Document ID: EPA-HQ-OPP-2008-0414-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-13T04:00Z

Supporting Statement for

An Information Collection Request (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection

Submission of Protocols and Study Reports for Environmental Research
Involving Human Subjects

OMB No. 2070-0169;         	EPA No. 2195.03

1(b)	Short Characterization/Abstract

	The Environmental Protection Agency (EPA, or the Agency) is responsible
for the regulation of pesticides under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and
Cosmetic Act (FFDCA).  In January 2006, EPA issued a final rule to amend
the Federal Policy for the Protection of Human Subjects (also known as
the Common Rule) at 40 CFR part 26.  EPA’s January 2006 final rule
significantly strengthens and expands the protections for subjects of
“third-party” human research (i.e., research that is not conducted
or supported by EPA).  In addition to other protections, the final rule
requires affected entities to submit information to EPA and an
institutional review board (IRB) prior to initiating, and to EPA upon
the completion of, certain studies that involve human research
participants.  The information collection activity imposed by this final
rule consists of activity-driven reporting and recordkeeping
requirements for those who intend to conduct research for submission to
EPA under the pesticide laws.  If such research involves intentional
dosing of human subjects, these individuals (respondents) are required
to submit study protocols to EPA and a cognizant local Human Subjects
IRB before such research is initiated so that the scientific design and
ethical standards that will be employed during the proposed study may be
reviewed and approved.  Also, respondents are required to submit
information about the ethical conduct of completed research that
involved intentional dosing of human subjects when such research is
submitted to EPA.

This renewal ICR estimates the third party response burden from
complying with the January 2006 final rule requirements. Information is
generally submitted by registrants of pesticide products to support the
registration of their products. It is estimated that the annual response
burden is approximately 1,400 hours valued at about $85,000.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

The 2006 Appropriations Act, Pub. L. No. 109-54, required EPA to issue
the final rule (Attachment C) addressing third-party intentional dosing
human toxicity studies for pesticides, and EPA conduct of intentional
dosing human toxicity studies for pesticides.  This ICR applies to all
of the information collection activities identified in the
Congressionally-mandated final rule.  EPA’s statutory authority to
require and collect information identified in the final rule already
existed under FIFRA and FFDCA.

  Sections 3(c)(5), 3(g) and 4(g)(2)(D) of FIFRA generally require EPA
to determine that a pesticide would not present any unreasonable adverse
effects on the environment when deciding to grant a new or amended
pesticide registration or to continue an existing registration.  Section
4(g)(2)(E) of FIFRA and section 408(b)(2)(A)(ii) of FFDCA generally
require EPA to determine that   SEQ CHAPTER \h \r 1 that there is a
reasonable certainty that no harm will result from aggregate exposure to
the residue of a pesticide chemical, including all anticipated dietary
exposures and all other exposures for which there is reliable
information when making pesticide tolerance decisions.  FIFRA section
12(a)(2)(P) forbids any person “to use any pesticide in tests on human
beings unless such human beings (i) are fully informed of the nature and
purposes of the test and of any physical and mental health consequences
which are reasonably foreseeable from, and (ii) freely volunteer to
participate in the test.”  EPA established this collection of
information as part of the final rule as authorized under section 25 of
FIFRA and section 408(e)(1)(C) of FFDCA to:

(1)	ensure that sound and appropriate scientific data are available to
EPA when 			making regulatory decisions about pesticides as described in
the previous 				paragraph; and,

(2)	protect the interests, rights and safety of human research subjects,
as required under FIFRA section 12(a)(2)(P). 

Sections 3(c)(5), 3(g), 4(g)(2), and 25 of FIFRA and sections
408(b)(2)(A)(ii) and 408(e)(1)(C) of FFDCA are included as Supporting
Statement attachments A and B, respectively.

 

2(b)	Practical Utility/Users of the Data

In order to ensure the availability of sound and appropriate scientific
data in its decisions, and to protect of the interests, rights and
safety of human research subjects, EPA extended the requirements of the
Agency’s Common Rule, 40 CFR Part 26, prospectively to third-party
research intended for submission to EPA under the pesticide laws and
involving intentional exposure of non-pregnant adult human subjects. 
The information provided allows   SEQ CHAPTER \h \r 1 EPA to review
protocols and related information before covered research involving
human subjects is initiated, but after it has been reviewed and approved
by a local IRB.  In addition, anyone who submits to EPA a report of
research with human subjects must submit concurrently documentation of
the ethical conduct of the research.  This information collection
activity allows EPA to ensure all human subjects in research conducted
by EPA (first party), conducted by entities with support from EPA
(second parties), or conducted by third parties with the intention to
submit it to EPA are treated ethically.

