Document ID: EPA-HQ-OPP-2007-0923-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-16T05:00Z

SUPPORTING STATEMENT FOR AN 

INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a).	Title of the Information Collection  

Pesticide Data Call-In Program Data Call-Ins for the Special Review and
Registration Review Programs; and Data Generation for Pesticide
Reregistration; and Data Acquisition for Anticipated Residue and Percent
of Crop Treated. 

OMB Nos.:  2070-new 0057; 2070-0107; and 2070-0164

 		

EPA Nos.:  2288.010922.07; 1504.05; and 1911.02

1(b).	Short Characterization/Abstract 

This is a proposal to consolidate and renew several currently approved
information collection requests (ICR).  The Environmental Protection
Agency’s (EPA), Office of Pesticide Programs (OPP) is proposing
consolidation into one document the ICRs for Data Call-Ins for the
Special Review and Registration Review Programs OMB Control No.:
2070-0057; EPA ICR No. 0922.07; the Data Generation for Pesticide
Reregistration OMB #.:2070-0107 EPA #.:1504.05 and the Data Acquisition
for Anticipated Residue and Percent of Crop Treated OMB No.:2070-0164;
EPA No.: 1911.02 ICRs.  These ICRs are currently due to expire on the
same day, June 30, 2008. 

Collectively, these ICRs enable the EPA to acquire the necessary data to
assess whether the continued registration of an existing pesticide
causes an unreasonable adverse effect on human health or the
environment.  For the four programs represented by these collections,
the Agency issues a Data Call-in (DCI) to collect the required
information to support the statutorily mandated pesticide reviews. These
ICRs are being consolidated because the programs they represent share
similar respondent populations, and the methodology the Agency uses to
calculate the Paperwork Reduction Act (PRA) burden hours and costs are
the same. The Agency is consolidating the ICRs into one document to
increase the clarity of review for the public, to streamline Agency
review and to meet the terms of clearance for renewal as required by
OMB.  The proposed consolidated ICR document will be titled the
“Pesticide Data Call-in Program ICR.”  

2.	NEED FOR AND USE OF THE COLLECTION

2(a).  Need/Authority for the Collection

EPA's Office of Pesticide Programs (OPP), under the Assistant
Administrator for Prevention, Pesticides and Toxic Substances, uses the
information collected under this ICR to obtain the data needed by OPP
scientists to assess and characterize pesticide risks, and to determine
whether the pesticide continues to meet the standards established by
law.  Before the Agency determines that specific data are needed, the
Agency will first search for available information (i.e., EPA databases
for information that may have been submitted to EPA under another ICR,
voluntarily, or submitted by another respondent; information that has
otherwise published in the literature; or information that is otherwise
publicly available).  Only if the needed data is not found will EPA
require the submission or generation of the specific data needed.  Such
data may include toxicology studies, fish and wildlife studies,
environmental fate studies, chemistry studies and/or other data needed
to analyze the potential risks and benefits associated with pesticide
chemicals.

Sections §3(a) and §12(a)(1) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) require a person to register a pesticide product
with the EPA before the pesticide product may be lawfully sold or
distributed in the United States.  A pesticide registration is a license
that allows a pesticide product to be sold and distributed for specific
uses under specified terms and conditions such as use instructions and
precautions.  The proponent of initial or continued registration always
bears the burden of demonstrating that a pesticide product meets the
statutory standard for registration.  A pesticide product may be
registered or remain registered only if it meets the statutory standard
for registration given in section §3(c) (5) of FIFRA, which is as
follows:

Its composition is such as to warrant the proposed claims for it.

Its labeling and other material required to be submitted comply with the
	requirements of this Act.

It will perform its intended function without unreasonable adverse
effects on the 	environment.

When used in accordance with widespread and commonly recognized practice
it 	will not generally cause unreasonable adverse effects on the
environment.

FIFRA §2(bb) defines “unreasonable adverse effects on the
environment'' as (1) “any unreasonable risk to man or the environment,
taking into account the economic, social, and environmental costs and
benefits of the use of any pesticide, or (2) a human dietary risk from
residues that result from a use of a pesticide in or on any food
inconsistent with the standard under section 408 of the Federal Food
Drug and Cosmetic Act.''

	The programs and DCI activities represented in this proposed renewal
and consolidation share a common statutory authority, Section 3(c) (2)
(B) of FIFRA, which authorizes EPA to require pesticide registrants to
generate and submit data to the Agency, when such data are needed to
maintain an existing registration of a pesticide. EPA’s determination
that additional data are needed can occur for various reasons, with the
following four reasons being the most common:  

The Re-registration Program: Section 4 of FIFRA requires EPA to
re-assess the health and safety data for all pesticide active
ingredients registered before November 1, 1984, to determine whether
these “older” pesticides meet the criteria for registration that
would be expected of a pesticide being registered today for the first
time. Section 4 directs EPA to use Section 3(c) (2) (B) authority to
obtain the required data. While, Reregistration Eligibility Decisions
are expected to be completed by 2006 for food-use pesticide ingredients
and 2008 for non-food use pesticide ingredients, the Agency may still
need to issue DCIs after FY 2008 to close out the program. (Attachment
A) 

   

The Registration Review Program: Section 3(g) of FIFRA contains
provisions to help achieve the goal of reviewing each pesticide every 15
years to assure that the pesticide continues to pose no risk of
unreasonable adverse effects on human health or the environment. 
Section 3(g) instructs EPA to use the section 3(c)(2)(B) authority to
obtain the required data. (Attachments B and C)   

The Special Review Program: Though rare, EPA may conduct a Special
Review (initiated under section 6 (b) of FIFRA) if EPA believes that a
pesticide poses risks of unreasonable adverse effects on human health or
the environment.  Section 3(c) (2) (B) of FIFRA provides a means of
obtaining any needed data. (Attachment CB)   

Anticipated Residue/Percent Crop Treated Information: Under section 408
of the Federal Food, Drug and Cosmetic Act (FFDCA), before a pesticide
may be used on food or feed crops, the Agency must establish a tolerance
for the pesticide residues on that crop or established an exemption from
the requirement to have a tolerance.  Section 408(b)(2)(E) and (F) of
FFDCA authorize the use of anticipated or actual residue (ARs) data and
percent crop treated (PCT) data to establish, modify, maintain, or
revoke a tolerance for a pesticide. (Attachment D)  The FFDCA requires
that if AR data are used, data must be reviewed five years after a
tolerance is initially established.  If PCT data are used, the FFDCA
affords EPA the discretion to obtain additional data if any or all of
several conditions, including but not limited to the following, are met:

the existing data have been found unreliable; 

exposure estimates underestimate exposures for any significant
population group; and 

dietary exposure must be re-evaluated periodically.

Enforcement and Unanticipated Incidents:  In extremely rare instances, a
need for a data call-in may arise from changes in the discovery of
deficiencies in previously submitted data, or from the discovery of
specific attributes of the pesticide or its ingredients.  This may give
rise to concerns such as observed or suspected adverse human health or
environmental effects attributed to the use of a pesticide.  Or such
data is needed in support of Agency enforcement cases resulting from
consumer complaints about the product, its storage stability, the
integrity of its container, or exaggerated advertising claims.  This
type of DCI is needed because the concern and therefore the need for
data arise not from a mandated review program like the programs
described above, but from unanticipated circumstances.  Section 3(c) (2)
(B) of FIFRA provides a means of obtaining any needed data.  

	In order to conduct the required re-evaluation, a Pesticide Registrant
may be required to submit specific data necessary to demonstrate that
residues do not exceed the residue levels used to establish the
tolerance. Under the authority of section 3(c) (2) (B) of FIFRA, the
Agency will issue a DCI to obtain any additional data. (Attachment D)   

2(b).  Practical Utility/Users of the Data   

EPA uses the information collected to carry out its statutory
responsibilities under sections section 4 of FIFRA,  section 3(g) of
FIFRA, section 6 (b) of FIFRA, and section 408 of FFDCA.  The data
collected allows EPA to assess whether the continued registration of an
existing pesticide causes an unreasonable adverse effect on human health
or the environment.  

The Agency issues DCIs as part of one or more statutorily mandated
review processes and has determined that more information is needed. 
Agency decisions requiring additional data are usually “triggered”
by the data requirements set forth in 40 CFR parts 150 through 180, with
the majority of the data requirements regarding studies captured in 40
CFR part 158.  

The Agency uses data requirements to ensure that the statutory standards
are met.  Some of these standards include, but are not limited to,
determining if a pesticide can remain registered because it does not
causes an unreasonable adverse effect on human health or the
environment, section §3(c) (5) and section 2(bb) of FIFRA, the safety
standard of section 408 of FFDCA, as amended, by the Food Quality
Protection Act of 1996 (FQPA) (see attachment E).  FQPA directs the
Agency to consider aggregate exposures from dietary and other
non-occupational sources when assessing the risks of a pesticide.  In
addition to dietary exposure, such sources as drinking water and
residential use must be considered.  Thus, EPA must make the statutory
determination that pesticide residues in food or feed will result in a
reasonable certainty of no harm to human health from aggregate exposure
through dietary, non-occupational, and drinking water routes of
exposure.  FQPA also directs EPA to consider the cumulative effects of
pesticides that share a “common mechanism of toxicity,” consider
special sensitivities of infants and children, and consider possible
endocrine disruptor effects.  EPA must also evaluate the data obtained
from registrants to ensure that residues in or on food are not above the
residue levels relied on for establishing the tolerance.  If the
submitted residue data demonstrates that the residue levels are above
the levels relied on for establishing the tolerance, EPA will take
appropriate action to modify or revoke the tolerance.

2(b)(1) Types of DCIs:  

 The data that EPA collects and reviews fall into three general
categories:  confirmatory data, voluntary data, and product-specific
data. 

Confirmatory Data.  In making a regulatory decision, additional generic
studies sometimes are required to confirm the Agency’s risk
assessments, findings, or conclusions about a pesticide, and to help
determine whether further use modifications will be necessary to reduce
risks of concern.  

Voluntary Data.  While EPA has always received voluntarily submitted
data, the advent of FQPA enactment on August 3, 1996, required EPA to
specifically consider a number of new factors when making pesticide
reregistration and other types of regulatory decisions.  On January 31,
1997, EPA issued Pesticide Registration (PR) Notice 97-1 identifying
areas in which the Agency may need additional data to fully assess risks
under FQPA.  The notice encouraged registrants to supplement their
original reregistration submissions with additional information that may
permit more accurate estimates of exposure and/or risk.  As a result of
PR Notice 97-1, EPA received large numbers of voluntarily submitted
studies for pesticides in reregistration, particularly for large volume,
controversial chemicals.  While the reregistration program is near
completion, the Agency still anticipates receiving a small number of
voluntarily submitted studies from registrants to fulfill other
statutory requirements.  

	Product-Specific Data.  After the existing data supporting a pesticide
are evaluated and a regulatory determination is made, EPA’s focus
turns to the information and data required to make regulatory decisions
at the product-specific level.  For every end-use product (that is,
every product that contains an active ingredient), certain data specific
to the product as formulated and sold (including acute toxicity and
product chemistry studies), revised labeling, and in certain instances,
the Agency requires the submission of a Confidential Statement of
Formula.  Additional Formula.  For example: Registrants are required to
submit a Confidential Statement of Formula (EPA Form 8570-4) to comply
with registration-related requirements under FIFRA section 3, such as
when a registrant seeks to add uses for a currently-registered
pesticide, or when the registrant changes a registered pesticide’s
formulation.  The requirement is mentioned here since registrants have
not always submitted the required information immediately to EPA and the
deficiency may remain at the time of the regulatory review.  The
paperwork burden for the submission of Form 8570-4 is covered under OMB
Control No. 2070-0060 (Application for New/Amended Pesticide
Registration; EPA ICR. No. 0277.  

. Additional information and data are essential to making the final
regulatory decision regarding the particulars of a specific product.   

 NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a).  Non duplication

The information collected under these programs areis specific to the
needs of the federal pesticide law negating the need for similar data by
other federal agencies or any other office within EPA.  Prior to
requesting any information the Agency must review existing records for
the availability of the information that it is considering requesting. 
The Agency maintains files on all pesticide chemicals, which includes
all correspondence and information/data submitted. Before any DCI is
issued, these files are referenced to determine whether the necessary
data are already on hand, thereby eliminating duplicative data requests.
 For example: At this time, a majority of the percent-crop-treated
information can be obtained internally, thus DCIs will only be issued
when more data is necessary.  The data for anticipated residues, on the
other hand, is unique to the requirements of FIFRA, and, therefore, must
be submitted to the Agency.   EPA also provides for public comment
periods for all the review programs which may modify the DCI
requirements if warranted by information provided by registrants or the
public.  

 

OPP publishes a list of data submitters and encourages the registrants
to act cooperatively in the development of data or in its use.  OPP
encourages cost-sharing agreements among manufacturers of specific
pesticide chemicals in order to minimize the duplication of laboratory
tests and reduce the costs for developing the data. All DCI notices
explain the statutory provisions for cost-sharing agreements under
FIFRA.

3(b). Public Notice Required Prior to ICR Submission to OMB

Pursuant to 5 CFR 1320.8(d), EPA is publishing a Federal Register (FR)
notice soliciting comment on this information collection activity and
the Agency’s intent to renew, consolidate and request OMB approval of
this ICR.  The FR notice and the proposed renewal ICR as well as any
public comment are located in the docket for this action, which can be
accessed at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov  using the docket identifier
EPA-HQ-OPP-2007-0923 

3(c).  Consultations

Consultation and/or dialogue between registrants and the Agency
concerning data requirements, need for particular information and the
protocol to be used to conduct the study are frequent and ongoing.    

	Generally, all programs discussed in this DCI Program ICR are
intrinsically woven with the Agency's public participation review
process. This integrated public participation framework provides
consistent, predictable opportunities for public and stakeholder
involvement through public comment periods at regular intervals to help
inform EPA’s regulatory decision making.  EPA’s formalized public
participation process recs roecognizes process (See 69 FR 26819, May 14,
2004; also   HYPERLINK "http://www.epa.gov/oppsrrd1/public.htm" 
http://www.epa.gov/oppsrrd1/public.htm ) recognizes that all pesticides
do not present the same degree of risk or complexity of issues, the
Agency has included options for conducting a full six-phase process, a
modified four-phase process, or a streamlined low-risk process, as
appropriate. These options give EPA the flexibility to tailor its public
participation process to the uses and risks of each pesticide and to
obtain public input as needed while still making timely decisions and
meeting statutory deadlines and program goals.  If appropriate to
resolve scientific questions, the Agency may also seek peer review
and/or advice from the FIFRA Science Advisory Panel SAP).

	U Panel SAP.  The FIFRA SAP is a Federal advisory committee established
in 1975 under FIFRA that operates in accordance with requirements of the
Federal Advisory Committee Act. The FIFRA SAP is composed of a permanent
panel consisting of seven members who are appointed by the EPA
Administrator from nominees provided by the National Institutes of
Health and the National Science Foundation.  FIFRA, as amended by the
FQPA of 1996, established a Science Review Board consisting of at least
60 scientists who are available to the FIFRA SAP on an ad hoc basis to
assist in reviews conducted by the Panel.

	Until the DCI is issued, the registrant is not required to submit the
data.  Many manufacturers wait to generate and/or submit new or existing
data until EPA issues the DCI primarily because EPA’s issuance of a
DCI also triggers the data compensation provisions of section 3(g) (1)
(B) of FIFRA and the DCI provides tangible documentation of data
compensation rights.

EPA will consult with a variety of registrants regarding the information
collection activities in this ICR during the renewal process. 
Discussions with respondents will include whether the labor rate
estimates in the ICR are accurate and whether the estimates of burden
and methodology for arriving at the estimate are correct, and whether
respondents would consider submitting the information electronically,
such as through web forms. Any public comment received will be located
in the docket for this action, which can be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007-0923 

3(d).	Effects of Less Frequent Collection 

    

Information is collected under this ICR only when the Agency has
identified a need for the specific data, and only on a one-time basis. 
AR or PCT information is collected one time within the five years
preceding the reliance on such data.  The AR or PCT information
collection is required by sections 408(b)(2)(E)(I) and 408(b)(2)(F) of
the FFDCA and cannot be collected less frequently.

3(e).	General Guidelines

The only guideline established under the Paperwork Reduction Act (PRA)
that is exceeded in this collection is the time period for retaining
records.  Pursuant to FIFRA §8, EPA recordkeeping requirements in 40
CFR 169.2(k) state that records containing research data relating to
registered pesticides be retained as long as the registration is valid
and the producer remains in business.  Registrations are valid until
they are either voluntarily canceled or withdrawn by the registrant or
until EPA has cause to suspend or cancel the registration.  Since the
average period of marketability of a pesticide ranges from 15 to 30
years, the PRA guidelines specifying that data other than health,
medical or tax records not be required to be retained for more than
three years will be exceeded in this collection activity.

	3(e)(1). Forms

The forms associated with this ICR may also be used for other
information collection activities that are approved under separate OMB
Control numbers, e.g., and 2070-0060.  Specifically:

Confidential Statement of Formula, (EPA Form 8570-4)

Formulator's Exemption Statement, (EPA Form 8570-27)

 

Certification of Compliance with Data Gap Procedures, (EPA Form 8570-28)
  

Certification of Attempt to Enter into an Agreement with Registrants for
Development of Data (EPA Form 8570-32) 

Certification with Respect to Citation of Data (in Pesticide
Registration (PR) Notice 98-5) (EPA Form 8570-34) 

Data Matrix (also in PR Notice 98-5) (EPA Form 8570-35)

Summary of the Physical/Chemical Properties (EPA Form 8570-36) 

Self-Certification Statement for the Physical/Chemical Properties (EPA
Form 86570-37) 

The Data Call-In Response Form and the Requirements Status and
Registrant’s Response Form have been approved with the DCI related
ICRs by OMB for several years, although no official EPA Form number had
been assigned in the past.  These two forms are automatically generated
by EPA’s computer databases and are pre-populated with information
that is specific to each individual registrant that receives a Data
Call-In notice for a given pesticide.  These forms are not widely
accessible to general public.  Instead, EPA will continue to generate
the pre-populated, registrant-specific forms through the Agency’s
computer system when preparing to issue Data Call-In notices. 

In the past, under the separate renewals for these ICRs and in
accordance with 5 CFR 1320.5(a)(1)(iii)(C), EPA discontinued the display
of expiration dates on these forms  because the forms had not changed
after many years of use and were not expected to change in the future. 
The OMB approved prior ICR requests, and EPA will continue to omit the
expiration dates on these forms.  See Attachment F for accessibility to
forms.  

Copies of all forms are located in Attachment X ) 

	3(e)(2). DCI Justification Process

When OMB last approved these ICRs in 2005, OMB mandated in the terms of
clearance that EPA only issue DCIs that have prior approval by OMB. 
Thus, in a separate DCI approval request, EPA must provide OMB with
detailed information regarding the specifics about the DCI including,
all of the studies to be required for a particular chemical, need for
the data, total study costs, number of respondents impacted, PRA burden
hour and cost estimates, and impacts on small business.

3(f).	Confidentiality

Except as provided in FIFRA section 10(d)(1)(A), (B) or (C), health and
safety data submitted by registrants under FIFRA must be made available
by the Agency upon request from anyone not affiliated with a
multi-national pesticide firm. These exceptions, however, specifically
prohibit disclosure of the inert ingredients in a pesticide or of its
manufacturing, quality control processes, sales and production data, or
trade secrets. 

Registrants may claim at the time of submission that specific data are
subject to treatment as confidential for reasons other than falling
within the exclusions for mandatory release. All data subject to such
claims, or falling within FIFRA section 10(d)(1)(A), (B), or (C) are
handled strictly in accordance with the provisions of the FIFRA
Confidential Business Information Security Manual. The manual requires
that all CBI must be marked or flagged as such, all CBI must be kept in
secure (double-locked) areas, and all CBI intended to be destroyed must
be cleared by a Document Control Officer and shredded.

3(g).	Sensitive questions

No information of a sensitive or private nature is requested in
conjunction with this information collection activity, and this
information collection activity complies with the provisions of the
Privacy Act of 1974 and OMB Circular A-108.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a).  Respondents/NAICS Codes

Respondents to the information collection activities related to this ICR
consist of pesticide Registrants identified by the North American
Industrial Classification System (NAICS) code 325320 (Pesticide and
Other Agricultural Chemical Manufacturing). 

4(b).  Information Requested

      (i)  Data Items, Including Record Keeping Requirements

Considering the potential variation in the specific need identified for
the individual pesticide under review, the specific data items that may
be collected for the individual pesticides under this ICR are also
likely to vary from pesticide to pesticide.  However, based on the
specific need identified for the pesticide, the Agency may request, or
the registrant may voluntarily submit several types of data, including,
but not limited to: 

Product Chemistry

Residue Chemistry

Environmental Fate

Toxicology

Reentry Protection

Spray Drift

Wildlife and Aquatic Organisms

Plant Protection

Nontarget Insect

Product Performance

		Biochemical Pesticides

Microbial Pesticides

	Exposure Studies

	Dermal Absorption/Penetration Studies

	Acute and Subchronic Neurotoxicity Studies

	Cholinesterase Determination

	Biomonitoring Studies (in Children)

	Monte Carlo Probabilistic Assessments/Acute and Chronic Dietary
Exposure 			Analyses

	Historical Water Monitoring Data 

	Field Monitoring Studies and Evaluations

	Runoff and Drift Monitoring Studies

	Pesticide Removal Studies using Vegetative Filter Strips

	Retrospective Analyses of Surface Water Contamination

	Analyses of Use Patterns

	Research Studies of Applications and Use in Professional Markets

	Comparative Formulations/Application Methods/Resulting Crop Residue
Studies

	Mechanistic Studies for Carcinogenicity 

	Studies on Potential to React with DNA

	Monitoring data (States, special monitoring , market basket, single
serving, etc.)

	Field trials, 

	Processing studies,  

	Reduction in residue data (washing, peeling, cooking, etc.), 

	Livestock feeding studies  

	Metabolism studies

	Percent crop treated data

These categories, which are defined in greater detail in 40 CFR Part
158, basically consist of the criteria for information and/or data that
are necessary to make a regulatory finding. In finding.   (See
guidelines and policies to assist registrants with responding to DCIs;
see science policy at   HYPERLINK
"http://www.epa.gov/pesticides/science/policies.htm" 
http://www.epa.gov/pesticides/science/policies.htm  and test guidelines
at   HYPERLINK "http://www.epa.gov/opptsfrs/home/guidelin.htm" 
http://www.epa.gov/opptsfrs/home/guidelin.htm .)   In addition to the
categories identified above, the Agency may also require that a special
study be conducted to provide critical information about the risks and
benefits of the pesticide in support of continued registration.  Agency
requests for special studies would be based on the particular
characteristics of the chemical, and the Agency’s need for such
information to make the required statutory finding. 

(ii) Respondent Activities

A pesticide registrant who receives a DCI will generally engage in the
following activities under this ICR. 

read instructions	

read the DCI letter to understand what data are to be submitted

plan activities	

plan the activities necessary to comply with the DCI, or develop options
to avoid having to submit data (e.g., exemption/waiver), submit 90-day
response to EPA 

create information	

conduct research, administer tests, analyze data to develop studies,
perform laboratory analysis, write study documents 

gather information	

search for existing data that will satisfy the DCI

compile and review	

assemble and evaluate data for accuracy and appropriateness for
compliance with the DCI

complete paperwork	

prepare necessary correspondence, documents and packages for submitting
data to EPA

maintain and file	

maintain the data and other information submitted to the Agency 

Registrants who receive a DCI notice from EPA must notify the Agency how
they intend to comply with the terms of the DCI notice within 90 days of
receipt of the notice.  Registrant options for complying with the DCI
notice vary greatly and thus the per respondent burden can also vary
greatly.  A summary of the registrant compliance options are listed
below:

	(iii) Reducing the PRA Burden: Variation of Response to A DCI

 

Voluntary Cancellation - Registrants opting to voluntarily cancel their
products containing the active ingredient that is subject to the DCI
must submit a completed Data Call-In Response Form.  If a product is
voluntarily cancelled, further sale and distribution of that product
after the effective date of cancellation must be in accordance with the
existing stocks provision of the individual DCI notice.

Deletion of Uses - Registrants choosing to amend their registration to
delete the uses of their product to which the requirements apply must
submit the Requirements Status and Registrant's Response Form, a
completed application for amendment, a copy of their proposed amended
labeling, and all other information required for processing the
application.  They must also complete a Data Call-In Response Form.  If
registrants choose to delete the use(s) subject to the DCI notice or
uses subject to specific data requirements, further sale, distribution,
or use of their product after one year from the due date of their 90-day
response must bear an amended label.

Generic Data Exemption - Registrants are entitled to apply for a generic
data exemption from the requirement to submit or cite generic data
concerning an active ingredient if the active ingredient in the product
is derived exclusively from purchased, registered pesticide products
containing the active ingredient.  To qualify for a generic data
exemption, a product must meet all of the following requirements:

a. The active ingredient(s) in the registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and be purchased from a source
not connected with the registrant; and,

b. Every registrant who is the ultimate source of the active
ingredient(s) in the product subject to the DCI notice must be in
compliance with the requirements of the notice and must remain in
compliance; and

c. The registrant of the product that is the subject of the DCI notice
must have provided to EPA an accurate and current "Confidential
Statement of Formula" for each of the products to which the Notice
applies.  

Registrants applying for the Generic Data Exemption complete and submit
a Data Call-In Response Form along with all supporting documentation. If
a generic data exemption is claimed, the registrant is not required to
complete the Requirements Status and Registrant's Response Form. Generic
data exemption cannot be selected as an option for product specific
data.

	Registrants who are granted a Generic Data Exemption rely on the
efforts of other persons to provide the Agency with the required data. 
If the registrant(s) who have committed to generate and submit the
required data fail to take appropriate steps to meet the requirements,
the Agency will consider that both the submitting and exempted
registrants are not in compliance and will normally initiate proceedings
to suspend the registrations of both registrants’ products unless the
registrant who was granted the generic data exemption commits to submit
and does submit the required data within the specified time.  In such
cases the Agency generally will not grant a time extension for
submitting the data.

Submission of Required Data - Registrants choosing this option must
agree to either:  submit the data required by the notice within the
specified time frame; enter into an agreement with one or more other
registrants to develop data jointly; make offers to cost-share; submit
an existing study that has not been submitted previously to the Agency
by anyone; submit or cite data to upgrade a study classified by EPA as
partially acceptable and upgradeable; or cite an existing study that EPA
has classified as acceptable or an existing study that has been
submitted but not reviewed by the Agency.

Submission of Data Waiver Request - A registrant may request either a
low volume/minor use waiver or a waiver based on the registrant’s
belief that the data requirement(s) do not apply to their product.  In
addition to the Requirements Status and Registrant's Response Form,
registrants requesting low volume/minor use waivers must submit the
following information:

a.  Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the
active ingredient(s), include foreign sales for those products that are
not registered in this country but are applied to sugar (cane or beet),
coffee, bananas, cocoa, and other such crops, by year for each of the
past five years.

b.  An estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site, by year for each of the past five
years.

c.  Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years, including information on
raw material cost, direct labor cost, advertising, sales and marketing,
and any other significant costs, listed separately.

d.  Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that
were directly related to the active ingredient(s), such as costs of
initial registration and any data development.

e.  A list of each data requirement for which the registrant is
requesting a waiver.

f.  The type of waiver sought and the estimated cost to the registrant
(listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data
requirements.

g.  A list of each data requirement for which the registrant is not
seeking any waiver and the estimated cost (listed separately for each
data requirement and associated test) of conducting the testing needed
to fulfill each of these data requirements.

h.  For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct
production costs of product(s) containing the active ingredient(s)
(following the parameters in item c above), indirect production costs of
product(s) containing the active ingredient(s) (following the parameters
in item d above), and costs of data development pertaining to the active
ingredient(s).   In addition, the registrant must provide a description
of the importance and unique benefits of the active ingredient(s) to
users and discuss the use patterns and the effectiveness of the active
ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies.  Registrants should provide information
on any of the following factors in order to assist EPA in making a
determination about the importance of an Active ingredient's benefits:

documentation of the usefulness of the active ingredient(s) in
Integrated Pest Management;

description of the beneficial impacts on the environment of use of the
active ingredient(s), as opposed to its registered alternatives;

information on the breakdown of the active ingredient(s) after use and
on its persistence in the environment, and description of the
product’s usefulness against pest(s) of public health significance.

Failure to submit sufficient information for the Agency to make a
determination regarding a request for a low volume minor use waiver will
result in denial of the request for a waiver.

	Request for Waiver of Data - A registrant may also request a waiver if
they believe that a particular data requirement should not apply because
the corresponding use is no longer registered or the requirement is
inappropriate.  In addition to the Requirements Status and Registrant's
Response Form, registrants requesting a waiver of data requirements must
submit a rationale explaining why the registrant believes the data
requirements should not apply, as well as copies of current product
labels and a current copy of the Confidential Statement of Formula for
each product.  If the Agency determines that a registrant does not
qualify for a waiver and that the data are required for the product(s),
the registrant must choose a method of meeting the requirements of the
notice within the 90-day time frame provided by the notice. Within 30
days of the registrant’s receipt of the Agency's written decision, the
registrant must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.



5.	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a).  Agency Activities

The following Agency activities are necessary to conduct a DCI under
this ICR:

develop DCI correspondence 	

prepare the DCI letter  identifying all the data needed

answer registrants' questions	

respond to any questions the registrant may have regarding the DCI

review data submissions 	

review data submissions for completeness and appropriateness

record DCI submissions 	

record submissions in tracking system for internal review

analyze data   	

conduct scientific reviews of data

store data 	

index data and store it in Agency files

5(b).  Collection Methodology and Management 

After initiating a statutorily mandated pesticide review whether a
Special Review, closeout of a Reregistration Review, a Registration
Review or a AR or PCT Review and determining that additional data is
needed, the Agency will issue a DCI when the need for additional data
has been identified.  

OPP tracks DCIs and all registrant responses through the Office of
Pesticide Programs Information Network (OPPIN), OPP's general purpose
action tracking system.  Additionally, the Reference Files System (REFS)
is used if the registrant voluntarily cancels a product in response to a
DCI.  The Pesticide Data Management System (PDMS) lists the bibliography
of data submitters for the DCI and OPPIN tracks the submissions.  All
correspondence associated with the issuance and response to the DCI is
filed in the master registration file or ‘registration jacket’ of
affected products.  Data submitted in response to a DCI is processed,
catalogued and archived in the PDMS.  Failures to comply with DCI
requirements are referred to EPA's Office of Enforcement and Compliance
Assurance for appropriate follow-up actions.

Although the Agency does not publish the submitted information, and
public access to the PDMS bibliography is made through the National
Pesticides Information Retrieval System (NPIRS).  NPIRS supports
searches of the PDMS database by chemical, subject, submission date,
laboratory, guideline number, and document type.  The public may request
copies of non-confidential studies through FOIA.

OPP continues to investigate the possibility of providing optional
electronic data transfer services to the industry as a means of
minimizing the burden of registration activities.  The Agency's
pesticide program, along with the pesticide industry, recognizes the
advantages in terms of accuracy, speed, cost and personnel from
electronic data transfer technologies.  In addition, OPP continues to
consult with industry associations and other federal agencies, and is
participating in an Agency-wide workgroup to develop electronic
reporting standards intended to facilitate the submission and use of
information about pesticides. 

5(c).  Small Entity Flexibility

Currently, pesticide registrants may be divided into two groups. 
Approximately 10 percent of the total: manufacture or import chemical
active ingredients intended for use as pesticides, sell these active
ingredients to other firms for formulation into pesticide products,
and/or make the end-products themselves.  The second, and by far the
larger, group of registrants purchase the active ingredients in their
pesticide products from members of the first group, and combine them
with pesticide inert ingredients or sometimes simply repackage them to
make their end-use products.

This second group is primarily comprised of small businesses.  When
small businesses use a registered source of the active ingredient to
formulate their products, they generally are exempt from generating
health and safety data for pesticide active ingredients ("generic
data").  Consequently, they usually need only respond to a DCI for
active ingredient data by claiming the "generic data exemption" (for
more detail, see section 4(b)(iii) “Reducing the PRA Burden”
Variation of Response to a DCI” of this document).  They do not incur
any other information burden associated with the data call-in.

5(d).  Collection Schedule

There is not a collection schedule per se.  DCIs are issued when the
need is identified.  The time frame in which the respondents must then
submit the requested material is specifically established for each DCI
based on the individual circumstances surrounding the particular DCI and
applicable review.  As part of the consolation and public participation
process, EPA works with respondents to ensure that sufficient time is
built into the individual DCIs to allow for respondents to gather and
submit the requested information. However, DCIs will generally be issued
whenever ARs data is relied upon, either to establish new tolerances or
reassess existing tolerances.  Registrants have five years before data
must generally be submitted in support of the ARs used.  Data must also
be periodically reviewed when PCT estimates are relied upon, but in most
cases the Agency will be able to internally collect or generate this
data.  In cases where the Agency is unable to get the information
itself, the registrant must submit data within five years of the use of
PCT estimates.  Additional time is provided for development of new
studies appropriate to the nature of the studies required.

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	Methodology Used To Estimate the Burden for DCIs 

To estimate the burden and costs for the paperwork related activities
for respondents to comply with DCIs notices issued under any of the
review programs, EPA estimates PRA activities to be 35% of the cost to
generate new data.  This methodology is based on using the average cost
estimates for the specific studies requests in each DCI and is only
applicable to DCI related data generation.  This approach was adopted
because it allows the Agency to consider the potential for there to be
greater burden related to a more complex study.  The premise is that a
more expensive study probably causes the respondent to incur more burden
hours and costs than generating a less expensive study.  The public,
registrants, key stakeholders, and OMB developed this percentage from
numerous sources of information including agency expertise, consultation
with industry, and repeated review on the Agency’s information
collection activities.  

To help calculate the PRA costs, the Agency maintains an archive of the
basic FIFRA study cost estimates that were developed through surveys of
independent testing laboratories, Agency economic analyses, and
registrant comments during ICR renewal periods.  To the extent possible,
EPA uses multiple sources to provide test cost estimates, which are
updated as needed.   

This methodology assumes all recipients of a DCI generate all of the
data as specified in the DCI notice.  Using this assumption however, the
Agency has chosen to overestimate the burden because not all DCI
recipients engage in all of the DCI activities.  The Agency is aware
that DCI recipients who engage in a taskforce for data generation,
voluntarily cancel the product or affected uses, submit or cite existing
data, or are granted a waiver incur fewer burden hours and cost.  Ts.   
 SEQ CHAPTER \h \r 1 The Agency actively encourages cost-sharing
agreements among manufacturers of specific pesticide chemicals to
minimize the duplication of laboratory tests conducted and to minimize
costs for DCI recipients.  

 

Common to developing the burden estimates for all DCIs, EPA uses the
following general assumptions:

Studies were submitted by registrants (not grower groups, or other
agencies, etc.);

studies had not been requested under a previous DCI;

studies were not a request to resubmit because the original study
submitted was not

complete or did not meet the data submission requirements; and

studies submitted that are based on preexisting data and can be found in
published, peer reviewed literature were not included.

A detailed discussion of the Agency’s “Methodology Used to Estimate
Paperwork Burden Hours and Costs by the Office of Pesticide Programs for
Submission of Required Data/Information for Responding to a Data Call-In
Notice” is available at Attachment FG to this document.

Updating Labor Rates 

	When estimating labor rates for OPP ICR renewals in recent years, the
Agency generally adjusted the labor rate estimates used in the previous
renewals by using methods such as the NASA Gross Domestic Product (GDP)
Deflator Inflation Calculator to index the labor cost for a particular
year.  However, for this ICR renewal, Agency economists developed
completely new estimates of wages, benefits and overhead for all labor
categories for affected industries, state government, and EPA employees.
 The goal is to use a transparent, consistent methodology and current,
publicly-available data, to provide more accurate estimates and allow
easy replication of the estimates.

	Methodology:	The methodology uses data on each sector and labor type
for an Unloaded wage rate (hourly wage rate), and calculates the Loaded
wage rate (unloaded wage rate + benefits), and the Fully loaded wage
rate (loaded wage rate + overhead).  Fully loaded wage rates are used to
calculate respondent costs.  This renewal uses 2003 base data.

	Unloaded Wage Rate:  Wages are estimated for labor types (management,
technical, and clerical) within applicable sectors. The Agency uses
average wage data for the relevant sectors available in the National
Industry-Specific Occupational Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at   HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm" 
http://www.bls.gov/oes/current/oes_nat.htm .  

	Sectors: The specific North American Industry Classification System
(NAICS) code and website for each sector is included in that sector’s
wage rate table.  Within each sector, the wage data are provided by
Standard Occupational Classification (SOC).  The SOC system is used by
Federal statistical agencies to classify workers into occupational
categories for the purpose of collecting, calculating, or disseminating
data (see   HYPERLINK "http://www.bls.gov/oes/current/oes_stru.htm" 
http://www.bls.gov/oes/current/oes_stru.htm  ).  

	Loaded Wage Rate: Unless stated otherwise, all benefits represent 43%
of unloaded wage rates, based on benefits for all civilian non-farm
workers, from   HYPERLINK "http://www.bls.gov/news.release/ecec.t01.htm"
 http://www.bls.gov/news.release/ecec.t01.htm . However, if other
sectors are listed for which 43% is not applicable; the applicable
percentage will be stated.

	Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA
guidelines 20-70%) to get overhead costs.

A copy of the formula work sheets used to re-estimate the labor rates
and to derive the fully loaded rates and overhead costs for this all of
the respondents (registrants) and the Agency for this ICR renewal are
listed in Attachment H.  

	Format 

	For reader clarity this consolidation document contains three separate
Pparts which discuss  “discuss “Section 6 - Estimating The Burden
And Cost Of The Collection.”   For this section only, discussions
regarding PRA burden and costs for each of the review programs have been
for each review program is   restructured into separate parts which
allow the reader/reviewer to readily identify the burden activities
associated with a particular review program.  The parts are labeled as
follows:

Part 1 – Section 6: Estimating the Burden and Cost of the Collection
for the Reregistration Review program (including reassessing import
tolerances).

Part 2 – Section 6: Estimating the Burden Aand Cost of the Collection
for the Special Review and Registration Review Programs 

Part 3 – Section 6: Estimating the Burden and Cost of the Collection
for the Anticipated Residue and Percent Crop Treated Review Programs

   

Part 4 – Section 6: Estimating the Burden and Cost of the Collection
for Enforcement and Unanticipated Incidents 

Part 1-  Section 6:

Estimating the Burden and Cost of the Collection for the Reregistration
Review program (including reassessing import tolerances).

 

Part 1 describes the burden activities associated with the
Reregistration review program, which also includes the burden activities
associated with import tolerance reassessment.  While the final
regulatory decisions for the Reregistration program are scheduled for
completion in 2008, the Agency will still issue Reregistration DCIs for
the life of this ICRin 2009. 

	6(a)   Estimating Respondent Burden – Reregistration 

The total estimated annual burden hours for respondents to comply with
thise information collection activity for the Reregistration Program to
be 165,351 hours, with the total annual respondent burden cost estimated
to be $5,789,404.  

The burden estimate is dependent upon the type or class of chemical
under review and whether there is a high, medium or low burden that are
directly related to the complexity of studies, and the cost of such
studies   required for a particular chemical.  Reregistration review
burden estimates are based only on Phase 5 (completion) activities and
for reassessing existing import tolerances.  EPA examined the historical
data for confirmatory, product specific and voluntary data that have
been submitted for representative pesticides in this program.  This
information was used to project the estimates in this ICR. As a result
of the review, EPA will not  adjust the estimated hourly burden per
response for any of the respondents for the renewal of this ICR.  

Over the next three years, EPA expects to issue 137 DCIs for active
ingredients and the pesticide products that contain them.  The breakdown
of the regulatory decisions decisions for the Reregistration Program
that EPA expects to make over the next 3 years is as follows:

Type of Decision	

No. of Pesticide Ingredients

Final and Interim Reregistration Eligibility Decisions (REDs) and
efficacy data (REDs & IREDs)	

107

Import tolerances (ingredients with no U.S. registrations)	

30

Total	

137

6(a)(1). Paperwork Burden Related to the Submission of Confirmatory Data
– Reregistration 

Confirmatory data are required of registrants to complete registrant
databases and to assist in the evaluation of risk findings.  For DCIs
involving confirmatory studies, EPA also assumed that only one
respondent – the manufacturer of the active ingredient – will
provide the data requested (i.e, one registrant will submit an average
of 9.8 “confirmatory” studies per DCI, and therefore, there will be
only one response submitted to EPA per DCI involving confirmatory data. 
EPA expects to issue 137 confirmatory DCIs over the next 3 years, which
equals an average of 45.66 confirmatory DCIs annually.  See Table 1
below for burden activity details.   

Table 1.  Annual Respondent Burden for DCIs Involving Confirmatory
Studies

             

                 Collection Activities	

Burden Hours	

Total

	

 Mgmt.

$103.62/hr	

   Tech.

  $67.05/hr	

   Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

12	

0	

0	

12	

$1,243.44

2. Discuss test and protocol with Agency	

6	

6	

0	

12	

$1,024.02

3. Plan activities	

24	

6	

0	

30	

$2,889.18

4. Create information	

18	

299	

36	

353	

$23.131.79

5. Gather information	

0	

30	

0	

30	

$2,011.50

6. Process, compile, review information for accuracy	

35	

48	

0	

83	

$6,845.10

7. Complete written forms	

0	

0	

12	

12	

$406.20

8. Record, disclose, display information	

11	

0	

24	

35	

$1,952.22

9. Store, file, or maintain information	

11	

0	

18	

29	

$1,749.12

Total Annual Burden	

117	

389	

90	

596	

$41,252.57

Estimated Total Annual Respondent Burden & Costs for DCIs Involving
Confirmatory Studies:

Burden: 596 hours per response x 1 response per DCI x 45.66 DCIs  =
27,213.36 burden hours.

Costs: $41,253 per response x 1 response per DCI x 45.66 DCIs =
$1,883,611.90

6(a) (2).  Paperwork Burden Related to Voluntarily Submitted Data -
Reregistration

Voluntary data consist of studies not required by the Agency but are
submitted by registrants to supplement a pesticide database.  To account
for the burden attributed to voluntarily submitted data, the Agency
inventoried the types of voluntarily submitted data for a range of
chemicals.  Based on a sampling of Reregistration Eligibility Decisions
(REDs) affected by FQPA tolerance reassessment submitted over an eight
year period (1996- 2004), the Agency received 67 voluntary data
submissions.  This averages to to 8.375 submissions annually.          

In the past, many of voluntarily submitted studies have been existing
studies, e.g., studies found in existing literature, or studies that
were slightly modified and resubmitted, or studies of lower cost.  Some
may be special studies such as a Monte ONTE CarloARLO, or limited market
basket survey, or other studies to provide the Agency with actual
exposure data.  Regardless of the voluntarily submitted status, the
Agency has categorized these data as high, medium or low burden and
averaged the burden for these studies as if they represented a cross
section of typical data requirements.      

           

For the next ICR renewal period, EPA recognizes that some registrants
will continue to submit voluntary data to support the activities for the
completion of the reregistration review program as well as and the other
review programs.  EPA expects to receive 255 voluntary such submissions
over the next three years; 16 of which are expected to be “low
burden” submissions and 89 of which are expected to be “high
burden” submissions.  Thus, EPA expects to receive about 88 voluntary
submissions annually; 5.3 of which are expected to be “low burden”
submissions and 3 of which are expected to be “high burden”
submissions.  For the details of the burden hours and costs see Table
2.A and Table 2. B. 

Table 2. A.  Annual Respondent Burden for Submissions of Voluntary Low
Burden Studies

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$103.62/hr	

Tech.

$67.05/hr	

Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

12	

0	

0	

12	

$1,243.44

2. Discuss test and protocol with Agency	

6	

6	

0	

12	

$1,024.02

3. Plan activities	

24	

6	

0	

30	

$2,889.18

4. Create information	

18	

299	

36	

353	

$23,131.11

5. Gather information	

0	

30	

0	

30	

$2,011.50

6. Process, compile, review information for accuracy	

35	

48	

0	

83	

$6,845.10

7. Complete written forms	

0	

0	

12	

12	

$ 406.20

8. Record, disclose, display information	

11	

0	

24	

35	

$1,952.22

9. Store, file, or maintain information	

11	

0	

18	

29	

$1,749.12

Total Annual Burden	

117	

389	

90	

596	

$41,252.57

Estimated Total Annual Respondent Burden & Costs for DCIs Involving
Voluntary Low Burden:

Burden: 596 hours x 5.3 responses  = 3,159 hours

Costs: $41,253 x 5.3 responses  = $218,640.90



Table 2. B.  Annual Respondent Burden for Submission of Voluntary High
Burden Studies

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$103.62/hr	

Tech.

