[Federal Register Volume 64, Number 249 (Wednesday, December 29, 1999)]
[Proposed Rules]
[Pages 72972-72985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33831]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR PARTS 160, 792, and 806

RIN 2020-AA26
[ECDIC-1998-02; FRL-5782-7]


Consolidation of Good Laboratory Practice Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to consolidate its Good Laboratory Practice 
Standards (GLPS), which currently exist in two separate regulations at 
40 CFR part 160 and 40 CFR part 792. The proposed consolidated GLPS 
rule would be applicable to programs under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control 
Act (TSCA) to which the current rules apply. In addition to the 
proposed consolidation, EPA is also proposing amendments to the GLPS 
that streamline and ease

[[Page 72973]]

compliance while still maintaining the rule's data integrity assurance 
purpose. The consolidation will reduce the volume of regulations 
administered by EPA without adversely affecting current data integrity 
requirements. GLPS are intended to ensure the integrity of data 
gathered from studies in a wide variety of disciplines such as 
toxicology, ecological effects, chemical fate, residue chemistry, and 
product performance testing. Under FIFRA, compliance with regulations 
on GLPS applies to all studies required to be submitted in support of 
pesticide registrations, reregistrations, and experimental use permits. 
Under TSCA, GLPS are required for testing conducted pursuant to consent 
agreements/orders and test rules issued under sections 4 and 5 of that 
Act. Failure to comply with applicable GLPS is an actionable violation 
which may result in civil or criminal penalties, and can render data 
from non-compliant studies unacceptable for consideration by EPA.

DATES: Comments, identified by the docket control number EC-1998-02, 
must be received by March 29, 2000.

ADDRESSES: By mail, submit comments to: Enforcement and Compliance 
Docket and Information Center (2201A), Office of Enforcement and 
Compliance Assurance, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring comments to: Enforcement and 
Compliance Docket and Information Center, Office of Enforcement and 
Compliance Assurance, Rm. 4033, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., Washington, DC. The telephone number for the Enforcement and 
Compliance Docket and Information Center is (202) 564-2614.
    Information submitted and any comment(s) concerning this proposed 
rule may be claimed confidential by marking any or all of that 
information as ``Confidential Business Information'' (CBI). Information 
so marked will not be disclosed except in accordance with procedures 
set forth in 40 CFR part 2. A copy of the comment(s) that does not 
contain CBI must be submitted for inclusion in the public record. 
Information not marked confidential may be disclosed publicly by EPA 
without prior notice to the submitter. Information on the proposed rule 
and any written comments received will be available for public 
inspection in Room 4033 at the Ariel Rios Bldg. address given above, 
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to Donna W[email protected]. Comments 
and data will also be accepted on disks in WordPerfect in 5.1/6.1 or 
ASCII file format. All comments and data in electronic form must be 
identified by the docket control number EC-1998-02. No CBI should be 
submitted through e-mail. Electronic comments on this proposed rule, 
but not the record, may be viewed or new comments filed online at many 
Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: David Stangel, Agriculture and 
Ecosystems Division, Office of Compliance (2225A), U. S. Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone: 
(202) 564-4162, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA proposes to amend the FIFRA GLPS (40 CFR part 160) and the TSCA 
GLPS (40 CFR part 792) to consolidate these regulations into one rule. 
In addition, EPA proposes to provide clarifications of certain 
requirements and amend other requirements of the rule to reflect the 
experience gained in administering the GLPS.

A. Legal Authority

    These GLPS are promulgated under the authority of sections 3, 4, 5, 
6, 8, 18, 24(c), and 25(a) of FIFRA, 7 U.S.C. 136 et seq., as amended, 
sections 408, 4091, and 701 of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., the Reorganization Plan 
No. 3 of 1970, and sections 4(b)(1) and 5 of TSCA, 15 U.S.C. 2603 et 
seq.
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    1Prior to August 3, 1996 (the effective date of the Food Quality 
Protection Act of 1996), data were submitted to the Agency pursuant 
to section 409. References in this rule to section 409 remain with 
respect to such data.
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B. Background

    EPA published FIFRA and TSCA GLPS in the Federal Register on 
November 29, 1983 (48 FR 53946 and 48 FR 53922), which were codified as 
40 CFR parts 160 and 792 respectively, and were amended on August 17, 
1989 (54 FR 34052 and 54 FR 34034). These TSCA and FIFRA regulations 
were initially promulgated to address assuring the validity of data in 
the wake of investigations by EPA and the Food and Drug Administration 
(FDA) during the mid-1970's which revealed that some studies submitted 
to the Agencies had not been conducted in accordance with acceptable 
laboratory practices. Some studies had been conducted so poorly that 
the resulting data could not be relied upon in EPA's regulatory 
decision-making process. In some cases, results were selectively 
reported, underreported, or fraudulently reported. In addition, it was 
discovered that some testing facilities displayed poor animal care 
procedures and inadequate recordkeeping techniques. The GLPS specify 
minimum practices and procedures in order to ensure the quality and 
integrity of data submitted to EPA in support of a research or 
marketing permit for a pesticide product, or the quality and integrity 
of data submitted in accordance with a TSCA section 4 or 5 requirement.
    When EPA published its initial FIFRA and TSCA GLPS in the Federal 
Register of November 29, 1983, EPA sought to harmonize the requirements 
and language with those regulations promulgated by the FDA in the 
Federal Register of December 22, 1978 (43 FR 60013), and codified as 21 
CFR part 58. Differences between the two Agencies' current GLPS 
regulations existed only to the extent necessary to reflect the 
Agencies' different statutory responsibilities under TSCA, FIFRA, and 
FFDCA. Similar to the FDA GLPS regulations, the FIFRA and TSCA GLPS 
delineate standards for studies required to be submitted to EPA for its 
regulatory decision-making.
    Compliance with EPA's FIFRA and TSCA GLPS has been monitored 
through a program of laboratory inspections and data audits coordinated 
between EPA and FDA. Under an Interagency Agreement originated in 1978 
between FDA and EPA, FDA carries out GLPS inspections at laboratories 
which conduct health effects testing. EPA primarily performs GLPS 
inspections for environmental laboratories and conducts data audits for 
health effects and environmental studies. Because of the cooperative 
nature of FDA's and EPA's GLPS programs, it is important that the GLPS 
remain substantially consistent not only between programs within each 
Agency but also between Agencies.
    FDA revised its GLPS regulations on September 4, 1987 (52 FR 
33768), to simplify the regulations and reduce the regulatory burden on 
testing facilities without compromising study integrity. EPA published 
amendments to its FIFRA and TSCA GLPS in the Federal Register of August 
17, 1989 (54 FR 34052 and 54 FR 34043 respectively). During that 
rulemaking, EPA expanded the applicability of its FIFRA GLPS to cover 
all data required to be submitted under FIFRA.
    On March 4, 1995, the President directed all Federal agencies to 
conduct

[[Page 72974]]

a comprehensive review of the regulations these agencies administer and 
reduce or eliminate unnecessary or duplicative regulations. In 
response, EPA conducted a review of its regulations to determine 
candidates for such reductions. During this process, EPA identified the 
FIFRA and TSCA GLPS as providing an opportunity for such reductions. 
The goal of consistency of GLPS resulted in the same regulatory 
language being duplicated throughout these two rules. This proposed 
rulemaking reflects EPA's belief that it is not necessary to duplicate 
the same language in two separate regulations.
    Since the 1989 rulemaking, EPA has received many requests for 
clarifications with respect to compliance requirements, especially 
regarding FIFRA studies that came under GLPS coverage in 1989. EPA's 
responses to those requests facilitated compliance with the FIFRA GLPS 
rule and have been made available to the regulated community in a 
Question and Answer document which may be obtained from the address 
listed above in the ``FOR FURTHER INFORMATION CONTACT'' section.
    EPA has been in communication with representatives of the regulated 
community who indicated that it would improve the quality of and 
compliance with the GLPS if previous clarifications were incorporated. 
As a result of these initial consultations, EPA believes that it makes 
sense to incorporate these clarifications and consider other 
suggestions for improving these regulations, and is proposing several 
modifications to the GLPS requirements as part of this rulemaking.

