[Federal Register: August 3, 2009 (Volume 74, Number 147)]
[Notices]
[Page 38437-38438]
[DOCID:fr03au09-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0347]

Draft Guidance for Industry: Guide to Minimize Microbial Food
Safety Hazards of Melons; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Guide to Minimize Microbial Food Safety Hazards of Melons.'' This draft
guidance is intended to cover the entire melon supply chain, both
domestic firms and foreign firms exporting melons into the United
States, to enhance the safety of melons by recommending practices to
minimize microbial food safety hazards and to prevent microbial
contamination. This draft guidance, when finalized, will supplement
existing FDA guidances, including the 1998 ``Guidance to Industry:
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables,'' which applies to fresh produce commodities, and the 2008
``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards
of Fresh-cut Fruits and Vegetables,'' which applies to fresh-cut
produce.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by October 2, 2009.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Office of Food Safety (HFS-317), Center for Food Safety
and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. Submit
written comments on the draft guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:  Willette Crawford, Center for Food

Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Guide to Minimize Microbial Food Safety
Hazards of Melons.'' This draft guidance covers melons that are grown
and harvested for fresh market (i.e., fresh, unprocessed form) or for
``fresh-cut/value-added products'' (i.e., minimally processed, such as
trimmed, peeled, sliced or diced, and then bagged or prepackaged),
cooled, shipped to retail, wholesale or for processing, and offered for
sale to the consumer. The term ``melons'' as used in this draft
guidance includes raw agricultural commodities and fresh-cut/value-
added products derived from cantaloupe (also known as muskmelons),
honeydew, watermelon, and variety melons (e.g., ``Canary,''
``Crenshaw,'' and ``Galia''). This draft guidance is based primarily on
melon industry guidelines issued in 2005 (Ref. 1), along with agency
experience and information from other recent public and private
programs.
    FDA is issuing this draft guidance as Level 1 draft guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the
agency's current thinking on the microbiological hazards presented by
fresh and fresh-cut melons and the recommended control measures for
such hazards in production and harvesting, postharvest operations,
processing, distribution, and retail and food service handling of such
produce. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to publish
notice in the Federal Register soliciting public comment on each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, FDA will publish a
60-day notice on the proposed collection of information in a future
issue of the Federal Register.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The draft guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or http://
www.regulations.gov.

V. References

    The following reference has been placed on display in the Division
of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852
and may be seen by interested persons between 9 a.m. and 4 p.m., Monday
through Friday.
    1. Fleming, P., Pool, W., and Gorny, J., editors; ``Commodity
Specific Food Safety Guidelines for the Melon Supply Chain'' (1st
ed.); Produce Marketing Association and United Fresh Produce
Association; November 7, 2005. Accessed online at http://
www.fda.gov/Food/FoodSafety/Product-SpecificInformation/
FruitsVegetablesJuices/GuidanceComplianceRegulatoryInformation/
ucm168609.htm.

    Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18452 Filed 7-31-09; 8:45 am]

BILLING CODE 4160-01-S


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	 		WASHINGTON, D.C. 20460

Office Of

Prevention, Pesticides

And Toxic Substances

MEMORANDUM

May 9, 2006

Subject: 	Carbaryl: Risk Analysis For Open Cab Airblast Applicators
Based On MRID 464482-01 	Using 2 Different Types Of Head Protection; DP
Barcode: D328176; PC Code: 056801

From:	Jeffrey L. Dawson, Chemist/Risk Assessor

		Reregistration Branch 1

		Health Effects Division (7509C)

Through: 	Whang Phang, PhD, Branch Senior Scientist

		Reregistration Branch 1

		Health Effects Division (7509C)

To:	Christina Scheltema, Chemical Review Manager

		Special Review & Reregistration Division (7508C)

	Updated risk estimates for open cab airblast applicators using carbaryl
were completed based on the results of MRID 464482-01.  This study was
conducted by the Agricultural Handlers Exposure Task Force (AHETF) using
carbaryl and it evaluated open cab applicator exposures who wore typical
work clothing (i.e., long pants, shoes, socks, long-sleeved shirt),
chemical resistant gloves, no respirators, and either a "SouWester" hat
or hooded tyvek jacket.  Bayer Crop Protection, the primary registrant
for carbaryl, is a member of the AHETF so there are no data compensation
issues related to the use of MRID 464482-01 in this assessment.  A data
evaluation record exists for this study and can be referred to if
additional information regarding this study is desired (i.e., D316628;
Dated May 10, 2006).  Arithmetic mean unit exposure values were used in
these calculations from the study as recommended in the data evaluation
record.