3.		NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non duplication

		The information requirements identified in the final rule do not
duplicate other federal agency information collections.  Other federal
agencies have adopted the Common Rule and FDA has established
requirements similar to those in the Common Rule for third-party
researchers who perform human testing intended for submission to FDA.  
None of those requirements, however, apply to third-party research that
is intended for submission to EPA.

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 the 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 indentifier EPA-HQ-OPP-2008-0414.

3(c)	Consultations

 		During preparation of this ICR renewal, EPA staff will contact
respondent representatives to seek feedback on the burden estimates in
the ICR and the clarity of guidance provided.  Their responses to
EPA’s consultation efforts will be summarized and made publicly
available with the final ICR renewal request, as Attachment D.

3(d)	Effects of Less Frequent Collection

  SEQ CHAPTER \h \r 1 	Not applicable.  This is an event-driven
information collection activity and is conducted only as information is
submitted to EPA for consideration.  As such there is no set collection
frequency for the collection of this information.

3(e)	General Guidelines

		  SEQ CHAPTER \h \r 1 The only guideline established under the
Paperwork Reduction Act (PRA) that may be exceeded in this collection is
the time period for retaining records.  EPA’s requirement at 40 CFR
169.2(k) states that records containing research data relating to
registered pesticides be retained for 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.  This is an
existing requirement that was not changed by the final rule.  In any
case, EPA asserts that recordkeeping requirement merely codifies the
usual and customary business practices of IRBs and third-party
researchers; therefore no burden is attributed to the activity. 

  SEQ CHAPTER \h \r 1 OMB regulations require agencies to provide a
statement indicating whether the

collection of information involves the use of automated, electronic,
mechanical, or

other technological collection techniques or other forms of information
technology, e.g.,

permitting electronic submission of responses, and an explanation of the
decision (5 CFR

1320.5(a)(iii)(E)).  EPA is not   SEQ CHAPTER \h \r 1 offering a fully
electronic submission option at this time.  EPA is developing an
internet portal that would adequately secure any confidential and/or
sensitive information submitted electronically; however, EPA is not yet
ready to accept such information in this way.

		Respondents that submit study protocols and/or reports to EPA may
elect to submit certain information  SEQ CHAPTER \h \r 1 
“electronically” via compact disc.  Ordinarily, registrants would be
required to submit 3 paper copies of study data to EPA.  Under this
hybrid option, registrants need only submit 2 paper copies if they
submit the required study data in Adobe Acrobat Portable Document Format
(PDF) on a compact disc.  Once EPA staff have become familiar with the
electronic submission process and the technology, OPP believes that this
option will allow the Agency to achieve operating efficiencies in the
regulation of pesticides through the promotion and facilitation of the
electronic submission process, including the delivery, review, data
interchange capability and archiving of data supporting national
pesticide registration.    SEQ CHAPTER \h \r 1 OPP expects that
registrants will spend less time and money preparing copies and sending
their submissions using the hybrid paper-electronic submission option,
and stand to benefit from the efficiencies that EPA expects to
experience during data reviews.

3(f)		Confidentiality

		  SEQ CHAPTER \h \r 1 EPA has implemented procedures to protect any
confidential, trade secret or proprietary information from disclosure
that provide strict instructions regarding access to and contact with
documents confidential business information (CBI).  These procedures
comply with EPA’s CBI regulations at 40 CFR Part 2, Subpart B.

3(g)	Sensitive Questions

This information collection activity complies with the provisions of the
Privacy Act of 1974 and OMB Circular A-108.  No information of a
sensitive or private nature is requested in conjunction with this
information collection activity.  The protection of human research
subjects’ privacy is a basic, long-standing principle within the
scientific community.  Reports of human research submitted to federal
agencies should not identify subjects by name, or include recognizable
photographs, or otherwise identify them.  On the rare occasion that the
Agency receives identifying information, such information will be
treated as confidential and not released to third parties unless
required by law. 

4. 		THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents/NAICS Codes

		This collection of information applies to any entity that submits
protocols and study reports for environmental research involving human
subjects under FIFRA and/or FFDCA. Although EPA has only received such
third-party research in conjunction with FIFRA from pesticide
registrants, it is conceivable that other entities could submit such
information to EPA under FIFRA and/or FFDCA in the future.    SEQ
CHAPTER \h \r 1 The North American Industrial Classification System
(NAICS) code for the principal respondents to this ICR is 325320
(Pesticide and other Agricultural Chemical Manufacturing).

