Document ID: EPA-HQ-OPPT-2008-0220-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-18T04:00Z

Supporting Statement for a Request for OMB Review under

the Paperwork Reduction Act

IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title and Number of the Information Collection

Title:	TSCA Section 5(a)(2) Significant New Use Rules for Existing
Chemicals

EPA ICR No.:  1188.08	OMB Control No.:  2070-0038

1(b)	Short Characterization

Section 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2604
(see Attachment 1), authorizes EPA to determine that a use of a chemical
substance is a “significant new use.”  EPA must make this
determination by rule after considering all relevant factors, including
those listed in TSCA section 5(a)(2).  Once EPA determines that a use of
a chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a notice to EPA at least 90 days before they
manufacture, import or process the substance for that use.  Regulations
implementing significant new uses appear at 40 CFR part 721 (see
Attachment 2).

Once EPA receives a significant new use rule (SNUR) notice, EPA may take
regulatory action under TSCA sections 5(e), 5(f), 6 or 7 to control the
activities for which it has received a SNUR notice.  If EPA does not
take action, TSCA section 5(g) requires EPA to explain in the Federal
Register its reasons for not taking action.

Persons who intend to export a substance identified in a proposed or
final SNUR are subject to the export notification provisions of TSCA
section 12(b).  The regulations that interpret TSCA section 12(b) appear
at 40 CFR part 707.

2.  NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

TSCA section 5(a)(2) provides the Office of Pollution Prevention and
Toxics (OPPT) with the authority to monitor and control significant new
uses of existing chemical substances.  The factors considered by the
Administrator in determining a significant new use are:

1)	The projected volume of manufacturing and processing of a chemical
substance;

2)	The extent to which a use changes the type or form of exposure of
human beings or the environment to a chemical substance;

3)	The extent to which a use increases the magnitude and duration of
exposure of human beings or the environment to a chemical substance; and

4)	The reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, and disposal of a chemical
substance.

Once the Administrator makes such a designation, the Agency proposes a
Significant New Use Rule (SNUR).  If a final rule is promulgated, a
person who intends to engage in a significant new use of a chemical
covered by a SNUR must notify EPA of his/her intentions.  This
notification, made via the Significant New Use Notice (SNUN), must occur
at least 90 days prior to commencing the new use of the identified
substance.  The required notice must be submitted on EPA’s
Premanufacture Notice (PMN) form.  The PMN form provides data on the
identity and use of, and possible exposures to, the chemical substance. 
In addition, the PMN form provides test data plus descriptions of health
and environmental effects data based on the manufacture, processing,
use, distribution in commerce, and disposal of the chemical.

The Agency has 90 days to evaluate a SNUN once it has been received. 
This evaluation focuses on the health and environmental effects of the
substance’s significant new use.  Should EPA find cause for concern,
the Agency can take regulatory action as per TSCA sections 5(e) and
5(f).  Likewise, the Agency may extend the evaluation period by up to 90
days with good cause.  If EPA takes no action at the end of the review
period, the submitter can engage in the intended new use without any
restrictions.

2(b)	Practical Utility/Users of the Data

EPA uses this information to evaluate the health and environmental
effects of the significant new use.  During the evaluation period EPA
can take further regulatory action pursuant to TSCA sections 5(e) and
5(f).  Under TSCA section 5(e), the Administrator may issue an order to
prohibit or limit the manufacture, import, processing, distribution in
commerce, use, or disposal of such substance.  TSCA section 5(f) allows
the Administrator to, among other things, prohibit or limit the
manufacture of the chemical substance, if the substance presents or will
present an unreasonable risk of injury to health or the environment.

To date EPA has promulgated SNURs on 352 existing chemicals.  Presented
in Attachment 6 are selected case history abstracts for some of these
substances.  These abstracts highlight the needs of a particular office
and the facts surrounding a substance.  This information when applied to
the Regulatory Selection Criteria has resulted in final SNURs.



NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA

3(a)	Non-Duplication

EPA is the only Federal Agency that collects information on significant
new uses of chemical substances.  A notification of an intent to engage
in a significant new use serves two functions: as a notice, and as a
document that contains information about a chemical substance and
potential exposures to that substance.  The notification element is
unique to SNURs and therefore not obtainable elsewhere.  The chemical
information aspect will also contain unique information.  Only the
person who intends to commence a significant new use of a chemical
substance will know the potential for human and environmental exposures
to that substance, the quantity intended to be produced, imported, or
processed, and the manner in which the person will engage in the
significant new use.

A person submitting a significant new use notice is not required to
develop test data.  However, the person must submit data that are known
to or reasonably ascertainable by that person.  For published data the
submitter need only provide a literature citation (40 CFR
720.50(d)(3)(ii)).  For existing chemicals that are related to the
chemical substance that is the subject of the SNUR (e.g., impurities,
byproducts), neither the published data nor a literature citation need
be submitted.  Also, notices need not include information previously
submitted to EPA (unless the previously submitted information was
claimed confidential, in which case it must be resubmitted).

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

Prior to submission to OMB, this ICR will be made available to the
public for comment through a Federal Register notice.  The public will
have 60 days to provide comments.  Any comments received will be given
consideration when completing the supporting statement that is submitted
to OMB.