II. Summary of Proposed Changes

A. Consolidation

    Currently, EPA has GLPS at 40 CFR part 160 and part 792. These 
rules are identical in general format, each consisting of the following 
subparts: A--General Provisions; B--Organization and Personnel; C--
Facilities; D--Equipment; E--Testing Facilities Operation; F--Test, 
Control, and Reference Substances; G--Protocol for and Conduct of a 
Study; H and I--[Reserved]; and J--Records and Reports.
    Most of the sections under these subparts are identical between the 
two rules. In such cases, EPA proposes to continue the current language 
except where amended as provided in Unit II.B. of this preamble. Some 
sections include rule differences for the two regulatory areas--TSCA 
and FIFRA. In such cases, it is necessary to provide separate, distinct 
sections, or subsections applicable to those programs.
    Therefore, the proposed 40 CFR part 806 will continue the common 
language currently found in both 40 CFR parts 160 and 792. Current 
differences between the TSCA and FIFRA rules will be treated in one of 
two ways: (1) Differences which are programmatic and necessary will be 
continued in the form of separate regulatory provisions under the 
consolidated GLPS; and (2) differences that are determined to be 
inadvertent, e.g., typographic errors, minor grammatical differences, 
etc., will be eliminated.
    1. Program differences. The two subparts in which there are 
significant differences between the two rules are Subpart A (General 
Provisions) and Subpart J (Records and Reports). All other subparts are 
virtually identical.
    a. Subpart A--General Provisions--i. Sec. 806.1--Scope. Section 
806.1(a) proposes to include the relevant statutory authorities under 
FIFRA and FFDCA (currently applicable to pesticides studies), and the 
authorities under TSCA (currently applicable to substances regulated 
under TSCA). In Sec. 806.1(a)(2), the Agency states that the GLPS apply 
to any study which any person conducts, initiates, or supports by a 
certain date. If a study is initiated prior to that date but conducted 
after that date, the GLPS would apply to the study. Only if the study 
is completed prior to the effective date of the rule would it not be 
subject to the amended GLPS.
    ii. Sec. 806.3--Definitions. Section 806.3 includes definitions 
which are specific to program areas and are currently listed separately 
in the two rules.
    iii. Sec. 806.12--Statement of Compliance or Noncompliance. Section 
806.12 proposes specific and separate applicability under the current 
program areas (toxics and pesticides) which provide for compliance 
statements.
    b. Subpart J--Records and Reports. -- Sec. 806.195--Retention of 
Records. Section 806.195 proposes separate record retention 
requirements for documentation records, raw data, and specimens 
pertaining to FIFRA and TSCA studies.

B. Clarifying Amendments

    In addition to consolidating the regulations, the Agency is 
proposing to amend the current regulatory language in 40 CFR parts 160 
and 792 to clarify certain requirements and simplify others. These 
amendments are being proposed in response to feedback received from the 
regulated community as well as comments received in response to 
publication of the Agency's intent to consolidate the FIFRA and TSCA 
GLPS.
    1. Subpart A--General Provisions. The proposal would amend the 
current definitions of the terms ``carrier'' and ``test systems'' by 
adding the word ``air'' to each definition to clarify that air is 
considered both a carrier and a test system in certain circumstances. 
This change will alleviate confusion on this point.
    EPA proposes to amend the current definition of the term ``quality 
assurance unit'' by deleting the phrase ``the study director'' and 
adding the phrase ``individual(s) directly involved in the conduct of 
the study, including the study director.'' This change is being 
proposed because it is equally improper for persons other than the 
study director who are working directly on the study to perform quality 
assurance of the study.
    EPA proposes to amend the current definition of the term 
``vehicle'' by adding examples of substances which are considered 
vehicles.
    EPA proposes to amend the current Secs. 160.10 and 792.10 by adding 
the phrase ``prior to initiation of the study,'' to the end of the 
sentence as well as requiring the notification to be made in writing. 
This change clarifies a number of questions that have been raised in 
the past and is in keeping with normal practices. Section 806.10 
reflects the change.
    EPA proposes to amend the current Secs. 160.17(a)(2) and 
792.17(a)(2) by changing the reference to FFDCA section 406, which was 
a typographical error, to section 408, the proper reference. EPA 
proposes to amend the term ``consent agreement'' to ``consent 
agreement/order'' and the reference to ``section 4 of TSCA'' to 
``section 4 or 5 of TSCA'' throughout the proposed rule to reflect that 
GLPS are required in both test rules and consent agreements/orders, and 
that testing can be required under both sections 4 and 5 of TSCA. 
Section 806.17(a)(2) reflects these changes.
    EPA proposes to amend the current Secs. 160.33(f) and 792.33(f) to 
read: ``. . .during or at the close or termination of the study.'', to 
address those instances where a study is terminated prior to completion 
of the study. Section 806.33(f) reflects the change.
    2. Subpart B--Organization and Personnel. EPA proposes to amend the 
current Secs. 160.35(b)(1) and 792.35(b)(1) to include the following 
language ``. . .indexed to permit expedient retrieval, which identifies 
the. . .'' to allow the study director to employ an indexing system 
which may not reference the test substance but would still allow the

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facility to quickly extract the information. Section 806.35(b)(1) 
reflects this change. EPA proposes to amend the current 
Secs. 160.35(b)(2) and 792.35(b)(2) to read: ``. . .all protocols until 
study completion pertaining. . . .'' Protocols are required to be 
archived at the completion of a study and requiring the maintenance of 
another copy of the protocol would be duplicative. Section 806.35(b)(2) 
reflects this change.
    3. Subpart C--Facilities. Questions have been raised in the past 
about the applicability of the language in the current Secs. 160.43(a) 
and 792.43(a); specifically whether co-exposure of test species to the 
test substance (e.g., inhalation studies) is allowable given the 
requirement for proper separation of species or test systems. Co-
exposure of test species in inhalation studies is allowable unless the 
study protocol specifically prohibits the practice. Section 806.43(a) 
reflects this change.
    4. Subpart D--Equipment. The Agency proposes to amend the current 
Secs. 160.63 and 792.63 by adding paragraph (d) to address the 
integrity of data stored and manipulated by computers, data processors, 
and automated laboratory procedures to make it clear that these types 
of equipment are subject to the same provisions as other laboratory 
equipment. Section 806.63 reflects this change.
    5. Subpart E--Testing Facilities Operation. The Agency is proposing 
to amend the current Secs. 160.83 and 792.83 to allow the testing 
facility to develop a documentation performance standard as an 
alternative to an expiration date for the contents of transfer bottles 
and wash bottles. The testing facility has the option of labeling 
transfer and wash bottles or developing another well documented system 
to ensure that these solutions have not deteriorated or exceeded their 
expiration date. Section 806.63 reflects this change. EPA specifically 
requests comment on a documentation performance standard that would 
provide the same assurances that the solutions have not deteriorated or 
exceeded their expiration date. Other alternatives being considered 
include the development of a list of substances that do not require 
expiration dates, e.g., distilled water.
    6. Subpart F--Test, Control, and Reference Substances. The Agency 
proposes to amend the current Secs. 160.105(b) and 792.105(b) to allow 
concurrent determination of solubility as well as stability of the 
test, control, or reference substance. The rule presently allows only 
concurrent determination of the stability of the test, control, or 
reference substance. Section 806.105(b) reflects this change.
    EPA proposes to amend the current Secs. 160.105(c) and 792.105(c) 
to allow the study director the options of discarding containers which 
contained the test substance, with proper recordkeeping of the 
disposition of the containers, or retaining the containers until the 
termination of the study. The proposal to relax the requirement for 
retention of test substance containers is being made to address the 
burden of retaining containers in field studies where large amounts of 
the test substance are used. The approach proposed is prescriptive in 
nature and gives the testing facility and study director EPA's position 
on what the Agency considers adequate documentation. EPA is requesting 
comments on whether such a prescriptive approach is necessary or should 
be relaxed to state that the study director may authorize container 
disposal and simply note in the raw data that this has been done.
    In addition, the Agency is proposing to amend the current 
Secs. 160.105(c) and 792.105(c) by deleting the term ``where 
appropriate'' from the first sentence to now read ``. . .expiration 
date, if any, and storage conditions necessary to maintain the 
identity, . . .'' because information on storage conditions is always 
appropriate. Section 806.105(c) reflects these changes.
    The Agency proposes to amend the current Secs. 160.113(a)(2) and 
792.113(a)(2) by the addition of the following language ``. . 
.reference substance in the mixture; or if the solubility of the 
substance is difficult to determine, appropriate homogeneity data, by 
the testing facility. . .'' to address those situations in which the 
test, control, or reference substance is insoluble and may create 
emulsions that are very difficult to analyze. Section 806.113(a)(2) 
reflects this change. EPA proposes to amend the current 
Secs. 160.113(b) and 792.113(b) to exempt tank mixes and solutions 
prepared for immediate administration (within 12 hours) in mammalian 
acute toxicology studies, metabolism studies, or mutagenicity studies 
from requirements for concentration determinations (but not from 
uniformity determinations) under Secs. 160.113(a)(1) and 792.113(a)(1) 
and solubility determinations under Secs. 160.113(a)(2) and 
792.113(a)(2). This addition is being proposed in response to comments 
that these mixes must be made and used quickly, and it is not possible 
to perform solubility testing before the experimental start date. 
Section 806.113(b) reflects this change.
    7. Subpart G--Protocol for and Conduct of a Study. EPA proposes to 
amend the current Secs. 160.120(a)(2) and 792.120(a)(2) to exempt 
metabolism studies from the requirement to identify the test, control, 
or reference substance when their identities are to be determined 
during the study. In metabolism studies, the identity of the metabolite 
or metabolites may not be known at the time that the protocol is 
written. EPA proposes that the protocol need not identify reference 
substances for metabolites when they cannot be identified before the 
beginning of the study. This proposal does not affect the requirement 
to identify metabolism study test, reference, or control substances at 
the beginning of the study, unless the purpose of the study is to 
identify them. Section 806.120(a)(2) reflects this change.
    EPA proposes to amend the current Secs. 160.120(c) and 792.120(c) 
to allow discontinued studies or studies otherwise terminated before 
completion to be finalized by writing a protocol amendment with the 
reasons for the termination, in lieu of preparing a final report. All 
documentation for the terminated study must be retained in accordance 
with Sec. 806.195. Sponsors are still obligated to meet section 6(a)(2) 
of FIFRA and section 8(e) of TSCA requirements for submission of 
adverse effects data including, but not limited to, those generated by 
terminated studies. Section 806.120(c) reflects this change.
    8. Subpart J--Records and Reports. EPA proposes to amend the 
current Secs. 160.185(a)(1) and 792.185(a)(1) by deleting the words 
``terminated or discontinued,'' because Sec. 806.120(c) was added to 
address terminated or discontinued studies. Section 806.185(a)(1) 
reflects this change.
    EPA proposes to amend the current Secs. 160.185(a)(7) and 
792.185(a)(7) by deleting the phrase ``or other test organisms,'' 
because the required information is relevant chiefly to animal systems. 
Section 806.185(a)(7) reflects this change.
    Finally, EPA proposes to amend the current Sec. 792.195 by 
replacing the existing record retention requirements for studies 
submitted under sections 4 and 5 of TSCA with a single requirement to 
retain records for a period of 5 years following the date on which the 
final report of the study is submitted to the Agency. The change will 
simplify record retention requirements for persons required to retain 
records by providing a single standard for record retention. Section 
806.195 reflects this change.