$67.05/hr	

Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

72	

0	

0	

72	

$7,460.64

2. Discuss test and protocol with Agency	

36	

36	

0	

72	

$6,144.12

3. Plan activities	

144	

36	

0	

180	

$17,339.40

4. Create information	

108	

1,791	

215	

2,114	

$145,833.03

5. Gather information	

0	

179	

0	

179	

$12,001.95

6. Process, compile, review information for accuracy	

215	

287	

0	

502	

$41,521.65

7. Complete written forms	

0	

0	

72	

72	

$2,437.20

8. Record, disclose, display information	

72	

0	

144	

216	

$12,335.04

9. Store, file, or maintain information	

72	

0	

108	

180	

$11,116.44

Total Annual Burden	

719	

2,329	

539	

3,587	

$256,189.43

Estimated Total Annual Respondent Burden for DCIs Involving Voluntary
High Burden:

Burden: 3,587 hours x 3 responses = 9,565 hours

Costs: $256,189 x 3 responses = $768,567

6(a)(3).  Paperwork Burden Related to the Submission of Product-Specific
Data – Reregistration 

	Product-specific data is generally comprised of toxicity and product
chemistry data. In the past for DCIs involving product-specific data
(sometimes referred to as PDCIs), EPA examined several typical
reregistration cases with a typical number of batches and EPA’s
estimate of the number and type of PDCI studies required.  EPA noted
that while the number pesticide products captured by a RED for an active
ingredient (and, therefore, the number of responses per PDCI associated
with a RED) vary greatly from 1 to more than 100, the average number of
responses per PDCI was three (3). It is a common industry practice where
the manufacturer of the active ingredient and the companies that use
that active ingredient in their products share their financial and
scientific resources in order to provide EPA with a complete DCI
response.  This helps industry avoid a duplication of effort and thereby
minimize the burden and cost impacts on each individual company.   

	Additionally, tThe industry practice regarding the citation of data on
similar products and the citation of existing data previously submitted
to the Agency could also be the reason that the number of studies called
in under the PDCI typically differs significantly from the number of new
studies actually generated in response to the PDCCI.  For example, in
2004 the Agency evaluated a sampling of 95 pesticide product reviews
(PDCIs) related to 5 randomly selected pesticide chemicals to determine
the number of new Acute Toxicity and Product Chemistry studies generated
in response to a DCI.  Based on this evaluation, it was determined that
approximately 18% of the Acute Toxicity data requirements and
approximately 10% of the Product Chemistry data requirements were newly
generated data.  Among the six Acute Toxicity requirements surveyed,
(acute oral, acute dermal, acute inhalation, acute eye irritation, acute
dermal irritation and dermal sensitization), the Acute eye irritation
(870.2400), and Acute dermal irritation (870.2500) studies accounted for
as much as 50% of the new data produced (in equal proportions).  The
other 50% of the new data is equally distributed between the remaining
four study requirements.   Among the ten Product Chemistry requirements
surveyed, (Storage Stability (830.6317), Corrosion Characteristics
(830.6320), Viscosity (830.7100) and the Analytical Methods (830.1800)
guidelines accounted for approximately 90% of the new data produced (in
equal proportions).  The remaining 10% of the new data was equally
distributed between the Flammability (830.6315), pH (830.7000), Density
(830.7300), and various requirements for technical/pure active
ingredients including Preliminary analysis (830.1700), Water solubility
(830.7840 or 830.7860), and Vapor pressure (830.7950).  

I.

	The AThe.   Agency projects 49 PDCIs (16.33 annually) will be called-in
over the next three years.  This equates to about 28% of the 137 DCIs to
be issued for this ICR renewal.  The Agency will again predict each PDCI
will generate about three (3) responses.   Table 3 provides the detail
for these burden activities.      

Table 3.   Annual Respondent Burden Estimates for Product Specific DCI
Activities

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$103.62/hr	

Tech.

$67.05/hr	

Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

51	

0	

0	

51	

$5,284.62

2. Discuss test and protocol with Agency	

26	

26	

0	

52	

$4,437.42

3. Plan activities	

102	

26	

0	

128	

$12,312.54

4. Create information	

77	

1,280	

154	

1,511	

$99,015.64

5. Gather information	

0	

128	

0	

128	

$8,582.40

6. Process, compile, review information for accuracy	

154	

204	

0	

358	

$29,635.68

7. Complete written forms	

0	

0	

51	

51	

$1,726.35

8. Record, disclose, display information	

51	

0	

102	

153	

$8,737.32

9. Store, file, or maintain information	

51	

0	

77	

128	

$7,891.07

Total Annual Burden	

512	

1,664	

384	

2,560	

$177,623.04

Estimated Total Annual Respondent Burden for Product Specific DCI
Activities:

Burden: 2,560 hours x 3 responses per DCI x 16.33 DCIs = 125,414.40
hours.

Costs: $177,623 x 3 responses per DCI x 16.33 DCIs = $2,900,583.50

6(b).  Estimating Respondent Costs - Reregistration 

The total annual cost for all respondents is estimated to be $5,789,404.
 Respondent costs are based on managerial, technical and clerical burden
hours estimated at $103.62, $67.05, and $33.85 per hour, respectively. 
For a period of some years when estimating the labor rates for most OPP
program ICR renewals, the Agency adjusted the ICR renewal labor rates by
using the NASA Gross Domestic Product (GDP) Deflator Inflation
Calculator to index the labor cost for a particular year.  However, in
July 2006 Agency economist completely re-estimated wages , benefits, and
overhead for all labor categories for the pesticide industry, state
government, and Agency employees.  The rates are lower than those used
in the previous ICR.  However, the Agency believes these rates are a
more accurate refection of the current market labor rates.  The Agency
analysis uses currently available information on labor rates and other
benefits form publicly available websites.  A copy of the formulas used
to re-estimate the labor rates, derive the fully loaded rates and
overhead costs are listed in Attachment G.         

	6(c).  Estimating Agency Burden and Cost - Reregistration 

The Agency’s annual burden hours and costs for developing DCI
correspondence, communication with registrants, developing documents,
tracking and storing the evaluation of the data submissions, and other
DCI processing activities is detailed in Table 4 below.  The formula for
used to calculate the Agency labor rates is detailed in Attachment H. 
For this renewal, EPA projects a slight decrease in the burden hours and
costs associated with the performance of the duties issuing and
processing DCIs.  The decrease is attributable to the reduction of the
number of DCIs, from 142 to 137, the Agency plans to issue over the next
three years. 

Table 4. Annual Agency Burden Estimates

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$101.16/hr	

Tech.

$66.88/hr	

Cler.

$39.23/hr	

Hours	

Costs

a. Develop DCI correspondence	

948	

9,480	

948	

11,376	

$766,915.97

b. Answer DCI questions from registrants	

119	

4,740	

0	

4,859	

$329,049.24

c. Review, evaluate data submission	

238	

138,029	

0	

138,267	

$9,231,379.52

d. Record DCI submissions	

0	

0	

1,896	

1,896	

$74,380.08

e. Store data	

0	

0	

238	

238	

$9,336.74

Total Annual Agency Burden	

1,305	

152,249	

3,082	

156,636	

$10,411,061.55

 6(d).	Bottom Line Hours and Cost Tables – Reregistration 

The total annual estimated burden hours and costs for the
Rereregistration review program for the next three years is represented
in Table 5 below.

Table 5.  Annual Bottom Line Hours And Costs / Master Table

Collection Activity	

Burden Hours	

         Costs

DCI Involving Confirmatory Studies	

27,213	

$1,883,612

Voluntary Low Burden Studies	

3,159	

$218,641

Voluntary High Burden Studies	

9,565 	

$786,567

Product Specific DCIs 	

125,414	

$2,900,584

Total Annual Respondent Burden and Costs 	

165,351 	

$5,789,404 

Total Annual Agency Burden 	

156,636	

$10,411,061.55

6(e).	Reasons for Change in Burden - Reregistration 

In the ICR renewal, EPA projects a slight decrease in the estimated
number of DCIs the Agency will issue annually, from 47.33 to 45.66,
compared to the last ICR. Consequently, EPA expects that the associated
burden will decrease because less DCI responses will be submitted to the
Agency each year.  Part of this reduction is also attributable to the
reduction of DCI responses for product specific data, 16.33 instead of
30.33, as reported in the last ICR.  However, EPA is projecting it will
receive about the same number of voluntarily submitted data of 8.33
responses (5.3 low burden and 3 high burden) annually.  EPA’s estimate
of the burden breakdown for each individual respondent for each labor
category (management, technical and clerical) remains unchanged from the
previous ICR.  The overall adjustments in the burden for this ICR result
in a net decrease  hoursdecrease hours annually from 275,063 to 165,351,
which is directly related to the decrease in the number of DCIs to be
issued.  Part of the reduction in the estimated costs, for respondents
and Agency personnel is attributable to EPA’s methodology which
re-estimated  labor rates for industry and the Agency.  The decrease is
a program adjustment. 

6(f).  Burden Statement - Reregistration 

The total estimated respondent burden hours are 496,053 hours for the
next three years at an estimated burden cost of $17,314,212. (indexed to
2006 dollars).  



Part 2 – Section 6:

Estimating the Burden and Cost of the Collection 

for the Special Review and Registration Review Programs 



Part 2 describes the burden activities associated with the Special
Review and Registration Review programs.  

6(a)   Estimating Respondent Burden – Special Review 

	 Special Review Program 

Special Reviews, though rare, are conducted when the Agency determines
such a review is warranted.  In the Special Review Program, EPA focuses
on specific hazards or uses of a pesticide.   Special Reviews are not
intended to be comprehensive evaluations of the pesticide, instead the
DCIs are to address the specific hazard or exposure concerns are that
are at issue.   

The total estimated annual respondent burden hours and costs for Special
Review is estimated at 919 burden hours with the total annual respondent
cost estimated at $56,202. 

 The potential number of Special Review DCIs required, the type of data,
and the number of respondents affected is quite variable.  Thus, a
Special Review DCI may request data on more than one pesticide, and may
involve two or more respondents who are encouraged to join together to
provide the needed data.  The annual burden estimate is based on the
following assumptions: (a) that the Agency would issue 1one DCI under
the Special Review program in any given 12-month period, and (b) that
for each Special Review DCI issued, there would be 1one response.    The
Agency has also assumed an average total test cost of $500,000 per
Special Review DCI.  

Over a three-year ICR approval period, three responses would be expected
and the total respondent burden for Special Review related activities is
estimated to be 2,757 hours. This estimate remains unchanged from the
previous ICR.  Because of the variability inherent in each Special
Review DCI, the estimates serve as a proxy for what the actual burdens
are likely to be.  Although the Agency estimated that an average of 1
respondent per Special Review DCI is expected because historically, a
majority of the Special Review DCIs has only affected 1 or 2
respondents, on rare occasions, some previous Special Review DCIs have,
exceeded this.  In recent years, the Agency has not issued one Special
Review DCI each year over a three-year period.  Table 1A details the
estimated annual respondent burden hours and costs for Special Review
DCIs



Table 1A:  	Estimated Annual Burden hours and Cost Estimates for Special
Review DCIs per Respondent

	

	BURDEN HOURS (per year) 	

TOTALS

COLLECTION ACTIVITIES	

Mgmt.  $103.62/hr	

Tech.

 $67.05/hr	

Cler.

 $33.85/hr	

	Hrs	

	Cost

1) Read and discuss test requirements	

18	

0	

0	

18	

$1,865.16

2) Discuss test and protocol with Agency	

9	

9	

0	

18	

$1,536.03

3) Plan activities	

0	

0	

0	

0	

$0

4) Create information	

37	

9	

0	

46	

$4,437.39

5) Gather information	

28	

460	

0	

488	

$29,617.74

6) Process, compile, review  information for accuracy	

0	

46	

0	

46	

$3,084.30

7) Complete written forms	

55	

74	

55	

184	

$12,522.55

8) Record, disclose, display information	

0	

0	

18	

18	

$609.30

9) Store, file, or maintain information	

36	

0	

65	

166	

$5,930.57

TOTAL	

183

	

598

	

138

	

919	              $56,201.85

Special Review Estimated Annual  Respondent Burden hours and Cost 

Hours: 919 hours per response X 1 response X 1 DCI= 919 hours

Costs: $56,202 per response X 1 response X 1 DCI= $56,202

6(a)(1) Estimating the Respondent Burden – Registration Review 

	Registration Review

While the agency projected burden hours and cost of issuing DCI for the
Registration Review program in the last ICR, no DCI could be issued
until the final procedural rules for the registration review program
were issued.  The final rules were published August 9, 2006 (71 FR
45719) and became effective October 10, 2006.   The first dockets for
registration review cases were opened in February 2007 and a majority of
dockets opened to date have identified the need for additional data in
order to complete the preliminary risk assessment. The Agency is
actively developing the internal protocols necessary to issue DCIs under
this program. .  Estimates include additional activities anticipated by
the reauthorization of the Pesticide Registration Improvement Act
amendments of October 9, 2007. 

The total estimated annual burden hours for respondents to comply with
this information collection activity is 6547,374835  hours with the
total annual respondent cost estimated to be $34,362595,625587.  

During Registration Review, EPA will, among other things, update the
databases of pesticides to obtain data that were not required when the
pesticide was registered or reregistered, but which are now required and
determined necessary.  Like the Special Review program, the potential
number of Registration review DCIs that will be issued, the type of
data, and the number of respondents affected will be quite variable.

  Over the next 3 years EPA expects to issue 90121 DCIs (3041 annually)
for the Registration Review Program.  The Agency assumes that one
respondent “registrant” will provide the data requested.  The Agency
estimates one registrant will submit an average of 1.5 studies per DCI. 
 A detailed illustration of the estimated annual respondent burden hours
and costs is listed in Table 1B.  



Table 1B:  Estimated Annual Respondent Burden Hours and Costs for
Registration Review DCIs 

	

	BURDEN HOURS (per year) 	

TOTALS

COLLECTION ACTIVITIES	

Mgmt.  $103.62/hr	

Tech. 67.05/hr	

Cler.

$33.85/hr	

	Hrs	

Cost

1) Read and discuss test requirements	

22	

0	

0	

22	

$2,279.64

2) Discuss test and protocol with Agency	

11	

11	

0	

22	

$1,877.37

3) Plan activities	

44	

11	

0	

55	

$5,296.83

4) Create information	

33	

544	

33	

610	

$41,011.71

5) Gather information	

0	

54	

0	

54	

$3,620.70

6) Process, compile, review  information for accuracy	

65	

87	

0	

152	

$12,568.65

7) Complete written forms	

0	

0	

22	

22	

$744.70

8) Record, disclose, display information	

22	

0	

44	

66	

$3,769.04

9) Store, file, or maintain information	

22	

0	

38	

60	

$3,565.94

TOTAL	

219	

707	

137	

1,063	

$74,724.58

Registration Review Estimated Annual Respondent Burden Hours and Cost 

Hours: 1063 hours per response X 1.5 responses X 3041 DCIs =
4765,835374.5 hours

Costs: $74,725 per response X 1.5 responses X 3041 DCIs =
$34,362595,625.587.5 



6(b).	Estimating Respondent Costs - Special Review and Registration 
Review

The estimated annual cost for all respondents for Special Review and
Registration review is estimated to be $3,418,827.   Respondent costs
are based on managerial, technical and clerical burden hours estimated
at $103.62, $67.05, and $33.85 per hour, respectively..  For a period of
some years when estimating the labor rates for most OPP program ICR
renewals, the Agency adjusted the ICR renewal labor rates by using the
NASA Gross Domestic Product (GDP) Deflator Inflation Calculator to index
the labor cost for a particular year.  However, in July 2006 Agency
economist completely re-estimated wages, benefits, and overhead for all
labor categories for the pesticide industry, state government, and
Agency employees.  The rates are lower than those used in the previous
ICR.  However, the Agency believes these rates are a more accurate
refection of the current market labor rates.  The Agency analysis uses
currently available information on labor rates and other benefits form
publicly available websites.  A copy of the formulas used to re-estimate
the labor rates, derive the fully loaded rates and overhead costs are
listed in Attachment X.         

 For Special review only,  the Agency has assumed an average total test
cost of $500,000 per Special Review DCI.  This test cost is still the
basis for calculating the value of labor-cost per hour for management,
technical, and clerical staff involved in conducting the
paperwork-related activities associated with DCIs.

6(c).  	Estimating Agency Burden and Cost - Special Review Registration
Review

Special Review – Agency Burden 

In this ICR, the estimated average number of Agency burden hours per
response for Special Review is the same as in the previous ICR; i.e.,
1,348 hours.  Over a three-year ICR approval period, 3 responses are
expected and the total Agency burden hour and cost is estimated at 4,044
(1,348 x 3) hours..  See Table 2A for the detail of the Agency burden
hours and costs for processing Special Reviews.  

Table 2A: Estimated Annual Agency Burden and hours Cost for Special
Review DCIs 

	Collection 

Activities	

	Burden Hours 	

Total

	

	Mgmt.

	$101.16/hr	

	Tech.

	$66.88/hr	

	Cler.

	$39.23/hr	

Hours	

Cost

Develop DCI correspondence needed	

32	

	160	

	60	

252	

$16,291.72

Answer registrants' questions regarding the DCI	

	4	

	160	

	0	

164	

$11,105.44

Review and analyze data submissions	

	4	

	880	

	0	

884	

$59,259.04

Record DCI submissions	

	0	

	0	

	40	

40	

$1,569.20

Store Data	

	0	

	0	

      8	

8	

$313.40

TOTAL	

	40	

 1,200	

	108	

1,348	

$88,539.24

Hours: 13468 per response X 1.5 responses X 130 DCIs =   2,02260,570
Hours 

Costs: $88,539 per response X 1.5 responses X 130 DCIs =
$3,984,255.132,808.5 

Registration Review – Agency Burden

The annual estimated Agency burden hours and costs for Registration
Review are illustrated in Table 2B below.   

Table 2B:Estimated Annual Agency Burden Hours and Costs for Registration
Review DCIs

	Collection 

Activities	

	Burden Hours 	

Total

	

	Mgmt.

	$101.16/hr	

	Tech.

	$66.88/hr	

	Cler.

	$39.23/hr	

Hours	

Cost

Develop DCI correspondence needed	

64	

	320	

	120	

504	

$32,583.94

Answer registrants' questions regarding the DCI	

	4	

	160	

	0	

164	

$11,105.44

Review and analyze data submissions	

	4	

	0	

	0	

4	

$404.64

Record DCI submissions	

	0	

	0	

	80	

80	

$3,138.40

Store Data	

	0	

	0	

      8	

8	

$265.84

TOTAL	

	72	

 480	

	208	

760	

$47,497.76

Registration Review Estimated Agency Annual Burden Hours and Costs

Hours: 760 per response x 1.5 responses x 3041 DCIs = 34,20046,740 hours

Costs: $47,498 per response x 1.5 responses x 3041 DCIs = $2,137,
4102,921,127

6(d). 	Bottom Line Burden Hours and Cost Tables/ Master Table for
Special Review and Registration Review

The estimated total and annual Respondent burden hours and costs are
illustrated in Table 3, while the estimated total and annual Agency
burden hours and costs are illustrated in Table 4.



Table 3: Bottom Line Respondent Burden Hours and Costs/ Master Table  

	

	

Per Response	

Number of Responses	

Totals

	

Hours	

 Cost 

Hours	

Cost

Special Review	

919	

$56,202  	

1      	

    919	

$56, 202

Registration Review	

1,063	

$74,735 	

451	

 473,835,583	

$3,360643,071355 

TOTAL ANNUAL BURDEN	

1,982	

$130,937 	

462	

  484,754502	

$3,531,681120,337

TOTAL 3 YEAR BURDEN	

5,946	

 $392,811  	

13826	

  14633,506262	

$10,595,0439,361,011 

 Table 4: Bottom Line Agency Burden Hours and Costs/Master Table  

	

	

Per Response	

Number of Responses	

Totals

	

Hours	

 Costs 

Hours	

Cost

Special Review	

1,348	

$88,539	

1          	

1,348	

$88,539

Registration Review	

760	

$47,498	

451	

34,2001,160	

$21,137947,,410418

TOTAL ANNUAL BURDEN	

2,108	

$136,037	

462	

35,5482,508	

$2,225035,949957

TOTAL 3 YEAR BURDEN	

6,324	

 $416,340	

13826	

140,844	

$6,610777,847871

6(e). 	Reasons for Change in Burden - Special Review Review and
Registration Review

This ICR renewal request will result in a slight increase decrease in
the annual respondent burden of 15,967545  hours, i.e., from 64,699 to
4865,754374 hours, when compared with the previous ICR.  Most of the
burden increasedecrease can be attributed to the increase reduction of
in the number of DCIs (401 DCIs verses 3040 DCIs) to be issued under the
Registration review program that is now underway.  This is a program
adjustment.     

6(f).  Burden Statement - Special Review and Registration Review

The annual respondent burden for the information collection activities
under this ICR is estimated to average 919 hours for Special Review DCIs
and 48,65,374754 hours for Registration Review DCIs.  



Part 3 – Section 6

Estimating the Burden and Cost of the Collection for 

the Anticipated Residue and Percent Crop Treated Review Programs

   



Part 3 describes the burden activities associated with the Anticipated
Residue and Percent Crop Treated (AR/PCT) review programs.  The AR/PCT
review program requires the Agency to re-evaluate of previous Agency
decisions regarding the establishment of a tolerance (maximum residue
limit) for pesticide residues on food or feed crops.  The law also
requires that tolerance decisions based on ARs or PCT data be verified
to ensure that residues in or on food are not above the residue levels
relied on for establishing the tolerance.

	6(a)   Estimating Respondent Burden - AR/PCT

The annual respondent range between 59 and 13,636 burden hours per DCI,
depending upon the type of DCI response requested.  The total estimated
burden for this ICR of XXXX burden hours is based on the Agency’s
estimate of the potential burden and number of responses for each of the
following four types of potential DCIs:

Type 1- DCI for anticipated residues requiring a base set of data
(13,636 hrs.); 

Type 2- DCI for anticipated residues requiring minimum data (69 hrs.); 

Type 3- DCI for anticipated residues collected from publicly available
sources (137 hrs.);

 and 

Type 4- DCI for percent crop treated using existing information (59
hrs.).  

After re-evaluation the burden hours from the last ICR, the Agency is
not changing the burden hour estimates from the last ICR renewal period.
 The following information presents the Agency’s burden estimates for
each type of DCI.  

AR DCI Type 1 - DCI for anticipated residues requiring a base set of
data:

Respondent burden hours for generating and submitting data in response
to a DCI for anticipated residues requiring a base set of data to be
submitted are estimated at 13,636 burden hours per response.  And one
response equals one DCI.  EPA also considered the typical burden for
reading instructions, planning activities, compiling and reviewing the
submission, submitting the data to EPA, and related record keeping in
estimating the total per response burden and costs.  Using the USDA’s
Pesticide Data Program (PDP) which generates publicly available
monitoring data as the basis, EPA estimated the burden for conducting a
monitoring study to gather the necessary data.  Portions of the annual
respondent burden hours and cost are related to generation of new data
for meeting 40 CFR part 158 data requirements for anticipated residues. 

In most cases, registrants will be able to get the information from
federal and state monitoring programs, thus EPA estimates that no more
than two registrants might generate their own monitoring data in
response to the DCI.  The total annual burden hours for a Type -1 AR DCI
is estimated to be 27,272 hours,  The Agency projects only two (2) Type
1 AR DCIs will be issued generating one response per DCI.



TABLE 1 

Type 1 AR DCI- Annual Respondent Burden/Cost Estimates for Anticipated
Residues 

Generating Anticipated Residue Data

	

BURDEN HOURS (per year)	

TOTAL

ACTIVITIES	

Mgmt. $103.62	

Tech. 

$67.05	

Cler. 

.$33.85	

Hours	

Costs

1) Read instructions	

2	

0	

0	

2	

207.24

2) Plan activities	

4	

0	

0	

4	

414.48

3) Create information	

0	

13,600	

0	

13,600	

911,880.00

4) Gather information	

0	

16	

0	

16	

1,072.80

5) Compile and review	

1	

8	

0	

9	

 640.02

6) Complete paperwork	

2	

0	

2	

4	

275.01

7) Maintain and file	

0	

0	

1	

1	

33.85

TOTAL	

9	

13,624	

3	

13,636	

$914,443.40

Type I AR DCI	Burden: 13,636 per response x 1 response x 2 DCIs = 27,272
hours

			Costs: $914,443 per response x 1 response x 2 DCIs = $1,828,886

Type 2 AR DCI - DCI for anticipated residues verification use
information data:

Minimum data captures the burden for cases in which the respondent
verifies that nothing has changed; i.e., the formulation, use rate,
geographic distribution of use, etc. have not changed since the ARs
where used to establish or reassess the tolerance.  The EPA estimates
that this verification for updating use information is estimated at 69
burden hours per response.  EPA estimates that no more than 10
respondents each year will comply with a DCI by submitting a base set of
data for updating use information.  As such, the total respondent burden
hours per year are estimated at 690 hours.  See Table 2.

TABLE 2

Type 2 AR DCI - Annual Respondent Burden/Cost Estimates for Anticipated
Residues Requiring Minimum Data for Verifying Use Information 

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $103.62	

Tech. 

$67.05	

Cler. $

33.85	

Hours	

Costs

1) Read Instructions	

8	

0	

0	

8	

828.96

2) Plan Activities	

16	

0	

0	

16	

1657.92

3) Create Information	

0	

0	

0	

0	

0

4) Gather Information	

0	

16	

0	

16	

1072.80

5) Compile and Review	

2	

16	

0	

18	

1280.04

6) Complete Paperwork	

2	

0	

8	

10	

470.04

7) Submit and File	

0	

0	

1	

1	

33.85

Total	

28	

32	

9	

69	

$5,293.61

Type 2 AR DCI 	Burden: 69 per response x 10 responses x 1 DCI = 690
hours

			Cost: $5,294 per response x 10 responses x 1 DCI = $52,940.    

Type 3 AR DCI  - DCI for anticipated residues collected from publicly
available sources:

The average respondent burden for submitting a base set of data for
updating monitoring information is estimated at 137 burden hours per
year.  EPA estimates that an average of 4 respondents each year is
likely to be able to comply with a DCI by submitting data from publicly
available sources.  As such, the total annual respondent burden for this
type of DCI is estimated to be 548 burden hours.  See Table 3.

TABLE 3  

Type 3 AR DCI: Annual Respondent Burden/Cost Estimates for Anticipated
Residues Collected from Publicly Available Sources

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $103.62	

Tech.

$67.05	

Cler. 

$33.85	

Hours	

Costs

1) Read Instructions	

8	

0	

0	

8	

828.96

2) Plan Activities	

16	

0	

0	

16	

1,657.96

3) Create Information	

0	

0	

0	

0	

0

4) Gather Information	

0	

60	

0	

60	

4,023.00

5) Compile and Review	

2	

40	

0	

42	

2889.24

6) Complete Paperwork	

2	

0	

8	

10	

478.04

7) Submit and File	

0	

0	

1	

1	

33.85

Total	

28	

100	

9	

137	

9,911.05

Type 3 AR DCI  	Burden: 137 per response x 4 responses x 1 DCI = 548
hours.

		Cost:  $9,911 per response x 4 responses x 1 DCI = $39,644

Type 4 PCT DCI - DCI for percent crop treated using existing
information:  

The annual per respondent burden for generating percent crop treated
estimates using existing information is estimated to be 59 burden hours.
 Percent crop treated estimates are generally conducted within the
Agency, and only in rare instances would a registrant need to gather the
information; one DCI  per year impacting one respondent is probably an
overestimation.  The estimated costs assume that cost of purchasing or
obtaining percent crop treated information derived from existing,
contracted data sources.  See Table 4.



TABLE 4 

Type 4 PCT DCI - Annual Respondent Burden/Cost Estimates for Percent
Crop Treated Using Existing Information

	

Burden Hours (per year)	

Total

 Activities	

Mgmt. $103.62	

Tech. 

$67.05	

Cler.

$33.85	

Hours	

Costs

1) Read Instructions	

  1	

  1	

  0	

  2	

1070.67

2) Plan Activities	

  0	

  2	

  0	

  2	

134.1

3) Create  Information	

  0	

  8	

  0	

  8	

536.4

4) Gather Information	

  0	

 22	

  0	

 22	

1475.1

5) Compile and Review	

  1	

 20	

  0	

 21	

1444.62

6) Complete Paperwork	

  1	

  0	

  2	

  3	

1071.6732

7) Submit and File	

  0	

  0	

  1	

  1	

33.85

Total	

  3	

 53	

  3	

 59	

$3,96566..4061

Type 4 PCT DCI -	Burden: 59 hours per response x 1 response x 1 DCI= 59
hours 

			Cost: $3,96566 per response x 1 response x 1 DCI = $3,96566  

6(b)	Estimating Respondent Costs - AR/PCT DCIs

The total annual cost for all respondents of AR and PCT DCIs is
estimated to be $1,925,4356.  Respondent costs are based on managerial,
technical and clerical burden hours estimated at $103.62, $67.05, and
$33.85 per hour, respectively.  For a period of some years when
estimating the labor rates for most OPP program ICR renewals, the Agency
adjusted the ICR renewal labor rates by using the NASA Gross Domestic
Product (GDP) Deflator Inflation Calculator to index the labor cost for
a particular year.  However, in July 2006 Agency economist completely
re-estimated wages , benefits, and overhead for all labor categories for
the pesticide industry, state government, and Agency employees.  The
rates are lower than those used in the previous ICR.  However, the
Agency believes these rates are a more accurate refection of the current
market labor rates.  The Agency analysis uses currently available
information on labor rates and other benefits form publicly available
websites. .   A copy of the methodology and formulas used to re-estimate
the labor rates, derive the fully loaded rates and overhead costs are
listed in Attachment G for respondents and Attachment H for the Agency. 
      

6(c)	Estimating Agency Burden and Costs – AR/PCT

The Agency’s annual burden hours and costs for developing DCI
correspondence, communication with registrants, developing documents,
tracking and storing the evaluation of the data submissions, and other
DCI processing activities is detailed in Table 5 and Table 6 below.  The
methodology for used to calculate the Agency labor rates is detailed in
Attachment X.  Costs are indexed to 2006 dollars).  For this renewal,
EPA projects the same number of burden hours associated with the
performance of the duties issuing and processing AR DCIs as was
projected in the last ICR.   Thus, like the last ICR, this renewal will
project the Agency will process 4 AR DCIs and 1 PCT DCI annually.  

TABLE 5  

Annual Estimated Agency Burden Hour and Cost 

For Processing AR DCIs Types 1-3

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $101.16	

Tech. 

$66.88	

Cler. 

$39.23	

Hours	

Costs

Develop DCI notice	

  1	

  0	

  2	

  3	

179.62

Answer Registrants' questions	

  0	

  4	

  5	

  9	

463.67

IN-process data submissions	

  0	

  0	

  4	

  4	

156.92

Analyze data	

  1	

 80	

  0	

 81	

5451.56

Record and store DCI data	

  0	

  0	

  2	

  2	

78.46

Total	

  2	

 84	

 13	

 99	

$6,330.23

AR DCIs Types 1-3  	

Annual Estimated Agency Burden: 99 hours x 16 responses = 1,584 hrs

Annual Estimated Agency Cost: $6,330 x 16 responses = $101,280. 

TABLE 6 

Annual Estimated Agency Burden Hours and Costs for 

Processing Type 4 - PCT DCIs 

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $101.16	

Tech. 

$66.88	

Cler. 

$39.23	

Hours	

Costs

Develop DCI notice	

  1	

  0	

  2	

  3	

140.39

Answer Registrants' questions	

  0	

  4	

  5	

  9	

463.67

IN-process data submissions	

  0	

  0	

  4	

  4	

156.92

Analyze data	

  1	

 40	

  0	

 41	

2776.36

Record and store DCI data	

  0	

  0	

  2	

  2	

78.46

Total	

  2	

 44	

 13	

 59	

$3615.80

Type 4 PCT DCIs  - Estimated Annual Agency Burden Activities  

Hours: 59 hours x 1 response = 59 hours

Costs: $3,616 x 1 response = $3,616

6(d)	Bottom Line Burden Hours and Cost Table

The total estimated annual respondent burden is 28,569 burden hours
(28,509 burden hours for all AR DCI submissions + 59 burden hours for
PCT DCI submissions), with an associated cost of $1,925,4356
($1,921,4701 or all AR DCI submissions + $3,965 for PCT DCI submissions)
see table below.  

The total estimated annual Agency burden is 1,643 burden hours (1,584
burden hours for all AR DCI submissions + 59 burden hours for PCT DCI
submissions), with an associated cost of $104,896 ($101,280 for all AR
DCI submissions + $3,616 for PCT DCI submissions). See Table 7 below.   

Table 7 

Annual Bottom Line Hours and Costs/Master Table  

	

Key Activities	

Hours	

Costs

Respondents	

Type 1- DCI: generating anticipated residue data.	

27,272	

$1,828,886

	

Type 2- DCI for submitting minimal verification of use information  	

690	

$52,940

	

Type 3- submitting anticipated residue data from publicly available
sources	

548	

$39,644

	

Type 4- submitting percent crop treated data using existing information.

59	

$3,9656

Total estimated respondent burden/costs.	

28,569	

$1,926,4356

Agency 	

Type 1-3 AR DCIs for managing anticipated residue DCI’s	

1,584	101,280

	

Type -4 PCT DCIs for managing percent crop treated DCI’s.	

59	

$3,616

Total Agency burden/costs.	

1,643	

$104,896

6(e)	Reasons for Change in Burden - AR/PCT

For this ICR renewal the annual estimated respondent burden hours are
28,569 hours at a cost of $1,925,4356.  There is no increase in the
burden hours over the last ICR renewal.  However, Tthe costs have
decreased slightly due to the adjustment attributable to EPA’s
methodology which re-estimatedion of  labor rates for industry and the
Agency.  This is a program adjustment.  EPA’s estimate of the burden
breakdown for each individual respondent for each labor category
(management, technical and clerical) remains unchanged from the previous
ICR. . 

6(f)	Burden Statement - AR/PCT

The estimated total respondent burden for this ICR over the next three
years is 85,707 hours with the annual burden hours ranging from 59 hours
to 13,636 hours per response, depending on the type of DCI. 

Part 4-  Section 6:

Estimating the Burden and Cost of the Collection for the Enforcement and
Unanticipated Incidents   



Part 4 describes the burden activities associated with the Enforcement
and Unanticipated Incident DCI activities.  

6(a)   Estimating Respondent Burden – Enforcement and Unanticipated
Incident 

The total estimated annual respondent burden hours and costs for
Enforcement and Unanticipated Incident DCI is estimated at 6,266 burden
hours for the life of the ICR.   

 The potential number of DCIs required, the type of data, and the number
of respondents potentially affected is quite variable.  Thus, a this
type of DCI may request data on more than one pesticide, and may involve
two or more respondents who are encouraged to join together to provide
the needed data.  The variability inherent in this type of  DCI means
the estimates serve only as a proxy for what the actual burdens are
likely to be. The annual burden estimate is based on the following
assumptions: (a) that the Agency would issue only one DCI for this type
of activity and only once during the life cycle of the ICR and (b) for
the DCI issued there would be one response.  The Agency has also assumed
an average total test cost of $500,000 per Enforcement and Unanticipated
Incident DCI.  

 Historically, there is very little information documenting the need for
this type of DCI but such events have occurred.  For example one of the
worst cases occurred in 1976 when the  Food an Drug Administration (FDA)
conducting a routine inspection uncovered deficiencies in the manner in
which studies were being conducted at Industrial Biotest Laboratories,
Inc., (IBT) one of the largest independent laboratories in the U.S. at
the time.  By 1978 EPA and FDA were conducting joint audits of two other
IBT facilities and uncovered similar problems and the case had been
referred to the Department of Justice. This turned out to be a massive
undertaking.  Of  the 1205 IBT studies identified by EPA, 801 studies,
or  approximately 66%, were considered significant to regulatory
decisions such as the induction of tumors, birth defects, genetic
mutations, neurotoxicity and other chronic reproductive effects.  Of the
801 studies considered significant to regulatory decisions, 594  were
found to be invalid by EPA and Canada.  By 1983, EPA warned pesticide
product registrants that products supported by invalid health effects
studies conducted by IBT faced suspension action unless replaced by
other tests or a commitment to further testing. (EPA Releases Report on
IBT Lab Studies; Warns of Suspension Action, Environmental News EPA
Press Release, Monday July 11, 1983) (see also House of Representatives,
Committee on Agriculture, Washington, DC, Improving Data- Pesticide
Decisions, July 27 1983; Statement of Edwin Johnson, Director, Office of
Pesticide Programs, Environmental Protection Agency)        

The estimate of respondent burden hours per response for Enforcement and
Unanticipated Incident Activities is 6,266 hours and is based on the
same burden hour break down projected in the 2001 ICR OMB 2070-0122; EPA
no 1503.04 which the Agency allowed to expire 12/31/04.  The estimated
Agency burden hours is based on Agency estimates similar to the burdens
projected for the special review program, 1348 burden hours.  While the
Agency does not anticipate using any of these burden hours, the Agency
will project a one time burden estimate for the three year life cycle of
ICR. Table 1 lists the potential respondent burden hours and costs and
Table 2 lists the potential Agency burden hours and costs and Table 3,
lists the potential  three year bottom line totals for Enforcement and
Unanticipated Incident Activities.   



6(b).	Estimating Respondent Costs - Enforcement Unanticipated Incident
Activities 

The estimated three year cost for all respondents for Enforcement
Unanticipated Incident Activities is estimated to be $420,291.  
Respondent costs are based on managerial, technical and clerical burden
hours estimated at $103.62, $67.05, and $33.85 per hour, respectively.  
      

TABLE 1.   TOTAL RESPONDENT BURDEN/COST ESTIMATES

Enforcement and Unanticipated Incident DCI 

	Burden Hours (per year)	

Totals

Collection Activities	

Mgmt. $103.62	

Tech. $67.05	

Cler.

 $33.85	

Hours	

Costs

1)Read Instructions	

2	

0	

0	

2	

207.24

2)Plan Activities	

2	

0	

0	

2	

207.24

3)Create  Information	

0	

6,249	

0	

6,249	

418,6995.45

4)Gather Information	

0	

3	

0	

3	

201.15

5)Compile and Review	

1	

4	

0	

5	

371.82

6)Complete Paperwork	

2	

0	

2	

4	

274.94

7)Submit and File	

0	

0	

1	

1	

33.85

Total	

7	

6,256	

3	

6,266	

420,291.69

TOTAL BURDEN HOURS: 6,266 hours x 1 response = 6,266 hours 

TOTAL BURDEN COSTS: $420,291 x 1 response = $420,291 

6(c).  	Estimating Agency Burden and Cost - Enforcement Unanticipated
Incident Activities 

TABLE 2:  TOTAL AGENCY BURDEN AND HOURS COST 

Enforcement And Unanticipated Incident  DCI 

	Collection 

Activities	

	Burden Hours 	

Total

	

	Mgmt.

	$101.16/hr	

	Tech.

	$66.88/hr	

	Cler.

	$39.23/hr	

Hours	

Cost

Develop DCI correspondence needed	

32	

	160	

	60	

252	

16,291.72

Answer registrants' questions regarding the DCI	

	4	

	160	

	0	

164	

11,105.44

Review and analyze data submissions	

	4	

	880	

	0	

884	

59,259.04

Record DCI submissions	

	0	

	0	

	40	

40	

1569.20

Store Data	

	0	

	0	

      8	

8	

313.84

TOTAL	

	40	

 1,200	

	108	

1,348	

88,539.24

Hours: 1348 per response X 1 responses X 1 DCI =   1348 Hours 

Costs: $88,539 per response X 1 responses X 1 DCI = $88,539 

6(d). 	Bottom Line Burden Hours and Cost Tables/ Master Table for
Enforcement and Unanticipated Incident DCI 

 

Table 3: Bottom Line Burden Hours and Costs/ Master Table  

Enforcement and Unanticipated Incidents	

	

Number of Responses

	

Hours	

 Cost 

	Respondents	6,266	$420,291	1

Agency 	1348	$88,539	1

6(e). 	Reasons for Change in Burden - Enforcement and Unanticipated
Incident DCIs 

This new ICR burden will result in a increase in the total estimated
respondent burden of 6,266 hours for the three year life cycle of this
ICR (or 2067 burden hours annually).  This is a new program activity.   
 

6(f).  Burden Statement - Enforcement and Unanticipated Incident DCIs 

The total respondent burden for the information collection activities
for the three year life cycle of this ICR is estimated to average 6,266
burden hours for Enforcement and Unanticipated Incident activities.

	According to the Paperwork Reduction Act, “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.  For this collection, it is the time reading the regulations,
planning the necessary data collection activities, conducting tests,
analyzing data, generating reports and completing other required
paperwork, and storing, filing, and maintaining the data.  The 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 number for this information collection
appears at the beginning and the end of this document.  In addition OMB
control numbers for EPA’s regulations, after initial display in the
final rule, are listed in 40 CFR part 9.

	 The Agency has established a public docket for this ICR under Docket
ID No. EPA-HQ-OPP-2007-XXX0923X, which is available for online viewing
at   HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. 
This docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.  The docket telephone number is (703)
305-5805.  You may submit comments regarding the Agency's need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques.  

Comments may be submitted to EPA electronically through
http://www.regulations.gov or by mail addressed to Director, Collection
Strategies Division, U.S. Environmental Protection Agency (2822T), 1200
Pennsylvania Ave., NW, Washington, D.C. 20460.  You can also send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention: Desk Office for EPA.  Include docket ID No.
EPA-HQ-OPP-2007-XXXX0923 and OMB control numbers 2070-0057; 2070-0107;
and 2070-0164 in any correspondence but do not submit any DCI or other
related information (e.g., forms, reports, etc.) to these addresses.  

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public
docket established for this ICR under docket identification number
EPA-HQ-OPP-2007-0923.  These attachments are available for online
viewing at   HYPERLINK "http://www.regulations.gov_" 
www.regulations.gov  or otherwise accessed as described in this section
6(f) of the supporting statement.

ATTACHMENT A:	Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 4 - Reregistration of Registered Pesticides. - this
attachment is part of the supporting statement available as part of the
electronic docket. 

ATTACHMENT B: Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) - Sec. 136a.

			Registration of pesticides (includes section 3(g) – Registration
Review; and section 3(c) (2)(B) for Data Call-Ins).  This attachment is
part of the supporting statement available as part of the electronic
docket.  

  			  

ATTACHMENT C: 40 CFR Parts 9 and 155, Pesticides; Procedural Regulations
for Registration Review; Final Rule, August 9, 2006 (71 FR 45720).  This
attachment is part of the supporting statement available as part of the
electronic docket.  

 

 ATTACHMENT D:	Federal Food, Drug, and Cosmetic Act (FFDCA); Section 408
- Tolerances and Exemptions for Pesticide Chemical Residues (21 U.S.C.
346a).  This attachment is part of the supporting statement available as
part of the electronic docket.  

ATTACHMENT E:	Reserved for consultations

ATTACHMENT F:	Forms that are commonly associated with Data Call-ins are
listed below and are only available electronically as a PDF file on the
internet cite at   HYPERLINK "http://www.epa.gov/opprd001/forms/" 
http://www.epa.gov/opprd001/forms/ 

	

			EPA Form No. 8570-4 - Confidential Statement of Formula.   This
attachment is only electronically via the Internet.  

			

			EPA Form 8570-27 - Formulator's Exemption Statement. This attachment
is only electronically via the Internet.  

 

 		EPA Form 8570-28 - Certification of Compliance with Data Gap
Procedures, 			This attachment is only electronically via the Internet. 

 

			EPA Form 8570-32 - Certification of Attempt to Enter into an
Agreement with 				Registrants for Development of Data Form.  This
attachment is only available 				electronically via the Internet. 

			EPA Form 8570-34 - Certification with Respect to Citation of Data
Form 

			This attachment is only available electronically via the Internet. 

			EPA Form 8570-35 - Data Matrix Form.  This attachment is only
available 				electronically via the Internet. 

			EPA Form 8570-36 - Summary of the Physical/Chemical Properties Form 

			This attachment is only available electronically via the Internet. 

			EPA Form 8570-37 - Self-Certification Statement for the
Physical/Chemical Properties.   This attachment is only available
electronically via the Internet.

			The forms below have been approved with the DCI related ICRs by OMB
for several years, although no official EPA Form number had been
assigned in the past.  These two forms are automatically generated by
EPA’s computer databases and are pre-populated with information that
is specific to each individual registrant that receives a Data Call-In
notice for a given pesticide.  These forms are not widely accessible to
general public.  