3(c)	Consultations

In addition to the public notice and comment period required by the OMB
regulations that implement the Paperwork Reduction Act (see Section 3(b)
of this Supporting Statement), the OMB regulations, 5 CFR 1320.8(d)(1),
also require agencies to consult with potential ICR respondents and data
users about specific aspects of an ICR before the agency submits the ICR
to OMB for review and approval.  In accordance with this regulation and
based on OPPTS Regulatory Coordination Staff guidance, EPA will solicit
comments from nine potential ICR respondents and data users with respect
to the renewal of this ICR.

3(d)	Effects of Less Frequent Collection

Whenever a person intends to engage in a significant new use, they must
notify EPA.  This is an explicit requirement of TSCA.  TSCA section
5(a)(1)(B) states, “... no person may ... manufacture or process any
chemical substance for a use which the Administrator has determined ...
is a significant new use ... unless such person submits to the
Administrator ...  a notice ...”  The consequence of  less frequent
collection of information (i.e., requiring only the first person who
intends to engage in a significant new use to submit notice) is a
violation of TSCA and would allow manufacturers, importers and
processors to use a substance in a manner that EPA has determined may
cause significant adverse exposures to the substance without prior
notification to EPA.

3(e)	General Guidelines

This information collection activity is necessary to implement the
statutory requirements of TSCA section 5(a)(2) and is consistent with
the requirements of 5 CFR 1320.6.

3(f)	Confidentiality

Information provided in a significant new use notice may receive
confidential treatment.  TSCA section 14 allows a manufacturer, importer
or processor to designate submitted information as confidential business
information (CBI).  The Agency has developed a comprehensive system to
prevent the unauthorized disclosure of CBI.  This system includes
procedures for logging CBI in and out of designated locked file
cabinets, for photocopying and transmitting CBI, and for restricting
confidential information only to personnel with CBI security clearance. 
No one is allowed access to CBI until they have received instructions
for handling CBI.

Special procedures also restrict access to computerized CBI.  These
security measures apply to CBI submitted by manufacturers as well as CBI
generated by EPA staff in the course of their review.  A wrongful
disclosure of CBI may result in either a fine or imprisonment.

3(g)	Sensitive Questions

This section is not applicable.  The information requested is not
sensitive in nature.

4.  THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondent NAICS Codes

Respondents affected by this collection activity are mainly NAICS
categories 325 - Chemicals and Allied Products Manufacturers and 32411-
Petroleum Refining.

4(b)	Information Requested

 (i) Data items, including record keeping requirements

Information submitted under this collection must include, insofar as it
is known to or reasonably ascertainable by the submitter, information
described in TSCA section 8(a)(2) (i.e., chemical identity, use, and
exposure data), as well as test data, and descriptions of other data
related to the effects on health and the environment of the manufacture,
processing, use, distribution in commerce, and disposal of the chemical
substance (TSCA section 5(d)).  After a notice has been received, EPA
has 90 days (extendable to 180 days) to evaluate the notice’s content.

 (ii) Respondent Activities

Only those persons who intend to engage in a significant new use of a
chemical substance must submit notice of their intentions to EPA. 
Submitters are required to use the Premanufacture Notice (PMN) form (EPA
Form 7710-25; see Attachment 3), which was developed to facilitate the
information collection process for new chemical substances.

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

5(a)	Agency Activities

A significant new use rule (SNUR) on an existing chemical substance is
the product of a process that is designed to develop the appropriate
information-gathering collection for a substance.  This process has
three major steps: Chemical Referral, Regulatory Selection, and
Regulation Development.

Step 1.  Chemical Referral:  EPA offices that have identified
information-gathering or follow-up monitoring needs for a particular
chemical may refer the substance to OPPT.  A systematic process has been
developed for receiving and handling chemical referrals.  Offices
referring substances are asked to prepare concise summaries of relevant
data.  This information is used to select a regulatory approach and for
rulemaking activities.

Step 2.  The Regulatory Selection Process - Referral and Review:  Once
an office has detailed its need for information, an information
collection approach is determined that best satisfies that office’s
needs.  The rulemaking options are: a TSCA section 8(a) reporting rule,
a TSCA section 8(c) call-in, a TSCA section 8(d) health and safety data
reporting rule, a TSCA section 5(a)(2) SNUR, or any combination of the
above.  It may also be determined that an alternative approach is more
appropriate (e.g., use of existing data sources, no data-gathering at
the present time, TSCA section 4 or 6 action, or referral to another
office for information-gathering under a different statutory authority).

Step 3.  Regulatory Development:  Prior to the development of a rule,
the recommended rulemaking approach must be reviewed by the referring
office and approved by the Office Director of OPPT.  If the
recommendation is approved, then the rulemaking process begins.

A SNUR is drafted only if it is an appropriate approach for a particular
substance that has received approval prior to the development of the
rule.  The proposal then undergoes intra-agency review, OMB review and
public comment.  Once a decision has been made to promulgate an
information collection rule, the next decision is to determine whether a
TSCA section 8(a) rule or a TSCA section 5 SNUR is most appropriate. 
Attachment 5 identifies the selection criteria that are applied in
determining whether a TSCA section 8(a) rule or SNUR is proposed.