		4(b)	Information Requested

Data items, including record keeping requirements

		The final rule sets forth those additional information activities that
are necessary to ensure the protection of human subjects of research
when such research is submitted to EPA for consideration under FIFRA
and/or FFDCA. 

Respondent Activities

	The following information activities are required:

 

Rule Familiarization and Training - read, and understand what data are
to be submitted and understand the protocols must be developed to comply
with the Common Rule.

Submit Protocol to an IRB and EPA – Prepare and submit a proposal for
test protocol to IRB for review.  After approval by the IRB, submit the
proposal and related documentation, including a record of the IRB
approval, to EPA.

Prepare and Submit Ethics Information  for EPA Review - once a study is
conducted, compile applicable records to document ethical conduct of the
research.

Store, File and Maintain Information – ensure that research
information is placed in central records as required by FIFRA and
consistent with section 3(e) of this ICR.

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

5(a)	Agency Activities

		EPA’s information-related activities associated with this collection
consist of the following:

Conduct Prior review on study protocol – review and comment on study
protocol, document comments/review.

Review Ethical Aspect of a Protocol and Study Report – make formal EPA
determination on usefulness and ethical aspects of the study.

Record and Report Information – Document any formal decisions made.

Store, File and Maintain Information – compile information into
appropriate databases and archive.  

5(b)	Collection Methodology and Management

  SEQ CHAPTER \h \r 1 	OPP completed a major review of its information
tracking systems to improve their efficiency and accuracy. This review
resulted in the development of a new integrated information system,
which, when complete, will improve the quality of the Agency's databases
and allows the EPA to respond more timely and accurately to queries from
registrants and the public, including requests made under the FOIA.

	OPP is also investigating 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 is consulting with industry
associations and other federal agencies, and participating in an
Agency-wide workgroup to develop electronic reporting standards intended
to facilitate collection of information from industry. 

		OPP does not publish the studies submitted.  However, it maintains
records of each study in the Office of Pesticide Programs Information
Network (OPPIN), and provides public access to OPPIN bibliographies
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, and
the public may request copies of studies that are non-confidential by
submitting a FOIA request.

5(c)	Small Entity Flexibility

Although the Agency cannot predict whether or how many small entities
might engage in the subject matter research, the burden and related cost
for researchers to comply with these information collection activities
is estimated to be a trivially small portion of the overall cost of
performing such studies.  After reviewing the history of EPA’s
consideration on human research in its various program offices, EPA
estimates that only a limited number of third-party human studies will
be impacted by these activities each year.  Because both the number of
affected studies is relatively small and the estimated current costs of
compliance with the Common Rule are low, the potential overall burden
and costs from these activities to third parties are also estimated to
be small, regardless of their size.  As a result, EPA has not provided
any special flexibility for small entities.

5(d)	Collection Schedule

		A   SEQ CHAPTER \h \r 1 periodic collection schedule is not
appropriate for the information collection activity.  The information
collection activity is initiated by the respondents and therefore EPA
expects that respondents will engage in the activities described in this
ICR only once, whenever developing and performing a given research study
that involves human subjects as governed by EPA’s regulations.

6. 		ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a)	Estimating Respondent Burden

		EPA is estimating only the incremental burden imposed upon respondents
for compliance with the paperwork requirements established in the final
rule.  EPA is neither estimating, de novo, the estimated paperwork
burden for compliance with the 1991 Common Rule in this ICR nor the
paperwork burden associated with the generation of certain study data
that is already covered by other ICRs, such as those requested by EPA in
a Data Call-In under FIFRA section 3(c)(2)(B).  EPA does assume that
IRBs are already in compliance with the 1991 Common Rule requirements
and therefore believes that there is no additional burden imposed upon
IRBs for compliance with the paperwork requirements established in the
final rule and discussed in this document.

		Based upon historical data, EPA anticipates that respondents will
submit to OPP an average of 33 pesticide research studies per year under
FIFRA and/or FFDCA that will involve intentional exposure of human
subjects.  EPA also expects to receive other types of pesticide research
involving human subjects; an average of 29 studies annually.  While EPA
assumes that researchers conducting these studies would already be
required to comply with the 1991 Common Rule requirements, they will be
subject to some additional paperwork requirements under EPA’s Common
Rule amendments.  Therefore, EPA is estimating only the burden and costs
associated with the paperwork activities that are described in the final
rule.