III. Public Docket

    A record has been established for this rulemaking under docket 
number EC-

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1998-02. This record is available for public inspection from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 4033, Office of Enforcement and Compliance 
Assurance, Environmental Protection Agency, Ariel Rios Bldg., 1200 
Pennsylvania Ave., Washington, DC. Written requests should be mailed 
to: Enforcement and Compliance Docket and Information Center (2201A), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

IV. Statutory Review

    In accordance with FIFRA section 25(a), this proposal was submitted 
to the FIFRA Scientific Advisory Panel, the Secretary of Agriculture, 
and appropriate Congressional Committees. No comments were received.

V. Regulatory Assessment Requirements

A. Executive Order 12866

    Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993), 
it has been determined that this proposed action is not a ``significant 
regulatory action'' and is therefore not subject to the Office of 
Management and Budget (OMB) review. The Agency believes that the 
amendments associated with this action constitute regulatory relief, 
and therefore will not impose any additional costs or burdens. The 
analysis related to the costs and burdens of the original requirements 
were discussed in conjunction with their promulgation in 1989. Because 
this action consolidates the requirements contained in the original 
GLPS, no new costs or burdens are imposed. Instead, the Agency believes 
that the consolidation of the GLPS may actually increase efficiencies 
for those companies that are required to use both TSCA and FIFRA GLPS, 
because these companies will now only have one version of GLPS to use. 
Additionally, many of the changes in the rule allow the laboratories to 
use more efficient means of achieving the requirements of the GLPS. The 
Agency solicits comments on the impacts of this consolidation on the 
regulated community.

B. Executive Order 12898

    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 
entitled Federal Actions to Address - Environmental Justice in Minority 
Populations and Low-Income Populations, the Agency has considered 
environmental justice related issues with regard to the potential 
impacts of this action on the environmental and health conditions in 
low-income and minority communities. The Agency believes that this 
action will not adversely impact low-income and minority communities. 
These regulations consolidate existing regulations and have not been 
the subject of any environmental justice concerns in the past.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If EPA 
complies by consulting, Executive Order 13084 requires EPA to provide 
OMB, in a separately identified section of the preamble to the rule, a 
description of the extent of EPA's prior consultation with 
representatives of affected Tribal governments, a summary of the nature 
of their concerns, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 13084 requires EPA to develop 
an effective process permitting elected and other representatives of 
Indian tribal governments ``to provide meaningful and timely input in 
the development of regulatory policies on matters that significantly or 
uniquely affect their communities.''
    Today's proposed rule does not significantly or uniquely affect the 
communities of Indian tribal governments. The proposed rule does not 
involve or impose any requirements that affect Indian Tribes. 
Accordingly, the requirements of section 3(b) of Executive Order 13084 
do not apply to this document.

D. Unfunded Mandates Reform Act and Executive Order 12875

    This proposed action does not contain any new requirements or 
impose any additional burden because it proposes to consolidate 
requirements together which currently exist in two separate 
rulemakings. As such, this proposed action is expected to result in 
savings and burden relief rather than in an expenditure by any State, 
local, or Tribal governments, or by anyone in the private sector, and 
will not result in any unfunded Federal mandates as defined by Title II 
of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
    In addition, since this action does not contain any Federal 
mandates on States, localities, or Tribes, it is not subject to the 
requirements of Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993).

E. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (5 
U.S.C. 601 et seq.), the Agency hereby certifies that this regulatory 
action does not have any significant adverse economic impacts on a 
substantial number of small entities. This proposed rule does not 
impose any new requirements that would impose any adverse impacts on 
small entities. In consolidating the existing requirements, EPA is 
allowing those companies that are currently conducting various testing 
for use either pursuant to FIFRA or TSCA, to adhere to and follow a 
single GLP standard. Given the efficiencies provided, the Agency has 
determined that this proposal will not result in adverse impacts. As 
such, no impact analysis is required.
    Information related to this determination has been included in the 
docket for this rulemaking, and, in accordance with Small Business 
Administration (SBA) policy, will be provided to the Chief Counsel for 
Advocacy of the SBA upon request. Any comments regarding the economic 
impacts that this regulatory action may impose on small entities should 
be submitted to the Agency at the address listed under Unit III. of 
this preamble.

F. Paperwork Reduction Act

    This proposed action does not contain any new information 
collection requirements. The GLPS do not directly impose any 
information collection requirements, but they describe standards 
regarding testing conducted for other information collections currently 
approved by the Office of Management and Budget (OMB) under the 
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.:
    Maximum Residue Limit (MRL) Petitions on Food/Feed Crops and New 
Inert Ingredients (EPA ICR No. 597.06, OMB Control No. 2070-0024)
    Notice of Pesticide Registration by States to Meet a Special Local 
Need (SLN) under FIFRA Section 24(c) (EPA ICR No. 595.06, OMB Control 
No. 2070-0055)
    Application for New or Amended Registration (EPA ICR No. 277.10, 
OMB Control No. 2070-0060)
    Application for Experimental Use Permit (EUP) to Ship a Pesticide 
for Experimental Purposes Only (EPA ICR

[[Page 72977]]

No. 276.08, OMB Control No. 2070-0040)
    Data Call-In for Special Review Chemicals (EPA ICR No. 922.05, OMB 
Control No. 2070-0057)
    Application and Summary Report for an Emergency Exemption for 
Pesticides (EPA ICR No. 596.05, OMB Control No. 2070-0032)
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

G. Request for Comment on Potential Voluntary Consensus Standards to 
Consider for Future Regulatory Actions

    This proposal does not involve a regulatory action that would 
require the Agency to consider voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Section 12(d) directs EPA to use voluntary consensus standards 
in its regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, business practices, etc.) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA requires EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards when 
the NTTAA directs the Agency to do so.
    As indicated earlier, these guidelines represent an Agency effort 
to harmonize the test guidelines between the Office of Pesticide 
Programs (OPP) and the Office of Pollution Prevention and Toxics 
(OPPT), as well as harmonizing the OPP and OPPT test guidelines with 
those of the Organization for Economic Cooperation and Development. The 
process for developing and amending these test guidelines includes the 
extensive involvement of the scientific community, including peer 
review by the FIFRA SAP and other expert scientific panels, and 
providing extensive public comment.
    In the future, these test guidelines could be incorporated into 
regulatory actions taken by EPA pursuant to TSCA section 4. Although 
the NTTAA requirements do not specifically apply to the issuance of 
these particular test guidelines today, EPA invites your comment on 
whether or not there are any voluntary consensus standards that should 
be considered during the development of any future action under TSCA. 
Future actions under TSCA section 4 would go through notice and comment 
rulemaking or be negotiated as voluntary testing enforcement 
agreements/consent orders/decrees, allowing for additional public 
comment on this issue. Nevertheless, the Agency is interested in 
whether or not there are any voluntary consensus standards that EPA 
should considered in lieu of these test guidelines when the Agency 
develops any future regulatory action that incorporates these test 
guidelines. Any comments provided will assist the Agency in complying 
with the NTTAA by facilitating the Agency's identification of voluntary 
consensus standards that should be considered during the development of 
a proposed regulatory action that incorporates any standards included 
in these test guidelines. Please submit your comments to the person 
identified in the FOR FURTHER INFORMATION CONTACT section.

H. Executive Order 13045

    Executive Order 13045 entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997) applies to any rule that: (1) is determined to be ``economically 
significant'' as defined under Executive Order 12866, and (2) concerns 
an environmental health or safety risk that EPA has reason to believe 
may have a disproportionate effect on children. If the regulatory 
action meets both criteria, the Agency must evaluate the environmental 
health or safety effects of the planned rule on children, and explain 
why the planned regulation is preferable to other potentially effective 
and reasonably feasible alternatives considered by the Agency.
    EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on health or safety risks, such that 
the analysis required under section 5-501 of the Order has the 
potential to influence the regulation. This proposed rule is not 
subject to Executive Order 13045 because it does not establish an 
environmental standard intended to mitigate health or safety risks.

I. Executive Order 13132

    On August 4, 1999, President Clinton issued a new executive order 
on federalism, Executive Order 13132 (64 FR 43255, August 10, 1999), 
which will take effect on November 2, 1999. In the interim, the current 
Executive Order 12612 (52 FR 41685, October 30, 1987), on federalism 
still applies. This proposed rule will not have a substantial direct 
effect on States, on the relationship between the national government 
and the States, or on the distribution of power and responsibilities 
among the various levels of government, as specified in Executive Order 
12612.