5(b)	Collection Methodology and Management

EPA has not been able to identify a more efficient, less expensive or
more flexible means of obtaining the required data and remain within the
constraints of TSCA.  There is no new technology applicable to the
collection of this information that would minimize the collection
burden.

To aid persons subject to this information collection, OPPT has set up a
TSCA Hotline that provides information regarding TSCA section 5(a)(2)
reporting as well as other regulatory information.  When Hotline staff
are unable to answer questions regarding TSCA section 5(a)(2), the
questions are referred to the OPPT Chemical Control Division (CCD) staff
for resolution.

5(c)	Small Entity Flexibility

All business, regardless of size, must comply with the requirements of
TSCA section 5.  However, OPPT has taken a number of steps intended to
minimize the burden placed on small business.  For instance, TSCA
section 26(d) established an Assistance Office to provide technical and
other nonfinancial assistance to manufacturers, importers and processors
of chemical substances and mixtures.  This office has established a
toll-free hotline, performs on-site field visits and consultations, and
has hired a contractor to assist small businesses, free of charge, in
complying with TSCA requirements.

5(d)	Collection Schedule

Whenever any person intends to engage in a significant new use of a
chemical substance, they are required to submit a notice of their
intentions to EPA not less than 90 days before beginning to manufacture,
import or process the substance for the intended use.

ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

This section presents estimates of the cost and burden associated with
the recordkeeping and reporting requirements for significant new use
rules for existing chemicals under TSCA Section 5(a)(2). The methodology
used to estimate the recordkeeping costs, reporting costs, and burden
for this ICR renewal is largely based on previous experience with SNURs,
and is largely consistent with the analysis presented in the supporting
statement prepared for the previous ICR. A summary of the steps employed
in this analysis is shown below:

 Step 1:	The total number of SNURs promulgated and SNUNs to be
submitted, on an annual basis and for the three year period during which
this ICR will be in effect, was projected. The estimate is based on the
Agency's experience with SNURs and submission of SNUNs from past
experience as well as EPA’s expectations for future actions. This step
appears in Section 4 of this analysis.

Step 2:	The average industry burden associated with recordkeeping,
reporting, and customer notification was estimated. The reporting burden
estimates used here are taken from an analysis performed in connection
with OPPT's amendments to its PMN program. This step appears in Section
5 of this analysis.

Step 3:	The unit costs for the different activities associated with
section 5(a)(2) were estimated next (e.g., submitting a SNUN). The costs
were derived by multiplying current estimates of unit labor costs by the
burden estimates presented in Step 2. This step appears in Section 6 of
this analysis.

Step 4:	Total industry costs and burden were computed by multiplying the
average burden and cost per activity by the expected number of
activities. This step appears in Section 7 of this analysis.

Step 5:	The final step estimates the cost to EPA. This step appears in
Section 8 of this analysis.

NUMBER OF SIGNIFICANT NEW USE NOTICES PROJECTED

During the years 2004-2007, EPA promulgated three existing chemical
SNURs under TSCA Section 5(a)(2).   However, EPA expects this activity
to increase over the next three year period as EPA initiates work under
its commitment under the Security and Prosperity Partnership (SPP) to
complete risk characterizations and take necessary actions on over 6,750
chemicals by 2012.   Therefore, EPA is estimating it will promulgate an
average of five existing chemical SNURs per year under TSCA Section
5(a)(2) during the time period covered by this ICR.

EPA may receive SNUNs as a result of SNURs   EPA develops SNURs for a
number of reasons, some based on findings from its new chemicals program
in order to bind manufacturers and processors of chemicals reviewed
under its Premanufacture Notice (PMN) review process to certain
requirements    SNURs are also developed under EPA’s existing chemical
program under TSCA Section 5(a)(2).  It is the latter SNURs that are
covered by this ICR, and therefore, only the SNUNs received based on
those SNURs are estimated here.

EPA’s experience is that in response to promulgation of well over
1,000 SNURs under both its new and existing chemicals programs, the
Agency receives on average only 10 SNUNs per year.  Of those SNUNs, only
a fraction are the result of SNURs promulgated under Section 5(a)(2). 
For this ICR, however, EPA is estimating 10 SNURs per year.

                                                                      
TABLE 1

	ANTICIPATED NUMBER OF SNURs AND SNUNs

Year	

Anticipated Number of SNURs	

Anticipated Number of SNUNS

First Year	

5	

10

Second Year	

5	

10

Third Year	

5	

10

Three Year Totals	

15	

30

Given the uncertainty in projecting possible new uses for existing
chemicals, it is not possible to determine if a large or small number of
firms would be affected by any given SNUR, or whether any one firm might
engage in more than one new use. Thus, this analysis makes the
assumption that no firm submits more than one SNUN. The total number of
firms engaging in new uses cannot be estimated.

 	6(a)	Estimating Respondent Burden

A. Alternative Responses

The burden associated with a SNUR could involve a number of possible
industry responses. That is, when a SNUR is promulgated, a firm seeking
to engage in a new use for a subject chemical has five options regarding
possible courses of action that may generate reporting burden:

1)	The company could submit a SNUN. This option would be chosen by any
company not intending to abide by the provisions of the SNUR. 