The rule familiarization activities are intended to include
respondent-EPA communications regarding protocol development. Also, EPA
believes that protocols approved by an IRB and submitted to EPA will be
the same.  Therefore, although such respondents will be required to
submit protocols twice - once to an IRB and once to EPA - before a study
commences, EPA has estimated the burden related to protocol development
only once.  Lastly, the burden related to the development and submission
to EPA of ethics information that must be submitted to EPA along with
the completed human studies is expected to be minimal as much of the
information is likely generated during the study period. As shown in
Tables 1 and 2, the total annual estimated burden associated with this
information collection activity is 1,056 hours for all submitted
pesticide research that involves intentional exposure of human subjects,
and 348 hours for all other pesticide research that involves human
subjects.  Therefore the total annual burden for this information
collection activity is estimated to be 1,404 hours.

Table 1. Respondent Burden & Cost Estimates – Research Involving
Intentional Exposure of Human Subjects 

Activities	Average Burden Hours Per Response	Total Per Response

	Mgmt.

$96/hr	Tech.

$63/hr	Cler.

$32/hr	Hours	Cost ($)

Rule Familiarization

And Training	2	2	0	4	318

Prepare and Submit  Protocol for IRB and EPA Review	0	15	2	17	1,009

Prepare and Submit Ethics Information of Completed Human Studies to EPA
0	8	1	9	536

Store, File and Maintain Information	0	0	2	2	64

Total per response	2	25	5	32	1,927

	Annual Burden:	32 hours per study * 33 studies submitted per year =
1,056 hours

	Annual Costs:		$1,927 per study * 33 studies submitted per year =
$63,591

Table 2. Respondent Burden & Cost Estimates – All Other Submitted
Research with Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Mgmt.

$96/hr	Tech.

$63/hr	Cler.

$32/hr	Hours	Cost ($)

Rule Familiarization

And Training	1	1	0	2	159

Prepare and Submit Ethics Information of Completed Human Studies to EPA
0	8	1	9	536

Store, File and Maintain Information	0	0	1	1	32

Total per response	1	9	2	12	727

	Annual Burden:	12 hours per study * 29 studies submitted per year = 348
hours

	Annual Costs:		$727 per study * 29 studies submitted per year = $21,083

6(b)	Estimating Respondent Costs

  SEQ CHAPTER \h \r 1 The estimated annual cost for all respondents is
$84,674.  Respondent labor rates are estimated to be $96, $63, and $32
per hour, respectively, for managerial, technical and clerical labor. 
These labor rates were derived from the Bureau of Labor Statistics’  
SEQ CHAPTER \h \r 1 May 2004 National Industry-Specific Occupational
Employment and Wage Estimates for NAICS code 325300.  These labor rates
are fully loaded and include benefits and overhead costs, using a
methodology developed by OPP’s Biological and Economic Analysis
Division (see Attachment E).

6(c)	Estimating Agency Burden and Cost

  SEQ CHAPTER \h \r 1 	The estimated Agency annual cost is $1,040,219. 
EPA activities include: communicating with respondents, reviewing the
ethical aspects of submitted study protocols and completed study
reports, documenting decisions, and information management activities to
record, file, and track the submissions.    SEQ CHAPTER \h \r 1 Agency
labor rates are $115, $83, and $59 per hour for management (GS-15, step
4), technical (GS-13, step 4), and clerical (GS-7, step 4) staff,
respectively.  These rates are fully loaded based on Office of Personnel
Management salary tables for federal employees for 2005 and include
locality pay for the Washington, DC-Baltimore area.  The details of the
calculations are identified in Tables 3 and 4.

Table 3. Agency Burden & Cost Estimates – Review of Research Involving
Intentional Exposure of Human Subjects 

Activities 	Average Burden Hours Per Study	Total Per Study

	Mgmt. $115/hr 	Tech. $83/hr 	Cler. $59/hr 	Hours 	Cost ($) 

Rule Familiarization And Training 	2 	2 	0 	4 	396 

Primary Review Scientific and Ethical Aspects of a Protocol	1 	50 	0 	51
	4,265 

Primary Review Ethical Aspects of a Completed Study Report	1 	20 	0 	21 
1,775 

Secondary Review of scientific and ethical aspects of protocol, and
review of ethical aspects of the completed study 

$11,472*

Record and Report Information 	0 	0 	2 	2 	118 

Store, File and Maintain Information	0	0	2	2	118

Total per study	4 	72 	4 	80 	$18,144 

* Cost of 15 experts earning about $400/day conducting secondary review.