			Data Call-In Response Form – This form is a part of Attachment F
and is only available as an electronic attachment to the supporting
statement.  This form can  be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007-0923 

			Requirements Status and Registrant’s Response - This form is a part
of Attachment F and is only available as an electronic attachment to the
supporting statement.  This form can only be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007-0923 

ATTACHMENT G:  General Methodology Used to Estimate Paperwork Burden
Hours and Costs by the Office of Pesticide Programs for Submission of
Required Data/Information for Responding to a Data Call-In Notice.  This
document can only be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007- 0923.

 

ATTACHMENT H: 	Work Sheets to Calculate Industry and EPA Labor Costs -
this attachment is part of the supporting statement available as part of
the electronic docket EPA-HQ-OPP-2007-0923.



Attachment A

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 

Section 4 - Reregistration of Registered Pesticides

SEC. 4. [7 U.S.C. 136a–1] REREGISTRATION OF REGISTERED PESTICIDES. 

(a) GENERAL RULE.—The Administrator shall reregister, in accordance
with this section, each registered pesticide containing any active
ingredient contained in any pesticide first registered before November
1, 1984, except for any pesticide as to which the Administrator has
determined, after November 1, 1984, and before the effective date of
this section [December 24, 1988], that— 

(1) there are no outstanding data requirements; and (2) the requirements
of section 3(c)(5) have been satisfied. 

(b) REREGISTRATION PHASES.—Reregistrations of pesticides under this
section shall be carried out in the following phases: 

(1) The first phase shall include the listing under subsection (c) of
the active ingredients of the pesticides that will be reregistered. 

(2) The second phase shall include the submission to the Administrator
under subsection (d) of notices by registrants respecting their
intention to seek reregistration, identification by registrants of
missing and inadequate data for such pesticides, and commitments by
registrants to replace such missing or inadequate data within the
applicable time period.

(3) The third phase shall include submission to the Administrator by
registrants of the information required under subsection (e). 

(4) The fourth phase shall include an independent, initial review by the
Administrator under subsection (f) of submissions under phases two and
three, identification of outstanding data requirements, and the
issuance, as necessary, of requests for additional data. 

(5) The fifth phase shall include the review by the Administrator under
subsection (g) of data submitted for reregistration and appropriate
regulatory action by the Administrator. 

(c) PHASE ONE.— 

(1) PRIORITY FOR REREGISTRATION.—For purposes of the reregistration of
the pesticides described in subsection (a), the Administrator shall list
the active ingredients of pesticides and shall give priority to, among
others, active ingredients (other than active ingredients for which
registration standards have been issued before the effective date of
this section [December 24, 1988]) that — 

(A) are in use on or in food or feed and may result in postharvest
residues; 

(B) may result in residues of potential toxicological concern in potable
ground water, edible fish, or shellfish; 

(C) have been determined by the Administrator before the effective date
of this section [December 24, 1988] to have significant outstanding data
requirements; or 

(D) are used on crops, including in greenhouses and nurseries, where
worker exposure is most likely to occur. 

(2) REREGISTRATION LISTS.—For purposes of reregistration under this
section, the Administrator shall by order— 

(A) not later than 70 days after the effective date of ingredients for
which registration standards have been issued this section [December 24,
1988], list pesticide active before such effective date; 

(B) not later than 4 months after such effective date, list the first
150 pesticide active ingredients, as determined under paragraph (1); 

(C) not later than 7 months after such effective date, list the second
150 pesticide active ingredients, as determined under paragraph (1); and

(D) not later than 10 months after such effective date, list the
remainder of the pesticide active ingredients, as determined under
paragraph (1). 

Each list shall be published in the Federal Register. 

(3) JUDICIAL REVIEW.—The content of a list issued by the Administrator
under paragraph (2) shall not be subject to judicial review. 

(4) NOTICE TO REGISTRANTS.—On the publication of a list of
Administrator shall send by certified mail to the registrants of the
pesticide active ingredients under paragraph (2), the pesticides
containing such active ingredients a notice of the time by which the
registrants are to notify the Administrator under subsection (d) whether
the registrants intend to seek or not to seek reregistration of such
pesticides.

(d) PHASE TWO.— 

(1) IN GENERAL.—The registrant of a pesticide that contains an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) shall submit to the Administrator, within the time period
prescribed by paragraph (4), the notice described in paragraph (2) and
any information, commitment, or offer described in paragraph (3). 

(2) NOTICE OF INTENT TO SEEK OR NOT TO SEEK REREGISTRATION.—

(A) The registrant of a pesticide containing an active ingredient listed
under subparagraph (B), (C), or (D) of subsection (c)(2) shall notify
the Administrator by certified mail whether the registrant intends to
seek or does not intend to seek reregistration of the pesticide.

(B) If a registrant submits a notice under subparagraph (A) of an
intention not to seek reregistration of a pesticide, the Administrator
shall publish a notice in the Federal Register stating that such a
notice has been submitted. 

(3) MISSING OR INADEQUATE DATA.—Each registrant of a pesticide that
contains an active ingredient listed under subparagraph (B), (C), or (D)
of subsection (c)(2) and for which the registrant submitted a notice
under paragraph (2) of an intention to seek reregistration of such
pesticide shall submit to the Administrator—

(A) in accordance with regulations issued by the Administrator under
section 3, an identification of— 

(i) all data that are required by regulation to support the registration
of the pesticide with respect to such active ingredient; 

(ii) data that were submitted by the registrant previously in support of
the registration of the pesticide that are inadequate to meet such
regulations; and 

(iii) data identified under clause (i) that have not been submitted to
the Administrator; and 

(B) either— 

(i) a commitment to replace the data identified under subparagraph
(A)(ii) and submit the data identified under subparagraph (A)(iii)
within the applicable time period prescribed by paragraph (4)(B); or 

(ii) an offer to share in the cost to be incurred by a person who has
made a commitment under clause (i) to replace or submit the data and an
offer to submit to arbitration as described by section 3(c)(2)(B) with
regard to such cost sharing. For purposes of a submission by a
registrant under subparagraph (A)(ii), data are inadequate if the data
are derived from a study with respect to which the registrant is unable
to make the certification prescribed by subsection (e)(1)(G) that the
registrant possesses or has access to the raw data used in or generated
by such study.  For purposes of a submission by a registrant under such
subparagraph, data shall be considered to be inadequate if the data are
derived from a study submitted before January 1, 1970, unless it is
demonstrated to the satisfaction of the Administrator that such data
should be considered to support the registration of the pesticide that
is to be reregistered. 

(4) TIME PERIODS.— 

(A) A submission under paragraph (2) or (3) shall be made — 

(i) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(B), not later than 3 months after the date of
publication of the listing of such active ingredient; 

(ii) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(C), not later than 3 months after the date of
publication of the listing of such active ingredient; and 

(iii) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(D), not later than 3 months after the date of
publication of the listing of such active ingredient.

On application, the Administrator may extend a time period prescribed by
this subparagraph if the Administrator determines that factors beyond
the control of the registrant prevent the registrant from complying with
such period.

(B) A registrant shall submit data in accordance with a commitment
entered into under paragraph (3)(B) within a reasonable period of time,
as determined by the Administrator, but not more than 48 months after
the date the registrant submitted the commitment. The Administrator, on
application of a registrant, may extend the period prescribed by the
preceding sentence by no more than 2 years if extraordinary
circumstances beyond the control of the registrant prevent the
registrant from submitting data within such prescribed period. Upon
application of a registrant, the Administrator shall, in the case of a
minor use, extend the deadline for the production of residue chemistry
data under this subparagraph for data required solely to support that
minor use until the final deadline for submission of data under this
section for the other uses of the pesticide established as of the date
of enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996]
if— 

(i) the data to support other uses of the pesticide on a food are being

provided; 

(ii) the registrant, in submitting a request for such an extension
provides a schedule, including interim dates to measure progress, to
assure that the data production will be completed before the expiration
of the extension period; 

(iii) the Administrator has determined that such extension will not
significantly delay the Administrator’s schedule for issuing a
reregistration eligibility determination required under this section;
and 

(iv) the Administrator has determined that based on existing data, such
extension would not significantly increase the risk of any unreasonable
adverse effect on the environment.4–1  If the Administrator grants an
extension under this subparagraph, the Administrator shall monitor the
development of the data and shall ensure that the registrant is meeting
the schedule for the production of the data.4–1 If Administrator
determines that the registrant is not meeting or the has not met the
schedule for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) or other provisions
of this section, as appropriate, regarding the continued registration of
the affected products with the minor use and shall inform the public of
such action. Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension under
this subparagraph if the Administrator determines that the extension for
the minor use may cause an unreasonable adverse effect on the
environment. In such circumstance, the Administrator shall provide
written notice to the registrant revoking the extension of time for
submission of data. Such data shall instead be due in accordance with
the date then established by the Administrator for submission of the
data. 

(5) CANCELLATION AND REMOVAL.— 

(A) If the registrant of a pesticide does not submit a notice under
paragraph (2) or (3) within the time prescribed by paragraph (4)(A), the
Administrator shall issue a notice of intent to cancel the registration
of such registrant for such pesticide and shall publish the notice in
the Federal Register and allow 60 days for the submission of comments on
the notice. On expiration of such 60 days, the Administrator, by order
and without a hearing, may cancel the registration or take such other
action, including extension of applicable time periods, as may be
necessary to enable reregistration of such pesticide by another person. 

(B)(i) If— 

(I) no registrant of a pesticide containing an active ingredient listed
under subsection (c)(2) notifies the Administrator under paragraph (2)
that the registrant intends to seek reregistration of any pesticide
containing that active ingredient; 

(II) no such registrant complies with paragraph (3)(A); or 

(III) no such registrant makes a commitment under paragraph (3)(B) to
replace or submit all data described in clauses (ii) and (iii) of
paragraph (3)(A); 

the Administrator shall publish in the Federal Register a notice of
intent to remove the active ingredient from the list established under
subsection (c)(2) and a notice of intent to cancel the registrations of
all pesticides containing such active ingredient and shall provide 60
days for comment on such notice.

4–1 Indentation of the following sentences of this subparagraph is so
in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably
should be indented the same as flush matter of this subparagraph. 

(I) during the comment period a person acquires the rights of the
registrant in that registration;

(II) during the comment period that person furnishes a notice of intent
to reregister the pesticide in accordance with paragraph (2); and 

(III) not later than 120 days after the publication of the notice under
this subparagraph, that person has complied with paragraph (3) and the
fee prescribed by subsection (i)(1) has been paid. 

(6) SUSPENSIONS AND PENALTIES.—The Administrator shall issue a notice
of intent to suspend the registration of a pesticide in accordance with
the procedures prescribed by section 3(c)(2)(B)(iv) if the Administrator
determines that (A) progress is insufficient to ensure the submission of
the data required for such pesticide under a commitment made under
paragraph (3)(B) within the time period prescribed by paragraph (4)(B)
or (B) the registrant has not submitted such data to the Administrator
within such time period.  If the registrant does not commit to support a
specific minor use of the pesticide, but is supporting and providing
data in a timely and adequate fashion to support uses of the pesticide
on a food, or if all uses of the pesticide are nonfood uses and the
registrant does not commit to support a specific minor use of the
pesticide but is supporting and providing data in a timely and adequate
fashion to support other nonfood uses of the pesticide, the
Administrator, at the written request of the registrant, shall not take
any action pursuant to this paragraph in regard to such unsupported
minor use until the final deadline established as of the date of
enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996], for
the submission of data under this section for the supported uses
identified pursuant to this paragraph unless the Administrator
determines that the absence of the data is significant enough to cause
human health or environmental concerns. On such a determination the
Administrator may refuse the request for extension by the registrant.
Upon receipt of the request the from the registrant, the Administrator
shall publish in Federal Register a notice of the receipt of the request
and the effective date upon which the uses not being supported will be
voluntarily deleted from the registration pursuant to section 6(f)(1).
If the Administrator grants an extension under this paragraph, the
Administrator shall monitor the development of the data for the uses
being supported and shall ensure that the registrant is meeting the
schedule for the production of such data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may proceed
in accordance with section 3(c)(2)(B)(iv) regarding the continued
registration of the affected products with the minor and other uses and
shall inform the public of such action in accordance with section
6(f)(2). Notwithstanding this subparagraph, the Administrator may deny,
modify, or revoke the temporary extension under this paragraph if the
Administrator determines that the continuation of the minor use may
cause an unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in writing,
to the registrant a notice revoking the temporary extension and
establish a new effective date by which the minor use shall be deleted
from the registration. 

(e) PHASE THREE.— 

(1) INFORMATION ABOUT STUDIES.—Each registrant of a pesticide that
contains an active ingredient listed under subparagraph (B), (C), or (D)
of subsection (c)(2) who has submitted a notice under subsection (d)(2)
of an intent to seek the reregistration of such pesticide shall submit,
in accordance with the guidelines issued under paragraph (4), to the
Administrator— 

(A) a summary of each study concerning the active ingredient previously
submitted by the registrant in support of the registration of a
pesticide containing such active ingredient and considered by the
registrant to be adequate to meet the requirements of section 3 and the
regulations issued under such section; 

(B) a summary of each study concerning the active ingredient previously
submitted by the registrant in support of the registration of a
pesticide containing such active ingredient that may not comply with the
requirements of section 3 and the regulations issued under such section
but which the registrant asserts should be deemed to comply with such
requirements and regulations; 

(C) a reformat of the data from each study summarized under subparagraph
(A) or (B) by the registrant concerning chronic dosing, oncogenicity,
reproductive effects, mutagenicity, neurotoxicity, teratogenicity, or
residue chemistry of the active ingredient that were submitted to the
Administrator before January 1, 1982; 

(D) where data described in subparagraph (C) are not required for the
active ingredient by regulations issued under section 3, a reformat of
acute and subchronic dosing data submitted by the registrant to the
Administrator before January 1, 1982, that the registrant considers to
be adequate to meet the requirements of section 3 and the regulations
issued under such section; 

(E) an identification of data that are required to be submitted to the
Administrator under section 6(a)(2) indicating an adverse effect of the
pesticide; 

(F) an identification of any other information available that in the
view of the registrant supports the registration; 

(G) a certification that the registrant or the Administrator possesses
or has access to the raw data used in or generated by the studies that
the registrant summarized under subparagraph (A) or (B); 

(H) either — 

(i) a commitment to submit data to fill each outstanding data
requirement identified by the registrant; or 

(ii) an offer to share in the cost of developing such data to be
incurred by a person who has made a commitment under clause (i) to
submit such data, and an offer to submit to arbitration as described by
section 3(c)(2)(B) with regard to such cost sharing; and 

(I) evidence of compliance with section 3(c)(1)(D)(ii) and regulations
issued thereunder with regard to previously submitted data as if the
registrant were now seeking the original registration of the pesticide. 

A registrant who submits a certification under subparagraph (G) that is
false shall be considered to have violated this Act and shall be subject
to the penalties prescribed by section 14. 

(2) TIME PERIODS.— 

(A) The information required by paragraph (1) shall be submitted to the 

Administrator— 

(i) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(B), not later than 12 months after the date of
publication of the listing of such active ingredient; 

(ii) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(C), not later than 12 months after the date of
publication of the listing of such active ingredient; and 

(iii) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(D), not later than 12 months after the date of
publication of the listing of such active ingredient.

(B) A registrant shall submit data in accordance with a commitment
entered into under paragraph (1)(H) within a reasonable period of time,
as determined by the Administrator, but not more than 48 months after
the date the registrant submitted the commitment under such paragraph.
The Administrator, on application of a registrant, may extend the period
prescribed by the preceding sentence by no more than 2 years if
extraordinary circumstances beyond the control of the registrant prevent
the registrant from submitting data within such prescribed period. Upon
application of a registrant, the Administrator shall, in the case of a
minor use, extend the deadline for the production of residue chemistry
data under this subparagraph for data required solely to support that
minor use until the final deadline for submission of data under this
section for the other uses of the pesticide established as of the date
of enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996]
if— 

(i) the data to support other uses of the pesticide on a food are being

provided; 

(ii) the registrant, in submitting a request for such an extension
provides a schedule, including interim dates to measure progress, to
assure that the data production will be completed before the expiration
of the extension period; 

(iii) the Administrator has determined that such extension will not
significantly delay the Administrator’s schedule for issuing a
reregistration eligibility determination required under this section;
and 

(iv) the Administrator has determined that based on existing data, such
extension would not significantly increase the risk of any unreasonable
adverse effect on the environment.4–2 If the Administrator grants an
extension under this subparagraph, the Administrator shall monitor the
development of the data and shall ensure that the registrant is meeting
the schedule for the production of the data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) or other provisions
of this section, as appropriate, regarding the continued registration of
the affected products with the minor use and shall inform the public of
such action. 

4–2 Indentation of the following sentences of this subparagraph is so
in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably
should be indented the same as flush matter of this subparagraph.

Notwithstanding the provisions of this subparagraph, the Administrator
may take action to modify or revoke the extension under this
subparagraph if the Administrator determines that the extension for the
minor use may cause an unreasonable adverse effect on the environment.
In such circumstance, the Administrator shall provide written notice to
the registrant revoking the extension of time for submission of data.
Such data shall instead be due in accordance with the date then
established by the Administrator for submission of the data.

(3) CANCELLATION.— 

(A) If the registrant of a pesticide fails to submit the information
required by paragraph (1) within the time prescribed by paragraph (2),
the Administrator, by order and without hearing, shall cancel the
registration of such specific minor use of the pesticide. If the
registrant does not commit to support a pesticide, but is supporting and
providing data in a timely and adequate fashion to support uses of the
pesticide on a food, or if all uses of the pesticide are nonfood uses
and the registrant does not commit to support a specific minor use of
the pesticide but is supporting and providing data in a timely and
adequate fashion to support other nonfood uses of the pesticide, the
Administrator, at the written request of the registrant, shall not take
any action pursuant to this subparagraph in regard to such unsupported
minor use until the final deadline established as of the date of
enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996], for
the submission of data under this section for the supported uses
identified pursuant to this subparagraph unless the Administrator
determines that the absence of the data is significant enough to cause
human health or environmental concerns. On the basis of such
determination, the Administrator may refuse the request for extension by
the registrant. Upon receipt of the request from the registrant, the
Administrator shall publish in the Federal Register a notice of the
receipt of the request and the effective date upon which the uses not
being supported will be voluntarily deleted from the registration
pursuant to section 6(f)(1). If the Administrator grants an extension
under this subparagraph, the Administrator shall monitor the development
of the data for the uses being supported and shall ensure that the
registrant is meeting the schedule for the production of such data. If
the Administrator determines that the registrant is not meeting or has
not met the schedule for the production of such data, the Administrator
may proceed in accordance with section 3(c)(2)(B)(iv) regarding the
continued registration of the affected products with the minor and other
uses and shall inform the public of such action in accordance with
section 6(f)(2). Notwithstanding this subparagraph, the Administrator
may deny, modify, or revoke the temporary extension under this
subparagraph if the Administrator determines that the continuation of
the minor use may cause an unreasonable adverse effect on the
environment. In the event of modification or revocation, the
Administrator shall provide, in writing, to the registrant a notice
revoking the temporary extension and establish a new effective date by
which the minor use shall be deleted from the registration. 

(B)(i) If the registrant of a pesticide submits the information
required by paragraph (1) within the time prescribed by paragraph (2)
and such information does not conform to the guidelines for submissions
established by the Administrator, the Administrator shall determine
whether the registrant made a good faith attempt to conform its
submission to such guidelines. 

(ii) If the Administrator determines that the registrant made a good
faith attempt to conform its submission to such guidelines, the
Administrator shall provide the registrant a reasonable period of time
to make any necessary changes or corrections. 

(iii)(I) If the Administrator determines that the registrant did not
make a good faith attempt to conform its submission to such guidelines,
the Administrator may issue a notice of intent to cancel the
registration. Such a notice shall be sent to the registrant by certified
mail. 

(II) The registration shall be canceled without a hearing or further
notice at the end of 30 days after receipt by the registrant of the
notice unless during that time a request for a hearing is made by the
registrant. 

(III) If a hearing is requested, a hearing shall be conducted under
section 6(d), except that the only matter for resolution at the hearing
shall be whether the registrant made a good faith attempt to conform its
submission to such guidelines. The hearing shall be held and a
determination made within 75 days after receipt of a request for
hearing. 

(4) GUIDELINES.— 

(A) Not later than 1 year after the effective date of this section
[December 24, 1988], the Administrator, by order, shall issue guidelines
to be followed by registrants in— 

(i) summarizing studies; 

(ii) reformatting studies; 

(iii) identifying adverse information; and 

(iv) identifying studies that have been submitted previously that may
not meet the requirements of section 3 or regulations issued under such
section, 

under paragraph (1). 

(B) Guidelines issued under subparagraph (A) shall not be subject to
judicial

review. 

(5) MONITORING.—The Administrator shall monitor the progress of
registrants in acquiring and submitting the data required under
paragraph (1). 

(f) PHASE FOUR.— 

(1) INDEPENDENT REVIEW AND IDENTIFICATION OF OUTSTANDING DATA
REQUIREMENTS.— 

(A) The Administrator shall review the submissions of all registrants of
pesticides containing a particular active ingredient under subsections
(d)(3) and (e)(1) to determine if such submissions identified all the
data that are missing or inadequate for such active ingredient. To
assist the review of the Administrator under this subparagraph, the
Administrator may require a registrant seeking reregistration to submit
complete copies of studies summarized under subsection (e)(1).

(B) The Administrator shall independently identify and publish in the
Federal Register the outstanding data requirements for each active
ingredient that is listed under subparagraph (B), (C), or (D) of
subsection (c)(2) and that is contained in a pesticide to be
reregistered under this section. The Administrator, at the same time,
shall issue a notice under section 3(c)(2)(B) for the submission of the
additional data that are required to meet such requirements.

(2) TIME PERIODS.— 

(A) The Administrator shall take the action required by paragraph (1)—

(i) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(B), not later than 18 months after the date of
the listing of such active ingredient; 

(ii) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(C), not later than 24 months after the date of
the listing of such active ingredient; and 

(iii) in the case of a pesticide containing an active ingredient listed
under subsection (c)(2)(D), not later than 33 months after the date of
the listing of such active ingredient. 

(B) If the Administrator issues a notice to a registrant under paragraph
(1)(B) for the submission of additional data, the registrant shall
submit such data within a reasonable period of time, as determined by
the Administrator, but not to exceed 48 months after the issuance of
such notice. The Administrator, on application of a registrant, may
extend the period prescribed by the preceding sentence by no more than 2
years if extraordinary circumstances beyond the control of the
registrant prevent the registrant from submitting data within such
prescribed period. Upon application of a registrant, the Administrator
shall, in the case of a minor use, extend the deadline for the
production of residue chemistry data under this subparagraph for data
required solely to support that minor use until the final deadline for
submission of data under this section for the other uses of the
pesticide established as of the date of enactment of the Food Quality
Protection Act of 1996 [Aug. 3, 1996] if— 

(i) the data to support other uses of the pesticide on a food are being

provided; 

(ii) the registrant, in submitting a request for such an extension
provides a schedule, including interim dates to measure progress, to
assure that the data production will be completed before the expiration
of the extension period; 

(iii) the Administrator has determined that such extension will not
significantly delay the Administrator’s schedule for issuing a
reregistration eligibility determination required under this section;
and 

(iv) the Administrator has determined that based on existing data, such
extension would not significantly increase the risk of any unreasonable
adverse effect on the environment.4–3 If the Administrator grants an
extension under this subparagraph, the Administrator shall monitor the
development of the data and shall ensure that the registrant is meeting
the schedule for the production of the data. If the Administrator
determines that the registrant is not meeting or has not met the 

4–3 Indentation of the following sentences of this subparagraph is so
in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably
should be indented the same as flush matter of this subparagraph.

schedule for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) or other provisions
of this section, as appropriate, regarding the continued registration of
the affected products with the minor use and shall inform the public of
such action. Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension under
this subparagraph if the Administrator determines that the extension for
the minor use may cause an unreasonable adverse effect on the
environment. In such circumstance, the Administrator shall provide
written notice to the registrant revoking the extension of time for
submission of data. Such data shall instead be due in accordance with
the date then established by the Administrator for submission of the
data.

(3) SUSPENSIONS AND PENALTIES.—The Administrator shall issue a notice
of intent to suspend the registration of a pesticide in accordance with
the procedures prescribed by section 3(c)(2)(B)(iv) if the Administrator
determines that (A) tests necessary to fill an outstanding data
requirement for such pesticide have not been initiated within 1 year
after the issuance of a notice under paragraph (1)(B), or (B) progress
is insufficient to ensure submission of the data referred to in clause
(A) within the time period prescribed by paragraph (2)(B) or the
required data have not been submitted to the Administrator within such
time period. If the registrant does not commit to support a specific
minor use of the pesticide, but is supporting and providing data in a
timely and adequate fashion to support uses of the pesticide on a food,
or if all uses of the pesticide are nonfood uses and the registrant does
not commit to support a specific minor use of the pesticide but is
supporting and providing data in a timely and adequate fashion to
support other nonfood uses of the pesticide, the Administrator, at the
written request of the registrant, shall not take any action pursuant to
this paragraph in regard to such unsupported minor use until the final
deadline established as of the date of enactment of the Food Quality
Protection Act of 1996 [Aug. 3, 1996], for the submission of data under
this section for the supported uses identified pursuant to this
paragraph unless the Administrator determines that the absence of the
data is significant enough to cause human health or environmental
concerns. On such a determination the Administrator may refuse the
request for extension by the registrant. Upon receipt of the request
from the registrant, the Administrator shall publish in the Federal
Register a notice of the receipt of the request and the effective date
upon which the uses not being supported will be voluntarily deleted from
the registration pursuant to section 6(f)(1). If the Administrator
grants an extension under this paragraph, the Administrator shall
monitor the development of the data for the uses being supported and
shall ensure that the registrant is meeting the schedule for the
production of such data. If the Administrator determines that the
registrant is not meeting or has not met the schedule for the production
of such data, the Administrator may proceed in accordance with section
3(c)(2)(B)(iv) regarding the continued registration of the affected
products with the minor and other uses and shall inform the public of
such action in accordance with section 6(f)(2). Notwithstanding this
subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph if the Administrator determines
that the continuation of the minor use may cause an unreasonable adverse
effect on the environment. In the event of modification or revocation,
the Administrator shall provide, in writing, to the registrant a notice
revoking the temporary extension and establish a new effective date by
which the minor use shall be deleted from the registration. 

(g) PHASE FIVE.— 

(1) DATA REVIEW.—The Administrator shall conduct a thorough
examination of all data submitted under this section concerning an
active ingredient listed under subsection (c)(2) and of all other
available data found by the Administrator to be relevant. 

(2) REREGISTRATION AND OTHER ACTIONS.— 

(A) IN GENERAL.—The Administrator shall make a determination as to
eligibility for reregistration— 

(i) for all active ingredients subject to reregistration under this
section for which tolerances or exemptions from tolerances are required
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
not later than the last date for tolerance reassessment established
under section 408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)); and 

(ii) for all other active ingredients subject to reregistration under
this section, not later than October 3, 2008. 

(B) PRODUCT-SPECIFIC DATA.— 

(i) IN GENERAL.—Before reregistering a pesticide, the Administrator
shall obtain any needed product-specific data regarding the pesticide by
use of section 3(c)(2)(B) and shall review such data within 90 days
after its submission.

(ii) TIMING.— 

(I) IN GENERAL.—Subject to subclause (II), the Administrator shall
require that data under this subparagraph be submitted to the
Administrator not later than 8 months after a determination of
eligibility under subparagraph (A) has been made for each active
ingredient of the pesticide, unless the Administrator determines that a
longer period is required for the generation of the data.

(II) EXTRAORDINARY CIRCUMSTANCES.—In the case of extraordinary
circumstances, the  Administrator may provide such a longer period, of
not more than 2 additional years, for submission of data to the
Administrator under this subparagraph.

(C) After conducting the review required by paragraph (1) for each
active ingredient of a pesticide and the review required by subparagraph
(B) of this paragraph, the Administrator shall determine whether to
reregister a pesticide by determining whether such pesticide meets the
requirements of section 3(c)(5). If the Administrator determines that a
pesticide is eligible to be reregistered, the Administrator shall
reregister such pesticide within 6 months after the submission of the
data concerning such pesticide under subparagraph (B). 

(D) DETERMINATION TO NOT REREGISTER.— 

(i) IN GENERAL.—If after conducting a review under paragraph (1) or
subparagraph (B) of this paragraph the Administrator determines that a
pesticide should not be reregistered, the Administrator shall take
appropriate regulatory action. 

(ii) TIMING FOR REGULATORY ACTION.—Regulatory action under clause (i)
shall be completed as expeditiously as possible. 

(E) As soon as the Administrator has sufficient information with respect
to the dietary risk of a particular active ingredient, but in any event
no later than the time the Administrator makes a determination under
subparagraph (C) or (D) with respect to pesticides containing a
particular active ingredient, the Administrator shall— 

(i) reassess each associated tolerance and exemption from the
requirement for a tolerance issued under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a); 

(ii) determine whether such tolerance or exemption meets the
requirements of that Act; 

(iii) determine whether additional tolerances or exemptions should be

issued; 

(iv) publish in the Federal Register a notice setting forth the
determinations made under this subparagraph; and 

(v) commence promptly such proceedings under this Act and section 408 of
the Federal Food, Drug, and Cosmetic Act as are warranted by such
determinations. 

(h) COMPENSATION OF DATA SUBMITTER.—If data that are submitted by a
registrant under subsection (d), (e), (f), or (g) are used to support
the application of another person under section 3, the registrant who
submitted such data shall be entitled to compensation for the use of
such data as prescribed by section 3(c)(1)(D). In determining the amount
of such compensation, the fees paid by the registrant under this section
shall be taken into account. 

(i) FEES.— 

(1) INITIAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS.—The
registrants of pesticides that contain an active ingredient that is
listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that
is an active ingredient of any pesticide registered for a major food or
feed use shall collectively pay a fee of $50,000 on submission of
information under paragraphs (2) and (3) of subsection (d) for such
ingredient. 

(2) FINAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS.— 

(A) The registrants of pesticides that contain an active ingredient that
is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and
that is an active ingredient of any pesticide registered for a major
food or feed use shall collectively pay a fee of $100,000— 

(i) on submission of information for such ingredient under subsection
(e)(1) if data are reformatted under subsection (e)(1)(C); or 

(ii) on submission of data for such ingredient under subsection
(e)(2)(B) if data are not reformatted under subsection (e)(1)(C). 

(B) The registrants of pesticides that contain an active ingredient that
is listed under subsection (c)(2)(A) and that is an active ingredient of
any pesticide registered for a major food or feed use shall collectively
pay a fee of $150,000 at such time as the Administrator shall prescribe.

(3) FEES FOR OTHER PESTICIDE ACTIVE INGREDIENTS.— 

(A) The registrants of pesticides that contain an active ingredient
that is listed under subparagraph (B), (C), or (D) of subsection (c)(2)
and that is not an active ingredient of any pesticide registered for a
major food or feed use shall collectively pay fees in amounts determined
by the Administrator. Such fees may not be less than one-half of, nor
greater than, the fees required by paragraphs (1) and (2). A registrant
shall pay such fees at the times corresponding to the times fees
prescribed by paragraphs (1) and (2) are to be paid. 

(B) The registrants of pesticides that contain an active ingredient that
is listed under subsection (c)(2)(A) and that is not an active
ingredient of any pesticide that is registered for a major food or feed
use shall collectively pay a fee of not more than $100,000 and not less
than $50,000 at such time as the Administrator shall prescribe. 

(4) REDUCTION OR WAIVER OF FEES FOR MINOR USE AND OTHER PESTICIDES.—

(A) An active ingredient that is contained only in pesticides that are
registered solely for agricultural or nonagricultural minor uses, or a
pesticide the value or volume of use of which is small, shall be exempt
from the fees prescribed by paragraph (3). 

(B) The Administrator shall exempt any public health pesticide from the
payment of the fee prescribed under paragraph (3) if, in consultation
with the Secretary of Health and Human Services, the Administrator
determines, based on information supplied by the registrant, that the
economic return to the registrant from sales of the pesticide does not
support the registration or reregistration of the pesticide. 

(C) An antimicrobial active ingredient, the production level of which
does not exceed 1,000,000 pounds per year, shall be exempt from the fees
prescribed by paragraph (3). For purposes of this subparagraph, the term
“antimicrobial active ingredient” means any active ingredient that
is contained only in pesticides that are not registered for any food or
feed use and that are —

(i) sanitizers intended to reduce the number of living bacteria or
viable virus particles on inanimate surface or in water or air; 

(ii) bacteriostats intended to inhibit the growth of bacteria in the
presence of moisture; 

(iii) disinfectants intended to destroy or irreversibly inactivate
bacteria, fungi, or viruses on surfaces or inanimate objects; 

(iv) sterilizers intended to destroy viruses and all living bacteria,
fungi, and their spores on inanimate surfaces; or 

(v) fungicides or fungistats. 

(D)(i) Notwithstanding any other provision of this subsection, in the
case of a small business registrant of a pesticide, the registrant shall
pay a fee for the reregistration of each active ingredient of the
pesticide that does not exceed an amount determined in accordance with
this subparagraph. 

(ii) If during the 3-year period prior to reregistration the average
annual gross revenue of the registrant from pesticides containing such
active ingredient is— 

(I) less than $5,000,000, the registrant shall pay 0.5 percent of such

revenue; 

(II) $5,000,000 or more but less than $10,000,000, the registrant shall
pay 1 percent of such revenue; or 

(III) $10,000,000 or more, the registrant shall pay 1.5 percent of such
revenue, but not more than $150,000. 

(iii) For the purpose of this subparagraph, a small business registrant
is a corporation, partnership, or unincorporated business that— 

(I) has 150 or fewer employees; and

(II) during the 3-year period prior reregistration, had an average
annual gross revenue from to chemicals that did not exceed $40,000,000. 

(5) MAINTENANCE FEE.— 

(A) IN GENERAL.—Subject to other provisions of this paragraph, each
registrant of a pesticide shall pay an annual fee by January 15 of each
year for each registration, except that no fee shall be charged for more
than 200 registrations held by any registrant. 

(B) In the case of a pesticide that is registered for a minor
agricultural use, the Administrator may reduce or waive the payment of
the fee imposed under this paragraph if the Administrator determines
that the fee would significantly reduce the availability of the
pesticide for the use. 

(C) TOTAL AMOUNT OF FEES.—The amount of each fee prescribed under
subparagraph (A) shall be adjusted by the Administrator to a level that
will result in the collection under this paragraph of, to the extent
practicable, an aggregate amount of—

(i) for fiscal year 2004, $26,000,000; 

(ii) for fiscal year 2005, $27,000,000; 

(iii) for fiscal year 2006, $27,000,000; 

(iv) for fiscal year 2007, $21,000,000; and 

(v) for fiscal year 2008, $15,000,000. 

(D) MAXIMUM AMOUNT OF FEES FOR REGISTRANTS.—The maximum annual fee
payable under this paragraph by—

(i) 4–4 a registrant holding not more than 50 pesticide registrations
shall be—

(I) for fiscal year 2004, $84,000; 

(II) for each of fiscal years 2005 and 2006, $87,000; 

(III) for fiscal year 2007, $68,000; and 

(IV) for fiscal year 2008, $55,000; and 

(ii) 4–5 a registrant holding over 50 registrations shall be— 

(I) for fiscal year 2004, $145,000; 

(II) for each of fiscal years 2005 and 2006, $151,000; 

(III) for fiscal year 2007, $117,000; and 

(IV) for fiscal year 2008, $95,000.

4–4 Subclause margins are so in original (as added by sec.
501(c)(1)(B)(ii) of P.L. 108-199). Probably should be further indented.

4–5 Subclause margins are so in original (as added by sec.
501(c)(1)(B)(ii) of P.L. 108-199). Probably should be further indented.

(E) MAXIMUM AMOUNT OF FEES FOR SMALL BUSINESSES.—

(i) IN GENERAL.—For a small business, the maximum annual fee payable
under this paragraph by—

(I) a registrant holding not more than 50 pesticide registrations shall

be—

(aa) for fiscal year 2004, $59,000; 

(bb) for each of fiscal years 2005 and 2006, $61,000; 

(cc) for fiscal year 2007, $48,000; and 

(dd) for fiscal year 2008, $38,500; and 

(II) a registrant holding over 50 pesticide registrations shall be— 

(aa) for fiscal year 2004, $102,000; 

(bb) for each of fiscal years 2005 and 2006, $106,000; 

(cc) for fiscal year 2007, $82,000; and 

(dd) for fiscal year 2008, $66,500. 

(ii) DEFINITION OF SMALL BUSINESS.— 

(I) IN GENERAL.—In clause (i), the term “small business” means a
corporation, partnership, or unincorporated business that—

(aa) has 500 or fewer employees; and 

(bb) during the 3-year period prior to the most recent maintenance fee
billing cycle, had an average annual global gross revenue from
pesticides that did not exceed $60,000,000. 

(II) AFFILIATES.— 

(aa) IN GENERAL.—In the case of a business entity with 1 or more
affiliates, the gross revenue limit under subclause (I)(bb) shall apply
to the gross revenue for the entity and all of the affiliates of the
entity, including parents and subsidiaries, if applicable. 

(bb) AFFILIATED PERSONS.—For the purpose of item (aa), persons are
affiliates of each other if, directly or indirectly, either person
controls or has the power to control the other person, or a third person
controls or has the power to control both persons. 

(cc) INDICIA OF CONTROL.—For the purpose of item (aa), indicia of
control include interlocking management or ownership, identity of
interests among family members, shared facilities and equipment, and
common use of employees. 

(F) The Administrator shall exempt any public health pesticide from the
payment of the fee prescribed under paragraph (3) if, in consultation
with the Secretary of Health and Humans4–6 Services, the Administrator
determines, based on information supplied by the registrant, that the
economic return to the registrant from sales of the pesticide does not
support the registration or reregistration of the pesticide. 

(G) If any fee prescribed by this paragraph with respect to the
registration of a pesticide is not paid by a registrant by the time
prescribed, the Administrator, by order and without hearing, may cancel
the registration.

4–6 So in original (as added by sec. 232(2) of P.L. 104-170). Probably
should be “Human”.

(H) The authority provided under this paragraph shall terminate on
September 30,

2008. 

(6) OTHER FEES.—Except as provided in section 33, during the period
beginning on the date of enactment of this section [October 25, 1988]
and ending on September 30, 2010, the Administrator may not levy any
other fees for the registration of a pesticide under this Act except as
provided in paragraphs (1) through (5). 

(7) APPORTIONMENT.— 

(A) If two or more registrants are required to pay any fee prescribed by
paragraph (1), (2), or (3) with respect to a particular active
ingredient, the fees for such active ingredient shall be apportioned
among such registrants on the basis of the market share in United States
sales of the active ingredient for the 3 calendar years preceding the
date of payment of such fee, except that—

(i) small business registrants that produce the active ingredient shall
pay fees in accordance with paragraph (4)(C); and 

(ii) registrants who have no market share but who choose to reregister a
pesticide containing such active ingredient shall pay the lesser of—

(I) 15 percent of the reregistration fee; or

(II) a proportionate amount of such fee based on the lowest percentage
market share held by any registrant active in the marketplace. 

In no event shall registrants who have no market share but who choose to
reregister a pesticide containing such active ingredient collectively
pay more than 25 percent of the total active ingredient reregistration
fee. 

(B) The Administrator, by order, may require any registrant to submit
such reports as the Administrator determines to be necessary to allow
the Administrator to determine and apportion fees under this subsection,
to determine the registrant’s eligibility for a reduction or waiver of
a fee, or to determine the volume usage for public health pesticides. 

(C) If any such report is not submitted by a registrant after receiving
notice of such report requirement, or if any fee prescribed by this
subsection (other than paragraph (5)) for an active ingredient is not
paid by a registrant to the Administrator by the time prescribed under
this subsection, the Administrator, by order and without hearing, may
cancel each registration held by such registrant of a pesticide
containing the active ingredient with respect to reapportion the fee
among the remaining registrants and notify which the fee is imposed. The
Administrator shall the registrants that the registrants are required to
pay to the Administrator any unpaid balance of the fee within 30 days
after receipt of such notice. 

(j) EXEMPTION OF CERTAIN REGISTRANTS.—The requirements of subsections
(d), (e), (f), and (i) (other than subsection (i)(5)) regarding data
concerning an active ingredient and fees for review of such data shall
not apply to any person who is the registrant of a pesticide to the
extent that, under section 3(c)(2)(D), the person would not be required
to submit or cite such data to obtain an initial registration of such
pesticide. 

(k) REREGISTRATION AND EXPEDITED PROCESSING FUND.— 

(1) ESTABLISHMENT.—There shall be established in the Treasury of the
United States a reregistration and expedited processing fund which shall
be known as the Reregistration and Expedited Processing Fund.4–7

(2) 4–8 SOURCE AND USE.— 

(A) All moneys derived from fees collected by the Administrator under
subsection (i) shall be deposited in the fund and shall be available to
the Administrator, without fiscal year limitation, specifically to
offset the costs of reregistration and expedited processing of the
applications specified in paragraph (3). Such moneys derived from fees
may not be expended in any fiscal year to the extent such moneys derived
from fees would exceed money appropriated for use by the Administrator
and expended in such year for such costs of reregistration and expedited
processing of such applications. The Administrator shall, prior to
expending any such moneys derived from fees— 

(i) effective October 1, 1997, adopt specific and cost accounting rules
and procedures as approved by the General Accounting Office and the
Inspector General of the Environmental Protection Agency to ensure that
moneys derived from fees are allocated solely to the costs of
reregistration and expedited processing applications specified in
paragraph (3) in the same of the portion as appropriated funds; 

(ii) prohibit the use of such moneys derived from fees to pay for any
costs other than those necessary to achieve reregistration and expedited
processing of the applications specified in paragraph (3); and 

(iii) ensure that personnel and facility costs associated with the
functions to be carried out under this paragraph do not exceed agency
averages for comparable personnel and facility costs. 

(B) The Administrator shall also— 

(i) complete the review of unreviewed reregistration studies required to
support the reregistration eligibility decisions scheduled for
completion in accordance with subsection (l)(2); and 

(ii) contract for such outside assistance as may be necessary for review
of required studies, using a generally accepted competitive process for
the selection of vendors of such assistance. 

(3) REVIEW OF INERT INGREDIENTS; EXPEDITED PROCESSING OF SIMILAR
APPLICATIONS.— 

4–7  ADVANCE \d1 Sec. 501(b) of P.L. 104-170 amended sec. 4(k)(1) (7
U.S.C. 136a–1(k)(1)) by inserting “which shall be known as the
Reregistration and Expedited Processing Fund”, without specifying the
Act that was being amended. The amendment was executed to this Act to
effectuate the probable intent of Congress. 

 ADVANCE \d1 	4–8 Sec. 501(c) of P.L. 104-170 amended sec. 4(k)(2) (7
U.S.C. 136a–1(k)(2)) to read as provided above, without specifying the
Act that was being amended. The amendment was executed to this Act to
effectuate the probable intent of Congress.

(A) The Administrator shall use for each of the fiscal years 2004
through 2006, approximately $3,300,000, and for each of fiscal years
2007 and 2008, between 1/8 and 1/7, of the maintenance fees collected in
such fiscal year4–9 to obtain sufficient personnel and resources— 

(i) to review and evaluate new inert ingredients; and 

(ii) to ensure the expedited processing and review of any application 

  4–10 that —— 

(I) proposes the initial or amended registration of an end-use pesticide
that, if registered as proposed, would be identical or substantially
similar in composition and labeling to a currently-registered pesticide
identified in the application, or that would differ in composition and
labeling from any such currently-registered pesticide only in ways that
would not significantly increase the risk of unreasonable adverse
effects on the environment; 

(II) proposes an amendment to the registration of a registered pesticide
that does not require scientific review of data;

(III) proposes the initial or amended or registration of an end use
pesticide that, if registered as proposed, would be used for a public
health pesticide.

(B) Any amounts made available under subparagraph (A) shall be used to
obtain sufficient personnel and resources to carry out the activities
described in such subparagraph that are in addition to the personnel and
resources available to carry out such activities on the date of
enactment of this section [October 25, 1988]. 

(C) 4–11 So long as the Administrator has not met the time frames
specified in clause (ii) of section 3(c)(3)(B) with respect to any
application subject to section 3(c)(3)(B) that was received prior to the
date of enactment of the Food Quality Protection Act of 1996 [Aug. 3,
1996], the Administrator shall use the full amount of the fees specified
in subparagraph (A) for the purposes specified therein. Once all
applications subject to section 3(c)(3)(B) that were received prior to
such date of enactment have been acted upon, no limitation shall be
imposed by the preceding sentence of this subparagraph so long as the
Administrator meets the time frames

4–9 P.L. 107-73 (115 Stat. 686) amended sec. 4(k)(3)(A) by striking
“2001” and inserting “2002”; and by striking “1/7” and
inserting “1/10”. In an earlier enactment, sec. 501(d)(1) of P.L.
104-170 amended sec. 4(k)(3) (7 U.S.C. 136a–1(k)(3)) by striking
“for each of the fiscal years 1992, 1993, and 1994, 1/7th of the
maintenance fees collected, up to 2 million each year” and inserting
“for each of the fiscal years 1997 through 2001, not more than 1/7 of
the maintenance fees collected in such fiscal year”, without
specifying the Act that was being amended and without including a $
before “2 million”. The earlier amendment was executed to this Act,
and to strike “$2 million”, to effectuate the probable intent of
Congress. 