List of Subjects

40 CFR Part 160

    Environmental protection, Laboratories, Pesticides and pests, 
Reporting and recordkeeping requirements.

40 CFR Part 792

    Environmental protection, Hazardous substances, Laboratories, 
Reporting and recordkeeping requirements.

40 CFR Part 806

    Environmental protection, Data requirements, Good laboratory 
practice, Hazardous materials, Pesticides and pests, Reporting and 
recordkeeping requirements, Testing.

    Dated: October 28, 1999.
Carol M. Browner,
Administrator.
    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 160 [Removed]

    1. By removing part 160.

PART 792 [Removed]

    2. By removing part 792.
    3. By adding subchapter S consisting of part 806 to read as 
follows:

[[Page 72978]]

SUBCHAPTER S--STANDARDS, TEST METHODS, AND GUIDELINES
PART 806--GOOD LABORATORY PRACTICE STANDARDS
Subpart A--General Provisions
Sec.
806.1   Scope.
806.3   Definitions.
806.10   Applicability to studies performed under grants and 
contracts.
806.12   Statement of compliance or non-compliance.
806.15   Inspection of a testing facility.
806.17   Effects of non-compliance.
Subpart B--Organization and Personnel
806.29   Personnel.
806.31   Testing facility management.
806.33   Study director.
806.35   Quality assurance unit.

Subpart C--Facilities

806.41   General.
806.43   Test system care facilities.
806.45   Test system supply facilities.
806.47   Facilities for handling test, control, and reference 
substances.
806.49   Laboratory operation areas.
806.51   Specimen and data storage facilities.
Subpart D--Equipment
806.61   Equipment design.
806.63   Maintenance and calibration of equipment.
Subpart E--Testing Facilities Operation
806.81   Standard operating procedures.
806.83   Reagents and solutions.
806.90   Animal and other test system care.
 Subpart F--Test, Control, and Reference Substances
806.105   Test, control, and reference substance characterization.
806.107   Test, control, and reference substance handling.
806.113   Mixtures of substances with carriers.
Subpart G--Protocol for and Conduct of a Study
806.120   Protocol.
806.130   Conduct of a study.
806.135   Physical and chemical characterization studies.
Subparts H and I--[RESERVED]
Subparts J--Records and Reports
806.185   Reporting of study results.
806.190   Storage and retrieval of records and data.
806.195   Retention of records.

    Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 
136w; 15 U.S.C. 2603; 21 U.S.C. 346a, 348, 371, Reorganization Plan 
No. 3 of 1970.

Subpart A--General Provisions


Sec. 806.1   Scope.

    (a)(1) This part prescribes good laboratory practices for 
conducting studies that support or are intended to support applications 
for research or marketing permits for pesticide products regulated by 
the EPA. This part is intended to assure the quality and integrity of 
data submitted pursuant to sections 3, 4, 5, 8, 18, and 24(c) of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended 
(7 U.S.C. 136a, 136c, 136f, 136q, and 136v(c)) and sections 408 and 409 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 
U.S.C. 346a, 348).
    (2) This part applies to any study described by paragraph (a)(1) of 
this section which any person conducts, initiates, or supports on or 
after [Insert date 60 days after date of publication in the Federal 
Register of the final rule].
    (b)(1) This part also prescribes good laboratory practices for 
conducting studies relating to health effects, environmental effects, 
and chemical fate testing pursuant to the Toxic Substances Control Act 
(TSCA) (Public Law 94-469, 90 Stat. 2006, 15 U.S.C. 2603 et seq.). This 
part is intended to assure the quality and integrity of data submitted 
pursuant to test rules and testing consent agreements/orders issued 
under section 4 and section 5 of TSCA.
    (2) This part applies to any study described by paragraph (b)(1) of 
this section which any person conducts, initiates, or supports on or 
after [Insert date 60 days after date of publication in the Federal 
Register of the final rule].
     (3) It is EPA's policy that all data developed for submission 
under section 5 of TSCA be in accordance with provisions of this part. 
If data are not developed in accordance with the provisions of this 
part, EPA will consider such data insufficient to evaluate the health 
and environmental effects of the chemical substances unless the 
submitter provides additional information demonstrating that the data 
are reliable and adequate.


Sec. 806.3   Definitions.

    As used in this part, the following terms shall have the meanings 
specified:
    Application for research or marketing permit includes:
    (1) An application for registration, amended registration, or 
reregistration of a pesticide product under FIFRA sections 3, 4, or 
24(c).
    (2) An application for an experimental use permit under FIFRA 
section 5.
    (3) An application for an exemption under FIFRA section 18.
    (4) A petition or other request for establishment or modification 
of a tolerance, for an exemption for the need for a tolerance, or for 
other clearance under FFDCA section 408.
     (5) A petition or other request for establishment or modification 
of a food additive regulation or other clearance by EPA under FFDCA 
section 409.
     (6) A submission of data in response to a notice issued by EPA 
under FIFRA section 3(c)(2)(B).
     (7) Any other application, petition, or submission sent to EPA 
intended to persuade EPA to grant, modify, or leave unmodified a 
registration or other approval required as a condition of sale or 
distribution of a pesticide.
    Batch means a specific quantity or lot of a test, control, or 
reference substance that has been characterized according to 
Sec. 806.105(a).
    Carrier means any material, including but not limited to feed, 
water, soil, air, or nutrient media, with which the test substance is 
combined for administration to a test system.
    Control substance means any chemical substance or mixture, or any 
other material other than a test substance, feed, or water, that is 
administered to the test system in the course of a study for the 
purpose of establishing a basis for comparison with the test substance 
for known chemical or biological measurements.
    EPA means the U.S. Environmental Protection Agency.
    Experimental start date means the first date the test substance is 
applied to the test system.
    Experimental termination date means the last date on which data are 
collected directly from the study.
    FDA means the U.S. Food and Drug Administration.
    FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended 
(21 U.S.C. 321 et seq).
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act 
as amended (7 U.S.C. 136 et seq).
    Person includes an individual, partnership, corporation, 
association, scientific or academic establishment, government agency, 
or organizational unit thereof, and any other legal entity.
    Quality assurance unit means any person or organizational element 
(except individual(s) directly involved in the conduct of the study, 
including the study director), designated by testing facility 
management to perform the duties relating to quality assurance of the 
studies.
    Raw data means any laboratory worksheets, records, memoranda, 
notes, or exact copies thereof, that are the result of original 
observations and activities of a study and are necessary for the 
reconstruction and evaluation of the report of that study. In the event 
that exact transcripts of raw data have been prepared (e.g., tapes 
which have been transcribed verbatim, dated, and verified accurate by 
signature), the exact

[[Page 72979]]

copy or exact transcript may be substituted for the original source as 
raw data. Raw data may include photographs, microfilm or microfiche 
copies, computer printouts, any original data captured electronically 
or by some other medium, dictated observations, and recorded data from 
automated instruments.
    Reference substance means any chemical substance or mixture, or 
analytical standard, or material other than a test substance, feed, or 
water, that is administered to or used in analyzing the test system in 
the course of a study for the purposes of establishing a basis for 
comparison with the test substance for known chemical or biological 
measurements.
    Specimens means any material or sample derived from a test system 
for examination or analysis.
    Sponsor means:
    (1) A person who initiates and supports, by provision of financial 
or other resources, a study;
    (2) A person who submits a study to the EPA: in support of an 
application for a research or marketing permit; or in response to a 
TSCA section 4 test rule and/or a person who submits a study under a 
TSCA section 4 testing consent agreement/order or a TSCA section 5 
consent order to the extent the agreement, rule or order references 
this part; or
    (3) A testing facility, if it both initiates and actually conducts 
the study.
    Study means any experiment at one or more test sites, in which a 
test substance is studied in a test system under laboratory conditions 
or in the environment to determine or help predict its effects, 
metabolism, product performance (pesticide efficacy studies only as 
required by 40 CFR 158.640) environmental and chemical fate, 
persistence, or residue, or other characteristics in humans, other 
living organisms, or media. The term ``study'' does not include basic 
exploratory studies carried out to determine whether a test substance 
or a test method has any potential utility.
    Study completion date means the date the final report is signed by 
the study director.
    Study director means the individual responsible for the overall 
conduct of a study.
    Study initiation date means the date the protocol is signed by the 
study director.
    Test substance means a substance or mixture administered or added 
to a test system in a study, which substance or mixture:
    (1) Is the subject of an application for a research or marketing 
permit supported by the study, or is the contemplated subject of such 
an application; or
    (2) Is an ingredient, impurity, degradation product, metabolite, or 
radioactive isotope of a substance described by paragraph (1) of this 
definition, or some other substance related to a substance described by 
that paragraph, which is used in the study to assist in characterizing 
the toxicity, metabolism, or other characteristics of a substance 
described by that paragraph; or
    (3) Is used to develop data to meet the requirements of a TSCA 
section 4 test rule and/or is developed under a TSCA section 4 testing 
consent agreement/order or TSCA section 5 consent order to the extent 
the agreement, rule, or order references this part.
    Test system means any animal, plant, microorganism, chemical or 
physical matrix, including but not limited to soil, water or air, or 
subparts thereof, to which the test, control, or reference substance is 
administered or added for study. ``Test system'' also includes 
appropriate groups or components of the system not treated with the 
test, control, or reference substance.
    Testing facility means a person who actually conducts a study, 
i.e., actually uses the test substance in a test system. Testing 
facility encompasses only those operational units that are being or 
have been used to conduct studies.
    TSCA means the Toxic Substances Control Act (15 U.S.C., 2601 et 
seq.)
    Vehicle means any agent which facilitates the mixture, dispersion, 
or solubilization of a test substance with a carrier (e.g., water, 
mineral oil, animal feed).