2)	A company can request an equivalency determination. This option would
be chosen if a manufacturer/importer had reason to believe that there
may be alternative methods not considered by EPA that provide equivalent
or superior protection from exposure or release of the subject chemical.

3)	The company can comply with the SNUR, ensuring that all provisions of
the SNUR are implemented in connection with the planned use of the
subject chemical. 

4)	The company can request review of the SNUR for possible modification
or revocation.

5)	The company may simply decide to forgo the new use, avoiding
regulatory compliance activities altogether.

Additionally, under current regulations at 40 CFR 721.5(a)(2), all
manufacturers, processors, and importers of chemicals subject to SNURs
are subject to certain requirements regardless of whether they engage in
a significant new use unless certain information can be documented .
However, without prior knowledge of chemicals which would be the subject
of future SNURs, estimating the number of potentially affected entities
subject to 40 CFR 721.5(a)(2) is not possible.

The following section estimates the cost of submitting a SNUN (option 1)
and then discusses the other options.

B. Burden Estimates

TSCA Section 5(a)(2) imposes two requirements on industry. First,
manufacturers, processors, and importers of chemicals must choose among
the options mentioned above. This section presents estimates of
submitting SNUNs (i.e., the first option) and then briefly discusses the
other four options. Second, manufacturers, processors, and importers of
chemicals covered by SNURs will incur burden and costs to notify
customers of the hazards posed by the covered chemical.  Therefore, they
must first determine if their chemical is on the SNUR and then must
determine how to notify their customers.

Chemical Verification

When a SNUR is published, companies must review the rule to verify if
their chemical is subject to the rule.  During the 2004-2007 timeframe,
the majority of SNURs promulgated by the Agency under TSCA Section 5(a)
applied to new chemicals submitted to the Agency under the
Premanufacture Notice Program.  Only three SNURs applying to existing
chemicals were promulgated during the same time period.  The Agency
typically notifies the manufacturer(s) of chemicals subject to a SNUR
prior to its issuance.  Therefore it is estimated that no more than
0.167 hours (10 minutes) or of technical time per chemical is used to
verify if a chemical is 

subject to the rule.  This is equivalent to 6.8 hours (0.167
hours/chemical x 41 chemicals/SNUR) per SNUR.

Submitting a SNUN

In submitting a SNUN, individuals at different occupational levels must
spend time on the required recordkeeping and reporting activities. In
estimating the burden required to prepare a SNUN, the analysis uses the
breakdown of activities and activity estimates as developed for the
premanufacture notification (PMN) baseline model in the Agency's
"Regulatory Impact Analysis of Amendments to Regulations for TSCA
Section 5 Premanufacture Notifications" (OPPT, 1994). The PMN reporting
cost estimates were used because SNUNs would be filed on the standard
PMN form. Table 2 presents EPA's estimate of respondent reporting burden
associated with the filing of a SNUN.

When submitting an SNUN, manufacturers must maintian records associated
with the SNUN for five years.  In keeping with the conservative
assumptions already employed, the high end of the range of reporting
burden hours (i.e., 113.25 hours) will be used in subsequent cost
calculations (see Section 6 below). The recordkeeping associated with
preparing and filing a SNUN is assumed to require five percent of the
time spent on reporting. Thus, 5.67 record keeping hours ([113.25
hours]*[5 percent]) will be spent in preparation of a SNUN. The average
industry burden per notice, then, is 118.92 hours (113.25 + 5.67).

The estimates shown in Table 2 are average burden levels. Thus, it is
entirely possible that certain respondents may incur burden above or
below the estimates shown above; nevertheless, EPA believes the upper
bound of the range of average burden hours to be an appropriate estimate
for the calculations performed in this analysis.

Alternative Options

Should a company choose to request an equivalency determination (i.e.,
the second option), or review for modification/revocation (i.e., the
fourth option), EPA estimates that a data collection and preparation
effort similar to that of a SNUN would be required, and thus the burden
is estimated to range up to 118.92 hours for these alternatives, the
same as for submitting a SNUN.

In complying with a SNUR, a company would incur costs to ensure all
provisions of the SNUR were implemented at the subject facility (i.e.,
the third option). Since the nature of such provisions will vary
depending on the significant new uses identified in each respective
SNUR, estimating burden at this time is not possible.

The final alternative for a company considering a significant new use of
a chemical which is the subject of a SNUR is to forgo the new use (i.e.,
the fifth option). In carrying out such a response, no direct regulatory
burden or costs would be incurred.

Customer Notification

 As noted above, unless manufacturers, processors, and importers of
chemicals subject to SNURs have either notified recipients of such
chemicals and all significant new uses, verified that knowledge of the
SNUR has been otherwise acquired by recipients, or verified that
recipients are unable to engage in significant new uses, manufacturers,
processors, and importers must file a SNUN. Since it is not expected
that all such entities will have complete knowledge of all uses of any
products subject to a SNUR, and because filing a SNUN could require
significantly more burden, it is assumed that manufacturers, processors,
and importers will most often choose to notify their customers of SNUR
regulatory activities. As this notification may be accomplished by
simply annotating an MSDS, EPA estimates the associated burden to be
about 1 hour of a technical employee's time per manufacturer, processor,
or importer per chemical. 