4–10 So in original (as added by sec. 501(e)(2)(C) of P.L. 108-199).
Probably should be no indent before “that”.

4–11 Sec. 501(d)(2) of P.L. 104-170 added subpara. (C) to sec. 4(k)(3)
(7 U.S.C. 136a–1(k)(3)), without specifying the Act that was being
amended. The amendment was executed to this Act to effectuate the
probable intent of Congress.

specified in clause (ii) of section 3(c)(3)(B) on 90 percent of
affected applications in a fiscal year. Should the Administrator not
meet such time frames in a fiscal year, the limitations imposed by the
first sentence of this subparagraph shall apply until all overdue
applications subject to section 3(c)(3)(B) have been acted upon. 

(4) UNUSED FUNDS.—Money in the fund not currently needed to carry out
this section shall be—

(A) maintained on hand or on deposit; 

(B) invested in obligations of the United States or guaranteed thereby;
or 

(C) invested in obligations, participations, or other instruments that
are lawful investments for fiduciary, trust, or public funds. 

(5) 4–12 ACCOUNTING AND PERFORMANCE.—The Administrator shall take
all steps necessary to ensure that expenditures from fees authorized by
subsection (i)(5)(C)(ii) are used only to carry out the goals
established under subsection (l). The Reregistration and Expedited
Processing Fund shall be designated as an Environmental Protection
Agency component for purposes of section 3515(c) of title 31, United
States Code. The annual audit required under section 3521 of such title
of the financial statements of activities under this Act under section
3515(b) of such title shall include an audit of the fees collected under
subsection (i)(5)(C) and disbursed, of the amount appropriated to match
such fees, and of the Administrator’s attainment of performance
measures and goals established under subsection (l). Such an audit shall
also include a review of the reasonableness of the overhead allocation
and adequacy of disclosures of direct and indirect costs associated with
carrying out the reregistration and expedited processing of the
applications specified in paragraph (3), and the basis for and accuracy
of all costs paid with moneys derived from such fees. The Inspector
General shall conduct the annual audit and report the findings and
recommendations of such audit to the Administrator and to the Committees
on Agriculture of the House of Representatives and the Senate. The cost
of such audit shall be paid for out of the fees collected under
subsection (i)(5)(C). 	

(l) 4–13 PERFORMANCE MEASURES AND GOAL.—The Administrator shall
establish and publish annually in the Federal Register performance
measures and goals. Such measures and goals shall include— 

(1) the number of products reregistered, canceled, or amended, the
status of reregistration, the number and type of data requests under
section 3(c)(2)(B) issued to support product reregistration by active
ingredient, the progress in reducing the number of unreviewed, required
reregistration studies, the aggregate status of tolerances reassessed,
and the number of applications for registration submitted under
subsection (k)(3) that were approved or disapproved; 

4–12 Sec. 501(e) of P.L. 104-170 amended sec. 4(k)(5) (7 U.S.C.
136a–1(k)(5)) to read as provided above, without specifying the Act
that was being amended. The amendment was executed to this Act to
effectuate the probable intent of Congress.

4–13 Sec. 501(f) of P.L. 104-170 amended sec. 4 (7 U.S.C. 136a–1) by
redesignating subsecs. (l) and (m) as subsecs. (m) and (n),
respectively, and inserting a new subsec. (l), without specifying the
Act that was being amended. The amendments were executed to this Act to
effectuate the probable intent of Congress.

(2) the future schedule for reregistrations, including the projection
for such schedules that will be issued under subsection (g)(2)(A) and
(B) in the current fiscal year and the succeeding fiscal year; and 

(3) the projected year of completion of the reregistrations under this
section. 

(m) JUDICIAL REVIEW.—Any failure of the Administrator to take any
action required by this section shall be subject to judicial review
under the procedures prescribed by section 16(b). 

(n) AUTHORIZATION OF FUNDS TO DEVELOP PUBLIC HEALTH DATA.— 

(1) DEFINITION.—For the purposes of this section, “Secretary”
means the Secretary of Health and Human Services, acting through the
Public Health Service. 

(2) CONSULTATION.—In the case of a pesticide registered for use in
public health programs for vector control or for other uses the
Administrator determines to be human health protection uses, the
Administrator shall, upon timely request by the registrant or any other
interested person, or on the Administrator’s own initiative may,
consult with the Secretary prior to taking final action to suspend
registration under section 3(c)(2)(B)(iv), or cancel a registration
under section 4, 6(e), or 6(f). In consultation with the Secretary, the
Administrator shall prescribe the form and content of requests under
this section. 

(3) BENEFITS TO SUPPORT FAMILY.—The Administrator, after consulting
with the Secretary, shall make a determination whether the potential
benefits of continued use of the pesticide for public health or health
protection purposes are of such significance as to warrant a commitment
by the Secretary to conduct or to arrange for the conduct of the studies
required by the Administrator to support continued registration under
section 3 or reregistration under section 4. 

(4) ADDITIONAL TIME.—If the Administrator determines that such a
commitment is warranted and in the public interest, the Administrator
shall notify the Secretary and shall, to the extent necessary, amend a
notice issued under section 3(c)(2)(B) to specify additional reasonable
time periods for submission of the data.

(5) ARRANGEMENTS.—The Secretary shall make such arrangements for the
conduct of required studies as the Secretary finds necessary and
appropriate to permit submission of data in accordance with the time
periods prescribed by the Administrator. Such arrangements may include
Public Health Service intramural research activities, grants, contracts,
or cooperative agreements with academic, public health, or other
organizations qualified by experience and training to conduct such
studies. 

(6) SUPPORT.—The Secretary may provide for support of the required
studies using funds authorized to be appropriated under this section,
the Public Health Service Act, or other appropriate authorities. After a
determination is made under subsection (d), the Secretary shall notify
the Committees on Appropriations of the House of Representatives and the
Senate of the sums required to conduct the necessary studies. 

(7) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be
appropriated to carry out the purposes of this section $12,000,000 for
fiscal year 1997, and such sums as may be necessary for succeeding
fiscal years.

Attachment B

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - Sec. 136a.
	

Registration of pesticides (includes section 3(g) and Registration
Review; 

and section 3(c) (2)(B) for Data Call-Ins)     



From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

  January 3, 2005 and April 21, 2006]

[CITE: 7USC136a]

 

                          TITLE 7--AGRICULTURE

 

       CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL

 

             SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL

 

Sec. 136a. Registration of pesticides

(a) Requirement of registration

    Except as provided by this subchapter, no person in any State may 

distribute or sell to any person any pesticide that is not registered 

under this subchapter. To the extent necessary to prevent unreasonable 

adverse effects on the environment, the Administrator may by regulation 

limit the distribution, sale, or use in any State of any pesticide that 

is not registered under this subchapter and that is not the subject of 

an experimental use permit under section 136c of this title or an 

emergency exemption under section 136p of this title.

(b) Exemptions

    A pesticide which is not registered with the Administrator may be 

transferred if--

        (1) the transfer is from one registered establishment to another

    registered establishment operated by the same producer solely for 

    packaging at the second establishment or for use as a constituent 

    part of another pesticide produced at the second establishment; or

        (2) the transfer is pursuant to and in accordance with the 

    requirements of an experimental use permit.

(c) Procedure for registration

                       (1) Statement required

        Each applicant for registration of a pesticide shall file with 

    the Administrator a statement which includes--

            (A) the name and address of the applicant and of any other 

        person whose name will appear on the labeling;

            (B) the name of the pesticide;

            (C) a complete copy of the labeling of the pesticide, a 

        statement of all claims to be made for it, and any directions 

        for its use;

            (D) the complete formula of the pesticide;

            (E) a request that the pesticide be classified for general 

        use or for restricted use, or for both; and

            (F) except as otherwise provided in paragraph (2)(D), if 

        requested by the Administrator, a full description of the tests 

        made and the results thereof upon which the claims are based, or

        alternatively a citation to data that appear in the public 

        literature or that previously had been submitted to the 

        Administrator and that the Administrator may consider in 

        accordance with the following provisions:

                (i) With respect to pesticides containing active 

            ingredients that are initially registered under this 

            subchapter after September 30, 1978, data submitted to 

            support the application for the original registration of the

            pesticide, or an application for an amendment adding any new

            use to the registration and that pertains solely to such new

            use, shall not, without the written permission of the 

            original data submitter, be considered by the Administrator 

            to support an application by another person during a period 

            of ten years following the date the Administrator first 

            registers the pesticide, except that such permission shall 

            not be required in the case of defensive data.

                (ii) The period of exclusive data use provided under 

            clause (i) shall be extended 1 additional year for each 3 

            minor uses registered after August 3, 1996, and within 7 

            years of the commencement of the exclusive use period, up to

            a total of 3 additional years for all minor uses registered 

            by the Administrator if the Administrator, in consultation 

            with the Secretary of Agriculture, determines that, based on

            information provided by an applicant for registration or a 

            registrant, that--

                    (I) there are insufficient efficacious alternative 

                registered pesticides available for the use;

                    (II) the alternatives to the minor use pesticide 

                pose greater risks to the environment or human health;

                    (III) the minor use pesticide plays or will play a 

                significant part in managing pest resistance; or

                    (IV) the minor use pesticide plays or will play a 

                significant part in an integrated pest management 

                program.

          The registration of a pesticide for a minor use on a crop 

            grouping established by the Administrator shall be 

            considered for purposes of this clause 1 minor use for each 

            representative crop for which data are provided in the crop 

            grouping. Any additional exclusive use period under this 

            clause shall be modified as appropriate or terminated if the

            registrant voluntarily cancels the product or deletes from 

            the registration the minor uses which formed the basis for 

            the extension of the additional exclusive use period or if 

            the Administrator determines that the registrant is not 

            actually marketing the product for such minor uses.

                (iii) Except as otherwise provided in clause (i), with 

            respect to data submitted after December 31, 1969, by an 

            applicant or registrant to support an application for 

            registration, experimental use permit, or amendment adding a

            new use to an existing registration, to support or maintain 

            in effect an existing registration, or for reregistration, 

            the Administrator may, without the permission of the 

            original data submitter, consider any such item of data in 

            support of an application by any other person (hereinafter 

            in this subparagraph referred to as the ``applicant'') 

            within the fifteen-year period following the date the data 

            were originally submitted only if the applicant has made an 

            offer to compensate the original data submitter and 

            submitted such offer to the Administrator accompanied by 

            evidence of delivery to the original data submitter of the 

            offer. The terms and amount of compensation may be fixed by 

            agreement between the original data submitter and the 

            applicant, or, failing such agreement, binding arbitration 

            under this subparagraph. If, at the end of ninety days after

            the date of delivery to the original data submitter of the 

            offer to compensate, the original data submitter and the 

            applicant have neither agreed on the amount and terms of 

            compensation nor on a procedure for reaching an agreement on

            the amount and terms of compensation, either person may 

            initiate binding arbitration proceedings by requesting the 

            Federal Mediation and Conciliation Service to appoint an 

            arbitrator from the roster of arbitrators maintained by such

            Service. The procedure and rules of the Service shall be 

            applicable to the selection of such arbitrator and to such 

            arbitration proceedings, and the findings and determination 

            of the arbitrator shall be final and conclusive, and no 

            official or court of the United States shall have power or 

            jurisdiction to review any such findings and determination, 

            except for fraud, misrepresentation, or other misconduct by 

            one of the parties to the arbitration or the arbitrator 

            where there is a verified complaint with supporting 

            affidavits attesting to specific instances of such fraud, 

            misrepresentation, or other misconduct. The parties to the 

            arbitration shall share equally in the payment of the fee 

            and expenses of the arbitrator. If the Administrator 

            determines that an original data submitter has failed to 

            participate in a procedure for reaching an agreement or in 

            an arbitration proceeding as required by this subparagraph, 

            or failed to comply with the terms of an agreement or 

            arbitration decision concerning compensation under this 

            subparagraph, the original data submitter shall forfeit the 

            right to compensation for the use of the data in support of 

            the application. Notwithstanding any other provision of this

            subchapter, if the Administrator determines that an 

            applicant has failed to participate in a procedure for 

            reaching an agreement or in an arbitration proceeding as 

            required by this subparagraph, or failed to comply with the 

            terms of an agreement or arbitration decision concerning 

            compensation under this subparagraph, the Administrator 

            shall deny the application or cancel the registration of the

            pesticide in support of which the data were used without 

            further hearing. Before the Administrator takes action under

            either of the preceding two sentences, the Administrator 

            shall furnish to the affected person, by certified mail, 

            notice of intent to take action and allow fifteen days from 

            the date of delivery of the notice for the affected person 

            to respond. If a registration is denied or canceled under 

            this subparagraph, the Administrator may make such order as 

            the Administrator deems appropriate concerning the continued

            sale and use of existing stocks of such pesticide. 

            Registration action by the Administrator shall not be 

            delayed pending the fixing of compensation.

                (iv) After expiration of any period of exclusive use and

            any period for which compensation is required for the use of

            an item of data under clauses (i), (ii), and (iii), the 

            Administrator may consider such item of data in support of 

            an application by any other applicant without the permission

            of the original data submitter and without an offer having 

            been received to compensate the original data submitter for 

            the use of such item of data.

                (v) The period of exclusive use provided under clause 

            (ii) shall not take effect until 1 year after August 3, 

            1996, except where an applicant or registrant is applying 

            for the registration of a pesticide containing an active 

            ingredient not previously registered.

                (vi) With respect to data submitted after August 3, 

            1996, by an applicant or registrant to support an amendment 

            adding a new use to an existing registration that does not 

            retain any period of exclusive use, if such data relates 

            solely to a minor use of a pesticide, such data shall not, 

            without the written permission of the original data 

            submitter, be considered by the Administrator to support an 

            application for a minor use by another person during the 

            period of 10 years following the date of submission of such 

            data. The applicant or registrant at the time the new minor 

            use is requested shall notify the Administrator that to the 

            best of their knowledge the exclusive use period for the 

            pesticide has expired and that the data pertaining solely to

            the minor use of a pesticide is eligible for the provisions 

            of this paragraph. If the minor use registration which is 

            supported by data submitted pursuant to this subsection is 

            voluntarily canceled or if such data are subsequently used 

            to support a nonminor use, the data shall no longer be 

            subject to the exclusive use provisions of this clause but 

            shall instead be considered by the Administrator in 

            accordance with the provisions of clause (i), as 

            appropriate.

            (G) If the applicant is requesting that the registration or 

        amendment to the registration of a pesticide be expedited, an 

        explanation of the basis for the request must be submitted, in 

        accordance with paragraph (10) of this subsection.

                 (2) Data in support of registration

        (A) In general

            The Administrator shall publish guidelines specifying the 

        kinds of information which will be required to support the 

        registration of a pesticide and shall revise such guidelines 

        from time to time. If thereafter the Administrator requires any 

        additional kind of information under subparagraph (B) of this 

        paragraph, the Administrator shall permit sufficient time for 

        applicants to obtain such additional information. The 

        Administrator, in establishing standards for data requirements 

        for the registration of pesticides with respect to minor uses, 

        shall make such standards commensurate with the anticipated 

        extent of use, pattern of use, the public health and 

        agricultural need for such minor use, and the level and degree 

        of potential beneficial or adverse effects on man and the 

        environment. The Administrator shall not require a person to 

        submit, in relation to a registration or reregistration of a 

        pesticide for minor agricultural use under this subchapter, any 

        field residue data from a geographic area where the pesticide 

        will not be registered for such use. In the development of these

        standards, the Administrator shall consider the economic factors

        of potential national volume of use, extent of distribution, and

        the impact of the cost of meeting the requirements on the 

        incentives for any potential registrant to undertake the 

        development of the required data. Except as provided by section 

        136h of this title, within 30 days after the Administrator 

        registers a pesticide under this subchapter the Administrator 

        shall make available to the public the data called for in the 

        registration statement together with such other scientific 

        information as the Administrator deems relevant to the 

        Administrator's decision.

        (B) Additional data

            (i) If the Administrator determines that additional data are

        required to maintain in effect an existing registration of a 

        pesticide, the Administrator shall notify all existing 

        registrants of the pesticide to which the determination relates 

        and provide a list of such registrants to any interested person.

            (ii) Each registrant of such pesticide shall provide 

        evidence within ninety days after receipt of notification that 

        it is taking appropriate steps to secure the additional data 

        that are required. Two or more registrants may agree to develop 

        jointly, or to share in the cost of developing, such data if 

        they agree and advise the Administrator of their intent within 

        ninety days after notification. Any registrant who agrees to 

        share in the cost of producing the data shall be entitled to 

        examine and rely upon such data in support of maintenance of 

        such registration. The Administrator shall issue a notice of 

        intent to suspend the registration of a pesticide in accordance 

        with the procedures prescribed by clause (iv) if a registrant 

        fails to comply with this clause.

            (iii) If, at the end of sixty days after advising the 

        Administrator of their agreement to develop jointly, or share in

        the cost of developing, data, the registrants have not further 

        agreed on the terms of the data development arrangement or on a 

        procedure for reaching such agreement, any of such registrants 

        may initiate binding arbitration proceedings by requesting the 

        Federal Mediation and Conciliation Service to appoint an 

        arbitrator from the roster of arbitrators maintained by such 

        Service. The procedure and rules of the Service shall be 

        applicable to the selection of such arbitrator and to such 

        arbitration proceedings, and the findings and determination of 

        the arbitrator shall be final and conclusive, and no official or

        court of the United States shall have power or jurisdiction to 

        review any such findings and determination, except for fraud, 

        misrepresentation, or other misconduct by one of the parties to 

        the arbitration or the arbitrator where there is a verified 

        complaint with supporting affidavits attesting to specific 

        instances of such fraud, misrepresentation, or other misconduct.

        All parties to the arbitration shall share equally in the 

        payment of the fee and expenses of the arbitrator. The 

        Administrator shall issue a notice of intent to suspend the 

        registration of a pesticide in accordance with the procedures 

        prescribed by clause (iv) if a registrant fails to comply with 

        this clause.

            (iv) Notwithstanding any other provision of this subchapter,

        if the Administrator determines that a registrant, within the 

        time required by the Administrator, has failed to take 

        appropriate steps to secure the data required under this 

        subparagraph, to participate in a procedure for reaching 

        agreement concerning a joint data development arrangement under 

        this subparagraph or in an arbitration proceeding as required by

        this subparagraph, or to comply with the terms of an agreement 

        or arbitration decision concerning a joint data development 

        arrangement under this subparagraph, the Administrator may issue

        a notice of intent to suspend such registrant's registration of 

        the pesticide for which additional data is required. The 

        Administrator may include in the notice of intent to suspend 

        such provisions as the Administrator deems appropriate 

        concerning the continued sale and use of existing stocks of such

        pesticide. Any suspension proposed under this subparagraph shall

        become final and effective at the end of thirty days from 

        receipt by the registrant of the notice of intent to suspend, 

        unless during that time a request for hearing is made by a 

        person adversely affected by the notice or the registrant has 

        satisfied the Administrator that the registrant has complied 

        fully with the requirements that served as a basis for the 

        notice of intent to suspend. If a hearing is requested, a 

        hearing shall be conducted under section 136d(d) of this title. 

        The only matters for resolution at that hearing shall be whether

        the registrant has failed to take the action that served as the 

        basis for the notice of intent to suspend the registration of 

        the pesticide for which additional data is required, and whether

        the Administrator's determination with respect to the 

        disposition of existing stocks is consistent with this 

        subchapter. If a hearing is held, a decision after completion of

        such hearing shall be final. Notwithstanding any other provision

        of this subchapter, a hearing shall be held and a determination 

        made within seventy-five days after receipt of a request for 

        such hearing. Any registration suspended under this subparagraph

        shall be reinstated by the Administrator if the Administrator 

        determines that the registrant has complied fully with the 

        requirements that served as a basis for the suspension of the 

        registration.

            (v) Any data submitted under this subparagraph shall be 

        subject to the provisions of paragraph (1)(D). Whenever such 

        data are submitted jointly by two or more registrants, an agent 

        shall be agreed on at the time of the joint submission to handle

        any subsequent data compensation matters for the joint 

        submitters of such data.

            (vi) Upon the request of a registrant the Administrator 

        shall, in the case of a minor use, extend the deadline for the 

        production of residue chemistry data under this subparagraph for

        data required solely to support that minor use until the final 

        deadline for submission of data under section 136a-1 of this 

        title for the other uses of the pesticide established as of 

        August 3, 1996, if--

                (I) the data to support other uses of the pesticide on a

            food are being provided;

                (II) the registrant, in submitting a request for such an

            extension, provides a schedule, including interim dates to 

            measure progress, to assure that the data production will be

            completed before the expiration of the extension period;

                (III) the Administrator has determined that such 

            extension will not significantly delay the Administrator's 

            schedule for issuing a reregistration eligibility 

            determination required under section 136a-1 of this title; 

            and

                (IV) the Administrator has determined that based on 

            existing data, such extension would not significantly 

            increase the risk of any unreasonable adverse effect on the 

            environment. If the Administrator grants an extension under 

            this clause, the Administrator shall monitor the development

            of the data and shall ensure that the registrant is meeting 

            the schedule for the production of the data. If the 

            Administrator determines that the registrant is not meeting 

            or has not met the schedule for the production of such data,

            the Administrator may proceed in accordance with clause (iv)

            regarding the continued registration of the affected 

            products with the minor use and shall inform the public of 

            such action. Notwithstanding the provisions of this clause, 

            the Administrator may take action to modify or revoke the 

            extension under this clause if the Administrator determines 

            that the extension for the minor use may cause an 

            unreasonable adverse effect on the environment. In such 

            circumstance, the Administrator shall provide, in writing to

            the registrant, a notice revoking the extension of time for 

            submission of data. Such data shall instead be due in 

            accordance with the date established by the Administrator 

            for the submission of the data.

            (vii) If the registrant does not commit to support a 

        specific minor use of the pesticide, but is supporting and 

        providing data in a timely and adequate fashion to support uses 

        of the pesticide on a food, or if all uses of the pesticide are 

        nonfood uses and the registrant does not commit to support a 

        specific minor use of the pesticide but is supporting and 

        providing data in a timely and adequate fashion to support other

        nonfood uses of the pesticide, the Administrator, at the written

        request of the registrant, shall not take any action pursuant to

        this clause in regard to such unsupported minor use until the 

        final deadline established as of August 3, 1996, for the 

        submission of data under section 136a-1 of this title for the 

        supported uses identified pursuant to this clause unless the 

        Administrator determines that the absence of the data is 

        significant enough to cause human health or environmental 

        concerns. On the basis of such determination, the Administrator 

        may refuse the request for extension by the registrant. Upon 

        receipt of the request from the registrant, the Administrator 

        shall publish in the Federal Register a notice of the receipt of

        the request and the effective date upon which the uses not being

        supported will be voluntarily deleted from the registration 

        pursuant to section 136d(f)(1) of this title. If the 

        Administrator grants an extension under this clause, the 

        Administrator shall monitor the development of the data for the 

        uses being supported and shall ensure that the registrant is 

        meeting the schedule for the production of such data. If the 

        Administrator determines that the registrant is not meeting or 

        has not met the schedule for the production of such data, the 

        Administrator may proceed in accordance with clause (iv) of this

        subparagraph regarding the continued registration of the 

        affected products with the minor and other uses and shall inform

        the public of such action in accordance with section 136d(f)(2) 

        of this title. Notwithstanding the provisions of this clause, 

        the Administrator may deny, modify, or revoke the temporary 

        extension under this subparagraph if the Administrator 

        determines that the continuation of the minor use may cause an 

        unreasonable adverse effect on the environment. In the event of 

        modification or revocation, the Administrator shall provide, in 

        writing, to the registrant a notice revoking the temporary 

        extension and establish a new effective date by which the minor 

        use shall be deleted from the registration.

            (viii)(I) If data required to support registration of a 

        pesticide under subparagraph (A) is requested by a Federal or 

        State regulatory authority, the Administrator shall, to the 

        extent practicable, coordinate data requirements, test 

        protocols, timetables, and standards of review and reduce 

        burdens and redundancy caused to the registrant by multiple 

        requirements on the registrant.

            (II) The Administrator may enter into a cooperative 

        agreement with a State to carry out subclause (I).

            (III) Not later than 1 year after August 3, 1996, the 

        Administrator shall develop a process to identify and assist in 

        alleviating future disparities between Federal and State data 

        requirements.

        (C) Simplified procedures

            Within nine months after September 30, 1978, the 

        Administrator shall, by regulation, prescribe simplified 

        procedures for the registration of pesticides, which shall 

        include the provisions of subparagraph (D) of this paragraph.

        (D) Exemption

            No applicant for registration of a pesticide who proposes to

        purchase a registered pesticide from another producer in order 

        to formulate such purchased pesticide into the pesticide that is

        the subject of the application shall be required to--

                (i) submit or cite data pertaining to such purchased 

            product; or

                (ii) offer to pay reasonable compensation otherwise 

            required by paragraph (1)(D) of this subsection for the use 

            of any such data.

        (E) Minor use waiver

            In handling the registration of a pesticide for a minor use,

        the Administrator may waive otherwise applicable data 

        requirements if the Administrator determines that the absence of

        such data will not prevent the Administrator from determining--

                (i) the incremental risk presented by the minor use of 

            the pesticide; and

                (ii) that such risk, if any, would not be an 

            unreasonable adverse effect on the environment.

                           (3) Application

        (A) In general

            The Administrator shall review the data after receipt of the

        application and shall, as expeditiously as possible, either 

        register the pesticide in accordance with paragraph (5), or 

        notify the applicant of the Administrator's determination that 

        it does not comply with the provisions of the subchapter in 

        accordance with paragraph (6).

        (B) Identical or substantially similar

            (i) The Administrator shall, as expeditiously as possible, 

        review and act on any application received by the Administrator 

        that--

                (I) proposes the initial or amended registration of an 

            end-use pesticide that, if registered as proposed, would be 

            identical or substantially similar in composition and 

            labeling to a currently-registered pesticide identified in 

            the application, or that would differ in composition and 

            labeling from such currently-registered pesticide only in 

            ways that would not significantly increase the risk of 

            unreasonable adverse effects on the environment; or

                (II) proposes an amendment to the registration of a 

            registered pesticide that does not require scientific review

            of data.

            (ii) In expediting the review of an application for an 

        action described in clause (i), the Administrator shall--

                (I) within 45 days after receiving the application, 

            notify the registrant whether or not the application is 

            complete and, if the application is found to be incomplete, 

            reject the application;

                (II) within 90 days after receiving a complete 

            application, notify the registrant if the application has 

            been granted or denied; and

                (III) if the application is denied, notify the 

            registrant in writing of the specific reasons for the denial

            of the application.

        (C) Minor use registration

            (i) The Administrator shall, as expeditiously as possible, 

        review and act on any complete application--

                (I) that proposes the initial registration of a new 

            pesticide active ingredient if the active ingredient is 

            proposed to be registered solely for minor uses, or proposes

            a registration amendment solely for minor uses to an 

            existing registration; or

                (II) for a registration or a registration amendment that

            proposes significant minor uses.

            (ii) For the purposes of clause (i)--

                (I) the term ``as expeditiously as possible'' means that

            the Administrator shall, to the greatest extent practicable,

            complete a review and evaluation of all data, submitted with

            a complete application, within 12 months after the 

            submission of the complete application, and the failure of 

            the Administrator to complete such a review and evaluation 

            under clause (i) shall not be subject to judicial review; 

            and

                (II) the term ``significant minor uses'' means 3 or more

            minor uses proposed for every nonminor use, a minor use that

            would, in the judgment of the Administrator, serve as a 

            replacement for any use which has been canceled in the 5 

            years preceding the receipt of the application, or a minor 

            use that in the opinion of the Administrator would avoid the

            reissuance of an emergency exemption under section 136p of 

            this title for that minor use.

        (D) Adequate time for submission of minor use data

            If a registrant makes a request for a minor use waiver, 

        regarding data required by the Administrator, pursuant to 

        paragraph (2)(E), and if the Administrator denies in whole or in

        part such data waiver request, the registrant shall have a full-

        time period for providing such data. For purposes of this 

        subparagraph, the term ``full-time period'' means the time 

        period originally established by the Administrator for 

        submission of such data, beginning with the date of receipt by 

        the registrant of the Administrator's notice of denial.

                      (4) Notice of application

        The Administrator shall publish in the Federal Register, 

    promptly after receipt of the statement and other data required 

    pursuant to paragraphs (1) and (2), a notice of each application for

    registration of any pesticide if it contains any new active 

    ingredient or if it would entail a changed use pattern. The notice 

    shall provide for a period of 30 days in which any Federal agency or

    any other interested person may comment.

                    (5) Approval of registration

        The Administrator shall register a pesticide if the 

    Administrator determines that, when considered with any restrictions

    imposed under subsection (d) of this section--

            (A) its composition is such as to warrant the proposed 

        claims for it;

            (B) its labeling and other material required to be submitted

        comply with the requirements of this subchapter;

            (C) it will perform its intended function without 

        unreasonable adverse effects on the environment; and

            (D) when used in accordance with widespread and commonly 

        recognized practice it will not generally cause unreasonable 

        adverse effects on the environment.

    The Administrator shall not make any lack of essentiality a 

    criterion for denying registration of any pesticide. Where two 

    pesticides meet the requirements of this paragraph, one should not 

    be registered in preference to the other. In considering an 

    application for the registration of a pesticide, the Administrator 

    may waive data requirements pertaining to efficacy, in which event 

    the Administrator may register the pesticide without determining 

    that the pesticide's composition is such as to warrant proposed 

    claims of efficacy. If a pesticide is found to be efficacious by any

    State under section 136v(c) of this title, a presumption is 

    established that the Administrator shall waive data requirements 

    pertaining to efficacy for use of the pesticide in such State.

                     (6) Denial of registration

        If the Administrator determines that the requirements of 

    paragraph (5) for registration are not satisfied, the Administrator 

    shall notify the applicant for registration of the Administrator's 

    determination and of the Administrator's reasons (including the 

    factual basis) therefor, and that, unless the applicant corrects the

    conditions and notifies the Administrator thereof during the 30-day 

    period beginning with the day after the date on which the applicant 

    receives the notice, the Administrator may refuse to register the 

    pesticide. Whenever the Administrator refuses to register a 

    pesticide, the Administrator shall notify the applicant of the 

    Administrator's decision and of the Administrator's reasons 

    (including the factual basis) therefor. The Administrator shall 

    promptly publish in the Federal Register notice of such denial of 

    registration and the reasons therefor. Upon such notification, the 

    applicant for registration or other interested person with the 

    concurrence of the applicant shall have the same remedies as 

    provided for in section 136d of this title.

            (7) Registration under special circumstances

        Notwithstanding the provisions of paragraph (5)--

            (A) The Administrator may conditionally register or amend 

        the registration of a pesticide if the Administrator determines 

        that (i) the pesticide and proposed use are identical or 

        substantially similar to any currently registered pesticide and 

        use thereof, or differ only in ways that would not significantly

        increase the risk of unreasonable adverse effects on the 

        environment, and (ii) approving the registration or amendment in

        the manner proposed by the applicant would not significantly 

        increase the risk of any unreasonable adverse effect on the 

        environment. An applicant seeking conditional registration or 

        amended registration under this subparagraph shall submit such 

        data as would be required to obtain registration of a similar 

        pesticide under paragraph (5). If the applicant is unable to 

        submit an item of data because it has not yet been generated, 

        the Administrator may register or amend the registration of the 

        pesticide under such conditions as will require the submission 

        of such data not later than the time such data are required to 

        be submitted with respect to similar pesticides already 

        registered under this subchapter.

            (B) The Administrator may conditionally amend the 

        registration of a pesticide to permit additional uses of such 

        pesticide notwithstanding that data concerning the pesticide may

        be insufficient to support an unconditional amendment, if the 

        Administrator determines that (i) the applicant has submitted 

        satisfactory data pertaining to the proposed additional use, and

        (ii) amending the registration in the manner proposed by the 

        applicant would not significantly increase the risk of any 

        unreasonable adverse effect on the environment. Notwithstanding 

        the foregoing provisions of this subparagraph, no registration 

        of a pesticide may be amended to permit an additional use of 

        such pesticide if the Administrator has issued a notice stating 

        that such pesticide, or any ingredient thereof, meets or exceeds

        risk criteria associated in whole or in part with human dietary 

        exposure enumerated in regulations issued under this subchapter,

        and during the pendency of any risk-benefit evaluation initiated

        by such notice, if (I) the additional use of such pesticide 

        involves a major food or feed crop, or (II) the additional use 

        of such pesticide involves a minor food or feed crop and the 

        Administrator determines, with the concurrence of the Secretary 

        of Agriculture, there is available an effective alternative 

        pesticide that does not meet or exceed such risk criteria. An 

        applicant seeking amended registration under this subparagraph 

        shall submit such data as would be required to obtain 

        registration of a similar pesticide under paragraph (5). If the 

        applicant is unable to submit an item of data (other than data 

        pertaining to the proposed additional use) because it has not 

        yet been generated, the Administrator may amend the registration

        under such conditions as will require the submission of such 

        data not later than the time such data are required to be 

        submitted with respect to similar pesticides already registered 

        under this subchapter.

            (C) The Administrator may conditionally register a pesticide

        containing an active ingredient not contained in any currently 

        registered pesticide for a period reasonably sufficient for the 

        generation and submission of required data (which are lacking 

        because a period reasonably sufficient for generation of the 

        data has not elapsed since the Administrator first imposed the 

        data requirement) on the condition that by the end of such 

        period the Administrator receives such data and the data do not 

        meet or exceed risk criteria enumerated in regulations issued 

        under this subchapter, and on such other conditions as the 

        Administrator may prescribe. A conditional registration under 

        this subparagraph shall be granted only if the Administrator 

        determines that use of the pesticide during such period will not

        cause any unreasonable adverse effect on the environment, and 

        that use of the pesticide is in the public interest.

                  (8) Interim administrative review

        Notwithstanding any other provision of this subchapter, the 

    Administrator may not initiate a public interim administrative 

    review process to develop a risk-benefit evaluation of the 

    ingredients of a pesticide or any of its uses prior to initiating a 

    formal action to cancel, suspend, or deny registration of such 

    pesticide, required under this subchapter, unless such interim 

    administrative process is based on a validated test or other 

    significant evidence raising prudent concerns of unreasonable 

    adverse risk to man or to the environment. Notice of the definition 

    of the terms ``validated test'' and ``other significant evidence'' 

    as used herein shall be published by the Administrator in the 

    Federal Register.

                            (9) Labeling

        (A) Additional statements

            Subject to subparagraphs (B) and (C), it shall not be a 

        violation of this subchapter for a registrant to modify the 

        labeling of an antimicrobial pesticide product to include 

        relevant information on product efficacy, product composition, 

        container composition or design, or other characteristics that 

        do not relate to any pesticidal claim or pesticidal activity.

        (B) Requirements

            Proposed labeling information under subparagraph (A) shall 

        not be false or misleading, shall not conflict with or detract 

        from any statement required by law or the Administrator as a 

        condition of registration, and shall be substantiated on the 

        request of the Administrator.

        (C) Notification and disapproval

            (i) Notification

                A registration may be modified under subparagraph (A) 

            if--

                    (I) the registrant notifies the Administrator in 

                writing not later than 60 days prior to distribution or 

                sale of a product bearing the modified labeling; and

                    (II) the Administrator does not disapprove of the 

                modification under clause (ii).

            (ii) Disapproval

                Not later than 30 days after receipt of a notification 

            under clause (i), the Administrator may disapprove the 

            modification by sending the registrant notification in 

            writing stating that the proposed language is not acceptable

            and stating the reasons why the Administrator finds the 

            proposed modification unacceptable.

            (iii) Restriction on sale

                A registrant may not sell or distribute a product 

            bearing a disapproved modification.

            (iv) Objection

                A registrant may file an objection in writing to a 

            disapproval under clause (ii) not later than 30 days after 

            receipt of notification of the disapproval.

            (v) Final action

                A decision by the Administrator following receipt and 

            consideration of an objection filed under clause (iv) shall 

            be considered a final agency action.

        (D) Use dilution

            The label or labeling required under this subchapter for an 

        antimicrobial pesticide that is or may be diluted for use may 

        have a different statement of caution or protective measures for

        use of the recommended diluted solution of the pesticide than 

        for use of a concentrate of the pesticide if the Administrator 

        determines that--

                (i) adequate data have been submitted to support the 

            statement proposed for the diluted solution uses; and

                (ii) the label or labeling provides adequate protection 

            for exposure to the diluted solution of the pesticide.

              (10) Expedited registration of pesticides

        (A) Not later than 1 year after August 3, 1996, the 

    Administrator shall, utilizing public comment, develop procedures 

    and guidelines, and expedite the review of an application for 

    registration of a pesticide or an amendment to a registration that 

    satisfies such guidelines.

        (B) Any application for registration or an amendment, including 

    biological and conventional pesticides, will be considered for 

    expedited review under this paragraph. An application for 

    registration or an amendment shall qualify for expedited review if 

    use of the pesticide proposed by the application may reasonably be 

    expected to accomplish 1 or more of the following:

            (i) Reduce the risks of pesticides to human health.

            (ii) Reduce the risks of pesticides to nontarget organisms.

            (iii) Reduce the potential for contamination of groundwater,

        surface water, or other valued environmental resources.

            (iv) Broaden the adoption of integrated pest management 

        strategies, or make such strategies more available or more 

        effective.

        (C) The Administrator, not later than 30 days after receipt of 

    an application for expedited review, shall notify the applicant 

    whether the application is complete. If it is found to be 

    incomplete, the Administrator may either reject the request for 

    expedited review or ask the applicant for additional information to 

    satisfy the guidelines developed under subparagraph (A).

(d) Classification of pesticides

     (1) Classification for general use, restricted use, or both

        (A) As a part of the registration of a pesticide the 

    Administrator shall classify it as being for general use or for 

    restricted use. If the Administrator determines that some of the 

    uses for which the pesticide is registered should be for general use

    and that other uses for which it is registered should be for 

    restricted use, the Administrator shall classify it for both general

    use and restricted use. Pesticide uses may be classified by 

    regulation on the initial classification, and registered pesticides 

    may be classified prior to reregistration. If some of the uses of 

    the pesticide are classified for general use, and other uses are 

    classified for restricted use, the directions relating to its 

    general uses shall be clearly separated and distinguished from those

    directions relating to its restricted uses. The Administrator may 

    require that its packaging and labeling for restricted uses shall be

    clearly distinguishable from its packaging and labeling for general 

    uses.

        (B) If the Administrator determines that the pesticide, when 

    applied in accordance with its directions for use, warnings and 

    cautions and for the uses for which it is registered, or for one or 

    more of such uses, or in accordance with a widespread and commonly 

    recognized practice, will not generally cause unreasonable adverse 

    effects on the environment, the Administrator will classify the 

    pesticide, or the particular use or uses of the pesticide to which 

    the determination applies, for general use.

        (C) If the Administrator determines that the pesticide, when 

    applied in accordance with its directions for use, warnings and 

    cautions and for the uses for which it is registered, or for one or 

    more of such uses, or in accordance with a widespread and commonly 

    recognized practice, may generally cause, without additional 

    regulatory restrictions, unreasonable adverse effects on the 

    environment, including injury to the applicator, the Administrator 

    shall classify the pesticide, or the particular use or uses to which

    the determination applies, for restricted use:

            (i) If the Administrator classifies a pesticide, or one or 

        more uses of such pesticide, for restricted use because of a 

        determination that the acute dermal or inhalation toxicity of 

        the pesticide presents a hazard to the applicator or other 

        persons, the pesticide shall be applied for any use to which the

        restricted classification applies only by or under the direct 

        supervision of a certified applicator.

            (ii) If the Administrator classifies a pesticide, or one or 

        more uses of such pesticide, for restricted use because of a 

        determination that its use without additional regulatory 

        restriction may cause unreasonable adverse effects on the 

        environment, the pesticide shall be applied for any use to which

        the determination applies only by or under the direct 

        supervision of a certified applicator, or subject to such other 

        restrictions as the Administrator may provide by regulation. Any

        such regulation shall be reviewable in the appropriate court of 

        appeals upon petition of a person adversely affected filed 

        within 60 days of the publication of the regulation in final 

        form.

                    (2) Change in classification

        If the Administrator determines that a change in the 

    classification of any use of a pesticide from general use to 

    restricted use is necessary to prevent unreasonable adverse effects 

    on the environment, the Administrator shall notify the registrant of

    such pesticide of such determination at least forty-five days before

    making the change and shall publish the proposed change in the 

    Federal Register. The registrant, or other interested person with 

    the concurrence of the registrant, may seek relief from such 

    determination under section 136d(b) of this title.

    (3) Change in classification from restricted use to general 

                                     use

        The registrant of any pesticide with one or more uses classified

    for restricted use may petition the Administrator to change any such

    classification from restricted to general use. Such petition shall 

    set out the basis for the registrant's position that restricted use 

    classification is unnecessary because classification of the 

    pesticide for general use would not cause unreasonable adverse 

    effects on the environment. The Administrator, within sixty days 

    after receiving such petition, shall notify the registrant whether 

    the petition has been granted or denied. Any denial shall contain an

    explanation therefor and any such denial shall be subject to 

    judicial review under section 136n of this title.

(e) Products with same formulation and claims

    Products which have the same formulation, are manufactured by the 

same person, the labeling of which contains the same claims, and the 

labels of which bear a designation identifying the product as the same 

pesticide may be registered as a single pesticide; and additional names 

and labels shall be added to the registration by supplemental 

statements.

(f) Miscellaneous

           (1) Effect of change of labeling or formulation

        If the labeling or formulation for a pesticide is changed, the 

    registration shall be amended to reflect such change if the 

    Administrator determines that the change will not violate any 

    provision of this subchapter.

                   (2) Registration not a defense

        In no event shall registration of an article be construed as a 

    defense for the commission of any offense under this subchapter. As 

    long as no cancellation proceedings are in effect registration of a 

    pesticide shall be prima facie evidence that the pesticide, its 

    labeling and packaging comply with the registration provisions of 

    the subchapter.

           (3) Authority to consult other Federal agencies

        In connection with consideration of any registration or 

    application for registration under this section, the Administrator 

    may consult with any other Federal agency.

    (4) Mixtures of nitrogen stabilizers and fertilizer products

        Any mixture or other combination of--

            (A) 1 or more nitrogen stabilizers registered under this 

        subchapter; and

            (B) 1 or more fertilizer products,

    shall not be subject to the provisions of this section or sections 

    136a-1, 136c, 136e, 136m, and 136o(a)(2) of this title if the 

    mixture or other combination is accompanied by the labeling required

    under this subchapter for the nitrogen stabilizer contained in the 

    mixture or other combination, the mixture or combination is mixed or

    combined in accordance with such labeling, and the mixture or 

    combination does not contain any active ingredient other than the 

    nitrogen stabilizer.

(g) Registration review

                          (1) General rule

        (A) Periodic review

            The registrations of pesticides are to be periodically 

        reviewed. The Administrator shall by regulation establish a 

        procedure for accomplishing the periodic review of 

        registrations. The goal of these regulations shall be a review 

        of a pesticide's registration every 15 years. No registration 

        shall be canceled as a result of the registration review process

        unless the Administrator follows the procedures and substantive 

        requirements of section 136d of this title.

        (B) Limitation

            Nothing in this subsection shall prohibit the Administrator 

        from undertaking any other review of a pesticide pursuant to 

        this subchapter.

                              (2) Data

        (A) Submission required

            The Administrator shall use the authority in subsection 

        (c)(2)(B) of this section to require the submission of data when

        such data are necessary for a registration review.

        (B) Data submission, compensation, and exemption

            For purposes of this subsection, the provisions of 

        subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this section 

        shall be utilized for and be applicable to any data required for

        registration review.

(h) Registration requirements for antimicrobial pesticides

                      (1) Evaluation of process

        To the maximum extent practicable consistent with the degrees of

    risk presented by an antimicrobial pesticide and the type of review 

    appropriate to evaluate the risks, the Administrator shall identify 

    and evaluate reforms to the antimicrobial registration process that 

    would reduce review periods existing as of August 3, 1996, for 

    antimicrobial pesticide product registration applications and 

    applications for amended registration of antimicrobial pesticide 

    products, including--

            (A) new antimicrobial active ingredients;

            (B) new antimicrobial end-use products;

            (C) substantially similar or identical antimicrobial 

        pesticides; and

            (D) amendments to antimicrobial pesticide registrations.