Sec. 806.10   Applicability to studies performed under grant and 
contracts.

     When a sponsor or other person utilizes the services of a 
consulting laboratory, contractor, or grantee to perform all or a part 
of a study to which this part applies, that sponsor or person shall 
notify the consulting laboratory, contractor, or grantee, in writing, 
that the service is, or is part of, a study that must be conducted in 
compliance with the provisions of this part, prior to initiation of the 
study.


Sec. 806.12   Statement of compliance or non-compliance.

     Any person who submits to EPA either an application for a research 
or marketing permit and who, in connection with the application, 
submits data from a study to which this part applies, or a test 
required by a test rule or testing consent agreement/order issued under 
section 4 or 5 of TSCA, shall include in the application or submission 
a true and correct statement, signed by the applicant, the sponsor, and 
the study director, of one of the following types:
     (a) A statement that the study was conducted in accordance with 
this part.
     (b) A statement describing in detail all differences between the 
practices used in the study and those required by this part.
     (c) A statement that the person was not a sponsor of the study, 
did not conduct the study, and does not know whether the study was 
conducted in accordance with this part.


Sec. 806.15   Inspection of a testing facility.

     (a) Testing facility management shall permit an authorized 
employee or duly designated representative of EPA or FDA, at reasonable 
times and in a reasonable manner, to inspect the facility and to 
inspect (and in the case of records also to copy) all records and 
specimens required to be maintained regarding studies to which this 
part applies. The records inspection and copying requirements shall not 
apply to quality assurance unit records of findings and problems, or to 
actions recommended and taken, except that EPA may seek production of 
these records in litigation or formal adjudicatory hearings.
     (b) EPA will not consider reliable for purposes of supporting an 
application for a research or marketing permit, or showing that a 
chemical substance or mixture does not present a risk of injury to 
health or the environment, any data developed by a testing facility or 
sponsor that refuses to permit inspection in accordance with this part. 
The determination that a study will not be considered in support of an 
application for a research or marketing permit or reliable for other 
purposes does not, however, relieve the applicant for such a permit or 
the sponsor of a required test of any obligation under any applicable 
statute or regulation to submit the results of the study to EPA.
    (c) Because a testing facility is a place where chemicals are 
stored or held, it is subject to inspection under section 11 of TSCA.


Sec. 806.17   Effects of non-compliance.

    (a)(1) EPA may refuse to consider reliable for purposes of 
supporting an application for a research or marketing permit any data 
from a study which was not conducted in accordance with this part.
    (2) Submission of a statement required by Sec. 806.12 which is 
false may form the basis for cancellation, suspension, or modification 
of the

[[Page 72980]]

research or marketing permit, or denial or disapproval of an 
application for such a permit, under FIFRA section 3, 4, 5, 6, 18, or 
24 or FFDCA section 408 or 409, or for criminal prosecution under 18 
U.S.C. 2 or 1001 or FIFRA section 14, or for imposition of civil 
penalties under FIFRA section 14.
    (b)(1) The sponsor or any other person who is conducting or has 
conducted a test to fulfill the requirements of a test rule or testing 
consent agreement/order issued under section 4 or 5 of TSCA will be in 
violation of section 15 of TSCA if:
    (i) The test is not being or was not conducted in accordance with 
any requirement of this part;
     (ii) Data or information submitted to EPA under this part include 
information or data that are false or misleading, contain significant 
omissions, or otherwise do not fulfill the requirements of this part; 
or
     (iii) Entry in accordance with Sec. 806.15 for the purpose of 
auditing test data or inspecting test facilities is denied. Persons who 
violate the provisions of this part may be subject to civil or criminal 
penalties under section 16 of TSCA, legal action in United States 
District Court under section 17 of TSCA, or criminal prosecution under 
18 U.S.C. 2 or 1001.
     (2) EPA, at its discretion, may not consider reliable for purposes 
of showing that a chemical substance or mixture does not present a risk 
of injury to health or the environment any study which was not 
conducted in accordance with this part. EPA, at its discretion, may 
rely upon such studies for purposes of showing adverse effects. The 
determination that a study will not be considered reliable does not, 
however, relieve the sponsor of a required test of the obligation under 
any applicable statute or regulation to submit the results of the study 
to EPA.
    (3) If data submitted to fulfill a requirement of a test rule or 
testing consent agreement/order issued under section 4 or 5 of TSCA are 
not developed in accordance with this part, EPA may determine that the 
sponsor has not fulfilled its obligations under section 4 or 5 of TSCA 
and may require the sponsor to develop data in accordance with the 
requirements of this part in order to satisfy such obligations.

Subpart B--Organization and Personnel


Sec. 806.29   Personnel.

    (a) Each individual engaged in the conduct of or responsible for 
the supervision of a study shall have the appropriate education, 
training, and experience, or a combination thereof, to enable that 
individual to perform the assigned functions.
    (b) Each testing facility shall maintain a current summary of 
training and experience and job description for each individual engaged 
in or supervising the conduct of a study.
    (c) There shall be a sufficient number of personnel for the timely 
and proper conduct of the study according to the protocol.
    (d) Personnel shall take necessary personal sanitation and health 
precautions designed to avoid contamination of test systems and test, 
control, and reference substances.
    (e) Personnel engaged in a study shall wear clothing appropriate 
for the duties they perform. Such clothing shall be changed as often as 
necessary to prevent microbiological, radiological, or chemical 
contamination of test systems and test, control, and reference 
substances.
    (f) Any individual found at any time to have an illness that may 
adversely affect the quality and integrity of the study shall be 
excluded from direct contact with test systems, test, control, and 
reference substances, and any other operation or function that may 
adversely affect the study until the health or medical condition is 
corrected. All personnel shall be instructed to report to their 
immediate supervisors any health or medical conditions that may 
reasonably be considered to have an adverse effect on a study.


Sec. 806.31   Testing facility management.

    For each study, testing facility management shall:
    (a) Designate a study director as described in Sec. 806.33 before 
the study is initiated.
    (b) Replace the study director promptly if it becomes necessary to 
do so during the conduct of a study.
    (c) Assure that there is a quality assurance unit as described in 
Sec. 806.35.
    (d) Assure that test, control, and reference substances or mixtures 
have been appropriately tested for identity, strength, purity, 
stability, and uniformity, as applicable.
    (e) Assure that personnel, resources, facilities, equipment, 
materials and methodologies are available as scheduled.
    (f) Assure that personnel clearly understand the functions they are 
to perform.
    (g) Assure that any deviations from these regulations reported by 
the quality assurance unit are communicated to the study director and 
corrective actions are taken and documented.


Sec. 806.33   Study director.

     For each study, a scientist or other professional of appropriate 
education, training, and experience, or combination thereof, shall be 
identified as the study director. The study director has overall 
responsibility for the technical conduct of the study, as well as for 
the interpretation, analysis, documentation, and reporting of results, 
and represents the single point of study control. The study director 
shall assure that:
    (a) The protocol, including any change, is approved as provided by 
Sec. 806.120 and is followed.
    (b) All experimental data, including observations of unanticipated 
responses of the test system are accurately recorded and verified.
    (c) Unforeseen circumstances that may affect the quality and 
integrity of the study are noted when they occur, and corrective action 
is taken and documented.
     (d) Test systems are as specified in the protocol.
    (e) All applicable GLPS regulations are followed.
    (f) All raw data, documentation, protocols, specimens, and final 
reports are transferred to the archives during or at the close or 
termination of the study.


Sec. 806.35   Quality assurance unit.

