[Federal Register: November 28, 2000 (Volume 65, Number 229)]
[Proposed Rules]               
[Page 70809-70815]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 70809]]


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 Reduction-Hazard 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 
FSIS-regulated 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.



    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 
    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-the-fact 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 (Sec. 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 (Sec. 417.1). The possible sources from 
which food safety hazards might be expected to arise specifically 
include chemical contamination, pesticides, and drug residues 
(Sec. 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 (Sec. 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

[[Page 70810]]

critical limit at a CCP, and verification procedures (Secs. 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) (Secs. 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 
(Sec. 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 farm-to-
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'', 
    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 

    \2\ Reference 1 is a list of FSIS regulations, directives, and 
    \1\ Reference 2 describes the interagency infrastructure.
    \3\ NRP 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.

    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 
FSIS-regulated 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

[[Page 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 normal-appearing 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 ante-mortem 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 (Secs. 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 (Sec. 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 
(Secs. 417.4(a)), and the specification of consequences for incomplete 
corrective actions (Secs. 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 Sec. 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

[[Page 70812]]

adequacy of HACCP plans, including records review, direct observation 
or measurement at a CCP, and sample collection and analysis 
(Sec. 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 
    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\

    \4\ Reference 3 is ``Trends in the United States: Consumer 
Attitudes and the Supermarket,'' 2000, Food Marketing Institute.

    (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 

Rethinking the Approach to Residue Control--Best Available 

    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 
--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

[[Page 70813]]

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.

    \5\ Reference 4 is FSIS Notice 24-00.

--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 Sec. 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\

    \6\ Reference 5 is Council Directive 96/23/EC.
    \7\ Reference 6 is a list of live animal test methods.
    \8\ Reference 7 is general information describing the AOAC 
Institute and its activities.

    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.

    \9\ Reference 8 is the chapter of the 1985 NAS report (Chapter 
4) that addressed control of chemical hazards.

    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.

    \10\ Reference 9 is extra residue requirements for the EU.

(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

[[Page 70814]]

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.

    \11\ Reference 10 summarizes recent FSIS data that could serve 
as the basis for performance standards.

    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 

    \12\ Reference 11, sections 5 and 6 of the current Blue Book, 
describes the new approach.

    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 
    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,

[[Page 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,
[FR Doc. 00-30309 Filed 11-27-00; 8:45 am]