	

                                                                     
TABLE 2

	UNIT REPORTING BURDEN ESTIMATES ASSOCIATED WITH FILING A SNUN,

	BY LABOR CATEGORY

Activity	

Clerical Hours	

Technical Hours	

Managerial Hours	

Total Hours

General information/ instructions	

2 - 2.5	

1.5 - 2	

3 - 4	

6.5 - 8.5

Chemical identity	

1.5 - 2	

3 - 6	

1	

5.5 - 9

Trade name ID	

	

.25	

	

.25

Byproducts/impurities identification	

	

1	

	

1

Production & marketing

data	

1.5	

	

2 - 3	

3.5 - 4.5

Production volume	

	

1	

	

1

Category of use	

	

3	

	

3

Hazard information	

	

3 - 4	

	

3 - 4

Human exposure and 

environmental release	

2.5 - 3.5	

	

6 - 7	

8.5-10.5

Site information	

	

14 - 16	

	

14 - 16

Occupational exposure 	

	

13 - 14	

	

13 - 14

Environmental release/ disposal	

	

9 - 10	

	

9 - 10

Sites controlled by others	

2	

10 - 12	

2 - 2.5	

14 - 16.5

List of attachments	

2	

6 - 8	

1 - 1.5	

9 - 11.5

Certification	

	

	

.5	

.5

Data submissions	

.5	

1.5 - 2	

.5	

2.5 - 3

Totals	

12 - 14	

66.25 - 79.25	

16 - 20	

94.25 - 113.25

Source: OPPT, 1994.

	6(b)	Estimating Respondent Costs

The unit costs of filing a SNUN are estimated by monetizing the labor
time spent preparing the SNUN and then adding any fixed costs associated
with filing a SNUN. This section derives these unit costs.

A. Wages

The basic methodology for estimating the industry wage rates used in
this analysis is presented in Appendix A.  Wage data used to develop the
basic industry wage rates are derived from the U.S. Department of Labor,
Bureau of Labor Statistics (BLS) for all goods-producing private
industries.  The annual salary estimates were adjusted to final-quarter
(December) 2003 dollars using the BLS Employment Cost Index (ECI) for
white-collar occupations for all private industries.  

An overhead rate of 17 percent was applied to all wages based on
information provided by the chemical industry and chemical industry
trade associations.  Benefit rates were applied to wages as follows:
managerial, 47.7 percent; technical, 49.7 percent; and secretarial, 50.5
percent. Thus, total load factors are 64.7 percent for managerial labor,
66.7 percent for technical labor, and 67.5 percent for secretarial
labor. The estimated hourly wage rates are presented in Table 3. Details
on the calculation of the wage rates can be found in Appendix A.

	TABLE 3

	HOURLY WAGE AND LOAD RATES FOR INDUSTRY

Labor Category	

Wage Rate

Managerial	

$68.18

Technical	

$55.44

Clerical	

$27.47

			Note: Details on the calculation of these wages can be found in
Appendix A.

B. Summary of Unit Costs

Labor Costs

Chemical Verification

The Agency estimates that chemical verification will require 6.8 hours
per SNUR.    The total estimated cost per SNUR is estimated to be $377
(6.8 hours per SNUR x $55.44).

Costs for Submitting  a SNUN

Using these labor wage rates and the burden estimates presented above,
EPA estimates that the labor cost associated with filing a SNUN ranges
from $5,094 to $6,143. In addition, SNUN filers must pay a $2,500 user
fee to EPA. Thus, the total cost of filing a SNUN ranges from $7,594 to
$8,643.

	TABLE 4

	UNIT REPORTING BURDEN ESTIMATES ASSOCIATED WITH FILING A SNUN,

	BY LABOR CATEGORY

	

	

Hours	

Wage Rate	

Total Cost

Clerical	

12-14	

$27.47	

$330-$385

Technical	

66.25-79.25	

$55.44	

$3,673-$4,394

Managerial	

16-20	

$68.18	

$1,091-$1,364

Totals	

94.25-113.25	

-	

$5,094-$6,143

Costs for Record keeping

Record keeping requires 5.67 hours per SNUN.  Assuming that the record
keeping is performed by clerical staff, the costs for record keeping are
$156 [5.67 hours * $27.47 (clerical labor)

Alternative Responses

As noted in Section 4, five alternative responses to any particular SNUR
could be chosen by firms planning to engage in significant new uses of
subject chemicals.  Although EPA has not projected or quantified how
frequently these alternatives might be selected, the unit costs
associated with each option are discussed briefly below.

The estimated burden of requesting an equivalency determination (the
second option) or review for modification/revocation (the fourth option)
was judged to be similar to filing the SNUN; thus, total costs including
the EPA user fee were estimated to range from between $7,594 and $8,643.
 However, the firm may incur additional costs in developing the data
necessary to justify the alternative.  This option will be preferable to
compliance with the SNUR if the total cost of obtaining EPA approval of
a request is less than the costs of SNUR compliance.