    (a) A testing facility shall have a quality assurance unit which 
shall be responsible for monitoring each study to assure management 
that the facilities, equipment, personnel, methods, practices, records, 
and controls are in conformance with the regulations in this part. For 
any given study, the quality assurance unit shall be entirely separate 
from and independent of the personnel engaged in the direction and 
conduct of that study. The quality assurance unit shall conduct 
inspections and maintain records appropriate to the study.
    (b) The quality assurance unit shall:
    (l) Maintain a copy of a master schedule sheet of all studies 
conducted at the testing facility indexed to permit expedient 
retrieval, which identifies the test substance, the test system, nature 
of study, date study was initiated, current status of each study, date 
of completion or termination if study is not ongoing, identity of the 
sponsor, and name of the study director.
    (2) Maintain copies of all protocols until study completion 
pertaining to all studies for which the unit is responsible.
    (3) Inspect each study at intervals adequate to ensure the 
integrity of the study and maintain written and properly signed records 
of each periodic inspection showing the date of the

[[Page 72981]]

inspection, the study inspected, the phase or segment of the study 
inspected, the person performing the inspection, findings and problems, 
action recommended and taken to resolve existing problems, and any 
scheduled date for reinspection. Any problems which are likely to 
affect study integrity found during the course of an inspection shall 
be brought to the attention of the study director and management 
immediately.
    (4) Periodically submit to management and the study director 
written status reports on each study, noting any problems and the 
corrective actions taken.
    (5) Determine that no deviations from approved protocols or 
standard operating procedures were made without proper authorization 
and documentation.
    (6) Review the final study report to assure that such report 
accurately describes the methods and standard operating procedures, and 
that the reported results accurately reflect the raw data of the study.
    (7) Prepare and sign a statement to be included with the final 
study report which shall specify the dates inspections were made and 
findings reported to management and to the study director.
    (c) The responsibilities and procedures applicable to the quality 
assurance unit, the records maintained by the quality assurance unit, 
and the method of indexing such records shall be in writing and shall 
be maintained. These items including inspection dates, the study 
inspected, the phase or segment of the study inspected, and the name of 
the individual performing the inspection shall be made available for 
inspection to authorized employees or duly designated representatives 
of EPA or FDA.
    (d) An authorized employee or a duly designated representative of 
EPA or FDA shall have access to the written procedures established for 
the inspection and may request testing facility management to certify 
that inspections are being implemented, performed, documented, and 
followed-up in accordance with this paragraph.

Subpart C--Facilities


Sec. 806.41   General.

    Each testing facility shall be of suitable size and construction to 
facilitate the proper conduct of studies. Testing facilities which are 
not located within an indoor controlled environment shall be of 
suitable location to facilitate the proper conduct of studies. Testing 
facilities shall be designed so that there is a degree of separation 
that will prevent any function or activity from having an adverse 
effect on the study.


Sec. 806.43   Test system care facilities.

    (a) A testing facility shall have a sufficient number of animal 
rooms or other test system areas, as needed, to ensure: proper 
separation of species or test systems, isolation of individual 
projects, quarantine or isolation of animals or other test systems, and 
routine or specialized housing of animals or other test systems.
    (1) In tests with plants or aquatic animals, proper separation of 
species can be accomplished within a room or area by housing them 
separately in different chambers or aquaria. Separation of species is 
unnecessary where the protocol specifies the simultaneous exposure of 
two or more species in the same chamber, aquarium, or housing unit.
    (2) Aquatic toxicity tests for individual projects shall be 
isolated to the extent necessary to prevent cross-contamination of 
different chemicals used in different tests.
    (b) A testing facility shall have a number of animal rooms or other 
test system areas separate from those described in paragraph (a) of 
this section to ensure isolation of studies being done with test 
systems or test, control, and reference substances known to be 
biohazardous, including volatile substances, aerosols, radioactive 
materials, and infectious agents.
    (c) Separate areas shall be provided, as appropriate, for the 
diagnosis, treatment, and control of laboratory test system diseases. 
These areas shall provide effective isolation for the housing of test 
systems either known or suspected of being diseased, or of being 
carriers of disease, from other test systems.
    (d) Facilities shall have proper provisions for collection and 
disposal of contaminated water, soil, or other spent materials. When 
animals are housed, facilities shall exist for the collection and 
disposal of all animal waste and refuse or for safe sanitary storage of 
waste before removal from the testing facility. Disposal facilities 
shall be so provided and operated as to minimize vermin infestation, 
odors, disease hazards, and environmental contamination.
    (e) Facilities shall have provisions to regulate environmental 
conditions (e.g., temperature, humidity, photoperiod) as specified in 
the protocol.
    (f) For marine test organisms, an adequate supply of clean sea 
water or artificial sea water (prepared from deionized or distilled 
water and sea salt mixture) shall be available. The ranges of 
composition shall be as specified in the protocol.
    (g) For freshwater organisms, an adequate supply of clean water of 
the appropriate hardness, pH, and temperature, and which is free of 
contaminants capable of interfering with the study, shall be available 
as specified in the protocol.
    (h) For plants, an adequate supply of soil of the appropriate 
composition, as specified in the protocol, shall be available as 
needed.


Sec. 806.45   Test system supply facilities.

    (a) There shall be storage areas, as needed, for feed, nutrients, 
soils, bedding, supplies, and equipment. Storage areas for feed 
nutrients, soils, and bedding shall be separated from areas where the 
test systems are located and shall be protected against infestation or 
contamination. Perishable supplies shall be preserved by appropriate 
means.
    (b) When appropriate, plant supply facilities shall be provided. As 
specified in the protocol, these include:
    (1) Facilities for holding, culturing, and maintaining algae and 
aquatic plants.
    (2) Facilities for plant growth, including, but not limited to, 
greenhouses, growth chambers, light banks, and fields.
    (c) When appropriate, facilities for aquatic animal tests shall be 
provided. These include, but are not limited to, aquaria, holding 
tanks, ponds, and ancillary equipment, as specified in the protocol.


Sec. 806.47   Facilities for handling test, control, and reference 
substances.

    (a) As necessary to prevent contamination or mixups, there shall be 
separate areas for:
    (1) Receipt and storage of the test, control, and reference 
substances.
    (2) Mixing of the test, control, and reference substances with a 
carrier, e.g., feed.
    (3) Storage of the test, control, and reference substance mixtures.
    (b) Storage areas for test, control, and/or reference substance and 
for test, control, and/or reference mixtures shall be separate from 
areas housing the test systems and shall be adequate to preserve the 
identity, strength, purity, and stability of the substances and 
mixtures.


Sec. 806.49   Laboratory operation areas.

    Separate laboratory space and other space shall be provided, as 
needed, for the performance of the routine and

[[Page 72982]]

specialized procedures required by studies.


Sec. 806.51   Specimen and data storage facilities.

    Space shall be provided for archives, limited to access by 
authorized personnel only, for the storage and retrieval of all raw 
data and specimens from completed or terminated studies.

Subpart D--Equipment


Sec. 806.61   Equipment design.

    Equipment used in the generation, measurement, or assessment of 
data and equipment used for facility environmental control shall be of 
appropriate design and adequate capacity to function according to the 
protocol and shall be suitably located for operation, inspection, 
cleaning, and maintenance.


Sec. 806.63   Maintenance and calibration of equipment.

    (a) Equipment shall be adequately inspected, cleaned, and 
maintained. Equipment used for the generation, measurement, or 
assessment of data shall be adequately tested, calibrated, and/or 
standardized.
    (b) The written standard operating procedures required under 
Sec. 806.81(b)(11) shall set forth in sufficient detail the methods, 
materials, and schedules to be used in the routine inspection, 
cleaning, maintenance, testing, calibration, and/or standardization of 
equipment, and shall specify, when appropriate, remedial action to be 
taken in the event of failure or malfunction of equipment. The written 
standard operating procedures shall designate the person(s) responsible 
for the performance of each operation.
    (c) Written records shall be maintained of all inspection, 
maintenance, testing, calibrating, and/or standardizing operations. 
These records, containing the date of the operations, shall describe 
whether the maintenance operations were routine and followed the 
written standard operating procedures. Written records shall be kept of 
nonroutine repairs performed on equipment as a result of failure and 
malfunction. Such records shall document the nature of the defect, how 
and when the defect was discovered, and any remedial action taken in 
response to the defect.
    (d) The integrity of data from computers, data processors, and 
automated laboratory procedures involved in the collection, generation, 
or measurement of data shall be ensured through appropriate validation 
processes, maintenance procedures, disaster recovery, and security 
measures.

Subpart E--Testing Facilities Operation


Sec. 806.81  Standard operating procedures.

    (a) A testing facility shall have standard operating procedures in 
writing setting forth study methods that management is satisfied are 
adequate to ensure the quality and integrity of the data generated in 
the course of a study. All deviations in a study from standard 
operating procedures shall be authorized by the study director and 
shall be documented in the raw data. Significant changes in established 
standard operating procedures shall be properly authorized in writing 
by management.
    (b) Standard operating procedures shall be established for, but not 
limited to, the following:
    (1) Test system area preparation.
    (2) Test system care.
    (3) Receipt, identification, storage, handling, mixing, and method 
of sampling of the test, control, and reference substances.
    (4) Test system observations.
    (5) Laboratory or other tests.
    (6) Handling of test systems found moribund or dead during study.
    (7) Necropsy of test systems or postmortem examination of test 
systems.
    (8) Collection and identification of specimens.
    (9) Histopathology.
    (10) Data handling, storage, and retrieval.
    (11) Maintenance and calibration of equipment.
    (12) Transfer, proper placement, and identification of test 
systems.
    (c) Each laboratory or other study area shall have immediately 
available manuals and standard operating procedures relative to the 
laboratory or field procedures being performed. Published literature 
may be used as a supplement to standard operating procedures.
    (d) A historical file of standard operating procedures, and all 
revisions thereof, including the dates of such revisions, shall be 
maintained.


Sec. 806.83   Reagents and solutions.

    All reagents and solutions in the laboratory areas shall be labeled 
to indicate identity, titer or concentration, storage requirements, and 
expiration date. Deteriorated or outdated reagents and solutions shall 
not be used. As an alternative to labeling wash bottles and transfer 
bottles with the expiration date, the testing facility may develop a 
well-documented performance standard to ensure that the reagents or 
solutions have not deteriorated or are outdated.


Sec. 806.90   Animal and other test system care.