                (2) Review time period reduction goal

        Each reform identified under paragraph (1) shall be designed to 

    achieve the goal of reducing the review period following submission 

    of a complete application, consistent with the degree of risk, to a 

    period of not more than--

            (A) 540 days for a new antimicrobial active ingredient 

        pesticide registration;

            (B) 270 days for a new antimicrobial use of a registered 

        active ingredient;

            (C) 120 days for any other new antimicrobial product;

            (D) 90 days for a substantially similar or identical 

        antimicrobial product;

            (E) 90 days for an amendment to an antimicrobial 

        registration that does not require scientific review of data; 

        and

            (F) 120 days for an amendment to an antimicrobial 

        registration that requires scientific review of data and that is

        not otherwise described in this paragraph.

                         (3) Implementation

        (A) Proposed rulemaking

            (i) Issuance

                Not later than 270 days after August 3, 1996, the 

            Administrator shall publish in the Federal Register proposed

            regulations to accelerate and improve the review of 

            antimicrobial pesticide products designed to implement, to 

            the extent practicable, the goals set forth in paragraph 

            (2).

            (ii) Requirements

                Proposed regulations issued under clause (i) shall--

                    (I) define the various classes of antimicrobial use 

                patterns, including household, industrial, and 

                institutional disinfectants and sanitizing pesticides, 

                preservatives, water treatment, and pulp and paper mill 

                additives, and other such products intended to 

                disinfect, sanitize, reduce, or mitigate growth or 

                development of microbiological organisms, or protect 

                inanimate objects, industrial processes or systems, 

                surfaces, water, or other chemical substances from 

                contamination, fouling, or deterioration caused by 

                bacteria, viruses, fungi, protozoa, algae, or slime;

                    (II) differentiate the types of review undertaken 

                for antimicrobial pesticides;

                    (III) conform the degree and type of review to the 

                risks and benefits presented by antimicrobial pesticides

                and the function of review under this subchapter, 

                considering the use patterns of the product, toxicity, 

                expected exposure, and product type;

                    (IV) ensure that the registration process is 

                sufficient to maintain antimicrobial pesticide efficacy 

                and that antimicrobial pesticide products continue to 

                meet product performance standards and effectiveness 

                levels for each type of label claim made; and

                    (V) implement effective and reliable deadlines for 

                process management.

            (iii) Comments

                In developing the proposed regulations, the 

            Administrator shall solicit the views from registrants and 

            other affected parties to maximize the effectiveness of the 

            rule development process.

        (B) Final regulations

            (i) Issuance

                The Administrator shall issue final regulations not 

            later than 240 days after the close of the comment period 

            for the proposed regulations.

            (ii) Failure to meet goal

                If a goal described in paragraph (2) is not met by the 

            final regulations, the Administrator shall identify the 

            goal, explain why the goal was not attained, describe the 

            element of the regulations included instead, and identify 

            future steps to attain the goal.

            (iii) Requirements

                In issuing final regulations, the Administrator shall--

                    (I) consider the establishment of a certification 

                process for regulatory actions involving risks that can 

                be responsibly managed, consistent with the degree of 

                risk, in the most cost-efficient manner;

                    (II) consider the establishment of a certification 

                process by approved laboratories as an adjunct to the 

                review process;

                    (III) use all appropriate and cost-effective review 

                mechanisms, including--

                        (aa) expanded use of notification and non-

                    notification procedures;

                        (bb) revised procedures for application review; 

                    and

                        (cc) allocation of appropriate resources to 

                    ensure streamlined management of antimicrobial 

                    pesticide registrations; and

                    (IV) clarify criteria for determination of the 

                completeness of an application.

        (C) Expedited review

            This subsection does not affect the requirements or extend 

        the deadlines or review periods contained in subsection (c)(3) 

        of this section.

        (D) Alternative review periods

            If the final regulations to carry out this paragraph are not

        effective 630 days after August 3, 1996, until the final 

        regulations become effective, the review period, beginning on 

        the date of receipt by the Agency of a complete application, 

        shall be--

                (i) 2 years for a new antimicrobial active ingredient 

            pesticide registration;

                (ii) 1 year for a new antimicrobial use of a registered 

            active ingredient;

                (iii) 180 days for any other new antimicrobial product;

                (iv) 90 days for a substantially similar or identical 

            antimicrobial product;

                (v) 90 days for an amendment to an antimicrobial 

            registration that does not require scientific review of 

            data; and

                (vi) 120 days for an amendment to an antimicrobial 

            registration that requires scientific review of data and 

            that is not otherwise described in this subparagraph.

        (E) Wood preservatives

            An application for the registration, or for an amendment to 

        the registration, of a wood preservative product for which a 

        claim of pesticidal activity listed in section 136(mm) of this 

        title is made (regardless of any other pesticidal claim that is 

        made with respect to the product) shall be reviewed by the 

        Administrator within the same period as that established under 

        this paragraph for an antimicrobial pesticide product 

        application, consistent with the degree of risk posed by the use

        of the wood preservative product, if the application requires 

        the applicant to satisfy the same data requirements as are 

        required to support an application for a wood preservative 

        product that is an antimicrobial pesticide.

        (F) Notification

            (i) In general

                Subject to clause (iii), the Administrator shall notify 

            an applicant whether an application has been granted or 

            denied not later than the final day of the appropriate 

            review period under this paragraph, unless the applicant and

            the Administrator agree to a later date.

            (ii) Final decision

                If the Administrator fails to notify an applicant within

            the period of time required under clause (i), the failure 

            shall be considered an agency action unlawfully withheld or 

            unreasonably delayed for purposes of judicial review under 

            chapter 7 of title 5.

            (iii) Exemption

                This subparagraph does not apply to an application for 

            an antimicrobial pesticide that is filed under subsection 

            (c)(3)(B) of this section prior to 90 days after August 3, 

            1996.

            (iv) Limitation

                Notwithstanding clause (ii), the failure of the 

            Administrator to notify an applicant for an amendment to a 

            registration for an antimicrobial pesticide shall not be 

            judicially reviewable in a Federal or State court if the 

            amendment requires scientific review of data within--

                    (I) the time period specified in subparagraph 

                (D)(vi), in the absence of a final regulation under 

                subparagraph (B); or

                    (II) the time period specified in paragraph (2)(F), 

                if adopted in a final regulation under subparagraph (B).

                          (4) Annual report

        (A) Submission

            Beginning on August 3, 1996, and ending on the date that the

        goals under paragraph (2) are achieved, the Administrator shall,

        not later than March 1 of each year, prepare and submit an 

        annual report to the Committee on Agriculture of the House of 

        Representatives and the Committee on Agriculture, Nutrition, and

        Forestry of the Senate.

        (B) Requirements

            A report submitted under subparagraph (A) shall include a 

        description of--

                (i) measures taken to reduce the backlog of pending 

            registration applications;

                (ii) progress toward achieving reforms under this 

            subsection; and

                (iii) recommendations to improve the activities of the 

            Agency pertaining to antimicrobial registrations.

(June 25, 1947, ch. 125, Sec. 3, as added Pub. L. 92-516, Sec. 2, Oct. 

21, 1972, 86 Stat. 979; amended Pub. L. 94-140, Sec. 12, Nov. 28, 1975, 

89 Stat. 755; Pub. L. 95-396, Secs. 2(a), 3-8, Sept. 30, 1978, 92 Stat. 

820, 824-827; Pub. L. 100-532, title I, Secs. 102(b), 103, title VI, 

Sec. 601(b)(1), title VIII, Sec. 801(b), Oct. 25, 1988, 102 Stat. 2667, 

2677, 2680; Pub. L. 101-624, title XIV, Sec. 1492, Nov. 28, 1990, 104 

Stat. 3628; Pub. L. 102-237, title X, Sec. 1006(a)(3), (b)(1), (2), (c),

Dec. 13, 1991, 105 Stat. 1894-1896; Pub. L. 104-170, title I, 

Secs. 105(b), 106(b), title II, Secs. 210(b), (c)(1), (d), (e), (f)(2), 

222-224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494-1497, 1499, 1503, 

1504, 1508, 1510; Pub. L. 108-199, div. G, title V, Sec. 501(b), Jan. 

23, 2004, 118 Stat. 419.)

                            Prior Provisions

    A prior section 3 of act June 25, 1947, was classified to section 

135a of this title prior to amendment of act June 25, 1947, by Pub. L. 

92-516.

                               Amendments

    2004--Subsec. (h)(2)(F). Pub. L. 108-199, Sec. 501(b)(1), 

substituted ``120 days'' for ``90 to 180 days''.

    Subsec. (h)(3)(D)(vi). Pub. L. 108-199, Sec. 501(b)(2)(A), 

substituted ``120 days'' for ``240 days''.

    Subsec. (h)(3)(F)(iv). Pub. L. 108-199, Sec. 501(b)(2)(B), added cl.

(iv).

    1996--Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104-170, Sec. 210(b), 

added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii) 

as (iii) and (iv), respectively, and in cl. (iv) substituted ``(i), 

(ii), and (iii)'' for ``(i) and (ii)''.

    Subsec. (c)(1)(G). Pub. L. 104-170, Sec. 250(1), added subpar. (G).

    Subsec. (c)(2)(A). Pub. L. 104-170, Secs. 210(d)(1), 231, inserted 

heading, inserted ``the public health and agricultural need for such 

minor use,'' after ``pattern of use,'', and substituted ``potential 

beneficial or adverse effects on man and the environment'' for 

``potential exposure of man and the environment to the pesticide''.

    Subsec. (c)(2)(B). Pub. L. 104-170, Sec. 210(d)(2), inserted 

heading.

    Subsec. (c)(2)(B)(vi). Pub. L. 104-170, Sec. 210(c)(1), added cl. 

(vi).

    Subsec. (c)(2)(B)(vii). Pub. L. 104-170, Sec. 210(f)(2), added cl. 

(vii).

    Subsec. (c)(2)(B)(viii). Pub. L. 104-170, Sec. 222, added cl. 

(viii).

    Subsec. (c)(2)(C). Pub. L. 104-170, Sec. 210(d)(3), inserted 

heading.

    Subsec. (c)(2)(E). Pub. L. 104-170, Sec. 210(d)(4), added subpar. 

(E).

    Subsec. (c)(3)(A), (B). Pub. L. 104-170, Sec. 210(e)(1), (2), 

inserted headings.

    Subsec. (c)(3)(C), (D). Pub. L. 104-170, Sec. 210(e)(3), added 

subpars. (C) and (D).

    Subsec. (c)(9). Pub. L. 104-170, Sec. 223, added par. (9).

    Subsec. (c)(10). Pub. L. 104-170, Sec. 250(2), added par. (10).

    Subsec. (f)(4). Pub. L. 104-170, Sec. 105(b), added par. (4).

    Subsec. (g). Pub. L. 104-170, Sec. 106(b), added subsec. (g).

    Subsec. (h). Pub. L. 104-170, Sec. 224, added subsec. (h).

    1991--Subsec. (c)(1)(D). Pub. L. 102-237, Sec. 1006(a)(3)(B), (C), 

added subpar. (D) and redesignated former subpar. (D) as (F).

    Subsec. (c)(1)(E). Pub. L. 102-237, Sec. 1006(a)(3)(A), (C), added 

subpar. (E) and struck out former subpar. (E) which read as follows: 

``the complete formula of the pesticide; and''.

    Subsec. (c)(1)(F). Pub. L. 102-237, Sec. 1006(a)(3)(A), (B), (D), 

redesignated former subpar. (D) as (F), in cl. (i) substituted ``With'' 

for ``with'' and a period for semicolon at end, in cl. (ii) substituted 

``Except'' for ``except'' and a period for semicolon at end, in cl. 

(iii) substituted ``After'' for ``after'' and a period for semicolon at 

end, and struck out former subpar. (F) which read as follows: ``a 

request that the pesticide be classified for general use, for restricted

use, or for both.''

    Subsec. (c)(2)(A). Pub. L. 102-237, Sec. 1006(b)(1), (2), 

substituted ``the Administrator'' for ``he'' before ``requires'', 

``shall permit'', ``shall make'', and ``deems'', and substituted ``the 

Administrator's'' for ``his''.

    Subsec. (c)(2)(D). Pub. L. 102-237, Sec. 1006(c), clarified 

amendment made by Pub. L. 100-532, Sec. 102(b)(2)(A). See 1988 Amendment

note below.

    Subsec. (c)(3)(A). Pub. L. 102-237, Sec. 1006(b)(2), substituted 

``the Administrator's'' for ``his''.

    Subsec. (c)(5). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the 

Administrator'' for ``he'' before ``determines''.

    Subsec. (c)(6). Pub. L. 102-237, Sec. 1006(b)(1), (2), substituted 

``the Administrator'' for ``he'' before ``shall notify'' in two places 

and ``the Administrator's'' for ``his'' in four places.

    Subsec. (d)(1). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the 

Administrator'' for ``he'' before ``shall classify it for both'' in 

subpar. (A), before ``will classify'' in subpar. (B), and before ``shall

classify'' in subpar. (C).

    Subsec. (d)(2). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the 

Administrator'' for ``he'' before ``shall notify''.

    1990--Subsec. (c)(2)(A). Pub. L. 101-624 inserted after third 

sentence ``The Administrator shall not require a person to submit, in 

relation to a registration or reregistration of a pesticide for minor 

agricultural use under this subchapter, any field residue data from a 

geographic area where the pesticide will not be registered for such 

use.''

    1988--Subsec. (a). Pub. L. 100-532, Sec. 601(b)(1), substituted 

``Requirement of registration'' for ``Requirement'' in heading and 

amended text generally. Prior to amendment, text read as follows: 

``Except as otherwise provided by this subchapter, no person in any 

State may distribute, sell, offer for sale, hold for sale, ship, deliver

for shipment, or receive and (having so received) deliver or offer to 

deliver, to any person any pesticide which is not registered with the 

Administrator.''

    Subsec. (c)(1)(D). Pub. L. 100-532, Sec. 801(b)(1)-(4), in 

introductory provisions, substituted ``paragraph (2)(D)'' for 

``subsection (c)(2)(D) of this section'', in cl. (i), substituted ``(i) 

with'' for ``(i) With'' and ``, except that'' for ``: Provided, That'', 

in cl. (ii), substituted ``clause (i)'' for ``subparagraph (D)(i) of 

this paragraph'', and in cl. (iii), substituted ``clauses (i) and (ii)''

for ``subparagraphs (D)(i) and (D)(ii) of this paragraph''.

    Subsec. (c)(2)(A). Pub. L. 100-532, Sec. 801(b)(5)(A), (B), 

substituted ``(2) Data in support of registration.--

        ``(A) The''

for ``(2)(A) Data in support of registration.--The'', and directed that 

subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this 

section.

    Subsec. (c)(2)(B). Pub. L. 100-532, Secs. 102(b)(1), 801(b)(5)(C)-

(F), substituted ``(B)(i) If'' for ``(B) Additional data to support 

existing registration.--(i) If'', directed that cls. (ii) to (v) be 

aligned with left margin of subpar. (A), in cls. (ii) and (iii), 

inserted ``The Administrator shall issue a notice of intent to suspend 

the registration of a pesticide in accordance with the procedures 

prescribed by clause (iv) if a registrant fails to comply with this 

clause.'', in cl. (iv), substituted ``title. The only'' for ``title: 

Provided, that the only'', and in cl. (v), substituted ``paragraph 

(1)(D)'' for ``subsection (c)(1)(D) of this section''.

    Subsec. (c)(2)(C). Pub. L. 100-532, Sec. 801(b)(5)(G), (H), struck 

out ``Simplified procedures'' after ``(C)'' and directed that text be 

aligned with left margin of subpar. (A).

    Subsec. (c)(2)(D). Pub. L. 100-532, Sec. 102(b)(2)(A), and Pub. L. 

102-237, Sec. 1006(c), substituted ``the pesticide that is the subject 

of the application'' for ``an end-use product''.

    Subsec. (c)(2)(D)(i). Pub. L. 100-532, Sec. 102(b)(2)(B), struck out

``the safety of'' after ``data pertaining to''.

    Subsec. (c)(3). Pub. L. 100-532, Sec. 103, substituted ``(A) The 

Administrator'' for ``The Administrator'' and added subpar. (B).

    Subsec. (c)(7). Pub. L. 100-532, Sec. 801(b)(6), in introductory 

provisions, substituted ``paragraph (5)'' for ``subsection (c)(5) of 

this section'', in subpars. (A) and (B), substituted ``paragraph (5). 

If'' for ``subsection (c)(5) of this section: Provided, That, if'', and 

in subpar. (C), substituted ``prescribe. A'' for ``prescribe: Provided, 

that a''.

    Subsec. (d)(1)(A). Pub. L. 100-532, Sec. 801(b)(7), substituted 

``restricted use. If'' for ``restricted use, provided that if'' and 

``restricted uses. The Administrator'' for ``restricted uses: Provided, 

however, That the Administrator''.

    Subsec. (f)(2). Pub. L. 100-532, Sec. 801(b)(8), substituted ``this 

subchapter. As'' for ``this subchapter: Provided, That as''.

    Subsec. (g). Pub. L. 100-532, Sec. 801(b)(9), struck out subsec. (g)

which read as follows: ``The Administrator shall accomplish the 

reregistration of all pesticides in the most expeditious manner 

practicable: Provided, That, to the extent appropriate, any pesticide 

that results in a postharvest residue in or on food or feed crops shall 

be given priority in the reregistration process.''

    1978--Subsec. (c)(1)(D). Pub. L. 95-396, Sec. 2(a)(1), added subpar.

(D), and struck out provisions which required the applicant for 

registration of a pesticide to file with the Administrator a statement 

containing ``if requested by the Administrator, a full description of 

the tests made and the results thereof upon which the claims are based, 

except that data submitted on or after January 1, 1970, in support of an

application shall not, without permission of the applicant, be 

considered by the Administrator in support of any other application for 

registration unless such other applicant shall have first offered to pay

reasonable compensation for producing the test data to be relied upon 

and such data is not protected from disclosure by section 136h(b) of 

this title. This provision with regard to compensation for producing the

test data to be relied upon shall apply with respect to all applications

for registration or reregistration submitted on or after October 21, 

1972. If the parties cannot agree on the amount and method of payment, 

the Administrator shall make such determination and may fix such other 

terms and conditions as may be reasonable under the circumstances. The 

Administrator's determination shall be made on the record after notice 

and opportunity for hearing. If either party does not agree with said 

determination, he may, within thirty days, take an appeal to the Federal

district court for the district in which he resides with respect to 

either the amount of the payment or the terms of payment, or both. 

Registration shall not be delayed pending the determination of 

reasonable compensation between the applicants, by the Administrator or 

by the court.''.

    Subsec. (c)(2). Pub. L. 95-396, Secs. 2(a)(2)(A)-(D), 3, 4, 

designated existing provisions as subpar. (A), inserted in second 

sentence ``under subparagraph (B) of this paragraph'' after ``kind of 

information'', struck out from introductory text of third sentence 

``subsection (c)(1)(D) of this section and'' after ``Except as provided 

by'', and inserted provisions relating to establishment of standards for

data requirements for registration of pesticides with respect to minor 

uses and consideration of economic factors in development of standards 

and cost of development, and added subpars. (B) to (D).

    Subsec. (c)(5). Pub. L. 95-396, Sec. 5, provided for waiver of data 

requirements pertaining to efficacy.

    Subsec. (c)(7), (8). Pub. L. 95-396, Sec. 6, added pars. (7) and 

(8).

    Subsec. (d)(1)(A). Pub. L. 95-396, Sec. 7(1), authorized 

classification of pesticide uses by regulation on the initial 

classification and registered pesticides prior to reregistration.

    Subsec. (d)(2). Pub. L. 95-396, Sec. 7(2), substituted ``forty-five 

days'' for ``30 days''.

    Subsec. (d)(3). Pub. L. 95-396, Sec. 7(3), added par. (3).

    Subsec. (g). Pub. L. 95-396, Sec. 8, added subsec. (g).

    1975--Subsec. (c)(1)(D). Pub. L. 94-140 inserted exception relating 

to test data submitted on or after January 1, 1970, in support of 

application, inserted provision that compensation for producing test 

data shall apply to all applications submitted on or after October 21, 

1972, and provision relating to delay of registration pending 

determination of reasonable compensation, struck out requirement that 

payment determined by court not be less than amount determined by 

Administrator, and substituted ``If either party'' for ``If the owner of

the test data''.

                    Effective Date of 2004 Amendment

    Pub. L. 108-199, div. G, title V, Sec. 501(h), Jan. 23, 2004, 118 

Stat. 434, provided that: ``Except as otherwise provided in this section

[enacting section 136w-8 of this title, amending this section and 

sections 136a-1, 136x, and 136y of this title, and enacting provisions 

set out as notes under sections 136 of this title and section 346a of 

Title 21, Food and Drugs] and the amendments made by this section, this 

section and the amendments made by this section take effect on the date 

that is 60 days after the date of enactment of this Act [Jan. 23, 

2004].''

                    Effective Date of 1988 Amendment

    Amendment by Pub. L. 100-532 effective on expiration of 60 days 

after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a 

note under section 136 of this title.

                    Effective Date of 1978 Amendment

    Section 2(b) of Pub. L. 95-396 provided that: ``The amendment to 

section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and 

Rodenticide Act [subsec. (c)(1)(D) of this section] made by [subsec. 

(a)(1) of] this section shall apply with respect to all applications for

registration approved after the date of enactment of this Act [Sept. 30,

1978].''

                             Effective Date

    For effective date of section, see section 4 of Pub. L. 92-516, set 

out as a note under section 136 of this title.

                   Biological Pesticide Handling Study

    Section 1498 of Pub. L. 101-624 provided that:

    ``(a) Study.--Not later than September 30, 1992, the National 

Academy of Sciences shall conduct a study of the biological control 

programs and registration procedures utilized by the Food and Drug 

Administration, the Animal and Plant Health Inspection Service, and the 

Environmental Protection Agency.

    ``(b) Development of Procedures.--Not later than 1 year after the 

completion of the study under subsection (a), the agencies and offices 

described in such subsection shall develop and implement a common 

process for reviewing and approving biological control applications that

are submitted to such agencies and offices that shall be based on the 

study conducted under such subsection and the recommendation of the 

National Academy of Sciences, and other public comment.''

                      Education, Study, and Report

    Pub. L. 100-478, title I, Sec. 1010, Oct. 7, 1988, 102 Stat. 2313, 

provided that:

    ``(a) Education.--The Administrator of the Environmental Protection 

Agency in cooperation with the Secretary of Agriculture and the 

Secretary of the Interior, promptly upon enactment of this Act [Oct. 7, 

1988], shall conduct a program to inform and educate fully persons 

engaged in agricultural food and fiber commodity production of any 

proposed pesticide labeling program or requirements that may be imposed 

by the Administrator in compliance with the Endangered Species Act (16 

U.S.C. 1531 et seq.). The Administrator also shall provide the public 

with notice of, and opportunity for comment on, the elements of any such

program and requirements based on compliance with the Endangered Species

Act, including (but not limited to) an identification of any pesticides 

affected by the program; an explanation of the restriction or 

prohibition on the user or applicator of any such pesticide; an 

identification of those geographic areas affected by any pesticide 

restriction or prohibition; an identification of the effects of any 

restricted or prohibited pesticide on endangered or threatened species; 

and an identification of the endangered or threatened species along with

a general description of the geographic areas in which such species are 

located wherein the application of a pesticide will be restricted, 

prohibited, or its use otherwise limited, unless the Secretary of the 

Interior determines that the disclosure of such information may create a

substantial risk of harm to such species or its habitat.

    ``(b) Study.--The Administrator of the Environmental Protection 

Agency, jointly with the Secretary of Agriculture and the Secretary of 

the Interior, shall conduct a study to identify reasonable and prudent 

means available to the Administrator to implement the endangered species

pesticides labeling program which would comply with the Endangered 

Species Act of 1973, as amended, and which would allow persons to 

continue production of agricultural food and fiber commodities. Such 

study shall include investigation by the Administrator of the best 

available methods to develop maps and the best available alternatives to

mapping as means of identifying those circumstances in which use of 

pesticides may be restricted; identification of alternatives to 

prohibitions on pesticide use, including, but not limited to, 

alternative pesticides and application methods and other agricultural 

practices which can be used in lieu of any pesticides whose use may be 

restricted by the labeling program; examination of methods to improve 

coordination among the Environmental Protection Agency, Department of 

Agriculture, and Department of the Interior in administration of the 

labeling program; and analysis of the means of implementing the 

endangered species pesticides labeling program or alternatives to such a

program, if any, to promote the conservation of endangered or threatened

species and to minimize the impacts to persons engaged in agricultural 

food and fiber commodity production and other affected pesticide users 

and applicators.

    ``(c) Report.--The Administrator of the Environmental Protection 

Agency in cooperation with the Secretary of Agriculture and the 

Secretary of the Interior shall submit a report within one year of the 

date of enactment of this Act [Oct. 7, 1988], presenting the results of 

the study conducted pursuant to subsection (b) of this section to the 

Committee on Merchant Marine and Fisheries and the Committee on 

Agriculture of the United States House of Representatives, and the 

Committee on Environment and Public Works and the Committee on 

Agriculture, Nutrition, and Forestry of the United States Senate.''

Attachment C

40 CFR Parts 9 and 155 

Pesticides; Procedural Regulations for Registration Review; 

Final Rule, August 9, 2006 (71 FR 45720) 

Attachment C

40 CFR Parts 9 and 155 

Pesticides; Procedural Regulations for Registration Review; 

Final Rule, August 9, 2006 (71 FR 45720) 

[Federal Register: August 9, 2006 (Volume 71, Number 153)]

[Rules and Regulations]               

[Page 45719-45734]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr09au06-30]                         

[[Page 45719]]

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Part IV

 Environmental Protection Agency

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40 CFR Parts 9 and 155

 Pesticides; Procedural Regulations for Registration Review; Final Rule

[[Page 45720]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 155

[EPA-HQ-OPP-2004-0404; FRL-8080-4]

RIN 2070-AD29

 

Pesticides; Procedural Regulations for Registration Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes procedures for conducting the pesticide 

registration review program mandated by the Federal Insecticide, 

Fungicide, and Rodenticide Act. Under this rule, EPA will review 

existing pesticide registrations to determine whether they continue to 

meet the statutory standard for registration. The registration review 

program will begin in the fall of 2006. This rule provides for the 

establishment of pesticide cases for review, the scheduling of reviews, 

the initiation, completion and documentation of reviews, and associated 

public participation procedures. The registration review program 

established by this regulation is intended to ensure that all pesticide 

registrations are systematically reviewed in a manner that is based on 

sound science and provides for public participation, transparency and 

efficiency to protect public health and the environment. In addition, 

in order to display the OMB control number for the information 

collection requirements contained in this final rule, EPA is amending 

the table of OMB approval numbers for EPA regulations.

DATES: This final rule is effective on October 10, 2006.

ADDRESSES: EPA has established a docket for this action under Docket 

identification (ID) number EPA-HQ-OPP-2004-0404. All documents in the 

docket are listed in the docket index at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
. 

Although listed in the index, some information is not publicly 

available, e.g., CBI or other information whose disclosure is 

restricted by statute. Certain other material, such as copyrighted 

material, is not placed on the Internet and will be publicly available 

only in hard copy form. Publicly available docket materials are 

available either in the electronic docket at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov 

, or, if only available in hard copy, at the Office 

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 

Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA. The 

hours of operation of this Docket Facility are from 8:30 a.m. to 4 

p.m., Monday through Friday, excluding legal holidays. The Docket 

Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Field and External 

Affairs Division (7506P), Office of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-

0001; telephone number: 703-308-9341; fax number: 703-305-5884; e-mail 

address:   HYPERLINK "mailto:prunier.vivian@epa.gov" 
prunier.vivian@epa.gov .

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you hold 

pesticide registrations. Pesticide users or other persons interested in 

the regulation of the sale, distribution or use of pesticides may also 

be interested in this procedural regulation. Potentially affected 

entities may include, but are not limited to:

     Producers of pesticide products (NAICS code 32532).

     Producers of antifoulant paints (NAICS code 32551).

     Producers of antimicrobial pesticides (NAICS code 32561).

     Producers of nitrogen stabilizer products (NAICS code 

32531).

     Producers of wood preservatives (NAICS code 32519).

    This listing is not intended to be exhaustive, but rather provides 

a guide for readers regarding entities likely to be affected by this 

action. Other types of entities not listed in this unit could also be 

affected. The North American Industrial Classification System (NAICS) 

codes have been provided to assist you and others in determining 

whether this action might apply to certain entities. To determine 

whether you or your business may be affected by this action, you should 

carefully examine the applicability provisions in Sec.  155.40 of the 

rule. If you have any questions regarding the applicability of this 

action to a particular entity, consult the person listed under FOR 

FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 

Related Information?

    In addition to using   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov 
to access this 

document and other related information in the electronic docket, you 

may access this Federal Register document electronically through the 

EPA Internet under the ``Federal Register'' listings at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/fedrgstr/" 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&
log=linklog&to=http://www.epa.gov/fedrgstr/ 

.

II. Overview of this Document

    In this document, EPA presents its response to comments on the 

proposed rule to establish procedural regulations for the registration 

review of pesticides. In response to comments, EPA is modifying some 

aspects of the rule relating to procedures for public participation in 

the registration review process. The differences between the proposed 

rule and the final rule are described in Units VI. and X.

    In this document, the Agency describes:

     Statutory authority.

     History of this rulemaking.

     Response to comments on the rule.

     Response to comments on the operation and implementation 

of the program.

     Results of reviews required by statutes or executive 

orders.

     Changes to the rule.

     Procedural regulations for the registration review of 

pesticides.

III. Authority

A. EPA's Authority to License Pesticides

    FIFRA section 3(a) generally requires a person to register a 

pesticide product with the EPA before the pesticide product may be 

lawfully distributed or sold in the U.S. A pesticide registration is a 

license that allows a pesticide product to be distributed or sold for 

specific uses under specified terms and conditions. A pesticide product 

may be registered or remain registered only if it meets the statutory 

standard for registration given in FIFRA section 3(c)(5), as follows:

    (A) its composition is such as to warrant the proposed claims 

for it;

    (B) its labeling and other material required to be submitted 

comply with the requirements of this Act;

    (C) it will perform its intended function without unreasonable 

adverse effects on the environment; and

    (D) when used in accordance with widespread and commonly 

recognized practice it will not generally cause unreasonable adverse 

effects on the environment.

    FIFRA 2(bb) defines ``unreasonable adverse effects on the 

environment'' as

    (1) any unreasonable risk to man or the environment, taking into 

account the economic, social, and environmental costs and benefits 

of the use of any pesticide, or (2) a human dietary risk from 

residues that result from a use of a pesticide in or on any food 

inconsistent with the standard under section 408 of the Federal 

Food, Drug, and Cosmetic Act.

    The burden to demonstrate that a pesticide product satisfies the 

criteria for registration is at all times on the

[[Page 45721]]

proponents of initial or continued registration. (Industrial Union 

Dept. v. American Petroleum Institute, 448 U.S. 607, 653 n. 61 (1980); 

Environmental Defense Fund v. Environmental Protection Agency, 510 F.2d 

1292, 1297, 1302 (D.C. Cir. 1975).

B. EPA's Authority for Registration Review

    The Food Quality Protection Act (FQPA) of 1996 amended FIFRA to 

add, among other things, section 3(g), ``REGISTRATION REVIEW,'' as 

follows:

    (1)(A) GENERAL RULE. - The registrations of pesticides are to be 

periodically reviewed. The Administrator shall by regulation 

establish a procedure for accomplishing the periodic review of 

registrations. The goal of these regulations shall be a review of a 

pesticide's registration every 15 years. No registration shall be 

canceled as a result of the registration review process unless the 

Administrator follows the procedures and substantive requirements of 

section 6.

    (B) LIMITATION. - Nothing in this subsection shall prohibit the 

Administrator from undertaking any other review of a pesticide 

pursuant to this Act.

    (2)(A) DATA. - The Administrator shall use the authority in 

subsection (c)(2)(B) to require the submission of data when such 

data are necessary for a registration review.

    (B) DATA SUBMISSION, COMPENSATION, AND EXEMPTION. - For purposes 

of this subsection, the provisions of subsections (c)(1), (c)(2)(B), 

and (c)(2)(D) shall be utilized for and be applicable to any data 

required for registration review.

IV. Notice of Proposed Rulemaking

    EPA published proposed procedures for the registration review of 

pesticides on July 13, 2005 (70 FR 40251) (FRL-7718-4). A copy of the 

proposed rule may be found in Docket EPA-HQ-OPP-2004-0404, which can be 

accessed electronically at:   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.regulations.gov"  http://www.regulations.gov
. The 90-day 

comment period for this proposed rule ended on October 11, 2005.

    The preamble to the proposed rule discussed:

     Statutory authority and legislative history.

     The Agency's goals for the registration review program.

     Evaluating approaches to registration review.

     Factors considered in designing the registration review 

program.

     Design options considered for the registration review 

program.

     Testing the proposed registration review decision process.

     Proposed procedures for registration review.

     Relationship of registration review to other FIFRA 

activities.

     Phase-in of the registration review program.

     Results of reviews required by statutes and executive 

orders.

V. Overview of Comments

    EPA received 23 comments on the proposed rule, as follows:

     One individual.

     Two consultants.

     One public interest group.

     Four registrants.

     One State Pesticide Safety Coordinator.

     Three State Lead Agencies for pesticides.

     Five California water sanitation agencies.

     Six trade associations.

    The Agency's analysis of these comments showed that the comments 

can be organized into three broad topic areas:

     Requests for changes in the procedural regulations. These 

comments and the Agency's response are discussed in this preamble.

     Operation and implementation of the registration review 

program. These comments and the Agency's response are discussed in this 

preamble.

     Issues concerning the licensing of pesticides in general 

are described in the response to comments document that the Agency has 

placed in the docket for this rulemaking.

    In general, comments on the proposed rule resulted in minimal 

revisions in the final rule. Early implementation will continue to be 

discussed with the Pesticide Program Dialogue Committee, a stakeholder 

advisory committee established under the Federal Advisory Committee 

Act. EPA may issue additional guidance on the registration review 

program as it gains experience with these procedures.

VI. Comments on the Procedural Regulations

A. Sec.  155.40--General

    This section describes the purpose of the regulations in Subpart C-

-Registration Review Procedures and states that the goal of these 

procedures is a review of each pesticide's registration every 15 years. 

This section also specifies that the regulations apply to pesticides 

registered under section 3 or section 24(c) of FIFRA, states that the 

Agency may undertake any other review under FIFRA at any time and that 

the Agency will use FIFRA section 3(c)(2)(B) to require new data or 

information that are necessary for a pesticide's registration review.

    1. Authority to establish procedures for registration review. A 

trade association questioned EPA's authority to establish the proposed 

procedures for registration review. They asserted that in the absence 

of specific procedures in FIFRA for the administration of registration 

review, EPA must use procedures in FIFRA section 3(c)(8) which 

specifies procedures for conducting interim administrative review to 

develop a risk-benefit evaluation of a pesticide. Procedures for 

implementing FIFRA section 3(c)(8) are described in 40 CFR part 154.

    The Agency does not agree with this comment. FIFRA section 

3(g)(1)(A), which mandates a periodic review of the registration of 

pesticides, requires the Agency to establish procedures for conducting 

such reviews. This provision means that, except for limitations 

specified in FIFRA section 3(g)(1)(B) and FIFRA 3(g)(2), EPA has the 

authority to develop procedures for the conduct of this new program. 

Accordingly, EPA is not required to use procedures in FIFRA section 

3(c)(8) to conduct the review mandated in FIFRA section 3(g).

    2. Registration review of pesticides covered under FIFRA section 

25(b). An industry comment asked EPA to assure that products exempted 

from FIFRA regulation under section 25(b) of FIFRA are reviewed 

adequately, especially with regards to health claims.

    Pesticides that are exempt from FIFRA requirements under FIFRA 

section 25(b) are identified in 40 CFR 152.20, Exemptions for 

pesticides regulated by another Federal agency, and 40 CFR 152.25, 

Exemptions for pesticides of a character not requiring FIFRA 

regulation. Pesticides covered by FIFRA section 25(b) are not subject 

to registration review. However, some products that are exempt under 

FIFRA section 25(b) could be affected by actions taken in registration 

review. For example, pesticide-treated articles or substances described 

in Sec.  152.25(a) could be affected if issues arise during the 

registration review of a pesticide used to treat an article or 

substance. If the pesticide product or its use on treated articles or 

substances were canceled, the treated article or substance would no 

longer meet the requirements of Sec.  152.25(a), which specifies that 

the pesticide used to treat an article or substance must be registered 

for that use.

B. Sec.  155.42--Baseline Dates for Registration Review Cases

    In Sec.  155.42(d), EPA proposed to establish a baseline date for 

each registration review case. In general, the baseline date would be 

the date of initial registration of the oldest product in the 

registration review case or the date of reregistration, whichever is 

later.

[[Page 45722]]

The date of reregistration would be the date on which either a 

Reregistration Eligibility Decision (RED) or an Interim Reregistration 

Eligibility Decision (IRED) was signed, whichever date the Agency 

determines to be most appropriate.

    An industry comment suggested that to avoid duplication of effort, 

the Agency should amend Sec.  155.42 to use the date of approval of 

significant new uses as the baseline date for the registration review 

case.

    The Agency intended the baseline date to be the date of the last 

comprehensive review. A review of a new use may not be comprehensive--

previously approved uses may not be included in the evaluation of the 

new use. Generally, when conducting a registration review of a 

pesticide for which a significant new use was recently approved, EPA 

would not redo the recent review but would incorporate the risk 

assessment for the new use into the registration review.

    Another commenter asserted that baseline dates should be either the 

initial registration of a pesticide or the completion of the RED. The 

commenter stated that the IRED should not be used because it does not 

include an assessment of cumulative risk that is required for 

pesticides that have a common mechanism of toxicity with other 

substances. For such pesticides, the Agency should use the date of the 

RED (as opposed to IRED) to establish a common baseline date for all 

the pesticides included in the cumulative risk assessment.

    The Agency agrees that the RED would update the comprehensive IRED 

regarding cumulative risk or other issues but the RED itself may not be 

a comprehensive review. For cases where there is both an IRED and a 

RED, the Agency needs the flexibility to decide which document 

represents a comprehensive review. Accordingly, this final rule allows 

the Agency to use the date of either document as the baseline date.

C. Sec.  155.44--Establishing and Announcing Schedules for Registration 

Review

    1. Chronological vs. risk-based criteria as basis for establishing 

schedules for registration review. In Sec.  155.44, EPA proposed that 

schedules would be based on the baseline date of the registration 

review case or on the date of the last registration review of the 

registration review case. The rule allows the Agency to take into 

account other factors, such as achieving process efficiencies, when 

setting schedules. The preamble of the proposal described other factors 

that the Agency might consider. In July 2006, EPA released draft 

schedules that were developed using procedures in the proposed rule. 

Under the draft schedules, EPA would review chemically related 

registration review cases together.

    While most commenters supported the proposed chronological 

approach, public interest groups and water treatment authorities 

advocated risk-based approaches for scheduling. Several industry groups 

did not like the chemical groupings in the Agency's draft schedules, 

preferring that cases be scheduled for registration review in a 

strictly chronological order. They argued that grouping cases together 

undermines the chronological order of the schedule and that the order 

of groups in the schedule would be based on risk concerns. One industry 

group asked the Agency to include in the rule criteria for deviating 

from a chronologically based schedule and to consult registrants 

regarding the selection of new dates.

    While the Agency appreciates that there is a range of views as to 

how to set schedules for the registration review program, the 

establishment of schedules is within the Agency's discretion. EPA 

believes that reviewing similar cases together facilitates decision 

making for pesticides with similar scientific or regulatory issues and 

would be an efficient use of resources. Registrants or other 

stakeholders may notify the Agency regarding particular issues that 

could impact the schedule. The Agency would consider such issues as 

appropriate.

    2. Considerations that could change the registration review 

schedule. The Agency may consider factors other than the baseline date 

of the registration review case when developing schedules for 

registration review. As discussed in Unit IX.E. of the preamble of the 

proposed rule and as shown on the draft schedule released in July 2005, 

the Agency plans to cluster identified cases belonging to the same 

chemical class or group to promote efficiency of review for the Agency 

and provide a ``level playing field'' for industry. Additionally, 

because the Agency's economic analysis of this regulation suggested 

that a small business (i.e., a business that meets criteria established 

by the Small Business Administration) might face high data generation 

costs if it holds registrations in two or more registration review 

cases that are scheduled to undergo registration review in the same 

year, the Agency may schedule these cases out of chronological order.

    The Agency has a continuing obligation to respond to emerging risk 

concerns (discussed in Unit XI.B. of the preamble of the proposed 

rule). At any time, the Agency may receive new information that 

suggests that the Agency should reevaluate a previous decision to 

register a pesticide. After the registration review program begins, the 

Agency will continue to address emerging risk concerns. If a pesticide 

presents an urgent potential risk of concern, the Agency may opt to 

review all other aspects of the pesticide's registration at that time, 

rather than only looking at the risk of concern. In such cases, the 

Agency may update the registration review schedule by announcing the 

new date of the registration review of this case.

    In general, the Agency may consider these and other factors, 

including issues raised by the public or the registrant when reviewing 

a posted schedule, to schedule a pesticide registration review, or to 

modify the schedule of a pesticide registration review as appropriate.

    3. Three-year schedules. Although the preamble of the proposed rule 

contemplated maintaining a 3-year schedule, the proposed rule did not 

specify a timeframe. In response to comments requesting this change, 

the Agency has modified Sec.  155.44 to specify that the schedules 

would cover the current year and at least two subsequent years.

D. Sec.  155.46--Deciding that a Registration Review is Complete and 

Additional Review is Not Needed

    Under Sec.  155.46, the Agency may propose that no additional 

review of a pesticide is needed in order to determine whether the 

pesticide continues to meet FIFRA requirements for registration. The 

Agency would announce the availability of such proposals and take 

comment on them. In response to comments on a proposal made under Sec.  

155.46, EPA may reconsider its proposal and schedule a registration 

review of the pesticide.

    The Agency received one comment asking the Agency to clarify the 

purpose of this provision. The purpose of this provision is to give the 

Agency flexibility to not schedule a pesticide for registration review 

if the pesticide has such low toxicity, exposure or risk that another 

review would not change the Agency's position and would not be an 

effective use of resources. The Agency may also use this provision for 

a pesticide that has recently undergone a comprehensive review. In 

proposed decisions issued under Sec.  155.46, the Agency generally 

would explain why it believes that no additional review is

[[Page 45723]]

necessary and reference, as appropriate, publicly available 

documentation to support the Agency's position.

    To clarify the procedures it will use in Sec.  155.46, EPA is 

modifying the second sentence to read, ``In such cases, instead of 

establishing a pesticide registration review case docket as described 

in Sec.  155.50, the Agency may propose that, based on its 

determination that a pesticide meets the FIFRA standard for 

registration, no further review will be necessary.'' EPA is clarifying 

the status of pesticides subject to this section by adding the 

sentence, ``The date of the final notice of availability would be used 

as the date of the latest registration review for the purpose of 

scheduling subsequent registration reviews.''

E. Sec.  155.48--Data Call-In

    Section 155.48 provides that, as required by FIFRA section 3(g), 

EPA will use procedures in FIFRA section 3(c)(2)(B) to require 

submission of data that are needed to conduct a pesticide's 

registration review. This paragraph stipulates that the data protection 

provisions of FIFRA 3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the 

submission, compensation and exemption of data required to conduct a 

registration review.

    1. Data Call-In procedures. One comment asked why the proposed rule 

does not impose any requirements under FIFRA 3(c)(2)(B). The commenter 

suggested that additional data collection authorities are needed and 

procedures to ensure all necessary data must be included in this rule.

    The Agency finds that it is not necessary to develop new procedures 

for calling in data for registration review because FIFRA section 3(g) 

requires the Agency to use section 3(c)(2)(B) to collect the data, and 

that section provides EPA with sufficient authority to obtain any 

necessary data.

    2. Data compensation for ``voluntarily'' submitted data. Industry 

comments asked that the proposed rule clarify the data compensation 

status of information voluntarily submitted in response to registration 

review. Some comments suggested that the rule specify the mechanisms 

for requesting and obtaining a Data Call-In notice (DCI) before the 

data are submitted in order to protect data compensation rights. Other 

comments suggested that studies used in the registration review 

decision, particularly studies generated under revisions to the data 

requirements in 40 CFR part 158, be presented in the decision document. 

Registrants asked that in addition to determining whether a pesticide 

meets the FIFRA risk/benefit standard, EPA should assure that the 

registrant of the pesticide is entitled to use data supporting the 

risk/benefit determination for the pesticide.