Customer Notification

EPA assumes that the customer notification requirement will be handled
by technical labor. Section 5 of this analysis assumed that one hour of
labor per chemical would be required to perform the notification, thus
the unit cost of notification is estimated to be $55.44 (i.e., the
hourly wage for technical labor).   EPA estimates that each SNUR will
cover approximately 20 chemicals.  Furthermore, EPA assumes that there
are two manufacturers, processors, or importers per chemical. 
Therefore, the burden per SNUR is estimated to be 40 hours per SNUR ([20
chemicals per SNUR]*[1 hour per manufacturer, processor, or importer]*[2
manufacturers, processors, or importers per chemical]), and the cost per
SNUR is equal to $2,218 [($55.44 per hour)*(40 hours per SNUR)].

	TABLE 5

	SUMMARY OF UNIT COSTS

Unit Cost	

Estimated Cost

Chemical Verification	

$377 per SNUR

Submitting a SNUN	

Between $7,594  and $8,643 per SNUN

SNUN Record Keeping	

$156 per SNUN

Notifying Customers	

$2,218  per SNUR

Summary

Table 4 summarizes the unit costs estimated in this section. Reviewing a
SNUR to verify that a chemical is included is estimated to cost $377 per
SNUR.  Submitting a SNUN is estimated to cost between $7,594 and $8,643
per SNUN and notifying customers is estimated to cost $2,218 per SNUR.
As noted above, the upper bound cost for filing a SNUN ($8,643) will be
used in subsequent calculations.

TOTAL BURDEN AND COSTS TO INDUSTRY 

This section provides estimates of the total burden and costs imposed by
the TSCA Section 5(a) requirements. These estimates can be divided into
three categories: chemical verification, submitting SNUNs and notifying
customers.

A. Verifying Chemicals

The total cost and burden imposed on industry by Section 5(a)(2)
requirements can be calculated by multiplying the unit burden and cost
estimates by the expected number of SNURs. As noted above, this analysis
assumes that EPA will promulgate five SNURs per year.  Total burden and
costs for chemical verification are presented in Tables 6 and 7.

	TABLE 6

	TOTAL INDUSTRY BURDEN ASSOCIATED WITH CHEMICAL VERIFICATION

Activity	

Hours Per SNUR	

SNURs per Year	

Total hours

Chemical Verification	

6.8	

5	

34

	TABLE 7

	TOTAL INDUSTRY COSTS ASSOCIATED WITH CHEMICAL VERIFICATION

SNURs Per Year	

Cost Per SNUR	

Total Annual Cost	

Three Year Cost

5	

$377	

$1,885	

$5,655

Note: Estimates may contain some rounding error caused by rounding
dollar values to the nearest whole dollar.

B. Submitting SNUNs

The total cost and burden imposed on industry by Section 5(a)(2)
requirements can be calculated by multiplying the unit burden and cost
estimates by the expected number of SNURs and SNUNs. As noted above,
this analysis assumes that EPA will promulgate five SNURs and receive
ten SNUNs per year.

Table 8 presents the total burden of submitting SNUNs. Section 5 of this
analysis estimated that the reporting requirements for submitting SNUNs
would impose 113.25 hours for each SNUN. An additional 5.67 hours are
assumed to be required to satisfy recordkeeping requirements. Thus, a
total of 118.92 hours are required for each SNUN. From Section 4 of this
analysis, EPA estimates that it will receive ten SNUNs per year. Thus,
the total burden imposed on industry is estimated to be 1,189.2 hours
annually, or 3,567.6 hours over a three year period.



	TABLE 8

	TOTAL INDUSTRY BURDEN ASSOCIATED WITH SUBMITTING SNUNs

Activity	

Hours Per SNUN	

SNUNs per Year	

Total hours

Reporting	

113.25	

10	

1,132.5

Recordkeeping	

5.67	

10	

56.7

Total Annual Burden	

118.92	

10	

1,189.2

Three Year Burden	

-	

-	

3,567.6

The total cost of submitting SNUNs is presented in Table 9. Section 6 of
this analysis estimated that submitting SNUNs will cost affected parties
$8,643 per SNUN. Assuming 10 SNUNs per year (see Section 4) implies a
total annual cost of $86,430 ([10 SNUNs]*[$86,430 per SNUN]) and a three
year cost of $259,290 ([$86,430 per year]*[3 years]).

	TABLE 9

	TOTAL INDUSTRY COSTS ASSOCIATED WITH SUBMITTING SNUNs

	

SNUNs Per Year	

Cost Per SNUN	

Total Annual Cost	

Three Year Cost

10	

$8,643	

$86,430	

$259,290

Note: Estimates may contain some rounding error caused by rounding
dollar values to the nearest whole dollar.

	C. Customer Notification

Table 10 presents estimates of the customer notification burden and
costs. EPA estimates that burden for customer notification is 82 hours
per SNUR.  EPA estimates that 5 

SNURs will be promulgated per year.  The annual burden associated with
customer notification is estimated to be 200 hours (40 hours/SNUR * 5
SNURs/year).  The three year burden is estimated to be 600 hours.

