulemaking and policy development is

important. Consequently, in an effort to

better ensure that minorities, women,

and persons with disabilities are aware

of this rule, FSIS will announce the

publication of this document in the

FSIS Constituent Update. FSIS provides

a weekly FSIS Constituent Update,

which is communicated via fax to over

300 organizations and individuals. In

addition, the update is available on line

through the FSIS web page located at

http://www.fsis.usda.gov. The update is

used to provide information regarding

FSIS policies, procedures, regulations,

Federal Register notices, FSIS public

meetings, recalls, and any other types of

information that could affect or will be

of interest to our constituents/

stakeholders. The constituent fax list

consists of industry, trade, and farm

groups, consumer interest groups, allied

health professionals, scientific

professionals, and other individuals that

have requested to be included. Through

these various channels, FSIS is able to

provide information to a much broader,

more diverse audience. For more

information and to be added to the

constituent fax list, fax your request to

the Congressional and Public Affairs

Office, at (202) 720–5704.

Done at Washington, DC, on November 22,

2000.

Thomas J. Billy,

Administrator.

[FR Doc. 00–30309 Filed 11–27–00; 8:45 am]

BILLING CODE 3410–DM–p

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 98–NM–139–AD]

RIN 2120–AA64

Airworthiness Directives; Aerospatiale

Model ATR42–200, –300, and –320

Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

supersedure of an existing airworthiness

directive (AD), applicable to all

Aerospatiale Model ATR42–300 and

–320 series airplanes. The existing AD

requires repetitive ultrasonic

inspections to detect cracking of certain

lugs on the main landing gear (MLG),

replacement of cracked lugs with new or

serviceable parts, and a follow-on

inspection; and provides for an optional

terminating action for the repetitive

inspections. This action would remove

that terminating action and require new

repetitive inspections of the rubber

sealant to detect shearing, and

corrective action, if necessary. This

action also would require new one-time

visual and fluorescent penetrant

inspections to detect discrepancies of

certain lugs and refurbishment of the

MLG barrel and swing lever assemblies,

which would terminate the

requirements of this proposed AD. This

action would also revise the

applicability of the existing AD. This

proposal is prompted by issuance of

mandatory continuing airworthiness

information by a foreign civil

airworthiness authority. The actions

specified by the proposed AD are

intended to detect and correct

discrepancies of the MLG barrel lower

lugs, which could result in reduced

structural integrity and possible

collapse of the MLG.

DATES: Comments must be received by

December 28, 2000.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,

Attention: Rules Docket No. 98–NM–

139–AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

Comments may be inspected at this

location between 9:00 a.m. and 3:00

p.m., Monday through Friday, except

Federal holidays.

The service information referenced in

the proposed rule may be obtained from

Aerospatiale, 316 Route de Bayonne,

31060 Toulouse, Cedex 03, France. This

information may be examined at the

FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington.

FOR FURTHER INFORMATION CONTACT:

Norman B. Martenson, Manager,

International Branch, ANM–116, FAA,

Transport Airplane Directorate, 1601

Lind Avenue, SW., Renton, Washington

98055–4056; telephone (425) 227–2110;

fax (425) 227–1149.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Communications shall

identify the Rules Docket number and

be submitted in triplicate to the address

specified above. All communications

received on or before the closing date

for comments, specified above, will be

considered before taking action on the

proposed rule. The proposals contained

in this action may be changed in light

of the comments received.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the proposed rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report

summarizing each FAA-public contact

concerned with the substance of this