	Annual Burden:	80 hours/study * 33 studies = 2,640 hours

	Annual Costs:		$18,144/study * 33 studies = $598,752

Table 4. Agency Burden & Cost Estimates – Review of All Other
Submitted Research with Human Subjects

Activities 	Average Burden Hours Per Study	Total Per Study 

	Mgmt. $115/hr 	Tech. $83/hr 	Cler. $59/hr 	Hours 	Cost ($) 

Rule Familiarization And Training 	1 	1 	0 	2 	198 

Primary Review Ethical Aspects of a Completed Study Report 	1 	40 	0 	41
	3,435 

Secondary Review of scientific and ethical aspects of protocol, and
review of ethical aspects of the completed study

$11,472*

Record and Report Information 	0 	0 	1 	1 	59 

Store, File and Maintain Information 	0 	0 	1 	1 	59 

Total per study	2 	41 	2 	45 	$15,223 

* Cost of 15 experts earning about $400/day conducting secondary review.

	Annual Burden:	45 hours/study * 29 studies = 1,305 hours

	Annual Costs:		$15,223/study * 29 studies = $441,467

6(d)	Bottom Line Burden Hours and Cost Tables

		  SEQ CHAPTER \h \r 1 The total estimate represents the information
collection activities expected to occur annually over the next three
years.  Table 5 provides the total estimated annual burden and costs for
respondents, as well as the total estimated annual burden and costs for
the Agency:

Table 5.  Total   SEQ CHAPTER \h \r 1 Annual Bottom Line Burden and
Costs / Master Table

Collection Activity	Annual Burden Hours	Annual Costs

Annual Respondent Burden and Costs

Research Involving Intentional Exposure of Human Subjects (Table 1)
1,056	$63,591

All Other Submitted Research with Human Subjects (Table 2)	348	$21,083

Respondent Total	1,404	$84,674

Annual Agency Burden

Research Involving Intentional Exposure of Human Subjects (Table 3)
2,640	$598,752

All Other Submitted Research with Human Subjects (Table 4)	1,305
$441,467

Agency Total	3,945	$1,040,219

6(e)	Reasons for Change in Burden

		There is no change to the annual respondent burden estimate.

6(f)		Burden Statement

The total estimated annual paperwork burden to comply with this
information collection activity is 1,404  SEQ CHAPTER \h \r 1  hours. 
The average burden per activity is estimated to be 32 hours per response
for research involving intentional exposure of human subjects, and 12
hours per response for all other submitted research with human subjects.
 

According to the Paperwork Reduction Act, “burden” means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, disclose, or provide information to or for a Federal
agency.  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 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 (see
Attachment F). 

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0414, 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.  

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2008-0414 and
OMB Control No. 2070-0169, to (1) EPA online using www.regulations.gov
(our preferred method), or by mail to: Public Information and Records
Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.

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-2008-0414.  These attachments are available for online
viewing at   HYPERLINK "http://www.regulations.gov_" 
www.regulations.gov  or otherwise accessed as described in section 6(f)
of the supporting statement, and as noted below.

Attachment A:	FIFRA Sections 3(c)(5), 3(g), 4(g)(2), and 25

Attachment B:	FFDCA Sections 408(b)(2)(A)(ii) and 408(e)(1)(C)

Attachment C:	Final Rule; Protections for Test Subjects in Human
Research

Attachment D:	Placeholder for:  “Record of EPA Consultations With
Respondents Regarding the ICR Renewal”  [Attachment to be added to
revised, final  supporting statement to be released with the 2nd FR
Notice for this ICR renewal.]

Attachment E:	OPP Standard ICR Wages (Draft)

Attachment F:	Display Related to OMB Control #2070-0169 -Listings of
Related Regulations in 40 CFR 9.1

 Defined at FIFRA section 2(bb) 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 (21 U.S.C. 346a) . . . .”

 Source: US EPA (2005). “Human Study Submission to the Office of
Pesticide Programs by Year.”  Office of Pesticide Programs.

 Bureau of Labor Statistics. “May 2004 National Industry-Specific
Occupational Employment and Wage Estimates: NAICS 325300 - Pesticide,
Fertilizer, and Other Agricultural Chemical Manufacturing.” Accessed
at   HYPERLINK "http://www.bls.gov/oes/current/naics4_325300.htm" 
http://www.bls.gov/oes/current/naics4_325300.htm .

May 13, 2008

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