The cost of customer notification is estimated by multiplying the burden
hours by the unit cost of notification. Section 6 assumed that
notification would be accomplished using technical labor, valued at
$55.44 per hour. Thus, the total annual cost of customer notification is
$11,088 and the three year cost is $33,264.



	TABLE 10

	ESTIMATED BURDEN AND COST FOR CUSTOMER NOTIFICATION

Cost element	

Value/Estimate

Burden

Chemicals per SNUR [a]	

20

Hours per manufacturers/processors/importers [b]	

1.0

Manufacturers/processors/importers per chemical [c]	

2

SNURs per year [d]	

5

Total annual burden [e] = [a]*[b]*[c]*[d]	

200

Three year burden [f] = 3*[e]	

600

Cost

Cost per hour [g]	

$55.44

Total annual cost [h] = [e]*[g]	

$11,088

Three year cost [j] = 3*[h]	

$33,246

C. Summary of Industry Costs

The total estimated industry burden associated with SNURs is equal to
the total of chemical verification burden (34 annually), reporting and
record keeping burden (1,189 hours annually) plus the total customer
notification burden (200 hours annually) which is equal to 1,423 hours
annually.  The associated cost is estimated to be $99,403 annually. 
Over a three-year period, the burden is estimated to be 4,269 hours and
costs are estimated to be $298,209.

	6(c)	Estimating Agency Burden and Cost 

EPA will incur costs associated with the promulgation of SNURs and the
processing of SNUNs. The previous ICR estimated that the cost for
issuing a SNUR can be as high as $35,082 in 2003 dollars.  The Office of
Personnel Management reports that federal salaries increased by 11.57
percent (Washington, D.C. salary including locality adjustment) from
2003 to 2007 (Office of Personnel Management, 2008).   The annual salary
for EPA staff used for calculations of Agency costs is an average of the
OPM year 2007 annual salaries for GS-12 Steps 1 and 10 for Washington,
DC -- $66,767 and $86,801, respectively, or $76,784.  Multiplying by an
assumed loading factor of 1.6 to reflect fringe benefits and overhead
(Office of Policy Planning and Evaluation, 1992), the loaded annual
salary of EPA staff was calculated to be $122,854. Dividing the wage by
a 12 person-months/year results in $10,238/person-month.  Consistent
with the previous ICR, it is estimated that it will take 3.94
person-months of EPA staff time to develop a final SNUR.   Therefore,
the wage per person-month ($10,238) multiplied by a 3.94
person-months/SNUR yields an EPA cost per SNUR of $40,338.   

EPA(s costs to review and process SNUNs are assumed to be the same as
EPA costs to review PMNs.  These costs are estimated at $4,778 per case.
 The Agency actions required, full-time equivalent (FTE) staff needs,
and extramural costs such as for contractor support are derived in
Appendix B from EPA(s analysis of the Agency costs of processing PMN
submissions (RIB, 1994), with updates to 2007 dollars.     

 

Using the estimates of annual SNUR promulgation and SNUR notice
submissions presented above, EPA's estimated costs are presented in
Table 11. Promulgating SNURs and processing SNUNs are estimated to cost
the Agency $126,261 annually and $378,783 for three years. The Agency
may also incur a cost for modifying a SNUR if submitted data indicate a
need for such an action.  Costs to perform such a modification have not
been estimated.

	TABLE 11

	AGENCY COSTS

Activity	

Number Per Year	

Cost Per Action	

Annual Cost	

Three Year Cost

SNURs	

5	$40,338	$201,690	$605,070

SNUNs	10	$4,778	$47,780	$143,340

Totals 	15	$45,116	$249,470	$748,410

Note: Estimates may contain some rounding error caused by rounding
dollar values to the nearest whole dollar.

6(d)	Reasons for Change in Burden

Since the last clearance, annual industry burden estimates have
increased by 562 hours, from 861 hours to 1,423 hours. This change
results from updating estimates based upon an anticipated increase in
the number of SNURs promulgated from three to five per year and an
increase in the estimated number of SNUNs received from five to ten per
year.  Additionally, estimated number of chemicals per SNUR is estimated
to fall from 41 to 20.  All of these changes are adjustments.

	Regulatory Flexibility Analysis

Section 5(a)(c) affects new uses of chemicals and requires those
interested in engaging in such a use to notify the Agency of his/her
intentions.  Because the rule only covers uses which a small business
intends to undertake, a small business is not expected to immediately be
affected by the SNUR unless it is considering such a use in the future. 
 Although there may be some small businesses that may decide to
participate in SNUR related activities associated with certain
chemicals, it is impossible to estimate the number at this time. 
Additionally, the Agency has received few SNUNs related to existing
chemical SNURs in the past, suggesting that few, if any small businesses
would be affected.  This, coupled with the low unit costs associated
with filing a SNUN, suggests that the overall impact will be low for any
business which may choose to file a SNUN or notify customers of SNUR
activity.  These costs are not differentiated between small and large
businesses.

	6(e)	Burden Statement

The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0038, is estimated to be 118.9 hours
per response.  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 includes the time needed to
review instructions; develop, acquire, install and utilize technology
and systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information ; and transmit or
otherwise disclose the information.  An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. 
The OMB control number for this information collection appears above. 
In addition, the OMB control numbers for EPA’s regulation, after
initial display in the final rule, are listed in 40 CFR part 9.