    The Agency acknowledges the importance of this issue and agrees 

that this concern should be addressed in the conduct of the 

registration review program. FIFRA section 3(g)(2)(A) directs the 

Agency to utilize section 3(c)(2)(B) to require the submission of data 

when such data are necessary for a registration review. Similarly, 

FIFRA section 3(g) requires that the data compensation provisions, 

including those set forth in sections 3(c)(1), 3(c)(2)(B), and 

3(c)(2)(D) ``be utilized for and applicable to any data required for 

registration review.'' Hence, to the extent the Agency requires any 

data for registration review, such data are eligible for the data 

protections provided by the statute.

    If a company submits data or information to the docket voluntarily 

(as opposed to providing these data or information in response to a 

DCI), such data are not ``required'' data eligible for protection under 

the statute. However, the Agency may evaluate these data or information 

and find that it must rely on this information to support the continued 

registration of pesticide products. If the Agency makes such a finding 

in the course of a pesticide's registration review, this finding would 

be a determination that the voluntarily submitted data or information 

are now required. This would be a ``compensable event'' and would 

trigger the requirement for compensation to be addressed. The 

competitors to the original submitter would be required to submit their 

own data or offer data compensation to the data submitter for use of 

the study. A ``compensable event'' would also arise should the Agency 

issue a Data Call-In Notice for the same data as were previously 

submitted voluntarily, but a Data Call-In Notice is not necessary to 

trigger compensability should the Agency determine and announce as part 

of its registration review decision that the particular data were 

required to support the registrations in question.

    The Agency's registration review decision document may identify 

such data or information and the registration review decision document 

may establish a deadline for registrants whose registrations depend on 

such data to offer compensation to the owners of the data or submit 

their own data. The Agency may cancel the product registration of 

registrants who fail to adequately support a registration.

F. Sec.  155.50--Initiate a Pesticide's Registration Review

    EPA proposed to establish a docket for each registration review 

case, except for cases covered under Sec.  155.46. The docket would 

describe information that the Agency may consider in the course of a 

pesticide's registration review and describe information that the 

Agency does not have that might be useful in the review. The public 

would be invited to review information in the docket and submit, within 

60 days, any other information that they believe should be considered 

in the pesticide's review. A pesticide's registration review begins 

when EPA opens the docket for registration review case.

    1. Timeframe for submitting comments. As originally proposed, the 

timeframe for submitting comments in response to a notice issued under 

Sec.  155.50(b) would be ``60 calendar days.'' In response to comments 

that this time frame would not be long enough, the Agency is modifying 

this paragraph to specify that the time frame for such comment periods 

will be ``at least 60 calendar days.''

    2. Late submissions. Comments from industry and others asked the 

Agency to clarify its position regarding data or information submitted 

after the due date established in the notice announcing the opening of 

the pesticide registration review case docket.

    Under Sec.  155.50(c)(1), the Agency will consider late submissions 

if the Agency believes that the new data or information are critical 

for the regulatory decision, such as health effects or ecological 

effects data or exposure data that the EPA could use to refine a risk 

assessment.

    If a person has data or information that he/she believes that 

Agency should consider during the pesticide's registration review, but 

the data or information will not become available before the expiration 

of the comment period, he/she may either request an extension of the 

comment period, or in accordance with Sec.  155.52, consult with the 

Agency regarding a submission date for these materials.

    3. Information submitted under Sec.  155.50(c). Comments from 

industry asked the Agency to modify Sec.  155.50(c) to specify the 

types of information that might be submitted under this paragraph and 

to reference quality and scientific criteria for data that might be 

submitted as comments during a pesticide's registration review.

    In the preamble of the proposed rule, EPA described the kinds of 

information that, based on its experience in the pesticide 

reregistration program, might

[[Page 45724]]

be useful in registration review. As the Agency and its stakeholders 

gain experience in the registration review process, it may become clear 

what types of information are most useful. EPA could then develop 

appropriate guidance. In accordance with the Data Quality Act, EPA has 

already issued guidance regarding the quality of information that it 

relies upon for regulatory decisions. This guidance is available at 

EPA's website at:   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
&log=linklog&to=http://www.epa.gov/quality/informationguidelines/" 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&
log=linklog&to=http://www.epa.gov/quality/informationguidelines/ . 

The Agency will use this guidance in the registration review of 

pesticides.

G. Sec.  155.52--Stakeholder Engagement

    Under Sec.  155.52, the Agency may meet with registrants or other 

stakeholders during a pesticide's registration review or to prepare for 

a forthcoming review. This section explains the procedure for releasing 

minutes or other material relating to such meetings.

    Comments from industry asked that the rule provide an acceptable 

framework for activities in the pre-initiation stage. Other commenters 

remarked that non-registrants should have more access to the 

registration review process and that the public should be able to view 

all information, including reports from consumers about adverse 

effects. Additionally, they asserted that EPA should announce 

consultation opportunities in the Federal Register. Other comments from 

industry emphasized their concern that EPA not release confidential 

business information.

    In this document, the Agency is establishing procedures that 

provide the public with the opportunity to participate in the review 

process and to review materials that the Agency uses as the basis of 

proposed registration review decisions.

    The Agency generally does not announce in the Federal Register 

meetings with registrants or other stakeholders because it needs the 

flexibility to hold such meetings when the need arises. EPA may meet 

privately with industry to discuss proprietary or other confidential 

business information. Under Sec.  155.52(a) and (b), EPA will place in 

the docket minutes of meetings with registrants or other stakeholders. 

EPA's protection of information claimed to be confidential business 

information is governed by section 10 of FIFRA and the Agency's 

regulations in 40 CFR part 2.

H. Sec.  155.53--Conduct of a Pesticide's Registration Review

    This section describes how the Agency will assess the significance 

of changes in statutes and regulations, risk assessment procedures or 

methods, or data requirements and any new information about the 

pesticide to determine whether additional review of the pesticide is 

warranted. If a new review of the pesticide active ingredients or 

individual products in a registration review case is needed, the Agency 

will determine whether additional information is necessary to conduct 

the review. This section also provides for public review and comment 

during the review process. Under the proposed procedures, the Agency 

would generally establish comment periods of ``at least 60 calendar 

days,'' except in Sec.  155.53(c) where the comment period is ``at 

least 30 calendar days.''

    1. Agency's approach for conducting registration review. The Agency 

received several comments that disagreed with the Agency's proposed 

approach for conducting a pesticide's registration review. An industry 

trade association reiterated comments made in response to the April 

2000 Advance Notice of Proposed Rulemaking (65 FR 24585, April 26, 

2000) (FRL-6488-9) that the Agency should use a checklist or decision 

tree for deciding whether a pesticide continues to meet the 

requirements for registration. Other stakeholders expressed concern 

that the proposed approach was not sufficiently rigorous and would lead 

to relaxed standards.

    In the preamble of the proposed rule, the Agency described 

alternative approaches for conducting a pesticide's registration review 

and explained why it selected the proposed approach. The comments do 

not raise issues or concerns that would alter EPA's choice of approach. 

It is important to note, however, that although the Agency has not 

chosen to use a pure checklist approach, it is using a decision 

paradigm that ensures that the process will be transparent while still 

providing sufficient flexibility to allow for the scope and depth of a 

particular review to be tailored to the circumstances of the particular 

registration review case.

    2. Review of individual product registrations. Some registrants 

expressed their belief that the Agency should conduct a comprehensive 

review of individual product registrations to assure adequacy of 

product labels, product-specific data, and any claims for generic data 

exemption under FIFRA section 3(c)(2)(D).

    As explained in the preamble of the proposed rule, during the 

comment period on the initial registration review case docket, the 

public may comment on the need for a new review of individual product 

registrations. The Agency will continue to comply with its data 

protection obligations under FIFRA section 3(c)(2)(D).

    3. Public participation procedures. Several commenters noted that 

under the Agency's procedures for public participation in the 

reregistration and tolerance reassessment programs, the Agency may 

announce the availability of a revised risk assessment and may invite 

the public to suggest approaches for mitigating the risks identified in 

the revised risk assessment. The proposed procedures for registration 

review did not provide this opportunity.

    In response to this comment, the Agency is revising Sec.  155.53(c) 

so that it may provide the public an opportunity to comment on possible 

risk mitigation when a revised risk assessment shows risks of concern. 

However, if immediate action is warranted, the Agency may initiate 

cancellation or suspension procedures under FIFRA section 6. In this 

event, the Agency would not provide the opportunities for public 

comment described in Sec.  155.53(c) but would follow procedures in 

FIFRA section 6, as appropriate.

    4. Length of comment periods. Several commenters asserted that the 

comment periods provided in the proposed regulation were not long 

enough.

    Generally, where EPA publishes a document for comment, the Agency 

considers requests for extension if a reasonable basis for extension is 

provided. It is not necessary to modify these regulations to provide 

for extending comment periods.

I. Sec.  155.57--Registration Review Decision

    This section states that a registration review decision is the 

Agency's determination whether a pesticide meets, or does not meet, the 

standard for registration under FIFRA.

    1. Goal of registration review. The California Stormwater Quality 

Association asserted that the goal of registration review should be to 

protect water quality and minimize the need to mitigate pesticide 

impacts through Clean Water Act (CWA) mechanisms.

    The Agency believes that the goal of registration review is set 

forth in FIFRA section 3(g) and reiterated in Sec.  155.40. 

Registration review is a determination whether a pesticide continues to 

meet the FIFRA standard for registration, including, among other 

things, that the pesticide does not cause unreasonable effects on the 

environment. As part of this review, EPA will assess the effects of 

pesticides on water quality. However, while meeting CWA standards is 

important, it is not the only goal of registration review.

[[Page 45725]]

    2. FIFRA standard for registration. (a) Comments from industry 

strongly oppose EPA's intention to consider a pesticide's benefits 

during registration review. The comments referred to a discussion in 

the preamble of the proposed rule where EPA explained that it would 

evaluate information about the benefits of a pesticide with known high 

risks during registration review if a new and safer alternative to a 

pesticide has become available. The comments asserted that it is 

inappropriate for the Agency to base continued registration of a 

pesticide on a comparative benefits assessment with other pesticides. 

The comments cited FIFRA section 3(c)(5) to support their assertion 

that when pesticides meet the registration criteria of FIFRA, the 

Agency should not be allowed to make marketplace decisions of one 

product over another. FIFRA section 3(c)(5) states, ``The Administrator 

shall not make any lack of essentiality a criterion for denying 

registration of any pesticide. Where two pesticides meet the 

requirement of this paragraph, one should not be registered in 

preference to the other.''

    EPA believes the commenter misapprehends the nature of FIFRA's 

risk-benefit balancing standard. A determination that a pesticide meets 

the registration standard under FIFRA at one time does not necessarily 

mean that the same pesticide will meet the standard at all times in the 

future, even if the science associated with the risks posed by the 

pesticide does not change. Significant changes in the benefits picture, 

such as the development of pest resistance or new alternatives, can 

also affect whether a pesticide continues to meet the FIFRA 

registration standard. EPA does not intend to compare benefits of two 

or more pesticides that do not pose risks of concern. As the commenters 

noted, EPA may not make a determination of essentiality when two 

pesticides meet the FIFRA requirements for registration. However, when 

there are risks of concern for a pesticide, FIFRA requires EPA to weigh 

those risks against the benefits of that pesticide to determine whether 

the risks are unreasonable. Benefits are the advantages that accrue to 

the pesticide users or society in general, such as increased 

production, decreased production costs, pest-free homes, or disease-

vector control. The magnitude of those benefits often depends on the 

availability of alternative pest control measures, whether chemical, 

biological or cultural. Benefits are, in general, expected to be higher 

when there are no viable alternatives.

    During registration review, EPA may reassess a pesticide that has 

remained registered even though high risks are associated with the use 

of the pesticide. In its earlier review, the Agency may have found that 

the pesticide did not pose unreasonable risk because of the high 

benefits of the pesticide. In registration review, EPA may find that 

existing risk assessments that identify these risks of concern are 

still valid. EPA would then determine whether the pesticide continues 

to provide sufficient benefits to justify maintaining the registration. 

The benefits finding could depend on whether new, safer alternatives 

have been registered since EPA's earlier decision. EPA conducted 

similar analyses in the reregistration program.

    If EPA's review of a pesticide's registration appears to show that 

the pesticide does not meet the FIFRA standard for registration, EPA 

would follow procedures in FIFRA section 6 to change, cancel or suspend 

the pesticide's registration. This section sets out where it requires 

EPA to assess the benefits of the pesticide and provides opportunities 

for public hearings on whether the pesticide's registration should be 

changed, canceled, or suspended. The Agency would not analyze benefits 

when a registrant responds to the Agency's registration review finding 

by agreeing to the cancellation of a pesticide or termination of one or 

more of its uses under FIFRA section 6(f). However, FIFRA provides the 

public an opportunity to comment on the proposed action.

    (b) Another registrant asserted that the registration review 

regulations should contain language that specifically reaffirms the 

standard of imminent hazard and substantial risk as the basis for 

cancelling pesticide registrations. He cited a specific product example 

to illustrate his belief that the Agency employed a ``zero tolerance 

agenda'' during reregistration.

    The standard of ``imminent hazard'' referred to by the commenter 

applies to suspensions and emergency suspensions under FIFRA section 

6(c). This section sets forth the standard for a suspension or an 

emergency suspension. This is not the standard that the Agency will use 

in making registration review decisions. The Agency interprets 

registration review to be a determination that a pesticide continues to 

meet the standard for registration in FIFRA section 3(c)(5), or, where 

appropriate, section 3(c)(7). This standard specifies, among other 

things, that a pesticide may not pose unreasonable risk to man or the 

environment.

    When a pesticide poses risks of concern to humans or the 

environment, the Agency must address these risks. The options for 

addressing such risks include risk mitigation, determining that the 

risks are justified in light of the benefits of the pesticide, or 

initiating regulatory options to modify or cancel the registration. EPA 

generally consults with registrants and other stakeholders when 

deciding how to mitigate a risk. In addition, EPA has modified the 

proposed public participation procedures for registration review to 

generally add a public comment period when a pesticide poses risks of 

concerns so members of the public can provide suggestions for reducing 

the risk. This procedure provides registrants and other stakeholders an 

opportunity to provide input on the Agency's risk management decisions.

J. Sec.  155.58--Procedures for Issuing a Decision on a Registration 

Review Case

    In this section, EPA explains that it will issue proposed 

registration review decision documents for public review and comment. 

In comments on the proposed rule, various stakeholders advised the 

Agency of their expectations and needs regarding the documentation of 

registration review decisions and suggested how this documentation 

might be presented. EPA appreciates these suggestions. The Agency has 

consulted the Pesticide Program Dialogue Committee and has considered 

their recommendations together with comments submitted on the proposed 

procedural regulations. Nothing in the comments indicates the need to 

modify the regulation to specify the format of the registration 

decision document.

VII. Comments on the Operation of the Registration Review Program

A. Scope of the Registration Review Program

    1. Is registration review a safety net? In the preamble of the 

proposed rule, the Agency described how it intended to use registration 

review as the framework for managing the regulatory status of existing 

pesticides.

    Industry trade associations did not agree with this approach. In 

their comments, they asserted that EPA should not expand registration 

review beyond the intent of Congress because to do so risks repeating 

the Agency's experience with reregistration which began as a 5-year 

program in 1972 and still has not been completed. They asserted that 

registration review should not be a catch-all for other programs and 

actions. For example, special review, actions under FIFRA section 

3(c)(8),

[[Page 45726]]

FIFRA section 6 or the Pesticide Registration Improvement Act (PRIA) 

should not be included in the registration review program. They believe 

that new programs such as endocrine disruptor screening and testing 

should be conducted independently of registration review. The industry 

comments advocate that, as far as possible, registration review should 

be a safety net.

    EPA does agree that registration review is not the only mechanism 

for addressing pesticide registration issues, and will continue to use 

other provisions of FIFRA to address particular registration issues. 

However, EPA does not agree with the comment that registration review 

should function solely as a safety net to discover and resolve issues 

missed or overlooked in registration, tolerance reassessment, or 

reregistration activities. While EPA expects that it will occasionally 

discover issues that were overlooked in previous reviews, the purpose 

of registration review is to consider the pesticide in light of new 

knowledge that was not available for previous reviews.

    EPA interprets the Congressional mandate for registration review to 

be a periodic assessment whether a pesticide continues to meet the 

FIFRA standard for registration in light of new knowledge. Therefore, 

the scope of a pesticide's registration review includes all aspects of 

a pesticide's registration specified in section 3(c)(5) of FIFRA with 

respect to product composition, labeling and other required material, 

and risks and benefits. Registration of new pesticides or new uses of 

pesticides under PRIA is a separate program from registration review. 

However, in evaluating a new use under PRIA, the Agency would consider 

all relevant information, including information that it might consider 

during the pesticide's registration review.

    2. Incorporating evolving or new programs into registration review. 

As explained in the preamble of the proposed rule, EPA intends to 

incorporate new requirements, such as endocrine disruptor screening and 

testing or endangered species assessments into the registration review 

program as these aspects of risk assessment mature into routine 

evaluations for pesticides.

    Industry commenters advised the Agency to avoid using registration 

review as the sole process for handling new issues. They asserted that 

attaching all these assessments (endangered species assessments, 

endocrine disruptor screening and testing, review of substitutes, etc.) 

to a program intended to accomplish periodic review of all pesticides 

will undermine the timeliness of the review process for a great many 

pesticides. Commenters believe that this may result in an ever-changing 

schedule that will deprive registrants and users of predictability and 

lead to significant inefficiencies within the Agency.

    Again, EPA does not intend to use registration review as the only 

mechanism for addressing pesticide registration issues. However, EPA 

believes it is appropriate to use registration review as the framework 

for managing its responsibilities regarding existing pesticides. In 

making a FIFRA section 3(c)(5) decision as required under FIFRA section 

3(g), EPA must consider all information that pertains to that decision. 

EPA regards endangered species assessments required under the 

Endangered Species Act or endocrine disruptor screening and testing 

required under the Federal Food, Drug, and Cosmetic Act as part of the 

risk characterization of the pesticide that is intrinsic to the FIFRA 

risk/benefit decision. If knowledge exists on these or other scientific 

issues at the time of a pesticide's registration review, the Agency 

believes it must consider them when it makes its FIFRA (3)(c)(5) 

finding.

    3. Managing emerging issues. In the preamble of the proposed rule, 

the Agency explained that it will continue to give priority to emerging 

risk concerns. While reviewing the new risk concern, the Agency may 

find that it would be more efficient to review all other aspects of the 

pesticide's registration at the same time. The procedural regulations 

for registration review provide flexibility to amend the schedule to 

advance the registration review of a pesticide in this circumstance. 

The Agency would provide as much advance notice as possible regarding 

such changes in the schedule.

    Commenters took exception to EPA's approach for managing emerging 

issues arguing that newly discovered risks of potential concern should 

be dealt with outside of registration review if the risks are urgent. 

The commenters believe that registration reviews should not be 

rescheduled under this circumstance.

    The Agency does not agree that it should reassess the approach 

described in the preamble of the proposed rule. EPA fully explained its 

reasoning in the proposed rule and the comments do not persuade it 

otherwise. This is not to say that the Agency will not address urgent 

risks of concern outside the registration review process if the Agency 

determines that to be the appropriate course of action.

    4. Assessing risks of substitute pesticides. In the preamble of the 

proposed rule, EPA explained that it might advance the registration 

review of pesticides that are potential substitutes for a pesticide or 

some uses of the pesticide that are being canceled under FIFRA section 

6 because of risk concerns.

    Industry commenters expressed concern that EPA would even consider 

using the registration review program to address reviews that might be 

the outgrowth of cancellation proceedings.

    EPA generally would assess risks of substitute pesticides as part 

of the cancellation process in FIFRA section 6. In the rare event that 

it is necessary to perform a comprehensive review of a substitute 

pesticide, such a review might be tantamount to conducting the 

registration review of that pesticide. In such cases, EPA might find 

that it would be more efficient to conduct the registration review of 

the pesticide at the same time.

    5. Review of inert ingredients. In the preamble of the proposed 

rule, EPA explained that it would handle inert ingredients in a process 

that is separate from registration review.

    Some commenters agree with EPA's approach of dealing with inert 

ingredients. However, others question the need to review inert 

ingredients at all. A public interest group expressed concern that 

having separate review processes for active ingredients and inert 

ingredients could result in missing or ignoring synergistic effects of 

mixtures of ingredients.

    The Agency intends to follow the procedures outlined in the 

preamble of the proposed rule. The Agency recognizes that there may be 

interactions among the various chemicals in pesticide products. 

Currently, the Agency requires acute toxicity data for end-use 

products, i.e., formulations containing active and inert ingredients. 

These studies address, albeit to a limited extent, potential 

synergistic effects of mixtures of active and inert ingredients in a 

pesticide product. However, to test and review all of the potential 

combinations of ingredients would require significant resources. The 

Agency will consider new scientific methodologies to identify potential 

interactions among chemicals, should they become available.

B. Data and Information Collection in the Registration Review Program

    In the preamble of the proposed rule, the Agency described 

strategies for acquiring information to support a pesticide's 

registration review including issuing Data Call-In notices to require

[[Page 45727]]

data necessary to conduct a review and searching the published 

literature for pertinent information about a pesticide. The Agency 

explained that early acquisition of data or information that could be 

useful in refining a pesticide's risk assessment would reduce the time 

and effort needed to complete the review of a pesticide. As explained 

in the preamble, EPA might be able to identify data or information 

needs when it publishes the schedule for a pesticide's registration 

review. In some cases, data or information needs might become apparent 

when the Agency assembles the initial docket for the registration 

review case. In this event, the docket for the registration review case 

would identify data or information needs. In other cases, the Agency 

might not be able to identify data or information needs until it 

evaluates the information in the initial docket.

    1. Identification of information that may be used to refine risk 

assessments. An industry trade group acknowledged EPA's concern about 

redoing risk assessments when, in response to a preliminary risk 

assessment, a registrant or other stakeholder submits new data or 

information to refine the preliminary risk assessment. However, they 

believe that such iteration is inevitable. When registrants conduct 

their own risk assessments, they may use different assumptions or 

interpretations of data than the Agency uses in its risk assessments. 

When the Agency's risk assessment shows higher risks than the 

registrants found in their own assessments, they must either develop 

data or information to refine the risk assessment or cancel uses.

    EPA agrees that some iteration may be inevitable. However, the 

Agency publishes its risk assessment methods, including its approach 

for interpreting data. So it may be possible for registrants to 

anticipate the Agency's information or data needs in a forthcoming 

registration review and to reduce the degree of iteration in the risk 

assessment process.

    2. Information developed under the Clean Water Act. In public 

discussions about the proposed rule, EPA received a suggestion from 

water treatment authorities that the Agency might consider information 

developed under section 303(d) of the Clean Water Act, which identifies 

impaired water bodies.

    In comments, States raised the concern that they do not have the 

resources to assemble such data. Registrants expressed their concern 

that these data not be taken at face value because the criteria and 

process used to develop these data might affect the reliability of this 

information.

    EPA believes that information on water quality may be useful in 

registration review and will make efforts to obtain State data for CWA 

section 303(d) listings due to pesticides. When evaluating such data, 

EPA will take into account the procedures used to develop the data to 

assess the quality and usefulness of the data.

C. Work-Sharing

    The preamble of the proposed rule described the Agency's intention 

to develop work-sharing agreements with its partners in the 

Organization for Economic Cooperation and Development (OECD) or the 

North American Free Trade Agreement (NAFTA). In comments on the 

proposed rule, industry trade associations expressed concern that 

conducting reviews jointly with EPA's NAFTA or OECD partners might 

cause delays.

    EPA continues to believe that harmonization and work-sharing will 

result in process efficiencies and superior decisions. Since EPA's 

partners also have programs for reassessing pesticides, all parties 

could benefit by coordinating their efforts. EPA and its Canadian 

counterpart have begun discussions for work-sharing during registration 

review with the expectation that they will develop a work-sharing plan 

by the December 2006 meeting of the NAFTA Technical Working Group on 

Pesticides.

    EPA gave a presentation on the registration review program at the 

February 2006 meeting of the OECD Working Group on Pesticides. EPA 

intends to continue encouraging the OECD community to participate in 

work-sharing efforts.

    EPA may adjust its schedule slightly to take advantage of these 

potential opportunities for work-sharing.

D. Adequacy of EPA's Methods for Assessing Potential Risk to Water 

Quality

    California water-treatment authorities questioned the adequacy of 

EPA's assessment of risks with regard to water quality considerations 

including: Use of aquatic toxicity testing, surface water quality 

studies, and urban uses of pesticides, particularly when these uses 

result in pesticide residues in receiving waters for storm sewers or 

sewage treatment plants. The commenters reported that in some cases, 

pesticide residues in water released by a sewage treatment plant may 

exceed its NPDES permit, which would be a violation of the Clean Water 

Act. They also noted that residues from agricultural uses of 

pesticides, e.g., rice pesticides and pesticide degradates have been 

found in drinking water supplies.

    The Office of Pesticide Programs (OPP) will manage water-related 

issues within the framework of the registration review of pesticides. 

OPP expects that its capacity for characterizing risk will continue to 

improve as it works with the Office of Water to refine its models for 

estimating exposures and as more monitoring data become available.

E. Achieving Label Improvement through the Registration Review Program

    Several commenters see the registration review program as an 

opportunity to improve the quality of labels on individual pesticide 

products. One aspect of label improvement would be to minimize the 

number of different labels for the same product. According to comments, 

this situation arises because many States require State registration 

and impose their own labeling requirements.

    The Agency is committed to improving the consistency of labels. EPA 

already works with States on labeling issues. However, the Agency notes 

that section 24(b) of FIFRA prohibits States from establishing or 

maintaining labeling requirements. The Agency agrees that label 

improvement is a worthwhile goal for the registration review program.

VIII. Implementation Issues

A. Coordination of the Registration Review Rule with the Data 

Requirements Rule

    Industry comments asserted that EPA should delay implementing 

registration review until the recently proposed revisions to the data 

requirements in 40 CFR part 158 have been finalized. They stated their 

belief that EPA cannot make registration review decisions until it has 

completed revising the data requirements for the registration of 

pesticides. Industry is concerned that if registration review is 

initiated before a final rule on data requirements, different standards 

will apply to cases reviewed early in the program, negating one of the 

benefits of the review: to reduce market barriers.

    The Agency does not believe it is appropriate to delay 

implementation of the registration review program as suggested in the 

comments. In the absence of updated part 158 rules, the Agency makes 

case-by-case data determinations as a standard program practice. 

Registrants are familiar with this practice. While the Part 158 Data 

Requirements Rules and registration review decisions are related, they 

are

[[Page 45728]]

not inextricably linked. The revisions to part 158 have benefits but 

they are not a condition precedent to making registration review 

decisions.

    The part 158 updates may include provisions to codify current 

practices. The purpose of the part 158 rule is to capture with clarity 

and transparency changes in data requirements or application of data 

requirements that the Agency has made on a case-by-case document since 

it published its data requirements in 1984. This good-government goal 

will amplify understanding and further enhance consistency. However, 

the registration review program can operate effectively, as the 

registration, reregistration, and tolerance reassessment programs have, 

in the absence of these enhancements. Final promulgation of the part 

158 rules will simply improve on that sound foundation.

    Science will continue to evolve even after the Agency has completed 

the current revision of the data requirements in 40 CFR part 158. The 

Agency expects that it will change its data requirements to reflect 

this new knowledge. Because one of the goals of registration review is 

to incorporate evolving science, the Agency fully expects that it might 

apply new and different risk assessment tools to pesticides reviewed 

later in the 15-year cycle than it used when it reviewed pesticides 

early in the 15-year cycle.

    The Agency appreciates the commenter's concern about market 

barriers that might arise if the Agency uses different risk assessment 

tools when reviewing pesticides later in the 15-cycle than it used 

earlier in the cycle. Market barriers can be reduced if similar 

pesticides are reviewed at the same time. This is one of the benefits 

of the Agency's plan to group chemically related cases for review.

B. Transition from Reregistration to Registration Review

    Industry comments asserted that EPA must clarify when the 

registration review program will begin. EPA should address how it will 

handle the work of registration actions, reregistration actions, and 

other mandated regulatory actions before it commits to initiating the 

registration review program. EPA should clarify the transition process 

between the reregistration and registration review programs.

    The Agency has announced that the registration review program 

officially begins when these regulations go into effect. The Agency's 

first actions under the new program will be to issue schedules and to 

begin to open registration review case dockets. As noted in the 

comment, some pesticides will still be undergoing reregistration when 

the registration review program begins. The Agency recognizes that, to 

avoid confusion during the transition between the reregistration and 

registration review programs, it must clearly communicate whether 

action on an existing pesticide is taken under reregistration (FIFRA 

section 4) or registration review under FIFRA section 3(g).

C. Unresolved Problems from Reregistration Will Affect the Agency's 

Capacity to Conduct Registration Review

    Industry commented that EPA should not implement registration 

review of end-use products until it fixes the problems with the review 

of end-use products in reregistration. The review processes in 

registration review and reregistration are likely to be similar and 

registration review might duplicate the effort of reregistration, 

especially when a product may undergo product-specific review several 

times (e.g., a product that contains two or more active ingredients may 

belong in two or more registration review cases). The commenters are 

concerned that if EPA does not achieve efficiencies in the review of 

end-use products, the 15-year review will extend to 40 years.

    EPA expects reregistration to satisfy most product-specific data 

requirements and achieve many label improvements for end-use products. 

Although the Agency does not expect it will routinely require product-

specific data during registration review, it expects that registration 

review will be an important vehicle for the continuing update of 

labels. The Agency agrees that the review of end-use product labels 

could benefit from process improvements. The Agency believes that 

registrants and other stakeholders can help develop approaches to make 

this process more efficient.

IX. Program Costs

A. Impacts on Small Businesses

    Registrants commented that EPA has not accurately characterized the 

effects of registration review on small business. They suggested that 

per-company costs of $750,000 and 2% gross sales are not insignificant 

even for large entities and will have a direct adverse effect on small 

businesses. They believe that the cost projections are misleading 

because they do not include all costs incurred by a registrant such as 

existing reporting, recordkeeping, and financial burdens imposed by the 

Agency's many other on-going programs. Commenters suggested that EPA 

should re-evaluate the impacts on small business and reduce economic 

burden on them.

    EPA believes it has accurately characterized the impacts of the 

registration review procedures on the regulated community, including 

small businesses. The procedures in this rule establish what EPA will 

do to review a pesticide registration. They do not obligate a 

registrant to take any action.

    As part of the rulemaking process, EPA is required to estimate the 

economic impacts, including effects on small business, that occur as a 

consequence of the rule. Because costs resulting from existing 

reporting or recordkeeping requirements or costs from other Agency 

programs are not imposed by this rule, these costs are not included in 

the Agency's assessment of the impacts of this rule.

    The regulations do not impose new data requirements. They establish 

the process by which EPA will decide if additional data are necessary 

to determine whether a pesticide continues to meet FIFRA standards. 

That is, data generation costs are only indirectly a result of 

registration review procedures. It is important to realize that the 

per-company costs of $750,000 are primarily the cost of data 

generation; that is, they are not a direct cost imposed by this rule.

    The Agency has determined that this rule will not have a 

significant adverse impact on a substantial number of small businesses. 

Nonetheless, the Agency recognizes that, from the perspective of a 

small business whose product is undergoing registration review, the 

costs of data generation in registration review could be significant. 

Accordingly, the Agency is willing to work on a case-by-case basis with 

a small business for whom the requirements for data generation in 

registration review are burdensome. Data Call-In notices issued under 

FIFRA section 3(c)(2)(B) allow a registrant to request a data waiver 

that is based on economic factors. In lieu of a new study, the Agency 

is generally willing to consider whether substitute data or bridging 

data would be adequate. If a new study is required, the Agency may 

consider time extensions so that a registrant can spread the costs of 

data generation over a longer period of time. The Agency has made these 

options available to small businesses in the registration and 

reregistration programs and expects to continue to make them available 

for registration review.

B. Cost of Product-Specific Data

    Industry comments asserted that the economic assessment was 

incomplete

[[Page 45729]]

because it did not include the costs of generating product-specific 

data, in particular, the costs of repeating efficacy tests for public 

health pesticides. At public meetings on the proposed rule, the Agency 

said that it would require new product efficacy tests.

    These comments accurately describe the scope of the feasibility 

study. The purpose of the feasibility study was to test the validity of 

the registration review decision paradigm and to develop data for 

estimating the costs of the program. The Agency did not review 

individual product registrations in the feasibility study to determine 

whether new product-specific data, including efficacy data, would be 

required because the Agency believes that, to a great degree, these 

product-specific data requirements have been satisfied through the 

registration and reregistration programs and such data would generally 

not be needed to support a pesticide's registration review.

    During the registration review of a public health pesticide, the 

Agency would determine whether to continue to base the product's 

registration on existing product efficacy data. The Agency may ask for 

new product efficacy data if the product's composition has changed so 

that existing data no longer support the current composition of the 

product, or the test method is no longer valid, or there is information 

suggesting that the formulation might not be efficacious as claimed. 

The Agency did not review product chemistry data in the feasibility 

study to make case-by-case determinations whether existing product 

efficacy tests are appropriate for the composition of the product. The 

Agency has not revised antimicrobial efficacy test methods, so, for 

purposes of the feasibility study, the existing efficacy tests were 

considered to be valid. (If the Agency had information suggesting that 

a product in the feasibility study was not efficacious as claimed, the 

Agency would not wait until registration review to ask for new efficacy 

data. The Agency would have issued a DCI or initiated other action 

under FIFRA, as appropriate.) The Agency believes that the costs of 

replacing product efficacy data for a few products in a registration 

review case will be much lower than the costs of generating new generic 

data to support the active ingredient(s) in a registration review case. 

In any case, any costs for generating new product-specific efficacy 

data would not be a direct cost imposed by this procedural regulation.

X. Technical Changes to the Rule

    In addition to the changes made in response to comments, the final 

rule reflects that the Agency made the following technical changes to 

what was proposed:

    1. In Sec.  155.42(d), the Agency added clarifying phrases 

(indicated in italics) to the second and third sentences, as follows: 

``In general, the baseline date will be the date of initial 

registration of the oldest product in the case or the date of 

reregistration, whichever is later. The date of reregistration is the 

date on which the Registration Eligibility Decision or Interim 

Reregistration Eligibility Decision was signed, whichever date the 

Agency determines to be more appropriate based on the comprehensiveness 

of the review.''

    2. In Sec.  155.44, EPA is deleting the sentence, ``As indicated in 

Sec.  155.40, the Agency may change the schedule of a pesticide's 

registration review if circumstances warrant,'' because it is not a 

correct reference.

    3. In Sec.  155.48, EPA is deleting the phrase ``before, during or 

after a registration review'' because it is redundant.

    4. The Agency is modifying Sec.  155.50 as follows:

     In the first sentence add the phrase ``except for cases 

covered under Sec.  155.46.'' The sentence now reads, ``The Agency will 

initiate a pesticide's registration review by establishing a docket for 

each registration review case, except for cases covered under Sec.  

155.46, and opening it for public review.''

     Change the paragraph heading of Sec.  155.50(a) to 

``Contents of the registration review case docket.'' The Agency has 

deleted the first sentence of this paragraph and modified the last 

sentence to read, ``The Agency will consider including, but not limited 

to, the following information: . . .'' The Agency is making these 

changes to make clear that this paragraph describes the contents of the 

initial docket.

     Change Sec.  155.50(c) by adding ``during the comment 

period'' to the paragraph heading and by changing the first sentence in 

paragraph (c)(1) to read as follows: ``In order to ensure that the 

Agency will consider data or information in the conduct of a 

registration review, interested persons must submit the data or 

information during the comment period established in the notice 

described in paragraph (b) of this section.'' These changes are for 

clarity.

     Add paragraph Sec.  155.50(d) as follows, ``For the 

purposes of this subpart, the provisions of subpart B do not apply.'' 

EPA is making this change to eliminate any possible confusion as to 

whether docketing procedures in part 155 subpart B apply to 

registration review activities. Subpart B describes docketing and 

public participation procedures for the registration standard program 

that the Agency conducted before it began the reregistration process 

mandated in the 1988 amendments to FIFRA. The Agency will eventually 

issue a housekeeping rule to delete this subpart.

    5. In Sec.  155.52, the Agency is making editorial changes for 

clarity, as follows:

     Substitute ``other persons'' for ``public interest 

groups'' in the third sentence so that it reads, ``The Agency may 

consult with registrants, pesticide users, or other persons during a 

pesticide's registration review . . .''

     Add the phrase ``Minutes of'' to the paragraph heading of 

Sec.  155.52(a) so that it reads, ``Minutes of meetings with persons 

outside of government.''

    6. In Sec.  155.53, the Agency is making several editorial changes 

for clarity, as follows:

     Add the preposition ``of'' to the section heading of Sec.  

155.53 so that it reads, ``Conduct of a pesticide's registration 

review.''

     In the first sentence of this section, replace the 

reference to ``Sec.  155.51,'' which doesn't exist, with ``Sec.  

155.50(a), (b), and (c).''

     In the first sentence of Sec.  155.53(c)(1), replace the 

phrase ``ask for'' with the verb ``request.''

    7. In Sec.  155.58, the Agency is making an editorial change in 

paragraph (b)(3) by deleting the phrase ``precede, accompany or 

follow'' from the second sentence and replacing it with the phrase 

``may be issued in conjunction with.''

XI. FIFRA Review Requirements

    In accordance with FIFRA section 25(a) and 25(d), this rule was 

submitted to the FIFRA Science Advisory Panel (SAP), the Secretary of 

Agriculture (USDA), and appropriate Congressional Committees.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    Pursuant to Executive Order 12866, entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), the Office of Management and 

Budget (OMB) has designated this rule as a ``significant regulatory 

action'' under section 3(f) of the Executive Order because it may raise 

novel legal or policy issues arising out of legal mandates, the 

President's priorities, or the principles set forth in the Executive

[[Page 45730]]

Order. This action was therefore submitted to OMB for review under this 

Executive Order, and any changes to this document made at the 

suggestion of OMB have been documented in the public docket for this 

rulemaking.

    EPA has prepared an economic analysis of the potential impacts of 

the registration review procedures. In addition to analyzing the 

requirements contained in this rule, the Agency analyzed other 

potential actions that could occur during a registration review using 

other existing authorities that are not changed in this rule. The 

Agency's analysis, therefore, considers the potential impact of the 

registration review process, which includes the costs of a registrant's 

participation in the public review components of the process described 

in this rule and other potential requirements imposed by existing 

authorities such as data generation under FIFRA section 3(c)(2)(B). 

This analysis is contained in a document entitled Economic Analysis of 

the Procedural Regulations for the Registration Review of Pesticides. 

EPA placed a copy of this Economic Analysis in the public docket for 

this action when it published the proposed rule. Comments on the 

Economic Analysis did not warrant revision of this document and the 

Agency will rely on this document to support the final rule. The 

Economic Analysis is briefly summarized here.

    The rule does not require registrants to take specific action as 

part of the review of a pesticide registration, however, the Agency's 

analysis assumes that registrants will engage in their own evaluation 

of information provided by the Agency and other stakeholders, and 

participate in the public process described in this rule. The Agency 

estimates such industry costs to be around $1.2 million annually.

    The Agency recognizes that under other existing authorities a 

registrant may also need to submit data that they have or generate data 

as necessary to support the registration. As such, the analysis also 

considers the potential cost to industry from other anticipated 

activities under existing authorities that may occur during the 

registration review process, although such activities are not 

requirements in this rulemaking. These activities include potential 

data submission or generation activities related to DCIs, including the 

paperwork burden, and other activities that might occur under other 

existing authorities.

    Considering these other potential activities, the analysis shows an 

estimated total annual cost to industry of about $50 million, with the 

estimates for potential data generation activities accounting for 

approximately 70% of these costs. The Agency estimates about 68 

companies will be impacted each year; thus, per-company costs for the 

entire registration review process are likely to average less than 

$750,000 each year, even though some companies may have multiple 

chemicals under review during the year. Out of the universe of 2,000 

small businesses estimated to hold pesticide registrations, the Agency 

estimates that each year about 30 small businesses that have 

responsibility for providing data to support the registration of a 

pesticide would be involved in a registration review. Assuming the same 

level of participation and potential need to generate data, the 

estimated average cost of the registration review process is estimated 

to be less than 2% of the gross sales for small businesses involved in 

a registration review.

B. Paperwork Reduction Act (PRA)

    The information collection activities associated with the 

registration review program are already approved by the Office of 

Management and Budget (OMB) under the Paperwork Reduction Act, 44 

U.S.C. 3501 et seq. That Information Collection Request (ICR) document 

has been assigned EPA ICR number 0922.07, and OMB control number 2070-

0057. Although this action does not impose any new information 

collection requirements that would require additional approval by OMB, 

the Agency expects the approved burden estimate to increase with the 

full implementation of the registration review process. A copy of the 

OMB approved ICR has been placed in the public docket for this rule, 

and the Agency's estimated burden increase is presented in the economic 

analysis that has been prepared for this rule.

    As detailed in the Economic Analysis prepared for this rule, the 

annual respondent burden for information collection activities 

associated with the registration review program is estimated to average 

120,000 hours, with an estimated total annual respondent cost of 

$10,800,000. The July 13, 2005, proposed rule invited comments on the 

Agency's need for this information, the accuracy of the provided burden 

estimates, and any suggested methods for minimizing respondent burden, 

including the use of automated collection techniques. No comments were 

received. Therefore, the Agency has submitted an information correction 

worksheet request to OMB to amend its existing ICR covering the 

information collection activities associated with the registration 

review program so that it reflects the burden estimates in the Economic 

Analysis.

    Under the PRA, ``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.

    Under the PRA, 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 codified in Chapter 40 of the CFR, after 

appearing in the preamble of the final rule, are listed in 40 CFR part 

9, are displayed either by publication in the Federal Register or by 

other appropriate means, such as on the related collection instrument 

or form, if applicable. The display of OMB control numbers in certain 

EPA regulations is consolidated in 40 CFR part 9. For the ICR activity 

contained in this final rule, in addition to displaying the applicable 

OMB control number in this unit, the Agency is amending the table in 40 

CFR 9.1 to list the OMB control number assigned to this ICR activity. 

Due to the technical nature of the table, EPA finds that further notice 

and comment about amending the table is unnecessary. As a result, EPA 

finds that there is ``good cause'' under section 553(b)(B) of the 

Administrative Procedures Act (APA), 5 U.S.C. 553(b)(B), to amend this 

table without further notice and comment.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., the Agency hereby certifies that this rule will 

not have a significant adverse economic impact on a substantial number 

of small entities. This rule defines the procedures that EPA will 

follow to implement the statutory registration review provision. It 

does not impose any new requirements on the regulated community. As 

such, this rule does not have direct adverse impacts on small 

businesses, small non-profit

[[Page 45731]]

organizations, or small local governments.

    For purposes of assessing the impacts of this rule on small 

entities, small entity is defined as: (1) A small business as defined 

by the Small Business Administration's (SBA) regulations at 13 CFR 

121.201, which for the pesticide industry consists of businesses with 

fewer than 500 to 1,000 employees (range is based on NAICS sector 

variations); (2) a small governmental jurisdiction that is a government 

of a city, county, town, school district or special district with a 

population of less than 50,000; and (3) a small organization that is 

any not-for-profit enterprise which is independently owned and operated 

and is not dominant in its field. The regulated community does not 

include any small not-for-profit organizations. Small local government 

organizations, such as counties, may register a pesticide under FIFRA 

section 24(c). However, such registrants generally do not manufacture, 

distribute or sell pesticides and generally would not be responsible 

for generating data to support the registration of pesticides. 

Accordingly, the Agency finds that this rule does not have a direct 

adverse effect on small local governments.

D. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) 

(Public Law 104-4), EPA has determined that this action does not 

contain a Federal mandate that may result in expenditures of $100 

million or more for State, local, and tribal governments, in the 

aggregate, or the private sector in any one year. As described in Unit 

XIII.A., this rule is not expected to result in such expenditures. In 

addition, this action will not impact small governments, or local or 

tribal governments. Accordingly, this rule is not subject to the 

requirements of sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled Federalism (64 FR 

43255, August 10, 1999), EPA has determined that this rule does not 

have ``federalism implications,'' because it will not have substantial 

direct effects on the states, on the relationship between the national 

government and the states, or on the distribution of power and 

responsibilities among the various levels of government, as specified 

in the Order. Thus, Executive Order 13132 does not apply to this rule.

F. Executive Order 13175

    As required by Executive Order 13175, entitled Consultation and 

Coordination with Indian Tribal Governments (65 FR 67249, November 6, 

2000), EPA has determined that this rule does not have tribal 

implications because it will not have any affect on tribal governments, 

on the relationship between the Federal government and the Indian 

tribes, or on the distribution of power and responsibilities between 

the Federal government and Indian tribes, as specified in the Order. 

Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13211

    This rule is not subject to Executive Order 13211, entitled Actions 

Concerning Regulations that Significantly Affect Energy Supply, 

Disribution, or Use (66 FR 28355, May 22, 2001) because it is not 

designated as an ``economically significant'' regulatory action as 

defined by Executive Order 12866 (see Unit XIII.A.), nor is it likely 

to have any significant adverse effect on the supply, distribution, or 

use of energy.

H. Executive Order 13045

    Executive Order 13045, entitled Protection of Children from 

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 

1997) does not apply to this rule because this action is not designated 

as an ``economically significant'' regulatory action as defined by 

Executive Order 12866, (see Unit XIII.A.), nor does it establish an 

environmental standard, or otherwise have a disproportionate effect on 

children.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 

Act of 1995 ((NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary 

consensus standards in its regulatory activities unless to do so would 

be inconsistent with applicable law or impractical. Voluntary consensus 

standards are technical standards (e.g., materials specifications, test 

methods, sampling procedures) that are developed or adopted by 

voluntary consensus standards bodies. This rule does not impose any 

technical standards that would require EPA to consider any voluntary 

consensus standards.

J. Executive Order 12898

    This rule does not have an adverse impact on the environmental and 

health conditions in low-income and minority communities. Therefore, 

under Executive Order 12898, entitled Federal Actions to Address 

Environmental Justice in Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 1994), the Agency does not need 

to consider environmental justice-related issues.

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 

provides that before a rule may take effect, the Agency promulgating 

the rule must submit a rule report, which includes a copy of the rule, 

to each House of the Congress and the Comptroller General of the United 

States. EPA will submit a report containing this rule and other 

required information to the U.S. Senate, the U.S. House of 

Representatives, and the Comptroller General of the United States prior 

to publication of the rule in the Federal Register. This rule is not a 

``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

List of Subjects in 40 CFR Part 155

    Environmental protection, Administrative practice and procedure, 

Pesticides and pests.

    Dated: August 1, 2006.

Stephen L. Johnson,

Administrator.

0

Therefore, 40 CFR chapter I is amended as follows:

0

1. Part 9 is amended as follows:

PART 9--[AMENDED]

0

a. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 

2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 

1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 

300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 

300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 

9601-9657, 11023, 11048.

0

b. In Sec.  9.1, the table is amended by revising the existing heading 

for ``Registration Standards''; removing the entry under that heading; 

and adding a new entry to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

[[Page 45732]]

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

                   40 CFR citation                      OMB control no.

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

                                * * * * *

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

             Registration Standards and Registration Review

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

                                * * * * *

Part 155.............................................          2070-0057

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

* * * * *

0

2. Part 155 is amended as follows:

PART 155-REGISTRATION STANDARDS AND REGISTRATION REVIEW

0

a. The authority citation for part 155 continues to read as follows:

    Authority: 7 U.S.C. 1361.

0

b. By revising the heading of part 155 to read as set forth above.

0

c. By adding a new subpart C to read as follows:

Subpart C--Registration Review Procedures

Sec.

155.40 General.

155.42 Registration review cases.

155.44 Establish schedules for registration review.

155.46 Deciding that a registration review is complete and 

additional review is not needed.

155.48 Data Call-In.

155.50 Initiate a pesticide's registration review.

155.52 Stakeholder engagement.

155.53 Conduct of a pesticide's registration review.

155.56 Interim registration review decision.

155.57 Registration review decision.

155.58 Procedures for issuing a decision on a registration review 

case.

Subpart C--Registration Review Procedures

Sec.  155.40  General.

    (a) Purpose. These regulations establish procedures for the 

registration review program required in FIFRA 3(g). Registration review 

is the periodic review of a pesticide's registration to ensure that 

each pesticide registration continues to satisfy the FIFRA standard for 

registration. The goal of the registration review procedures is review 

of each pesticide's registration every 15 years.

    (1) Among other things, FIFRA requires that a pesticide generally 

will not cause unreasonable adverse effects on the environment. 

Registration review is intended to ensure that each pesticide's 

registration is based on current scientific and other knowledge 

regarding the pesticide, including its effects on human health and the 

environment.

    (2) If a product fails to satisfy the FIFRA standard for 

registration, the product's registration may be subject to cancellation 

or other remedies under FIFRA.

    (b) Applicability. This subpart applies to every pesticide product 

registered under FIFRA section 3 as well as all pesticide products 

registered under FIFRA section 24(c). It does not apply to products 

whose sale or distribution is authorized under FIFRA section 5 or 

section 18.

    (c) Limitations. (1) At any time, the Agency may undertake any 

other review of a pesticide under FIFRA, irrespective of the 

pesticide's past, ongoing, scheduled, or not yet scheduled registration 

review.

    (2) When the Agency determines that new data or information are 

necessary for a pesticide's registration review, it will require such 

data under FIFRA section 3(c)(2)(B).

Sec.  155.42  Registration review cases.

    (a) Establishing registration review cases. A registration review 

case will be composed of one or more active ingredients and all the 

products containing such ingredient(s). The Agency may group related 

active ingredients into a registration review case when the active 

ingredients are so closely related in chemical structure and 

toxicological profile as to allow common use of some or all required 

data for hazard assessment.

    (1) Existing pesticides. The Agency will assign each pesticide 

registered on or before the effective date of this regulation to a 

registration review case.

    (2) New pesticides. The Agency will assign each pesticide 

registered after the effective date of this regulation to an existing 

registration review case or to a new registration review case.

    (3) A pesticide product that contains multiple active ingredients 

will belong to the registration review cases for each of its active 

ingredients.

    (b) Modifying registration review cases. New data or information 

may suggest that a registration review case should be modified. The 

Agency may modify a registration review case in the following ways:

    (1) Add a new active ingredient to a registration review case. The 

Agency may determine that a new active ingredient is chemically and 

toxicologically similar to active ingredients in an existing 

registration review case and should be grouped with the ingredients in 

the existing registration review case.

    (2) Split a registration review case into two or more registration 

review cases. For example, new data or information may suggest that 

active ingredients in a registration review case are not as similar as 

previously believed and that they belong in two or more separate 

registration review cases.

    (3) Move an ingredient from one registration review case to 

another. For example, new data or information might suggest that an 

ingredient should not be grouped with the other ingredients in the 

registration review case and that it belongs in a different 

registration review case.

    (4) Merge two or more registration review cases into a single 

registration review case. For example, new data or information might 

suggest that the active ingredients in two or more registration review 

cases should be grouped together for registration review.

    (5) Delete an active ingredient from a registration review case. 

For example, the Agency will remove the ingredient from the case if the 

registrations of all products containing an active ingredient in a 

registration review case are canceled.

    (c) Closing a registration review case. The Agency will close a 

registration review case if all products in the case are canceled.

    (d) Establishing a baseline date for a registration review case. 

For the purpose of scheduling registration reviews, the Agency will 

establish a baseline date for each registration review case. In 

general, the baseline date will be the date of initial registration of 

the oldest pesticide product in the case or the date of reregistration, 

whichever is later. For the purpose of these procedures, the date of 

reregistration is the date on which the Reregistration Eligibility 

Decision or Interim Reregistration Decision was signed, whichever date 

the Agency determines to be more appropriate based on the 

comprehensiveness of the review.

    (1) The Agency generally will not change the baseline date for a 

registration review case when it modifies a case by adding or deleting 

ingredients or products.

    (2) When the Agency splits a registration review case into two or 

more cases, the new case(s) generally will have the baseline date of 

the original registration review case.

    (3) When the Agency merges two or more registration review cases 

into a single case, the Agency generally will use the earliest baseline 

date as the baseline date for the new case.

    (e) Announcing registration review cases and baseline dates. The 

Agency will maintain a list of registration review cases, including 

baseline dates, on its website.

[[Page 45733]]

Sec.  155.44  Establish schedules for registration review.

    The Agency will develop schedules for registration review that are 

generally based on the baseline date of the registration review case or 

on the date of the latest registration review of the registration 

review case. The Agency may also take into account other factors, such 

as achieving process efficiencies by reviewing related cases together, 

when developing schedules for registration review. The Agency will 

maintain schedules for the current year and at least two subsequent 

years on its website.

Sec.  155.46  Deciding that a registration review is complete and 

additional review is not needed.

    The Agency may determine that there is no need to reconsider a 

previous decision that a pesticide satisfies the standard of 

registration in FIFRA. In such cases, instead of establishing a 

pesticide registration review case docket as described in Sec.  155.50, 

the Agency may propose that, based on its determination that a 

pesticide meets the FIFRA standard for registration, no further review 

will be necessary. In such circumstances, the Agency will publish a 

notice in the Federal Register announcing the availability of the 

proposed decision and provide a comment period of at least 60 calendar 

days. The Agency will publish a notice in the Federal Register 

announcing the availability of a final version of the decision, an 

explanation of any changes to the proposed decision and its response to 

any comments. The date of the final notice of availability would be 

used as the date of the latest registration review for the purpose of 

scheduling subsequent registration reviews.

Sec.  155.48  Data Call-In.

    The Agency may issue a Data Call-In notice under FIFRA section 

3(c)(2)(B) at any time if the Agency believes that the data are needed 

to conduct the registration review. The provisions in FIFRA section 

3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission, 

compensation, and exemption of data required to conduct a registration 

review.

Sec.  155.50  Initiate a pesticide's registration review.

    The Agency will initiate a pesticide's registration review by 

establishing a docket for each registration review case, except for 

cases covered under Sec.  155.46, and opening it for public review.

    (a) Contents of the registration review case docket. The Agency 

will place in this docket information that will assist the public in 

understanding the types of information and issues that the Agency may 

consider in the course of the registration review. The Agency may 

include information from its files including, but not limited to, the 

following information:

    (1) An overview of registration review case status;

    (2) A list of current registrations and registrants, any Federal 

Register notices regarding pending registration actions, and current or 

pending tolerances;

    (3) Risk assessment documents;

    (4) Bibliographies concerning current registrations;

    (5) Summaries of incident data; and

    (6) Any other pertinent data or information.

    (b) Public review of the registration review case docket. The 

Agency will publish a notice in the Federal Register announcing the 

availability for public review of the information described in 

paragraph (a) of this section and establishing a comment period of at 

least 60 days. During this comment period, interested persons may 

identify any additional information they believe the Agency should 

consider in the course of the registration review.

    (c) Submission of data and other information during the comment 

period. The Agency may identify, either in the notice published under 

paragraph (b) of this section, or at any other time, data or 

information that it does not have but which may be useful, if 

available, for consideration in the registration review. Any person may 

submit data or information in response to such identification. In order 

to be considered during a pesticide's registration review, the 

submitted data or information must meet the requirements listed below.

    (1) In order to ensure that the Agency will consider data or 

information in the conduct of a registration review, interested persons 

must submit the data or information during the comment period 

established in the notice described in paragraph (b) of this section. 

The Agency may, at its discretion, consider data or information 

submitted at a later date.

    (2) The data or information must be presented in a legible and 

useable form. For example, an English translation must accompany any 

material that is not in English and a written transcript must accompany 

any information submitted as an audiographic or videographic record. 

Written material may be submitted in paper or electronic form.

    (3) Submitters must clearly identify the source of any submitted 

data or information.

    (4) Submitters may request the Agency to reconsider data or 

information that the Agency rejected in a previous review. However, 

submitters must explain why they believe the Agency should reconsider 

the data or information in the pesticide's registration review.

    (d) For the purposes of this subpart, the provisions of subpart B 

do not apply.

Sec.  155.52  Stakeholder engagement.

    In addition to the public participation opportunities described in 

Sec.  155.50 and Sec.  155.53(c), the Agency may meet with stakeholders 

regarding a forthcoming or ongoing registration review. For example, 

before conducting a pesticide's registration review, the Agency may 

consult with registrants or pesticide users regarding the use and usage 

of the pesticide. The Agency may consult with registrants, pesticide 

users, or other persons during a pesticide's registration review with 

regard to developing risk management options for a pesticide. The 

Agency may informally consult with officials of Federal, State or 

Tribal agencies regarding a forthcoming or ongoing registration review.

    (a) Minutes of meetings with persons outside of government. The 

Agency will place in the docket minutes of meetings with persons 

outside of government where the primary purpose of the meeting is to 

discuss a forthcoming or ongoing registration review. The Agency will 

place minutes of such meetings in the docket when it takes action under 

Sec.  155.58. At its discretion, the Agency may place minutes of such 

meetings in the docket sooner.

    (b) Exchange of documents or other written material. In the course 

of a meeting with a person outside of government, the Agency or that 

person may provide the other with a copy of a document or other written 

material that has not yet been released to the public. The Agency will 

place a copy of any such document or other written material in the 

docket along with the minutes of the meeting where the materials were 

exchanged.

    (c) Confidential business information. The Agency will not place 

confidential business information in the docket.

Sec.  155.53  Conduct of a pesticide's registration review.

    The Agency will review data and information described in Sec.  

155.50(a), (b), and (c) or submitted in response to a Data Call-In 

notice that it believes should be considered in the pesticide's 

registration review.

    (a) Assess changes since a pesticide's last review. The Agency will 

assess any changes that may have occurred since the Agency's last 

registration decision in order to determine the significance of

[[Page 45734]]

such changes and whether the pesticide still satisfies the FIFRA 

standard for registration. The Agency will consider whether to conduct 

a new risk assessment to take into account, among other things, any 

changes in statutes or regulations, policy, risk assessment procedures 

or methods, or data requirements. The Agency will consider whether any 

new data or information on the pesticide, including any data or 

information submitted under Sec.  155.50 or in response to a Data Call-

In notice, warrant conducting a new risk assessment or a new risk/

benefit assessment. The Agency will also consider whether any new data 

or information regarding an individual pesticide product, including any 

data or information submitted under Sec.  155.50 or in response to a 

Data Call-In notice, such as data or information about an inert 

ingredient in the pesticide product or other information or data 

relating to the composition, labeling or use of the pesticide product, 

warrant additional review of a pesticide product's registration.

    (b) Conduct new assessments as needed. (1) Active ingredient(s) in 

the registration review case. If the Agency finds that a new assessment 

of the pesticide is needed, it will determine whether it can base the 

new assessment on available data or information, including data or 

information submitted under Sec.  155.50 or in response to a Data Call-

In notice. If sufficient data or information are available, the Agency 

will conduct the new risk assessment or risk/benefit assessment. If the 

Agency determines that additional data or information are needed to 

conduct the review, the Agency will issue a Data Call-In notice under 

FIFRA section 3(c)(2)(B).

    (2) Individual product registrations. If the Agency finds that 

additional review of an individual product's registration is needed, it 

will review the pesticide product label, confidential statement of 

formula, product-specific data, or other pertinent data or information, 

as appropriate, to determine whether the registration of the individual 

product meets the FIFRA standard for registration. If the Agency 

determines that additional data or information are needed to conduct 

the review, the Agency will issue a Data Call-In notice under FIFRA 

section 3(c)(2)(B).

    (c) Public participation during a pesticide's registration review. 

The Agency will generally make available for public review and comment 

a draft risk assessment for a pesticide if a new risk assessment has 

been conducted. The Agency will publish a notice in the Federal 

Register announcing the availability of the draft risk assessment and 

provide a comment period of at least 30 calendar days. The Agency will 

publish a notice in the Federal Register announcing the availability of 

a revised risk assessment, an explanation of any changes to the 

proposed document, and its response to comments. If the revised risk 

assessment indicates risks of concern, the Agency may, in the notice 

announcing the availability of the revised risk assessment, provide a 

comment period of at least 30 calendar days for the public to submit 

suggestions for mitigating the risk identified in the revised risk 

assessment.

    (1) The Agency might not request comments on a draft risk 

assessment in cases where the Agency's initial screening of a pesticide 

indicates that it has low use/usage, affects few if any stakeholders or 

members of the public, poses low risk, and/or requires little or no 

risk mitigation. In such cases, the Agency will make a draft risk 

assessment available for public review and comment when it issues a 

proposed decision on the registration review case.

    (2) If the Agency finds that it is not necessary to conduct a new 

risk assessment, it will issue a proposed decision on the registration 

review case as described in Sec.  155.58.

Sec.  155.56  Interim registration review decision.

    The Agency may issue, when it determines it to be appropriate, an 

interim registration review decision before completing a registration 

review. Among other things, the interim registration review decision 

may require new risk mitigation measures, impose interim risk 

mitigation measures, identify data or information required to complete 

the review, and include schedules for submitting the required data, 

conducting the new risk assessment and completing the registration 

review. A FIFRA 3(c)(2)(B) notice requiring the needed data or 

information may precede, accompany, or follow issuance of the interim 

registration review decision. The Agency will follow procedures in 

Sec.  155.58 when issuing an interim registration review decision.

Sec.  155.57  Registration review decision.

    A registration review decision is the Agency's determination 

whether a pesticide meets, or does not meet, the standard for 

registration in FIFRA.

Sec.  155.58  Procedures for issuing a decision on a registration 

review case.

    (a) The Agency will publish a notice in the Federal Register 

announcing the availability of a proposed registration review decision 

or a proposed interim registration review decision. At that time, the 

Agency will place in the pesticide's registration review docket the 

Agency's proposed decision and the bases for the decision. There will 

be a comment period of at least 60 calendar days on the proposed 

decision.

    (b) In its proposed decision, the Agency will, among other things:

    (1) State its proposed findings with respect to the FIFRA standard 

for registration and describe the basis for such proposed findings.

    (2) Identify proposed risk mitigation measures or other remedies as 

needed and describe the basis for such proposed requirements.

    (3) State whether it believes that additional data are needed and, 

if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring 

such data may be issued in conjunction with a proposed or final 

decision on the registration review case or a proposed or final interim 

decision on a registration review case.

    (4) Specify proposed labeling changes; and

    (5) Identify deadlines that it intends to set for completing any 

required actions.

    (c) After considering any comments on the proposed decision, the 

Agency will issue a registration review decision or interim 

registration review decision. This decision will include an explanation 

of any changes to the proposed decision and the Agency's response to 

significant comments. The Agency will publish a notice in the Federal 

Register announcing the availability of a registration review decision 

or interim registration review decision. The registration review case 

docket will remain open until all actions required in the final 

decision on the registration review case have been completed.

    (d) If the registrant fails to take the action required in a 

registration review decision or interim registration review decision, 

the Agency may take appropriate action under FIFRA.

[FR Doc. E6-12904 Filed 8-8-06; 8:45 am]

BILLING CODE 6560-50-S

Attachment D

Federal Food, Drug, and Cosmetic Act (FFDCA) 

Section 408 - Tolerances and Exemptions for Pesticide Chemical Residues 

(21 U.S.C. 346a) 

Attachment D

Federal Food, Drug, and Cosmetic Act (FFDCA) 

Section 408 - Tolerances and Exemptions for Pesticide Chemical Residues 

(21 U.S.C. 346a) 

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

  January 3, 2005 and March 20, 2006]

[CITE: 21USC346a]

 

                        TITLE 21--FOOD AND DRUGS

 

             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT

 

                           SUBCHAPTER IV--FOOD

 

Sec. 346a. Tolerances and exemptions for pesticide chemical 

        residues

        

(a) Requirement for tolerance or exemption

                          (1) General rule

        Except as provided in paragraph (2) or (3), any pesticide 

    chemical residue in or on a food shall be deemed unsafe for the 

    purpose of section 342(a)(2)(B) of this title unless--

            (A) a tolerance for such pesticide chemical residue in or on

        such food is in effect under this section and the quantity of 

        the residue is within the limits of the tolerance; or

            (B) an exemption from the requirement of a tolerance is in 

        effect under this section for the pesticide chemical residue.

    For the purposes of this section, the term ``food'', when used as a 

    noun without modification, shall mean a raw agricultural commodity 

    or processed food.

                         (2) Processed food

        Notwithstanding paragraph (1)--

            (A) if a tolerance is in effect under this section for a 

        pesticide chemical residue in or on a raw agricultural 

        commodity, a pesticide chemical residue that is present in or on

        a processed food because the food is made from that raw 

        agricultural commodity shall not be considered unsafe within the

        meaning of section 342(a)(2)(B) of this title despite the lack 

        of a tolerance for the pesticide chemical residue in or on the 

        processed food if the pesticide chemical has been used in or on 

        the raw agricultural commodity in conformity with a tolerance 

        under this section, such residue in or on the raw agricultural 

        commodity has been removed to the extent possible in good 

        manufacturing practice, and the concentration of the pesticide 

        chemical residue in the processed food is not greater than the 

        tolerance prescribed for the pesticide chemical residue in the 

        raw agricultural commodity; or

            (B) if an exemption for the requirement for a tolerance is 

        in effect under this section for a pesticide chemical residue in

        or on a raw agricultural commodity, a pesticide chemical residue

        that is present in or on a processed food because the food is 

        made from that raw agricultural commodity shall not be 

        considered unsafe within the meaning of section 342(a)(2)(B) of 

        this title.

                (3) Residues of degradation products

        If a pesticide chemical residue is present in or on a food 

    because it is a metabolite or other degradation product of a 

    precursor substance that itself is a pesticide chemical or pesticide

    chemical residue, such a residue shall not be considered to be 

    unsafe within the meaning of section 342(a)(2)(B) of this title 

    despite the lack of a tolerance or exemption from the need for a 

    tolerance for such residue in or on such food if--

            (A) the Administrator has not determined that the 

        degradation product is likely to pose any potential health risk 

        from dietary exposure that is of a different type than, or of a 

        greater significance than, any risk posed by dietary exposure to

        the precursor substance;

            (B) either--

                (i) a tolerance is in effect under this section for 

            residues of the precursor substance in or on the food, and 

            the combined level of residues of the degradation product 

            and the precursor substance in or on the food is at or below

            the stoichiometrically equivalent level that would be 

            permitted by the tolerance if the residue consisted only of 

            the precursor substance rather than the degradation product;

            or

                (ii) an exemption from the need for a tolerance is in 

            effect under this section for residues of the precursor 

            substance in or on the food; and

            (C) the tolerance or exemption for residues of the precursor

        substance does not state that it applies only to particular 

        named substances and does not state that it does not apply to 

        residues of the degradation product.

                (4) Effect of tolerance or exemption

        While a tolerance or exemption from the requirement for a 

    tolerance is in effect under this section for a pesticide chemical 

    residue with respect to any food, the food shall not by reason of 

    bearing or containing any amount of such a residue be considered to 

    be adulterated within the meaning of section 342(a)(1) of this 

    title.

(b) Authority and standard for tolerance

                            (1) Authority

        The Administrator may issue regulations establishing, modifying,

    or revoking a tolerance for a pesticide chemical residue in or on a 

    food--

            (A) in response to a petition filed under subsection (d) of 

        this section; or

            (B) on the Administrator's own initiative under subsection 

        (e) of this section.

    As used in this section, the term ``modify'' shall not mean 

    expanding the tolerance to cover additional foods.

                            (2) Standard

        (A) General rule

            (i) Standard

                The Administrator may establish or leave in effect a 

            tolerance for a pesticide chemical residue in or on a food 

            only if the Administrator determines that the tolerance is 

            safe. The Administrator shall modify or revoke a tolerance 

            if the Administrator determines it is not safe.

            (ii) Determination of safety

                As used in this section, the term ``safe'', with respect

            to a tolerance for a pesticide chemical residue, means that 

            the Administrator has determined that there is a reasonable 

            certainty that no harm will result from aggregate exposure 

            to the pesticide chemical residue, including all anticipated

            dietary exposures and all other exposures for which there is

            reliable information.

            (iii) Rule of construction

                With respect to a tolerance, a pesticide chemical 

            residue meeting the standard under clause (i) is not an 

            eligible pesticide chemical residue for purposes of 

            subparagraph (B).

        (B) Tolerances for eligible pesticide chemical residues

            (i) Definition

                As used in this subparagraph, the term ``eligible 

            pesticide chemical residue'' means a pesticide chemical 

            residue as to which--

                    (I) the Administrator is not able to identify a 

                level of exposure to the residue at which the residue 

                will not cause or contribute to a known or anticipated 

                harm to human health (referred to in this section as a 

                ``nonthreshold effect'');

                    (II) the lifetime risk of experiencing the 

                nonthreshold effect is appropriately assessed by 

                quantitative risk assessment; and

                    (III) with regard to any known or anticipated harm 

                to human health for which the Administrator is able to 

                identify a level at which the residue will not cause 

                such harm (referred to in this section as a ``threshold 

                effect''), the Administrator determines that the level 

                of aggregate exposure is safe.

            (ii) Determination of tolerance

                Notwithstanding subparagraph (A)(i), a tolerance for an 

            eligible pesticide chemical residue may be left in effect or

            modified under this subparagraph if--

                    (I) at least one of the conditions described in 

                clause (iii) is met; and

                    (II) both of the conditions described in clause (iv)

                are met.

            (iii) Conditions regarding use

                For purposes of clause (ii), the conditions described in

            this clause with respect to a tolerance for an eligible 

            pesticide chemical residue are the following:

                    (I) Use of the pesticide chemical that produces the 

                residue protects consumers from adverse effects on 

                health that would pose a greater risk than the dietary 

                risk from the residue.

                    (II) Use of the pesticide chemical that produces the

                residue is necessary to avoid a significant disruption 

                in domestic production of an adequate, wholesome, and 

                economical food supply.

            (iv) Conditions regarding risk

                For purposes of clause (ii), the conditions described in

            this clause with respect to a tolerance for an eligible 

            pesticide chemical residue are the following:

                    (I) The yearly risk associated with the nonthreshold

                effect from aggregate exposure to the residue does not 

                exceed 10 times the yearly risk that would be allowed 

                under subparagraph (A) for such effect.

                    (II) The tolerance is limited so as to ensure that 

                the risk over a lifetime associated with the 

                nonthreshold effect from aggregate exposure to the 

                residue is not greater than twice the lifetime risk that

                would be allowed under subparagraph (A) for such effect.

            (v) Review

                Five years after the date on which the Administrator 

            makes a determination to leave in effect or modify a 

            tolerance under this subparagraph, and thereafter as the 

            Administrator deems appropriate, the Administrator shall 

            determine, after notice and opportunity for comment, whether

            it has been demonstrated to the Administrator that a 

            condition described in clause (iii)(I) or clause (iii)(II) 

            continues to exist with respect to the tolerance and that 

            the yearly and lifetime risks from aggregate exposure to 

            such residue continue to comply with the limits specified in

            clause (iv). If the Administrator determines by such date 

            that such demonstration has not been made, the Administrator

            shall, not later than 180 days after the date of such 

            determination, issue a regulation under subsection (e)(1) of

            this section to modify or revoke the tolerance.

            (vi) Infants and children

                Any tolerance under this subparagraph shall meet the 

            requirements of subparagraph (C).

        (C) Exposure of infants and children

            In establishing, modifying, leaving in effect, or revoking a

        tolerance or exemption for a pesticide chemical residue, the 

        Administrator--

                (i) shall assess the risk of the pesticide chemical 

            residue based on--

                    (I) available information about consumption patterns

                among infants and children that are likely to result in 

                disproportionately high consumption of foods containing 

                or bearing such residue among infants and children in 

                comparison to the general population;

                    (II) available information concerning the special 

                susceptibility of infants and children to the pesticide 

                chemical residues, including neurological differences 

                between infants and children and adults, and effects of 

                in utero exposure to pesticide chemicals; and

                    (III) available information concerning the 

                cumulative effects on infants and children of such 

                residues and other substances that have a common 

                mechanism of toxicity; and

                (ii) shall--

                    (I) ensure that there is a reasonable certainty that

                no harm will result to infants and children from 

                aggregate exposure to the pesticide chemical residue; 

                and

                    (II) publish a specific determination regarding the 

                safety of the pesticide chemical residue for infants and

                children.

        The Secretary of Health and Human Services and the Secretary of 

        Agriculture, in consultation with the Administrator, shall 

        conduct surveys to document dietary exposure to pesticides among

        infants and children. In the case of threshold effects, for 

        purposes of clause (ii)(I) an additional tenfold margin of 

        safety for the pesticide chemical residue and other sources of 

        exposure shall be applied for infants and children to take into 

        account potential pre- and post-natal toxicity and completeness 

        of the data with respect to exposure and toxicity to infants and

        children. Notwithstanding such requirement for an additional 

        margin of safety, the Administrator may use a different margin 

        of safety for the pesticide chemical residue only if, on the 

        basis of reliable data, such margin will be safe for infants and

        children.

        (D) Factors

            In establishing, modifying, leaving in effect, or revoking a

        tolerance or exemption for a pesticide chemical residue, the 

        Administrator shall consider, among other relevant factors--

                (i) the validity, completeness, and reliability of the 

            available data from studies of the pesticide chemical and 

            pesticide chemical residue;

                (ii) the nature of any toxic effect shown to be caused 

            by the pesticide chemical or pesticide chemical residue in 

            such studies;

                (iii) available information concerning the relationship 

            of the results of such studies to human risk;

                (iv) available information concerning the dietary 

            consumption patterns of consumers (and major identifiable 

            subgroups of consumers);

                (v) available information concerning the cumulative 

            effects of such residues and other substances that have a 

            common mechanism of toxicity;

                (vi) available information concerning the aggregate 

            exposure levels of consumers (and major identifiable 

            subgroups of consumers) to the pesticide chemical residue 

            and to other related substances, including dietary exposure 

            under the tolerance and all other tolerances in effect for 

            the pesticide chemical residue, and exposure from other non-

            occupational sources;

                (vii) available information concerning the variability 

            of the sensitivities of major identifiable subgroups of 

            consumers;

                (viii) such information as the Administrator may require

            on whether the pesticide chemical may have an effect in 

            humans that is similar to an effect produced by a naturally 

            occurring estrogen or other endocrine effects; and

                (ix) safety factors which in the opinion of experts 

            qualified by scientific training and experience to evaluate 

            the safety of food additives are generally recognized as 

            appropriate for the use of animal experimentation data.

        (E) Data and information regarding anticipated and actual 

                residue levels

            (i) Authority

                In establishing, modifying, leaving in effect, or 

            revoking a tolerance for a pesticide chemical residue, the 

            Administrator may consider available data and information on

            the anticipated residue levels of the pesticide chemical in 

            or on food and the actual residue levels of the pesticide 

            chemical that have been measured in food, including residue 

            data collected by the Food and Drug Administration.

            (ii) Requirement

                If the Administrator relies on anticipated or actual 

            residue levels in establishing, modifying, or leaving in 

            effect a tolerance, the Administrator shall pursuant to 

            subsection (f)(1) of this section require that data be 

            provided five years after the date on which the tolerance is

            established, modified, or left in effect, and thereafter as 

            the Administrator deems appropriate, demonstrating that such

            residue levels are not above the levels so relied on. If 

            such data are not so provided, or if the data do not 

            demonstrate that the residue levels are not above the levels

            so relied on, the Administrator shall, not later than 180 

            days after the date on which the data were required to be 

            provided, issue a regulation under subsection (e)(1) of this

            section, or an order under subsection (f)(2) of this 

            section, as appropriate, to modify or revoke the tolerance.

        (F) Percent of food actually treated

            In establishing, modifying, leaving in effect, or revoking a

        tolerance for a pesticide chemical residue, the Administrator 

        may, when assessing chronic dietary risk, consider available 

        data and information on the percent of food actually treated 

        with the pesticide chemical (including aggregate pesticide use 

        data collected by the Department of Agriculture) only if the 

        Administrator--

                (i) finds that the data are reliable and provide a valid

            basis to show what percentage of the food derived from such 

            crop is likely to contain such pesticide chemical residue;

                (ii) finds that the exposure estimate does not 

            understate exposure for any significant subpopulation group;

                (iii) finds that, if data are available on pesticide use

            and consumption of food in a particular area, the population

            in such area is not dietarily exposed to residues above 

            those estimated by the Administrator; and

                (iv) provides for the periodic reevaluation of the 

            estimate of anticipated dietary exposure.

                        (3) Detection methods

        (A) General rule

            A tolerance for a pesticide chemical residue in or on a food

        shall not be established or modified by the Administrator unless

        the Administrator determines, after consultation with the 

        Secretary, that there is a practical method for detecting and 

        measuring the levels of the pesticide chemical residue in or on 

        the food.

        (B) Detection limit

            A tolerance for a pesticide chemical residue in or on a food

        shall not be established at or modified to a level lower than 

        the limit of detection of the method for detecting and measuring

        the pesticide chemical residue specified by the Administrator 

        under subparagraph (A).

                     (4) International standards

        In establishing a tolerance for a pesticide chemical residue in 

    or on a food, the Administrator shall determine whether a maximum 

    residue level for the pesticide chemical has been established by the

    Codex Alimentarius Commission. If a Codex maximum residue level has 

    been established for the pesticide chemical and the Administrator 

    does not propose to adopt the Codex level, the Administrator shall 

    publish for public comment a notice explaining the reasons for 

    departing from the Codex level.

(c) Authority and standard for exemptions

                            (1) Authority

        The Administrator may issue a regulation establishing, 

    modifying, or revoking an exemption from the requirement for a 

    tolerance for a pesticide chemical residue in or on food--

            (A) in response to a petition filed under subsection (d) of 

        this section; or

            (B) on the Administrator's initiative under subsection (e) 

        of this section.

                            (2) Standard

        (A) General rule

            (i) Standard

                The Administrator may establish or leave in effect an 

            exemption from the requirement for a tolerance for a 

            pesticide chemical residue in or on food only if the 

            Administrator determines that the exemption is safe. The 

            Administrator shall modify or revoke an exemption if the 

            Administrator determines it is not safe.

            (ii) Determination of safety

                The term ``safe'', with respect to an exemption for a 

            pesticide chemical residue, means that the Administrator has

            determined that there is a reasonable certainty that no harm

            will result from aggregate exposure to the pesticide 

            chemical residue, including all anticipated dietary 

            exposures and all other exposures for which there is 

            reliable information.

        (B) Factors

            In making a determination under this paragraph, the 

        Administrator shall take into account, among other relevant 

        considerations, the considerations set forth in subparagraphs 

        (C) and (D) of subsection (b)(2) of this section.

                           (3) Limitation

        An exemption from the requirement for a tolerance for a 

    pesticide chemical residue in or on food shall not be established or

    modified by the Administrator unless the Administrator determines, 

    after consultation with the Secretary--

            (A) that there is a practical method for detecting and 

        measuring the levels of such pesticide chemical residue in or on

        food; or

            (B) that there is no need for such a method, and states the 

        reasons for such determination in issuing the regulation 

        establishing or modifying the exemption.

(d) Petition for tolerance or exemption

                    (1) Petitions and petitioners

        Any person may file with the Administrator a petition proposing 

    the issuance of a regulation--

            (A) establishing, modifying, or revoking a tolerance for a 

        pesticide chemical residue in or on a food; or

            (B) establishing, modifying, or revoking an exemption from 

        the requirement of a tolerance for such a residue.

                        (2) Petition contents

        (A) Establishment

            A petition under paragraph (1) to establish a tolerance or 

        exemption for a pesticide chemical residue shall be supported by

        such data and information as are specified in regulations issued

        by the Administrator, including--

                (i)(I) an informative summary of the petition and of the

            data, information, and arguments submitted or cited in 

            support of the petition; and

                (II) a statement that the petitioner agrees that such 

            summary or any information it contains may be published as a

            part of the notice of filing of the petition to be published

            under this subsection and as part of a proposed or final 

            regulation issued under this section;

                (ii) the name, chemical identity, and composition of the

            pesticide chemical residue and of the pesticide chemical 

            that produces the residue;

                (iii) data showing the recommended amount, frequency, 

            method, and time of application of that pesticide chemical;

                (iv) full reports of tests and investigations made with 

            respect to the safety of the pesticide chemical, including 

            full information as to the methods and controls used in 

            conducting those tests and investigations;

                (v) full reports of tests and investigations made with 

            respect to the nature and amount of the pesticide chemical 

            residue that is likely to remain in or on the food, 

            including a description of the analytical methods used;

                (vi) a practical method for detecting and measuring the 

            levels of the pesticide chemical residue in or on the food, 

            or for exemptions, a statement why such a method is not 

            needed;

                (vii) a proposed tolerance for the pesticide chemical 

            residue, if a tolerance is proposed;

                (viii) if the petition relates to a tolerance for a 

            processed food, reports of investigations conducted using 

            the processing method(s) used to produce that food;

                (ix) such information as the Administrator may require 

            to make the determination under subsection (b)(2)(C) of this

            section;

                (x) such information as the Administrator may require on

            whether the pesticide chemical may have an effect in humans 

            that is similar to an effect produced by a naturally 

            occurring estrogen or other endocrine effects;

                (xi) information regarding exposure to the pesticide 

            chemical residue due to any tolerance or exemption already 

            granted for such residue;

                (xii) practical methods for removing any amount of the 

            residue that would exceed any proposed tolerance; and

                (xiii) such other data and information as the 

            Administrator requires by regulation to support the 

            petition.

        If information or data required by this subparagraph is 

        available to the Administrator, the person submitting the 

        petition may cite the availability of the information or data in

        lieu of submitting it. The Administrator may require a petition 

        to be accompanied by samples of the pesticide chemical with 

        respect to which the petition is filed.

        (B) Modification or revocation

            The Administrator may by regulation establish the 

        requirements for information and data to support a petition to 

        modify or revoke a tolerance or to modify or revoke an exemption

        from the requirement for a tolerance.

                             (3) Notice

        A notice of the filing of a petition that the Administrator 

    determines has met the requirements of paragraph (2) shall be 

    published by the Administrator within 30 days after such 

    determination. The notice shall announce the availability of a 

    description of the analytical methods available to the Administrator

    for the detection and measurement of the pesticide chemical residue 

    with respect to which the petition is filed or shall set forth the 

    petitioner's statement of why such a method is not needed. The 

    notice shall include the summary required by paragraph (2)(A)(i)(I).

                  (4) Actions by the Administrator

        (A) In general

            The Administrator shall, after giving due consideration to a

        petition filed under paragraph (1) and any other information 

        available to the Administrator--

                (i) issue a final regulation (which may vary from that 

            sought by the petition) establishing, modifying, or revoking

            a tolerance for the pesticide chemical residue or an 

            exemption of the pesticide chemical residue from the 

            requirement of a tolerance (which final regulation shall be 

            issued without further notice and without further period for

            public comment);

                (ii) issue a proposed regulation under subsection (e) of

            this section, and thereafter issue a final regulation under 

            such subsection; or

                (iii) issue an order denying the petition.

        (B) Priorities

            The Administrator shall give priority to petitions for the 

        establishment or modification of a tolerance or exemption for a 

        pesticide chemical residue that appears to pose a significantly 

        lower risk to human health from dietary exposure than pesticide 

        chemical residues that have tolerances in effect for the same or

        similar uses.

        (C) Expedited review of certain petitions

            (i) Date certain for review

                If a person files a complete petition with the 

            Administrator proposing the issuance of a regulation 

            establishing a tolerance or exemption for a pesticide 

            chemical residue that presents a lower risk to human health 

            than a pesticide chemical residue for which a tolerance has 

            been left in effect or modified under subsection (b)(2)(B) 

            of this section, the Administrator shall complete action on 

            such petition under this paragraph within 1 year.

            (ii) Required determinations

                If the Administrator issues a final regulation 

            establishing a tolerance or exemption for a safer pesticide 

            chemical residue under clause (i), the Administrator shall, 

            not later than 180 days after the date on which the 

            regulation is issued, determine whether a condition 

            described in subclause (I) or (II) of subsection 

            (b)(2)(B)(iii) of this section continues to exist with 

            respect to a tolerance that has been left in effect or 

            modified under subsection (b)(2)(B) of this section. If such

            condition does not continue to exist, the Administrator 

            shall, not later than 180 days after the date on which the 

            determination under the preceding sentence is made, issue a 

            regulation under subsection (e)(1) of this section to modify

            or revoke the tolerance.

(e) Action on Administrator's own initiative

                          (1) General rule

        The Administrator may issue a regulation--

            (A) establishing, modifying, suspending under subsection 

        (l)(3) of this section, or revoking a tolerance for a pesticide 

        chemical or a pesticide chemical residue;

            (B) establishing, modifying, suspending under subsection 

        (l)(3) of this section, or revoking an exemption of a pesticide 

        chemical residue from the requirement of a tolerance; or

            (C) establishing general procedures and requirements to 

        implement this section.

                             (2) Notice

        Before issuing a final regulation under paragraph (1), the 

    Administrator shall issue a notice of proposed rulemaking and 

    provide a period of not less than 60 days for public comment on the 

    proposed regulation, except that a shorter period for comment may be

    provided if the Administrator for good cause finds that it would be 

    in the public interest to do so and states the reasons for the 

    finding in the notice of proposed rulemaking.

(f) Special data requirements

             (1) Requiring submission of additional data

        If the Administrator determines that additional data or 

    information are reasonably required to support the continuation of a

    tolerance or exemption that is in effect under this section for a 

    pesticide chemical residue on a food, the Administrator shall--

            (A) issue a notice requiring the person holding the 

        pesticide registrations associated with such tolerance or 

        exemption to submit the data or information under section 

        3(c)(2)(B) of the Federal Insecticide, Fungicide, and 

        Rodenticide Act [7 U.S.C. 136a(c)(2)(B)];

            (B) issue a rule requiring that testing be conducted on a 

        substance or mixture under section 4 of the Toxic Substances 

        Control Act [15 U.S.C. 2603]; or

            (C) publish in the Federal Register, after first providing 

        notice and an opportunity for comment of not less than 60 days' 

        duration, an order--

                (i) requiring the submission to the Administrator by one

            or more interested persons of a notice identifying the 

            person or persons who will submit the required data and 

            information;

                (ii) describing the type of data and information 

            required to be submitted to the Administrator and stating 

            why the data and information could not be obtained under the

            authority of section 3(c)(2)(B) of the Federal Insecticide, 

            Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or 

            section 4 of the Toxic Substances Control Act [15 U.S.C. 

            2603];

                (iii) describing the reports of the Administrator 

            required to be prepared during and after the collection of 

            the data and information;

                (iv) requiring the submission to the Administrator of 

            the data, information, and reports referred to in clauses 

            (ii) and (iii); and

                (v) establishing dates by which the submissions 

            described in clauses (i) and (iv) must be made.

        The Administrator may under subparagraph (C) revise any such 

        order to correct an error. The Administrator may under this 

        paragraph require data or information pertaining to whether the 

        pesticide chemical may have an effect in humans that is similar 

        to an effect produced by a naturally occurring estrogen or other

        endocrine effects.

                          (2) Noncompliance

        If a submission required by a notice issued in accordance with 

    paragraph (1)(A), a rule issued under paragraph (1)(B), or an order 

    issued under paragraph (1)(C) is not made by the time specified in 

    such notice, rule, or order, the Administrator may by order 

    published in the Federal Register modify or revoke the tolerance or 

    exemption in question. In any review of such an order under 

    subsection (g)(2) of this section, the only material issue shall be 

    whether a submission required under paragraph (1) was not made by 

    the time specified.

(g) Effective date, objections, hearings, and administrative review

                         (1) Effective date

        A regulation or order issued under subsection (d)(4), (e)(1), or

    (f)(2) of this section shall take effect upon publication unless the

    regulation or order specifies otherwise. The Administrator may stay 

    the effectiveness of the regulation or order if, after issuance of 

    such regulation or order, objections are filed with respect to such 

    regulation or order pursuant to paragraph (2).

                       (2) Further proceedings

        (A) Objections

            Within 60 days after a regulation or order is issued under 

        subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or 

        (n)(5)(C) of this section, any person may file objections 

        thereto with the Administrator, specifying with particularity 

        the provisions of the regulation or order deemed objectionable 

        and stating reasonable grounds therefor. If the regulation or 

        order was issued in response to a petition under subsection 

        (d)(1) of this section, a copy of each objection filed by a 

        person other than the petitioner shall be served by the 

        Administrator on the petitioner.

        (B) Hearing

            An objection may include a request for a public evidentiary 

        hearing upon the objection. The Administrator shall, upon the 

        initiative of the Administrator or upon the request of an 

        interested person and after due notice, hold a public 

        evidentiary hearing if and to the extent the Administrator 

        determines that such a public hearing is necessary to receive 

        factual evidence relevant to material issues of fact raised by 

        the objections. The presiding officer in such a hearing may 

        authorize a party to obtain discovery from other persons and may

        upon a showing of good cause made by a party issue a subpoena to

        compel testimony or production of documents from any person. The

        presiding officer shall be governed by the Federal Rules of 

        Civil Procedure in making any order for the protection of the 

        witness or the content of documents produced and shall order the

        payment of reasonable fees and expenses as a condition to 

        requiring testimony of the witness. On contest, such a subpoena 

        may be enforced by a Federal district court.