    (a) There shall be standard operating procedures for the housing, 
feeding, handling, and care of animals and other test systems.
    (b) All newly received test systems from outside sources shall be 
isolated and their health status or appropriateness for the study shall 
be evaluated. This evaluation shall be in accordance with acceptable 
veterinary medical practice or scientific methods.
    (c) At the initiation of a study, test systems shall be free of any 
disease or condition that might interfere with the purpose or conduct 
of the study. If during the course of the study, the test systems 
contract such a disease or condition, the diseased test systems should 
be isolated, if necessary. These test systems may be treated for 
disease or signs of disease provided that such treatment does not 
interfere with the study. The diagnosis, authorization of treatment, 
description of treatment, and each date of treatment shall be 
documented and shall be retained.
    (d) Warm-blooded animals, adult reptiles, and adult terrestrial 
amphibians used in laboratory procedures that require manipulations and 
observations over an extended period of time or in studies that require 
these test systems to be removed from and returned to their test 
system-housing units for any reason (e.g., cage cleaning, treatment, 
etc.), shall receive appropriate identification (e.g., tattoo, color 
code, ear tag, ear punch, etc.). All information needed to specifically 
identify each test system within the test system-housing unit shall 
appear on the outside of that unit. Suckling mammals and juvenile birds 
are excluded from the requirement of individual identification unless 
otherwise specified in the protocol.
    (e) Except as specified in paragraph (e)(1) of this section, test 
systems of different species shall be housed in separate rooms when 
necessary. Test systems of the same species, but used in different 
studies, should not ordinarily be housed in the same room when 
inadvertent exposure to test, control, or reference substances or test 
system mixup could affect the outcome of either study. If such mixed 
housing is necessary, adequate differentiation by space and 
identification shall be made.
    (1) Plants, invertebrate animals, aquatic vertebrate animals, and 
organisms that may be used in multispecies tests need not be housed in

[[Page 72983]]

separate rooms, provided that they are adequately segregated to avoid 
mixup and cross contamination.
    (2) [Reserved]
    (f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, 
growth chambers, and other holding, rearing and breeding areas, and 
accessory equipment, shall be cleaned and sanitized at appropriate 
intervals.
    (g) Feed, soil, and water used for the test systems shall be 
analyzed periodically to ensure that contaminants known to be capable 
of interfering with the study and reasonably expected to be present in 
such feed, soil, or water are not present at levels above those 
specified in the protocol. Documentation of such analyses shall be 
maintained as raw data.
    (h) Bedding used in animal cages or pens shall not interfere with 
the purpose or conduct of the study and shall be changed as often as 
necessary to keep the animals dry and clean.
    (i) If any pest control or cleaning materials are used, the use 
shall be documented. Cleaning and pest control materials that interfere 
with the study shall not be used.
    (j) All plant and animal test systems shall be acclimatized to the 
environmental conditions of the test, prior to their use in a study.

Subpart F--Test, Control, and Reference Substances


Sec. 806.105   Test, control, and reference substance characterization.

    (a) The identity, strength, purity, and composition, or other 
characteristics which will appropriately define the test, control, or 
reference substance shall be determined for each batch and shall be 
documented before its use in a study. Methods of synthesis, 
fabrication, or derivation of the test, control, or reference substance 
shall be documented by the sponsor or the testing facility, and the 
location of such documentation shall be specified.
    (b) When relevant to the conduct of the study, the solubility of 
each test, control, or reference substance shall be determined by the 
testing facility or the sponsor before the experimental start date or 
concurrently according to written standard operating procedures, which 
provide for periodic analysis of each batch. The stability of the test, 
control, or reference substance shall be determined before the 
experimental start date or concurrently according to written standard 
operating procedures, which provide for periodic analysis of each 
batch.
    (c) Each storage container for a test, control, or reference 
substance shall be labeled by name, Chemical Abstracts Service (CAS) 
registry number or code number, batch number, expiration date, if any, 
and storage conditions necessary to maintain the identity, strength, 
purity, and composition of the test, control, or reference substance. 
Storage containers shall be assigned to a particular test substance for 
the duration of the study. With the study director's written approval, 
test substance storage containers need not be retained after use, 
provided that full documentation of the disposition of the containers 
is maintained as raw data for the study. This documentation shall 
include:
    (1)(i) Information of shipments pertaining to each container 
leaving the storage site (examples of such records are shipping request 
records, bills of lading, carrier bills, and monthly inventories of 
warehouse activity).
    (ii) Test substance receipt records at each testing facility.
    (iii) Complete use logs of material taken from containers.
    (iv) A record of the final destination of the container, including 
the place and date of disposal or reclaiming, and any appropriate 
receipts.
    (2) An inventory record of empty containers before disposal, 
including sufficient information to uniquely identify containers, 
maintained in an up-to-date manner recording all arrivals of empty 
containers and their disposal. This record shall be maintained as raw 
data for this study.
    (3) Locations of facilities; where test substance is stored; where 
empty containers are stored prior to disposal; where records of use, 
shipment, and disposal of containers are maintained; and where the test 
substance is used in studies (i.e., testing facility).
    (d) For studies of more than 4 weeks from the experimental start to 
completion dates, reserve samples from each batch of test, control, and 
reference substances shall be retained for the period of time provided 
by Sec.  806.195.
    (e) The stability of test, control, and reference substances under 
storage conditions at the test site shall be known for all studies.


Sec. 806.107   Test, control, and reference substance handling.

    Procedures shall be established for a system for the handling of 
the test, control, and reference substances to ensure that:
    (a) There is proper storage.
    (b) Distribution is made in a manner designed to preclude the 
possibility of contamination, deterioration, or damage.
    (c) Proper identification is maintained throughout the distribution 
process.
    (d) The receipt and distribution of each batch is documented. Such 
documentation shall include the date and quantity of each batch 
distributed or returned.


Sec. 806.113   Mixtures of substances with carriers.

    (a) For each test, control, or reference substance that is mixed 
with a carrier, tests by appropriate analytical methods shall be 
conducted:
    (1) To determine the uniformity of the mixture and to determine, 
periodically, the concentration of the test, control, or reference 
substance in the mixture.
    (2) When relevant to the conduct of the study, to determine the 
solubility of each test, control, or reference substance in the 
mixture; or if the solubility of the substance is difficult to 
determine, appropriate homogeneity data, by the testing facility or the 
sponsor before the experimental start date.
    (3) To determine the stability of the test, control, or reference 
substance in the mixture before the experimental start date or 
concomitantly according to written standard operating procedures, which 
provide for periodic analysis of each batch.
    (b) Tank mixes prepared for application to soil or plants by 
typical agricultural practices within a 12-hour period between 
preparation and application, and solutions prepared for immediate 
administration in mammalian acute toxicology studies, metabolism 
studies, or mutagenicity studies, are exempt from requirements for 
concentration determinations (but not from uniformity determinations) 
under paragraph (a)(1) of this section and are exempt from requirements 
for solubility determinations under paragraph (a)(2) of this section.
    (c) Where any of the components of the test, control, or reference 
substance carrier mixture has an expiration date, that date shall be 
clearly shown on the container. If more than one component has an 
expiration date, the earliest date shall be shown.
    (d) If a vehicle is used to facilitate the mixing of a test 
substance with a carrier, assurance shall be provided that the vehicle 
does not interfere with the integrity of the test.

Subpart G--Protocol for and Conduct of a Study


Sec. 806.120   Protocol.

    (a) Each study shall have an approved written protocol that clearly 
indicates the objectives and all methods for the conduct of the study. 
The protocol shall contain but shall not necessarily be limited to the 
following information:

[[Page 72984]]

    (1) A descriptive title and statement of the purpose of the study.
    (2) Identification of the test, control, and reference substance by 
name, Chemical Abstracts Service (CAS) registry number or code number. 
When a reference substance for a metabolite cannot be identified prior 
to the beginning of a study (only in the case of metabolism studies), 
it is not necessary to identify the substance in the protocol. However, 
a statement must be included that the identity of the reference 
substance will be determined during the course of the study and 
maintained as raw data.
    (3) The name and address of the sponsor and the name and address of 
the testing facility at which the study is being conducted.
    (4) The proposed experimental start and termination dates.
    (5) Justification for selection of the test system.
    (6) Where applicable, the number, body weight range, sex, source of 
supply, species, strain, substrain, and age of the test system.
    (7) The procedure for identification of the test system.
    (8) A description of the experimental design, including methods for 
the control of bias.
    (9) Where applicable, a description and/or identification of the 
diet used in the study as well as solvents, emulsifiers and/or other 
materials used to solubilize or suspend the test, control, or reference 
substances before mixing with the carrier. The description shall 
include specifications for acceptable levels of contaminants that are 
reasonably expected to be present in the dietary materials and are 
known to be capable of interfering with the purpose or conduct of the 
study if present at levels greater than established by the 
specifications.
    (10) The route of administration and the reason for its choice.
    (11) Each dosage level, expressed in milligrams per kilogram of 
body or test system weight or other appropriate units, of the test, 
control, or reference substance to be administered and the method and 
frequency of administration.
    (12) The type and frequency of tests, analyses, and measurements to 
be made.
    (13) The records to be maintained.
    (14) The date of approval of the protocol by the sponsor and the 
dated signature of the study director.
    (15) A statement of the statistical method to be used.
    (b) All changes in or revisions of an approved protocol and the 
reasons therefore shall be documented, signed by the study director, 
dated, and maintained with the protocol.
    (c) Discontinued studies or studies otherwise terminated before 
completion shall be finalized by writing a protocol amendment providing 
the reason(s) for termination. All documentation for terminated studies 
including the protocol, protocol amendment(s), and raw data, if 
collected, shall be retained as provided at Sec. 806.195.