	The purpose of this study was to develop data that could be used to
predict exposures based on clothing/personal protective equipment
scenarios that are not currently available in the Pesticide Handlers
Exposure Database (PHED) and not routinely considered in Agency risk
assessments for this job function.  In PHED, the airblast application
scenarios commonly employed (similar to those monitored in MRID
464482-01) involve (1) the use of double layer clothing, chemical
resistant gloves, respirators, and no head protection or (2) the use of
an enclosed cab tractor.  The carbaryl risk assessment (D287532; Dated
March 14, 2003) provided risk estimates based on these scenarios and it
was found that the Agency in its risk management decision desired the
use of enclosed cabs as a result.  However, as indicated in the record
of public comments (see www.Regulations.gov) related to the carbaryl RED
decision, a number of stakeholders voiced concerns (e.g., US Apple) over
the requirement for enclosed cabs based on two key issues including (1)
cost of closed cab tractors is prohibitive and (2) smaller, overgrown
tree canopies in many orchards/groves preclude the use of closed cab
equipment because these machines will not easily fit through rows for
application.  As a result of these concerns, the Agency has developed
risk estimates based on MRID 464482-01.

	The risk calculations which have been completed for the purposes of
this assessment are included in Appendix A in their entirety.  The basic
inputs for hazard, acres treated, and application rates remain unchanged
from the previous carbaryl risk assessment (D287532; Dated March 14,
2003).  In Appendix A, both PHED and MRID 464482-01 unit exposure values
were used for the calculations for comparative purposes.  The results
based on PHED are identical to those presented in the 2003 risk
assessment.  Both noncancer and cancer risk estimates were calculated.
Noncancer risks (i.e., MOEs or Margins of Exposure) are summarized in
Table 1 below while cancer risks are summarized in Table 2.

Table 1:  Summary Of Noncancer Risks For Carbaryl Airblast Applicators
Based On PHED & MRID 464482-01

Application Target/Crops	Application Parameters	PHED - Based MOEs

[Included in D287532]	MRID 464482-01 Based MOEs

For Open Cab Airblast Application

	Rate

(lb ai/acre	Acres Treated	Open Cab Airblast

(double layer, gloves, PF 10 respirator, no hat)	Enclosed Cab With
Normal Work Clothing

(Eng. Control)	Open Cab Airblast

(double layer, gloves, no respirator,  "SouWester" hat)	Open Cab
Airblast

(double layer, gloves, no respirator, hooded tyvek jacket)

Citrus (CA 24C)	16	40	15.7	105	16.6	28.1

Citrus	7.5	40	33.6	224	35.4	60.0

Nut Trees	5	40	50.4	337	53.1	90.0

Pome & Stone Fruit (Max.)	3	40	83.9	561	88.5	150

Grapes	2	40	126	841	133	225

Pome & Stone Fruit (Avg.)	1.1	40	229	1529	241	409

Note:  Target MOE (i.e., MOE where risks are not of concern) is 100.
These values are summarized from Table 8 in Appendix A.