  SEQ CHAPTER \h \r 1    SEQ CHAPTER \h \r 1 To comment 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, EPA has
established a public docket for this ICR under Docket ID No.
EPA-HQ-OPPT-2008-0220.  The docket is available for public viewing at
the Pollution Prevention and Toxics Docket in the EPA Docket Center
(EPA/DC).  The EPA/DC Public Reading Room is located in the EPA West
Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC.  The
EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays.  The telephone number for the
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number
for the Pollution Prevention and Toxics Docket is (202) 566-0280.  An
electronic version of the public docket is available through the Federal
Docket Management System (FDMS) at     HYPERLINK
"http://www.regulations.gov"  www.regulations.gov .  Use FDMS to submit
or view public comments, access the index listing of the contents of the
public docket, and to access those documents in the public docket that
are available electronically.  Once in the system, select “search,”
then key in the docket ID number identified above.  Also, you can 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.  Please include the EPA Docket ID No.
EPA-HQ-OPPT-2008-0220 and OMB control number 2070-0038 in any
correspondence. 

                                                              
REFERENCES 

BLS, 2008a.  Bureau of Labor Statistics.  Employment Cost Index, Total
Compensation: White-Collar Occupations (Series ID: ECS11102I), ,
http://data.bls.gov/cgi-bin/srgate, extracted February 29, 2008. 

BLS, 2008b.  Bureau of Labor Statistics.  Employer Costs for Employee
Compensation - December 2003: Private industry, goods-producing workers
by occupational group, wages and total benefits (Series IDs
CCU420000112000D, CCU420000111000D, CCU420000114000D, CCU430000112000D,
CCU430000111000D, CCU430000114000D), http://data.bls.gov/cgi-bin/srgate,
extracted February 29, 2008.

EPAB, 1999.  Economic Analysis of Expedited Significant New Use Rules
for 41 Chemical

 Substances and  Background Support Document for Economic Analysis of
Significant New

 Use Rules.   Washington, DC: U.S.EPA/OPPT/EETD/EPAB, July 20, 1999. EPA
Docket 

 Office of Personnel Management (OPM), 2008.  Salary Tables 2003-DCB,
2004-DCB, 2005-DCB, 2006-DCB, 2007-DCB.   www.opm.gov.

Office of Policy, Planning, and Evaluation (OPPE), 1992.  Instructions
for Preparing Information Collection Requests (ICRs). Washington, DC:
U.S. EPA, June 1, 1992.

Office of Pollution Prevention and Toxics (OPPT), 1994. Regulatory
Impact Analysis of Amendments to Regulations for TSCA Section 5
Premanufacture Notifications.

RIB, 1994.  Regulatory Impacts Branch.  Regulatory Impact Analysis of
Amendments to Regulations for TSCA Section 5 Premanufacture
Notifications.  Washington, DC: U.S. EPA/OPPT/EETD/RIB, September 9,
1994.

Rice, 2002.  Cody Rice. Wage Rates for Economic Analysis of the Toxics
Release Inventory Program.  Washington, DC: U.S.EPA/OPPT/EETD/EPAB, June
10, 2002.

Shapiro, Michael, 1984. (Review of Agency SNUR Costs(, Memorandum to
Susan Hazen, Office of Toxic Substances, November 16.

USEPA, 1985. Response times and Labor Costs Final Data Element List
Comprehensive Assessment Information Rule, April 30, pp. 94-106.

     TSCA section 5(e) allows the Administrator to prohibit or limit the
manufacture, import, processing, distribution in commerce, use, or
disposal of the substance when the substance may present an unreasonable
risk.  TSCA section 5(f) allows the Administrator to use a TSCA section
6 regulation to prohibit or limit the manufacture of the substance when
the substance will present an unreasonable risk.

Unless manufacturers, processors, and importers of chemicals subject to
SNURs have either notified recipients of such chemicals and all
significant new uses, verified that knowledge of the SNUR has been
otherwise acquired by recipients, or verified that recipients are unable
to engage in significant new uses, manufacturers, processors, and
importers must file a SNUN

     The burden estimates presented in Table 2 differ from the PMN
Amendments analysis, which were based on a Chemical Manufacturers
Association survey, only in that burden for researching synonyms and
generic chemical names was not included in this analysis. This is
because subject chemicals would be existing chemicals, and such
information would already be known.

     The assumption that there are two manufacturers, processors, or
importers per chemical follows from previous ICRs for these
requirements.

     In deriving the totals for this analysis, EPA uses the upper bound
estimates for the number of hours and the cost of submitting SNUNs.

     This percentage increase is composed of four annual increases: a
4.42 percent increase in 2004, a 3.71 percent increase in 2005, a 3.44
percent increase in 2006, and a 3.44 percent increase in 2007. (Office
of Personnel Management, 2008).

     The 3.94 person-months estimate is from a memorandum from Michael
Shapiro, Economics and Technology Division, to Susan Hazen, Office of
Toxic Substances (Shapiro, 1984).

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