Sec. 806.130   Conduct of a study.

    (a) The study shall be conducted in accordance with the protocol.
    (b) The test systems shall be monitored in conformity with the 
protocol.
    (c) Specimens shall be identified by test system, study, nature, 
and date of collection. This information shall be located on the 
specimen container or shall accompany the specimen in a manner that 
precludes error in the recording and storage of data.
    (d) In animal studies where histopathology is required, records of 
gross findings for a specimen from postmortem observations shall be 
available to a pathologist when examining that specimen 
histopathologically.
    (e) All data generated during the conduct of a study, except those 
that are generated by automated data collection systems, shall be 
recorded directly, promptly, and legibly in ink. All data entries shall 
be dated on the day of entry and signed or initialed by the person 
entering the data. Any change in entries shall be made so as not to 
obscure the original entry, shall indicate the reason for such change, 
and shall be dated and signed or identified at the time of the change. 
In automated data collection systems, the individual responsible for 
direct data input shall be identified at the time of data input. Any 
change in automated data entries shall be made so as not to obscure the 
original entry, shall indicate the reason for change, shall be dated, 
and the responsible individual shall be identified.


Sec. 806.135   Physical and chemical characterization studies.

    (a) All provisions of the GLPS shall apply to physical and chemical 
characterization studies designed to determine stability, solubility, 
octanol water partition coefficient, volatility, and persistence (such 
as biodegradation, photodegradation, and chemical degradation studies) 
of test, control, or reference substances.
    (b) The following GLPS shall not apply to studies, other than those 
designated in paragraph (a) of this section, designed to determine 
physical and chemical characteristics of a test, control, or reference 
substance: Secs. 806.31(c), (d), and (g), 806.35(b) and (c), 806.43, 
806.45, 806.47, 806.49, 806.81(b)(1), (2), (6) through (9), and (12), 
806.90, 806.105(a) through (d), 806.113, 806.120(a)(5) through (12), 
and (15), 806.185(a)(5) through (8), (10), (12), and (14), and 
806.195(c) and (d).

Subparts H and I--[Reserved]

Subpart J--Records and Reports


Sec. 806.185   Reporting of study results.

    (a) With the exception of discontinued or otherwise terminated 
studies, as provided at Sec. 806.120(c), a final report shall be 
prepared for each study and shall include, but not necessarily be 
limited to, the following:
    (1) Name and address of the facility performing the study and the 
dates on which the study was initiated and was completed.
    (2) Objectives and procedures stated in the approved protocol, 
including any changes in the original protocol.
    (3) Statistical methods employed for analyzing the data.
    (4) The test, control, and reference substances identified by name, 
Chemical Abstracts Service (CAS) registry number or code number, 
strength, purity, and composition, or other appropriate 
characteristics.
    (5) Stability and, when relevant to the conduct of the study, 
solubility of the test, control, and reference substances under the 
conditions of administration.
    (6) A description of the methods used.
    (7) A description of the test system used. Where applicable, the 
final report shall include the number of animals used, sex, body weight 
range, source of supply, species, strain and substrain, age, and 
procedure used for identification. For other test organisms (plants, 
bacteria), similarly detailed descriptions of the test system are 
required.
    (8) A description of the dosage, dosage regimen, route of 
administration, and duration.
    (9) A description of all circumstances that may have affected the 
quality or integrity of the data.
    (10) The name of the study director, the names of other scientists 
or professionals, and the names of all supervisory personnel, involved 
in the study.
    (11) A description of the transformations, calculations, or 
operations performed on the data, a summary and analysis of the data, 
and a statement of the conclusions drawn from the analysis.

[[Page 72985]]

    (12) The signed and dated reports of each of the individual 
scientists or other professionals involved in the study, including each 
person who, at the request or direction of the testing facility or 
sponsor, conducted an analysis or evaluation of data or specimens from 
the study after data generation was completed.
    (13) The locations where all specimens, raw data, and the final 
report are to be stored.
    (14) The statement prepared and signed by the quality assurance 
unit as described in Sec. 806.35(b)(7).
    (b) The final report shall be signed and dated by the study 
director.
    (c) Corrections or additions to a final report shall be in the form 
of an amendment by the study director. The amendment shall clearly 
identify that part of the final report that is being added to or 
corrected and the reasons for the correction or addition, and shall be 
signed and dated by the person responsible. Modification of a final 
report to comply with the submission requirements of EPA does not 
constitute a correction, addition, or amendment to a final report.
    (d) A copy of the final report and of any amendment to it shall be 
maintained by the sponsor and the test facility.


Sec. 806.190   Storage and retrieval of records and data.

    (a) All raw data, documentation, records, protocols, specimens, and 
final reports generated as a result of a study shall be retained. 
Specimens obtained from mutagenicity tests, specimens of soil, water, 
and plants, and wet specimens of blood, urine, feces, and biological 
fluids, do not need to be retained after quality assurance 
verification. Correspondence and other documents relating to 
interpretation and evaluation of data, other than those documents 
contained in the final report, also shall be retained.
    (b) There shall be archives for orderly storage and expedient 
retrieval of all raw data, documentation, protocols, specimens, and 
interim and final reports. Conditions of storage shall minimize 
deterioration of the documents or specimens in accordance with the 
requirements for the time period of their retention and the nature of 
the documents of specimens. A testing facility may contract with 
commercial archives to provide a repository for all material to be 
retained. Raw data and specimens may be retained elsewhere provided 
that the archives have specific reference to those other locations.
    (c) An individual shall be identified as responsible for the 
archives.
    (d) Only authorized personnel shall enter the archives.
    (e) Material retained or referred to in the archives shall be 
indexed to permit expedient retrieval.


Sec. 806.195   Retention of records.

    (a) Record retention requirements set forth in this section do not 
supersede the record retention requirements of any other regulations in 
this subchapter.
    (b) Except as provided in paragraph (c) of this section, 
documentation records, raw data, and specimens pertaining to a study 
and required to be retained by this part shall be retained in the 
archive(s) for:
    (1) In the case of applicability under Sec. 806.1(a), whichever of 
the following periods is longest:
    (i) In the case of any study used to support an application for a 
research or marketing permit approved by EPA, the period during which 
the sponsor or any successor(s) hold(s) any research or marketing 
permit to which the study is pertinent.
    (ii) A period of at least 5 years following the date on which the 
results of the study are submitted to EPA in support of an application 
for a research or marketing permit.
    (iii) In other situations (e.g., where the study does not result in 
the submission of the study in support of an application for a research 
or marketing permit), a period of at least 2 years following the date 
on which the study is completed, terminated, or discontinued.
    (2) In the case of applicability under Sec.  806.1(b):
    (i) In the case of a study required to be conducted under TSCA 
section 4 or section 5, except for those items listed in paragraph (c) 
of this section, all documentation, records, raw data, and specimens 
pertaining to that study and required to be retained by this part shall 
be retained in the archive(s) for a period of at least 5 years 
following the date on which the final report of that required study is 
submitted to EPA.
    (ii) [Reserved]
    (c) Wet specimens, samples of test, control, or reference 
substances, and specially prepared material which are relatively 
fragile and differ markedly in stability and quality during storage, 
shall be retained only as long as the quality of the preparation 
affords evaluation. Specimens obtained from mutagenicity tests, 
specimens of soil, water, and plants, and wet specimens of blood, 
urine, feces, and biological fluids, do not need to be retained after 
quality assurance verification. In no case shall retention be required 
for longer periods than those set forth in paragraph (b) of this 
section.
    (d) The master schedule sheet, copies of protocols, and records of 
quality assurance inspections, as required by Sec. 806.35(c) shall be 
maintained by the quality assurance unit as an easily accessible system 
of records for the period of time specified in paragraph (b) of this 
section.
    (e) Summaries of training and experience and job descriptions 
required to be maintained by Sec. 806.29(b) may be retained along with 
all other testing facility employment records for the length of time 
specified in paragraph (b) of this section.
    (f) Records and reports of the maintenance and calibration and 
inspection of equipment, as required by Sec. 806.63(b) and (c), shall 
be retained for the length of time specified in paragraph (b) of this 
section.
    (g) If a facility conducting testing or an archive contracting 
facility goes out of business, all raw data, documentation, and other 
material specified in this section shall be transferred to the archives 
of the sponsor of the study. EPA shall be notified in writing of such a 
transfer.
    (h) Specimens, samples, or other non-documentary materials need not 
be retained after EPA has notified in writing the sponsor or testing 
facility holding the materials that retention is no longer required by 
EPA. Such notification normally will be furnished upon request after 
EPA or FDA has completed an audit of the particular study to which the 
materials relate and EPA has concluded that the study was conducted in 
accordance with this part.
    (i) Records required by this part may be retained either as 
original records or as true copies such as photocopies, microfilm, 
microfiche, or other accurate reproductions of the original records.

[FR Doc. 99-33831 Filed 12-28-99; 8:45 am]
BILLING CODE 6560-50-F