Table 2:  Summary Of Cancer Risks For Carbaryl Airblast Applicators
Based On PHED & MRID 464482-01

Application Target/Crops	Application Parameters	PHED - Based MOEs

[Included in D287532]	MRID 464482-01 Based MOEs

For Open Cab Airblast Application

	Rate

(lb ai/acre	Acres Treated	Open Cab Airblast

(double layer, gloves, PF 10 respirator, no hat)	Enclosed Cab With
Normal Work Clothing	Open Cab Airblast

(double layer, gloves, no respirator,  "SouWester" hat)	Open Cab
Airblast

(double layer, gloves, no respirator, hooded tyvek jacket)

Citrus (CA 24C)	16	40	5.6 x 10-6	8.2 x 10-7	3.9 x 10-6	2.6 x 10-6

Citrus	7.5	40	2.6 x 10-6	3.9 x 10-7	1.9 x 10-6	1.2 x 10-6

Nut Trees	5	40	1.7 x 10-6	2.6 x 10-7	1.2 x 10-6	8.2 x 10-7

Pome & Stone Fruit (Max.)	3	40	1.0 x 10-6	1.5 x 10-7	7.4 x 10-7	4.9 x
10-7

Grapes	2	40	7.0 x 10-7	1.0 x 10-7	4.9 x 10-7	3.3 x 10-7

Pome & Stone Fruit (Avg.)	1.1	40	3.8 x 10-7	5.7 x 10-8	2.7 x 10-7	1.8 x
10-7

Note:  Target cancer risk is 1x10-6.  These values are summarized from
Table 10 in Appendix A and represent the risks for professional
applicators (i.e., 30 days/year = frequency of use).  Risks for private
growers (i.e., 10 days/year = frequency of use) are available in
Appendix A/Table 9 for comparison.  The trends identified in the results
for professional and private users are similar.

	The noncancer risk estimates based on MRID 464482-01 still remain of
concern for all but the lowest application rates considered (i.e., ~3 lb
ai/acre or less depending upon hat type used).  For all use scenarios,
risks are of slightly less concern than for the corresponding PHED-based
values based on high levels of personal protective equipment yet are
still significantly lower than those associated with the use of enclosed
cab tractors.  The trend for cancer risks is similar although it should
be noted that cancer risks are of much less concern because all cancer
risks based on MRID 464482-01 are similar to or less than 1x10-6.

 PAGE

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[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41312-41313]
[FR Doc No: 2022-14826]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0720; FRL-9967-01-OCSPP]

Pesticide Registration Review; Pesticide Dockets Opened for
Review and Comment; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of the EPA's
preliminary work plans for the following chemicals: Ametoctradin,
Fenpyrazamine, Picoxystrobin, and Trichoderma species. With this
document, the EPA is opening the public comment period for registration
review for these chemicals.

DATES: Comments must be received on or before September 12, 2022.

ADDRESSES: Submit your comments, to the docket identification (ID)
number for the specific pesticide of interest provided in the Table in
Unit IV., through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Additional instructions on
commenting and visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: The Chemical Review Manager for the pesticide of interest
identified in Table 1 in Unit IV.
    For general questions on the registration review program, contact:
Melanie Biscoe, Pesticide Re-Evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager identified in Table 1 in Unit IV.

B. What should I consider as I prepare my comments for the EPA?

    1. Submitting CBI. Do not submit this information to the EPA
through regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Background

    Registration review is the EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. Registration review dockets contain
information that will assist the public in understanding the types of
information and issues that the Agency may consider during the course
of registration reviews. As part of the registration review process,
the Agency has completed preliminary workplans for all pesticides
listed in Table 1 in Unit IV. Through this program, the EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.

III. Authority

    The EPA is conducting its registration review of the chemicals
listed in Table 1 in Unit IV. pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
FIFRA section 3(g) provides, among other things, that the registrations
of pesticides are to be reviewed every 15 years. Under FIFRA, 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) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread
and commonly recognized practice, the pesticide product must perform
its intended function without unreasonable adverse effects on the
environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. Registration Reviews

A. What action is the Agency taking?

    A pesticide's registration review begins when the Agency
establishes a docket for the pesticide's registration review case and
opens the docket for public review and comment. Pursuant to 40 CFR
155.50, this notice announces the availability of the EPA's preliminary
work plans for the pesticides shown in

Table 1 and opens a 60-day public comment period on the work plans.