        (C) Final decision

            As soon as practicable after receiving the arguments of the 

        parties, the Administrator shall issue an order stating the 

        action taken upon each such objection and setting forth any 

        revision to the regulation or prior order that the Administrator

        has found to be warranted. If a hearing was held under 

        subparagraph (B), such order and any revision to the regulation 

        or prior order shall, with respect to questions of fact at issue

        in the hearing, be based only on substantial evidence of record 

        at such hearing, and shall set forth in detail the findings of 

        facts and the conclusions of law or policy upon which the order 

        or regulation is based.

(h) Judicial review

                            (1) Petition

        In a case of actual controversy as to the validity of any 

    regulation issued under subsection (e)(1)(C) of this section, or any

    order issued under subsection (f)(1)(C) or (g)(2)(C) of this 

    section, or any regulation that is the subject of such an order, any

    person who will be adversely affected by such order or regulation 

    may obtain judicial review by filing in the United States Court of 

    Appeals for the circuit wherein that person resides or has its 

    principal place of business, or in the United States Court of 

    Appeals for the District of Columbia Circuit, within 60 days after 

    publication of such order or regulation, a petition praying that the

    order or regulation be set aside in whole or in part.

                     (2) Record and jurisdiction

        A copy of the petition under paragraph (1) shall be forthwith 

    transmitted by the clerk of the court to the Administrator, or any 

    officer designated by the Administrator for that purpose, and 

    thereupon the Administrator shall file in the court the record of 

    the proceedings on which the Administrator based the order or 

    regulation, as provided in section 2112 of title 28. Upon the filing

    of such a petition, the court shall have exclusive jurisdiction to 

    affirm or set aside the order or regulation complained of in whole 

    or in part. As to orders issued following a public evidentiary 

    hearing, the findings of the Administrator with respect to questions

    of fact shall be sustained only if supported by substantial evidence

    when considered on the record as a whole.

                       (3) Additional evidence

        If a party applies to the court for leave to adduce additional 

    evidence and shows to the satisfaction of the court that the 

    additional evidence is material and that there were reasonable 

    grounds for the failure to adduce the evidence in the proceeding 

    before the Administrator, the court may order that the additional 

    evidence (and evidence in rebuttal thereof) shall be taken before 

    the Administrator in the manner and upon the terms and conditions 

    the court deems proper. The Administrator may modify prior findings 

    as to the facts by reason of the additional evidence so taken and 

    may modify the order or regulation accordingly. The Administrator 

    shall file with the court any such modified finding, order, or 

    regulation.

              (4) Final judgment; Supreme Court review

        The judgment of the court affirming or setting aside, in whole 

    or in part, any regulation or any order and any regulation which is 

    the subject of such an order shall be final, subject to review by 

    the Supreme Court of the United States as provided in section 1254 

    of title 28. The commencement of proceedings under this subsection 

    shall not, unless specifically ordered by the court to the contrary,

    operate as a stay of a regulation or order.

                           (5) Application

        Any issue as to which review is or was obtainable under this 

    subsection shall not be the subject of judicial review under any 

    other provision of law.

(i) Confidentiality and use of data

                          (1) General rule

        Data and information that are or have been submitted to the 

    Administrator under this section or section 348 of this title in 

    support of a tolerance or an exemption from a tolerance shall be 

    entitled to confidential treatment for reasons of business 

    confidentiality and to exclusive use and data compensation to the 

    same extent provided by sections 3 and 10 of the Federal 

    Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a, 136h].

                           (2) Exceptions

        (A) In general

            Data and information that are entitled to confidential 

        treatment under paragraph (1) may be disclosed, under such 

        security requirements as the Administrator may provide by 

        regulation, to--

                (i) employees of the United States authorized by the 

            Administrator to examine such data and information in the 

            carrying out of their official duties under this chapter or 

            other Federal statutes intended to protect the public 

            health; or

                (ii) contractors with the United States authorized by 

            the Administrator to examine such data and information in 

            the carrying out of contracts under this chapter or such 

            statutes.

        (B) Congress

            This subsection does not authorize the withholding of data 

        or information from either House of Congress or from, to the 

        extent of matter within its jurisdiction, any committee or 

        subcommittee of such committee or any joint committee of 

        Congress or any subcommittee of such joint committee.

                            (3) Summaries

        Notwithstanding any provision of this subsection or other law, 

    the Administrator may publish the informative summary required by 

    subsection (d)(2)(A)(i) of this section and may, in issuing a 

    proposed or final regulation or order under this section, publish an

    informative summary of the data relating to the regulation or order.

(j) Status of previously issued regulations

                  (1) Regulations under section 346

        Regulations affecting pesticide chemical residues in or on raw 

    agricultural commodities promulgated, in accordance with section 

    371(e) of this title, under the authority of section 346(a) \1\ of 

    this title upon the basis of public hearings instituted before 

    January 1, 1953, shall be deemed to be regulations issued under this

    section and shall be subject to modification or revocation under 

    subsections (d) and (e) of this section, and shall be subject to 

    review under subsection (q) of this section.

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    \1\ See References in Text note below.

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                  (2) Regulations under section 348

        Regulations that established tolerances for substances that are 

    pesticide chemical residues in or on processed food, or that 

    otherwise stated the conditions under which such pesticide chemicals

    could be safely used, and that were issued under section 348 of this

    title on or before August 3, 1996, shall be deemed to be regulations

    issued under this section and shall be subject to modification or 

    revocation under subsection (d) or (e) of this section, and shall be

    subject to review under subsection (q) of this section.

                 (3) Regulations under section 346a

        Regulations that established tolerances or exemptions under this

    section that were issued on or before August 3, 1996, shall remain 

    in effect unless modified or revoked under subsection (d) or (e) of 

    this section, and shall be subject to review under subsection (q) of

    this section.

                       (4) Certain substances

        With respect to a substance that is not included in the 

    definition of the term ``pesticide chemical'' under section 

    321(q)(1) of this title but was so included on the day before 

    October 30, 1998, the following applies as of October 30, 1998:

            (A) Notwithstanding paragraph (2), any regulation applying 

        to the use of the substance that was in effect on the day before

        October 30, 1998, and was on such day deemed in such paragraph 

        to have been issued under this section, shall be considered to 

        have been issued under section 348 of this title.

            (B) Notwithstanding paragraph (3), any regulation applying 

        to the use of the substance that was in effect on such day and 

        was issued under this section (including any such regulation 

        issued before August 3, 1996) is deemed to have been issued 

        under section 348 of this title.

(k) Transitional provision

    If, on the day before August 3, 1996, a substance that is a 

pesticide chemical was, with respect to a particular pesticidal use of 

the substance and any resulting pesticide chemical residue in or on a 

particular food--

        (1) regarded by the Administrator or the Secretary as generally 

    recognized as safe for use within the meaning of the provisions of 

    subsection (a) of this section or section 321(s) of this title as 

    then in effect; or

        (2) regarded by the Secretary as a substance described by 

    section 321(s)(4) of this title;

such a pesticide chemical residue shall be regarded as exempt from the 

requirement for a tolerance, as of August 3, 1996. The Administrator 

shall by regulation indicate which substances are described by this 

subsection. Any exemption under this subsection may be modified or 

revoked as if it had been issued under subsection (c) of this section.

(l) Harmonization with action under other laws

                     (1) Coordination with FIFRA

        To the extent practicable and consistent with the review 

    deadlines in subsection (q) of this section, in issuing a final rule

    under this subsection that suspends or revokes a tolerance or 

    exemption for a pesticide chemical residue in or on food, the 

    Administrator shall coordinate such action with any related 

    necessary action under the Federal Insecticide, Fungicide, and 

    Rodenticide Act [7 U.S.C. 136 et seq.].

         (2) Revocation of tolerance or exemption following 

                  cancellation of associated registrations

        If the Administrator, acting under the Federal Insecticide, 

    Fungicide, and Rodenticide Act, cancels the registration of each 

    pesticide that contains a particular pesticide chemical and that is 

    labeled for use on a particular food, or requires that the 

    registration of each such pesticide be modified to prohibit its use 

    in connection with the production, storage, or transportation of 

    such food, due in whole or in part to dietary risks to humans posed 

    by residues of that pesticide chemical on that food, the 

    Administrator shall revoke any tolerance or exemption that allows 

    the presence of the pesticide chemical, or any pesticide chemical 

    residue that results from its use, in or on that food. Subsection 

    (e) of this section shall apply to actions taken under this 

    paragraph. A revocation under this paragraph shall become effective 

    not later than 180 days after--

            (A) the date by which each such cancellation of a 

        registration has become effective; or

            (B) the date on which the use of the canceled pesticide 

        becomes unlawful under the terms of the cancellation, whichever 

        is later.

         (3) Suspension of tolerance or exemption following 

                   suspension of associated registrations

        (A) Suspension

            If the Administrator, acting under the Federal Insecticide, 

        Fungicide, and Rodenticide Act, suspends the use of each 

        registered pesticide that contains a particular pesticide 

        chemical and that is labeled for use on a particular food, due 

        in whole or in part to dietary risks to humans posed by residues

        of that pesticide chemical on that food, the Administrator shall

        suspend any tolerance or exemption that allows the presence of 

        the pesticide chemical, or any pesticide chemical residue that 

        results from its use, in or on that food. Subsection (e) of this

        section shall apply to actions taken under this paragraph. A 

        suspension under this paragraph shall become effective not later

        than 60 days after the date by which each such suspension of use

        has become effective.

        (B) Effect of suspension

            The suspension of a tolerance or exemption under 

        subparagraph (A) shall be effective as long as the use of each 

        associated registration of a pesticide is suspended under the 

        Federal Insecticide, Fungicide, and Rodenticide Act. While a 

        suspension of a tolerance or exemption is effective the 

        tolerance or exemption shall not be considered to be in effect. 

        If the suspension of use of the pesticide under that Act is 

        terminated, leaving the registration of the pesticide for such 

        use in effect under that Act, the Administrator shall rescind 

        any associated suspension of tolerance or exemption.

               (4) Tolerances for unavoidable residues

        In connection with action taken under paragraph (2) or (3), or 

    with respect to pesticides whose registrations were suspended or 

    canceled prior to August 3, 1996, under the Federal Insecticide, 

    Fungicide, and Rodenticide Act, if the Administrator determines that

    a residue of the canceled or suspended pesticide chemical will 

    unavoidably persist in the environment and thereby be present in or 

    on a food, the Administrator may establish a tolerance for the 

    pesticide chemical residue. In establishing such a tolerance, the 

    Administrator shall take into account both the factors set forth in 

    subsection (b)(2) of this section and the unavoidability of the 

    residue. Subsection (e) of this section shall apply to the 

    establishment of such tolerance. The Administrator shall review any 

    such tolerance periodically and modify it as necessary so that it 

    allows no greater level of the pesticide chemical residue than is 

    unavoidable.

    (5) Pesticide residues resulting from lawful application of 

                                  pesticide

        Notwithstanding any other provision of this chapter, if a 

    tolerance or exemption for a pesticide chemical residue in or on a 

    food has been revoked, suspended, or modified under this section, an

    article of that food shall not be deemed unsafe solely because of 

    the presence of such pesticide chemical residue in or on such food 

    if it is shown to the satisfaction of the Secretary that--

            (A) the residue is present as the result of an application 

        or use of a pesticide at a time and in a manner that was lawful 

        under the Federal Insecticide, Fungicide, and Rodenticide Act; 

        and

            (B) the residue does not exceed a level that was authorized 

        at the time of that application or use to be present on the food

        under a tolerance, exemption, food additive regulation, or other

        sanction then in effect under this chapter;

    unless, in the case of any tolerance or exemption revoked, 

    suspended, or modified under this subsection or subsection (d) or 

    (e) of this section, the Administrator has issued a determination 

    that consumption of the legally treated food during the period of 

    its likely availability in commerce will pose an unreasonable 

    dietary risk.

       (6) Tolerance for use of pesticides under an emergency 

                                  exemption

        If the Administrator grants an exemption under section 18 of the

    Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136p) 

    for a pesticide chemical, the Administrator shall establish a 

    tolerance or exemption from the requirement for a tolerance for the 

    pesticide chemical residue. Such a tolerance or exemption from a 

    tolerance shall have an expiration date. The Administrator may 

    establish such a tolerance or exemption without providing notice or 

    a period for comment on the tolerance or exemption. The 

    Administrator shall promulgate regulations within 365 days after 

    August 3, 1996, governing the establishment of tolerances and 

    exemptions under this paragraph. Such regulations shall be 

    consistent with the safety standard under subsections (b)(2) and 

    (c)(2) of this section and with section 18 of the Federal 

    Insecticide, Fungicide, and Rodenticide Act.

(m) Fees

                             (1) Amount

        The Administrator shall by regulation require the payment of 

    such fees as will in the aggregate, in the judgment of the 

    Administrator, be sufficient over a reasonable term to provide, 

    equip, and maintain an adequate service for the performance of the 

    Administrator's functions under this section. Under the regulations,

    the performance of the Administrator's services or other functions 

    under this section, including--

            (A) the acceptance for filing of a petition submitted under 

        subsection (d) of this section;

            (B) establishing, modifying, leaving in effect, or revoking 

        a tolerance or establishing, modifying, leaving in effect, or 

        revoking an exemption from the requirement for a tolerance under

        this section;

            (C) the acceptance for filing of objections under subsection

        (g) of this section; or

            (D) the certification and filing in court of a transcript of

        the proceedings and the record under subsection (h) of this 

        section;

    may be conditioned upon the payment of such fees. The regulations 

    may further provide for waiver or refund of fees in whole or in part

    when in the judgment of the Administrator such a waiver or refund is

    equitable and not contrary to the purposes of this subsection.

                             (2) Deposit

        All fees collected under paragraph (1) shall be deposited in the

    Reregistration and Expedited Processing Fund created by section 4(k)

    of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.

    136a-1(k)]. Such fees shall be available to the Administrator, 

    without fiscal year limitation, for the performance of the 

    Administrator's services or functions as specified in paragraph (1).

(n) National uniformity of tolerances

        (1) ``Qualifying pesticide chemical residue'' defined

        For purposes of this subsection, the term ``qualifying pesticide

    chemical residue'' means a pesticide chemical residue resulting from

    the use, in production, processing, or storage of a food, of a 

    pesticide chemical that is an active ingredient and that--

            (A) was first approved for such use in a registration of a 

        pesticide issued under section 3(c)(5) of the Federal 

        Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 

        136a(c)(5)] on or after April 25, 1985, on the basis of data 

        determined by the Administrator to meet all applicable 

        requirements for data prescribed by regulations in effect under 

        that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or

            (B) was approved for such use in a reregistration 

        eligibility determination issued under section 4(g) of that Act 

        [7 U.S.C. 136a-1(g)] on or after August 3, 1996.

          (2) ``Qualifying Federal determination'' defined

        For purposes of this subsection, the term ``qualifying Federal 

    determination'' means a tolerance or exemption from the requirement 

    for a tolerance for a qualifying pesticide chemical residue that--

            (A) is issued under this section after August 3, 1996, and 

        determined by the Administrator to meet the standard under 

        subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in 

        the case of an exemption) of this section; or

            (B)(i) pursuant to subsection (j) of this section is 

        remaining in effect or is deemed to have been issued under this 

        section, or is regarded under subsection (k) of this section as 

        exempt from the requirement for a tolerance; and

            (ii) is determined by the Administrator to meet the standard

        under subsection (b)(2)(A) (in the case of a tolerance) or 

        (c)(2) (in the case of an exemption) of this section.

                           (3) Limitation

        The Administrator may make the determination described in 

    paragraph (2)(B)(ii) only by issuing a rule in accordance with the 

    procedure set forth in subsection (d) or (e) of this section and 

    only if the Administrator issues a proposed rule and allows a period

    of not less than 30 days for comment on the proposed rule. Any such 

    rule shall be reviewable in accordance with subsections (g) and (h) 

    of this section.

                         (4) State authority

        Except as provided in paragraphs (5), (6), and (8) no State or 

    political subdivision may establish or enforce any regulatory limit 

    on a qualifying pesticide chemical residue in or on any food if a 

    qualifying Federal determination applies to the presence of such 

    pesticide chemical residue in or on such food, unless such State 

    regulatory limit is identical to such qualifying Federal 

    determination. A State or political subdivision shall be deemed to 

    establish or enforce a regulatory limit on a pesticide chemical 

    residue in or on a food if it purports to prohibit or penalize the 

    production, processing, shipping, or other handling of a food 

    because it contains a pesticide residue (in excess of a prescribed 

    limit).

                       (5) Petition procedure

        (A) In general

            Any State may petition the Administrator for authorization 

        to establish in such State a regulatory limit on a qualifying 

        pesticide chemical residue in or on any food that is not 

        identical to the qualifying Federal determination applicable to 

        such qualifying pesticide chemical residue.

        (B) Petition requirements

            Any petition under subparagraph (A) shall--

                (i) satisfy any requirements prescribed, by rule, by the

            Administrator; and

                (ii) be supported by scientific data about the pesticide

            chemical residue that is the subject of the petition or 

            about chemically related pesticide chemical residues, data 

            on the consumption within such State of food bearing the 

            pesticide chemical residue, and data on exposure of humans 

            within such State to the pesticide chemical residue.

        (C) Authorization

            The Administrator may, by order, grant the authorization 

        described in subparagraph (A) if the Administrator determines 

        that the proposed State regulatory limit--

                (i) is justified by compelling local conditions; and

                (ii) would not cause any food to be a violation of 

            Federal law.

        (D) Treatment

            In lieu of any action authorized under subparagraph (C), the

        Administrator may treat a petition under this paragraph as a 

        petition under subsection (d) of this section to modify or 

        revoke a tolerance or an exemption. If the Administrator 

        determines to treat a petition under this paragraph as a 

        petition under subsection (d) of this section, the Administrator

        shall thereafter act on the petition pursuant to subsection (d) 

        of this section.

        (E) Review

            Any order of the Administrator granting or denying the 

        authorization described in subparagraph (A) shall be subject to 

        review in the manner described in subsections (g) and (h) of 

        this section.

                    (6) Urgent petition procedure

        Any State petition to the Administrator pursuant to paragraph 

    (5) that demonstrates that consumption of a food containing such 

    pesticide residue level during the period of the food's likely 

    availability in the State will pose a significant public health 

    threat from acute exposure shall be considered an urgent petition. 

    If an order by the Administrator to grant or deny the requested 

    authorization in an urgent petition is not made within 30 days of 

    receipt of the petition, the petitioning State may establish and 

    enforce a temporary regulatory limit on a qualifying pesticide 

    chemical residue in or on the food. The temporary regulatory limit 

    shall be validated or terminated by the Administrator's final order 

    on the petition.

                (7) Residues from lawful application

        No State or political subdivision may enforce any regulatory 

    limit on the level of a pesticide chemical residue that may appear 

    in or on any food if, at the time of the application of the 

    pesticide that resulted in such residue, the sale of such food with 

    such residue level was lawful under this section and under the law 

    of such State, unless the State demonstrates that consumption of the

    food containing such pesticide residue level during the period of 

    the food's likely availability in the State will pose an 

    unreasonable dietary risk to the health of persons within such 

    State.

                             (8) Savings

        Nothing in this chapter preempts the authority of any State or 

    political subdivision to require that a food containing a pesticide 

    chemical residue bear or be the subject of a warning or other 

    statement relating to the presence of the pesticide chemical residue

    in or on such food.

(o) Consumer right to know

    Not later than 2 years after August 3, 1996, and annually 

thereafter, the Administrator shall, in consultation with the Secretary 

of Agriculture and the Secretary of Health and Human Services, publish 

in a format understandable to a lay person, and distribute to large 

retail grocers for public display (in a manner determined by the 

grocer), the following information, at a minimum:

        (1) A discussion of the risks and benefits of pesticide chemical

    residues in or on food purchased by consumers.

        (2) A listing of actions taken under subparagraph (B) of 

    subsection (b)(2) of this section that may result in pesticide 

    chemical residues in or on food that present a yearly or lifetime 

    risk above the risk allowed under subparagraph (A) of such 

    subsection, and the food on which the pesticide chemicals producing 

    the residues are used.

        (3) Recommendations to consumers for reducing dietary exposure 

    to pesticide chemical residues in a manner consistent with 

    maintaining a healthy diet, including a list of food that may 

    reasonably substitute for food listed under paragraph (2).

    Nothing in this subsection shall prevent retail grocers from 

providing additional information.

(p) Estrogenic substances screening program

                           (1) Development

        Not later than 2 years after August 3, 1996, the Administrator 

    shall in consultation with the Secretary of Health and Human 

    Services develop a screening program, using appropriate validated 

    test systems and other scientifically relevant information, to 

    determine whether certain substances may have an effect in humans 

    that is similar to an effect produced by a naturally occurring 

    estrogen, or such other endocrine effect as the Administrator may 

    designate.

                         (2) Implementation

        Not later than 3 years after August 3, 1996, after obtaining 

    public comment and review of the screening program described in 

    paragraph (1) by the scientific advisory panel established under 

    section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide

    Act [7 U.S.C. 136w(d)] or the science advisory board established by 

    section 4365 \2\ of title 42, the Administrator shall implement the 

    program.

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    \2\ See References in Text note below.

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                           (3) Substances

        In carrying out the screening program described in paragraph 

    (1), the Administrator--

            (A) shall provide for the testing of all pesticide 

        chemicals; and

            (B) may provide for the testing of any other substance that 

        may have an effect that is cumulative to an effect of a 

        pesticide chemical if the Administrator determines that a 

        substantial population may be exposed to such substance.

                            (4) Exemption

        Notwithstanding paragraph (3), the Administrator may, by order, 

    exempt from the requirements of this section a biologic substance or

    other substance if the Administrator determines that the substance 

    is anticipated not to produce any effect in humans similar to an 

    effect produced by a naturally occurring estrogen.

                    (5) Collection of information

        (A) In general

            The Administrator shall issue an order to a registrant of a 

        substance for which testing is required under this subsection, 

        or to a person who manufactures or imports a substance for which

        testing is required under this subsection, to conduct testing in

        accordance with the screening program described in paragraph 

        (1), and submit information obtained from the testing to the 

        Administrator, within a reasonable time period that the 

        Administrator determines is sufficient for the generation of the

        information.

        (B) Procedures

            To the extent practicable the Administrator shall minimize 

        duplicative testing of the same substance for the same endocrine

        effect, develop, as appropriate, procedures for fair and 

        equitable sharing of test costs, and develop, as necessary, 

        procedures for handling of confidential business information.

        (C) Failure of registrants to submit information

            (i) Suspension

                If a registrant of a substance referred to in paragraph 

            (3)(A) fails to comply with an order under subparagraph (A) 

            of this paragraph, the Administrator shall issue a notice of

            intent to suspend the sale or distribution of the substance 

            by the registrant. Any suspension proposed under this 

            paragraph shall become final at the end of the 30-day period

            beginning on the date that the registrant receives the 

            notice of intent to suspend, unless during that period a 

            person adversely affected by the notice requests a hearing 

            or the Administrator determines that the registrant has 

            complied fully with this paragraph.

            (ii) Hearing

                If a person requests a hearing under clause (i), the 

            hearing shall be conducted in accordance with section 554 of

            title 5. The only matter for resolution at the hearing shall

            be whether the registrant has failed to comply with an order

            under subparagraph (A) of this paragraph. A decision by the 

            Administrator after completion of a hearing shall be 

            considered to be a final agency action.

            (iii) Termination of suspensions

                The Administrator shall terminate a suspension under 

            this subparagraph issued with respect to a registrant if the

            Administrator determines that the registrant has complied 

            fully with this paragraph.

        (D) Noncompliance by other persons

            Any person (other than a registrant) who fails to comply 

        with an order under subparagraph (A) shall be liable for the 

        same penalties and sanctions as are provided under section 16 of

        the Toxic Substances Control Act [15 U.S.C. 2615] in the case of

        a violation referred to in that section. Such penalties and 

        sanctions shall be assessed and imposed in the same manner as 

        provided in such section 16.

                          (6) Agency action

        In the case of any substance that is found, as a result of 

    testing and evaluation under this section, to have an endocrine 

    effect on humans, the Administrator shall, as appropriate, take 

    action under such statutory authority as is available to the 

    Administrator, including consideration under other sections of this 

    chapter, as is necessary to ensure the protection of public health.

                       (7) Report to Congress

        Not later than 4 years after August 3, 1996, the Administrator 

    shall prepare and submit to Congress a report containing--

            (A) the findings of the Administrator resulting from the 

        screening program described in paragraph (1);

            (B) recommendations for further testing needed to evaluate 

        the impact on human health of the substances tested under the 

        screening program; and

            (C) recommendations for any further actions (including any 

        action described in paragraph (6)) that the Administrator 

        determines are appropriate based on the findings.

(q) Schedule for review

                           (1) In general

        The Administrator shall review tolerances and exemptions for 

    pesticide chemical residues in effect on the day before August 3, 

    1996, as expeditiously as practicable, assuring that--

            (A) 33 percent of such tolerances and exemptions are 

        reviewed within 3 years of August 3, 1996;

            (B) 66 percent of such tolerances and exemptions are 

        reviewed within 6 years of August 3, 1996; and

            (C) 100 percent of such tolerances and exemptions are 

        reviewed within 10 years of August 3, 1996.

    In conducting a review of a tolerance or exemption, the 

    Administrator shall determine whether the tolerance or exemption 

    meets the requirements of subsections \3\ (b)(2) or (c)(2) of this 

    section and shall, by the deadline for the review of the tolerance 

    or exemption, issue a regulation under subsection (d)(4) or (e)(1) 

    of this section to modify or revoke the tolerance or exemption if 

    the tolerance or exemption does not meet such requirements.

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

    \3\ So in original. Probably should be ``subsection''.

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

                           (2) Priorities

        In determining priorities for reviewing tolerances and 

    exemptions under paragraph (1), the Administrator shall give 

    priority to the review of the tolerances or exemptions that appear 

    to pose the greatest risk to public health.

                     (3) Publication of schedule

        Not later than 12 months after August 3, 1996, the Administrator

    shall publish a schedule for review of tolerances and exemptions 

    established prior to August 3, 1996. The determination of priorities

    for the review of tolerances and exemptions pursuant to this 

    subsection is not a rulemaking and shall not be subject to judicial 

    review, except that failure to take final action pursuant to the 

    schedule established by this paragraph shall be subject to judicial 

    review.

(r) Temporary tolerance or exemption

    The Administrator may, upon the request of any person who has 

obtained an experimental permit for a pesticide chemical under the 

Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et 

seq.] or upon the Administrator's own initiative, establish a temporary 

tolerance or exemption for the pesticide chemical residue for the uses 

covered by the permit. Subsections (b)(2), (c)(2), (d), and (e) of this 

section shall apply to actions taken under this subsection.

(s) Savings clause

    Nothing in this section shall be construed to amend or modify the 

provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et seq.] 

or the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136

et seq.].

(June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559, 

Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28, 1958, 72

Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct. 30, 1970, 84 

Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a), Nov. 18, 1971, 85 

Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. 

L. 98-620, title IV, Sec. 402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub. 

L. 102-300, Sec. 6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102-571,

title I, Sec. 107(7), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, 

Sec. 3(k), Aug. 13, 1993, 107 Stat. 776; Pub. L. 104-170, title IV, 

Sec. 405, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct.

30, 1998, 112 Stat. 3036.)

                       References in Text

    The Federal Rules of Civil Procedure, referred to in subsec. 

(g)(2)(B), are set out in the Appendix to Title 28, Judiciary and 

Judicial Procedure.

    Section 346 of this title, referred to in subsec. (j)(1), originally

consisted of subsecs. (a) and (b). Subsec. (a) was redesignated as the 

entire section 346 and subsec. (b) was repealed by Pub. L. 86-618, title

I, Sec. 103(a)(1), 74 Stat. 398.

    The Federal Insecticide, Fungicide, and Rodenticide Act, referred to

in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947, ch. 125,

as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, 

which is classified generally to subchapter II (Sec. 136 et seq.) of 

chapter 6 of Title 7, Agriculture. For complete classification of this 

Act to the Code, see Short Title note set out under section 136 of Title

7 and Tables.

    Section 4365 of title 42, referred to in subsec. (p)(2), was in the 

original ``section 8 of the Environmental Research, Development, and 

Demonstration Act of 1978'', and was translated as meaning section 8 of 

the Environmental Research, Development, and Demonstration Authorization

Act of 1978, to reflect the probable intent of Congress.

    The Toxic Substances Control Act, referred to in subsec. (s), is 

Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is 

classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15, 

Commerce and Trade. For complete classification of this Act to the Code,

see Short Title note set out under section 2601 of Title 15 and Tables.

                          Codification

    August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A), and 

(p)(1), (2), (7), was in the original references to the date of 

enactment of this subsection and the date of enactment of this section, 

which was translated as meaning the date of enactment of Pub. L. 104-

170, which amended this section generally, to reflect the probable 

intent of Congress.

                               Amendments

    1998--Subsec. (j)(4). Pub. L. 105-324 added par. (4).

    1996--Pub. L. 104-170 amended section generally, substituting, in 

subsec. (a), provisions relating to requirement for tolerance or 

exemption for provisions relating to conditions for safety; in subsec. 

(b), provisions relating to authority and standard for tolerance for 

provisions relating to establishment of tolerances; in subsec. (c), 

provisions relating to authority and standard for exemptions for 

provisions relating to exemptions; in subsec. (d), provisions relating 

to petition for tolerance or exemption for provisions relating to 

regulations pursuant to petition, publication of notice, time for 

issuance, referral to advisory committees, effective date, and hearings;

in subsec. (e), provisions relating to action on Administrator's own 

initiative for provisions relating to regulations pursuant to 

Administrator's proposals; in subsec. (f), provisions relating to 

special data requirements for provisions relating to data submitted as 

confidential; in subsec. (g), provisions relating to effective date, 

objections, hearings, and administrative review for provisions relating 

to advisory committees and their appointment, composition, compensation,

and clerical assistance; in subsec. (h), provisions relating to judicial

review for provisions relating to right of consultation; in subsec. (i),

provisions relating to confidentiality and use of data for provisions 

relating to judicial review; in subsec. (j), provisions relating to 

status of previously issued regulations for provisions relating to 

temporary tolerances; in subsec. (k), provisions relating to transitions

for provisions relating to regulations based on public hearings before 

January 1, 1953; in subsec. (l), provisions relating to harmonization 

with action under other laws for provisions relating to pesticides under

Federal Insecticide, Fungicide, and Rodenticide Act, functions of 

Administrator of Environmental Protection Agency, certifications, 

hearings, time limitations, opinions, and regulations; in subsec. (m), 

provisions relating to fees for provisions relating to amendment of 

regulations; in subsec. (n), provisions relating to national uniformity 

of tolerances for provisions relating to guaranties; in subsec. (o), 

provisions relating to consumer right to know for provisions relating to

payment of fees, services or functions conditioned on payment, and 

waiver or refund of fees; and adding subsecs. (p) to (s).

    1993--Pub. L. 103-80, Sec. 3(k)(6), substituted ``Administrator'' 

for ``Secretary'' wherever appearing except when followed by ``of 

Agriculture''.

    Subsec. (a)(1). Pub. L. 103-80, Sec. 3(k)(1), substituted 

``Administrator of the Environmental Protection Agency (hereinafter in 

this section referred to as the `Administrator')'' for ``Secretary of 

Health and Human Services''.

    Subsec. (d)(5). Pub. L. 103-80, Sec. 3(k)(2), substituted ``section 

556(c) of title 5'' for ``section 7(c) of the Administrative Procedure 

Act (5 U.S.C., sec. 1006(c))''.

    Subsec. (l). Pub. L. 103-80, Sec. 3(k)(3), substituted ``In the 

event'' for ``It the event'' before ``a hearing is requested''.

    Subsec. (n). Pub. L. 103-80, Sec. 3(k)(4), made technical amendment 

to reference to section 333(c) of this title to reflect amendment of 

corresponding provision of original act.

    Subsec. (o). Pub. L. 103-80, Sec. 3(k)(5), which directed the 

substitution of ``Administrator'' for ``Secretary of Health and Human 

Services'' wherever appearing in the original text, was executed by 

making the substitution in the first sentence before ``shall by 

regulation require'', the only place ``Secretary of Health and Human 

Services'' appeared in the original text.

    1992--Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102-300 

substituted ``Health and Human Services'' for ``Health, Education, and 

Welfare'' wherever appearing in the original statutory text.

    Subsec. (g). Pub. L. 102-571 substituted ``379e'' for ``376''.

    1984--Subsec. (i)(5). Pub. L. 98-620 struck out provision that 

required the court to advance on the docket and expedite the disposition

of all causes filed therein pursuant to this section.

    1972--Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted 

references to pesticide for references to economic poison wherever 

appearing therein.

    1971--Subsec. (g). Pub. L. 92-157 struck out ``, which the Secretary

shall by rules and regulations prescribe,'' after ``as compensation for 

their services a reasonable per diem'' prior to amendment in 1970, by 

Pub. L. 91-515, which overlooked such language when amending subsec. (g)

as provided in 1970 Amendment note.

    1970--Subsec. (g). Pub. L. 91-515 substituted provisions authorizing

members of an advisory committee to receive compensation and travel 

expenses in accordance with section 376(b)(5)(D) of this title, for 

provisions authorizing such members to receive as compensation a 

reasonable per diem for time actually spent on committee work, and 

necessary traveling and subsistence expenses while serving away from 

their places of residence.

    1958--Subsec. (i)(2). Pub. L. 85-791, Sec. 20(a), in first sentence,

substituted ``transmitted by the clerk of the court to the Secretary, 

or'' for ``served upon the Secretary, or upon'', substituted ``file in 

the court the record of the proceedings'' for ``certify and file in the 

court a transcript of the proceedings and the record'', and inserted 

``as provided in section 2112 of title 28'', and which, in second 

sentence, substituted ``the filing of such petition'' for ``such 

filing''.

    Subsec. (i)(3). Pub. L. 85-791, Sec. 20(b), in first sentence, 

substituted ``transmitted by the clerk of the court to the Secretary of 

Agriculture, or'' for ``served upon the Secretary of Agriculture, or 

upon'', substituted ``file in the court the record of the proceedings'' 

for ``certify and file in the court a transcript of the proceedings and 

the record'', and inserted ``as provided in section 2112 of title 28'', 

and, in second sentence, substituted ``the filing of such petition'' for

``such filing''.

                    Effective Date of 1984 Amendment

    Amendment by Pub. L. 98-620 not applicable to cases pending on Nov. 

8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date

note under section 1657 of Title 28, Judiciary and Judicial Procedure.

                    Effective Date of 1972 Amendment

    Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972, 

except if regulations are necessary for implementation of any provision 

that becomes effective on Oct. 21, 1972, and continuation in effect of 

subchapter I of chapter 6 of Title 7, Agriculture, and regulations 

thereunder, relating to control of economic poisons, as in existence 

prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92-516

and regulations thereunder, see section 4 of Pub. L. 92-516, set out as 

an Effective Date note under section 136 of Title 7.

                          Transfer of Functions

    Functions vested in Secretary of Health, Education, and Welfare [now

Health and Human Services] in establishing tolerances for pesticide 

chemicals under this section together with authority to monitor 

compliance with tolerances and effectiveness of surveillance and 

enforcement and to provide technical assistance to States and conduct 

research under this chapter and section 201 et seq. of Title 42, The 

Public Health and Welfare, and functions of Department of Agriculture 

and Secretary of Agriculture under subsec. (l) of this section 

transferred to Administrator of Environmental Protection Agency by 

Reorg. Plan No. 3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 

15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government 

Organization and Employees.

                             Tolerance Fees

    Pub. L. 108-199, div. G, title V, Sec. 501(d)(2), Jan. 23, 2004, 118

Stat. 422, provided that: ``Notwithstanding section 408(m)(1) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)), during the 

period beginning on October 1, 2003, and ending on September 30, 2008, 

the Administrator of the Environmental Protection Agency shall not 

collect any tolerance fees under that section.''

   Data Collection Activities To Assure Health of Infants and Children

    Section 301 of Pub. L. 104-170 provided that:

    ``(a) In General.--The Secretary of Agriculture, in consultation 

with the Administrator of the Environmental Protection Agency and the 

Secretary of Health and Human Services, shall coordinate the development

and implementation of survey procedures to ensure that adequate data on 

food consumption patterns of infants and children are collected.

    ``(b) Procedures.--To the extent practicable, the procedures 

referred to in subsection (a) shall include the collection of data on 

food consumption patterns of a statistically valid sample of infants and

children.

    ``(c) Residue Data Collection.--The Secretary of Agriculture shall 

ensure that the residue data collection activities conducted by the 

Department of Agriculture in cooperation with the Environmental 

Protection Agency and the Department of Health and Human Services, 

provide for the improved data collection of pesticide residues, 

including guidelines for the use of comparable analytical and 

standardized reporting methods, and the increased sampling of foods most

likely consumed by infants and children.''

ATTACHMENT E:	

Reserved for consultations

ATTACHMENT F:  Forms

		Forms that are commonly associated with Data Call-ins are listed below
and are  available electronically as a PDF file on the Office of
Pesticide Program, internet cite at   HYPERLINK
"http://www.epa.gov/opprd001/forms/"  http://www.epa.gov/opprd001/forms/

	

			EPA Form No. 8570-4 - Confidential Statement of Formula.   This
attachment is only electronically via the Internet.  

			

			EPA Form 8570-27 - Formulator's Exemption Statement. This attachment
is only electronically via the Internet.  

 

 		EPA Form 8570-28 - Certification of Compliance with Data Gap 			
Procedures.  This attachment is only electronically via the Internet.  

 

			EPA Form 8570-32 - Certification of Attempt to Enter into an
Agreement 				with Registrants for Development of Data Form.  This
attachment is only 				available electronically via the Internet. 

			EPA Form 8570-34 - Certification with Respect to Citation of Data
Form 

			This attachment is only available electronically via the Internet. 

			EPA Form 8570-35 - Data Matrix Form.  This attachment is only 				
available electronically via the Internet. 

			EPA Form 8570-36 - Summary of the Physical/Chemical Properties 			
Form.   This attachment is only available electronically via the
Internet. 

			EPA Form 8570-37 - Self-Certification Statement for the
Physical/Chemical Properties.   This attachment is only available
electronically via the Internet.

			The forms below have been approved with the DCI related ICRs by OMB
for several years, although no official EPA Form number had been
assigned in the past.  These two forms are automatically generated by
EPA’s computer databases and are pre-populated with information that
is specific to each individual registrant that receives a Data Call-In
notice for a given pesticide.  These forms are not widely accessible to
general public.  

			Data Call-In Response Form – This form is a part of Attachment F
and is only available as an electronic attachment to the supporting
statement.  This form can  be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007-0923 

			Requirements Status and Registrant’s Response - This form is a part
of Attachment F and is only available as an electronic attachment to the
supporting statement.  This form can only be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007-0923 

 

ATTACHMENT G: 

General Methodology Used to Estimate Paperwork Burden Hours and Costs 

by the Office of Pesticide Programs for Submission of Required 

Data/Information or Responding to a Data Call-In Notice.  

	This attachment is part of the supporting statement and is only
available as part of the electronic docket EPA-HQ-OPP-2007-0923.

ATTACHMENT H

Work Sheets to Calculate Industry and EPA Labor Costs

ATTACHMENT H

Work Sheets to Calculate Industry and EPA Labor Costs

INDUSTRY LABOR COSTS

Labor Category	

Formula	

Managerial	

Technical	

Clerical

Unloaded Hourly Rate1	

= W	$48.31 	$31.26 	$15.78 

Benefits Percentage2 	

Lb = B/W	43%	43%	43%

Benefits per hour	

B = W*Lb	$20.77 	$13.44 	$6.79 

Loaded Hourly Rate	

Wb = W + B 

       = W(1+Lb)	$69.08 	$44.70 	$22.57 

Overhead Percentage3	

Lo = OH/Wb	50%	50%	50%

Overhead per hour	

OH = Wb*Lo	$34.54 	$22.35 	$11.28 

Fully Loaded Hourly Rate	

Wf = Wb + OH

=  W + B + OH 	$103.62 	$67.05 	$33.85 

1.  Data Source:    HYPERLINK
"http://www.bls.gov/oes/current/naics4_325300.htm" 
http://www.bls.gov/oes/current/naics4_325300.htm   

     Management:   11-0000, Management Occupations

     Technical:   19-0000, Life, Physical, and Social Science
Occupations

     Clerical:    43-0000, Office and Administrative Support Occupations

     May 2006 data

2. Fringe benefits/wage per hour.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost
Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The
loading for indirect costs is within the range of 20-70% of the load
labor rate (wage + benefits) suggested in EPA guidance. 

EPA LABOR COSTS

Labor Category	

Formula	

Managerial	

Technical	

Clerical

Unloaded Hourly Rate1	

= W	$47.16 	$31.18 	$18.29 

Benefits Percentage2	

Lb = B/W	43%	43%	43%

Benefits per hour	

B = W*Lb	$20.28 	$13.41 	$7.86 

Loaded Hourly Rate	

Wb = W + B 

       = W(1+Lb)	$67.44 	$44.59 	$26.15 

Overhead Percentage3	

Lo = OH/Wb	50%	50%	50%

Overhead per hour	

OH = Wb*Lo	$33.72 	$22.29 	$13.08 

Fully Loaded Hourly Rate	

Wf = Wb + OH

=  W + B + OH 	$101.16 	$66.88 	$39.23 

1.  Data Source:    HYPERLINK
"http://www.bls.gov/oes/current/naics4_999100.htm" 
http://www.bls.gov/oes/current/naics4_999100.htm     

     Management:   11-0000, Management Occupations

     Technical:   19-0000, Life, Physical, and Social Science
Occupations

     Clerical:    43-0000, Office and Administrative Support Occupations

     May 2006 data

2. Fringe benefits/wage per hour.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost
Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The
loading for indirect costs is within the range of 20-70% of the load
labor rate (wage + benefits) suggested in EPA guidance. 

1RRegistrants are required to submit a Confidential Statement of Formula
(EPA Form 8570-4) to comply with registration-related requirements under
FIFRA section 3, such as when a registrant seeks to add uses for a
currently-registered pesticide, or when the registrant changes a
registered pesticide’s formulation.  The requirement is mentioned here
since registrants have not always submitted the required information
immediately to EPA and the deficiency may remain at the time of the
regulatory review.  The paperwork burden for the submission of Form
8570-4 is covered under OMB Control No. 2070-0060 (Application for
New/Amended Pesticide Registration; EPA ICR. No. 0277)					

 Registrants are required to submit a Confidential Statement of Formula
(EPA Form 8570-4) to comply with registration-related requirements under
FIFRA section 3, such as when a registrant seeks to add uses for a
currently-registered pesticide, or when the registrant changes a
registered pesticide’s formulation.  The requirement is mentioned here
since registrants have not always submitted the required information
immediately to EPA and the deficiency may remain at the time of the
regulatory review.  The paperwork burden for the submission of Form
8570-4 is covered under OMB Control No. 2070-0060 (Application for
New/Amended Pesticide Registration; EPA ICR. No. 0277)

 See 69 FR 26819, May 14, 2004; also   HYPERLINK
"http://www.epa.gov/oppsrrd1/public.htm" 
http://www.epa.gov/oppsrrd1/public.htm 

 The FIFRA SAP is a Federal advisory committee established in 1975 under
FIFRA that operates in accordance with requirements of the Federal
Advisory Committee Act. The FIFRA SAP is composed of a permanent panel
consisting of seven members who are appointed by the EPA Administrator
from nominees provided by the National Institutes of Health and the
National Science Foundation.  FIFRA, as amended by the FQPA of 1996,
established a Science Review Board consisting of at least 60 scientists
who are available to the FIFRA SAP on an ad hoc basis to assist in
reviews conducted by the Panel.

  For example, in 2004 the Agency evaluated a sampling of  95 pesticide
product reviews (PDCIs) related to 5 randomly selected pesticide
chemicals to determine the number of new Acute Toxicity and Product
Chemistry studies generated in response to a DCI.  Based on this
evaluation, it was determined that approximately 18% of the Acute
Toxicity data requirements and approximately 10% of the Product
Chemistry data requirements were newly generated data.  Among the six
Acute Toxicity requirements surveyed, (acute oral, acute dermal, acute
inhalation, acute eye irritation, acute dermal irritation and dermal
sensitization), the Acute eye irritation (870.2400), and Acute dermal
irritation (870.2500) studies accounted for as much as 50% of the new
data produced (in equal proportions).  The other 50% of the new data is
equally distributed between the remaining four study requirements.  
Among the ten Product Chemistry requirements surveyed, (Storage
Stability (830.6317), Corrosion Characteristics (830.6320), Viscosity
(830.7100) and the Analytical Methods (830.1800) guidelines accounted
for approximately 90% of the new data produced (in equal proportions). 
The remaining 10% of the new data was equally distributed between the
Flammability (830.6315), pH (830.7000), Density (830.7300), and various
requirements for technical/pure active ingredients including Preliminary
analysis (830.1700), Water solubility (830.7840 or 830.7860), and Vapor
pressure (830.7950).  

Draft:912/0526/07

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