                     Table 1--Preliminary Work Plans Being Made Available for Public Comment
----------------------------------------------------------------------------------------------------------------
                                                                                Chemical review manager
 Registration review case name and No.                   Docket ID No.                  and contact information
----------------------------------------------------------------------------------------------------------------
Ametoctradin Case Number 7066..........  EPA-HQ-OPP-2021-0647                          Quinn Gavin,
                                                                                [email protected],
<PHONE_NUMBER>.
Fenpyrazamine Case Number 7459.........  EPA-HQ-OPP-2022-0454                          Michelle Nolan,
                                                                                [email protected],
<PHONE_NUMBER>.
Picoxystrobin Case Number 7283.........  EPA-HQ-OPP-2022-0489                          Samantha Thomas,
                                                                                [email protected],
<PHONE_NUMBER>.
Trichoderma species Case Number 6050...  EPA-HQ-OPP-2021-0765                          Susanne Cerrelli,
                                                                                [email protected]
                                                                                ,<PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

B. What is in the docket?

    The registration review docket contains information 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:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
    Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
    The registration review procedural rule at 40 CFR 155.50(b)
provides for a minimum 60-day public comment period on all preliminary
registration review work plans. This comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary changes to a pesticide's workplan. All comments should be
submitted using the methods in ADDRESSES and must be received by the
EPA on or before the closing date. These comments will become part of
the docket for the pesticides included in Table 1 in Unit IV. Comments
received after the close of the comment period will be marked ``late.''
The EPA is not required to consider these late comments.
    The Agency will carefully consider all comments received by the
closing date and may provide a ``Response to Comments Memorandum'' in
the docket. The final registration review work plan will explain the
effect that any comments had on the final work plan and provide the
Agency's response to significant comments.
    Background on the registration review program is provided at:
https://www.epa.gov/pesticide-reevaluation.
    Authority: 7 U.S.C. 136 et seq.

    Dated: July 6, 2022.
Mary Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2022-14826 Filed 7-11-22; 8:45 am]
BILLING CODE 6560-50-P


178,436 x 0.01 = 1,784 SQGs) will determine that a contaminated soil
subject to LDRs no longer contains a listed hazardous waste or exhibits
a characteristic of hazardous waste and therefore, comply with 40 CFR
268.7(e).  These 1,937 generators (i.e., 153 + 1,784 = 1,937) are
expected to prepare and maintain documentation of these determinations,
including all supporting documentation.

(g)	Special Rules for Characteristic Wastes

EPA queried RCRAInfo to estimate that 1,494 generators (i.e., LQGs) are
treating their hazardous waste on site in 90-day units.  Based on
industry consultations, EPA estimates that, each year, 10 percent of
these LQGs (i.e., 1,494 x 0.10 = 149 LQGs) will de-characterize their
waste and prepare, submit, and maintain an initial notification and
certification under section 268.9(d).  On the other hand, industry
representatives contacted by the Agency believe that treatment
facilities generally have been in existence for some time and have
already submitted their initial notification and certification.  Hence,
this ICR assumes no treatment facilities will submit an initial notice
and certification under this requirement during the period covered by
this ICR.  In total, EPA estimates that, each year, a total of 149
facilities (i.e., 149 LQGs + 0 treatment facilities = 149 facilities)
will prepare, submit, and maintain initial one-time notifications and
certifications.

Based on industry consultations, EPA estimates that, each year, 10
percent of LQGs treating waste on site in 90-day units (i.e., 1,494 x
0.10 = 149 LQGs) and 10 percent of treatment facilities (i.e., 1,536 x
0.10 = 154 treatment facilities) will need to update their notification
and certifications because of a change in the waste or the receiving
facility.  In total, EPA estimates that, each year, a total of 303
facilities (i.e., 149 LQGs + 154 treatment facilities = 303 facilities)
will prepare, submit, and maintain updated notifications.

(4)	Demonstration for Alternative Treatment Technology (Exhibit 4A & 4B)

Based on its best judgment, EPA estimates that, each year, four
facilities will seek a variance from a specified treatment method.
These facilities are expected to read the regulations at 40 CFR 268.42.
In addition, these facilities are expected to prepare and submit a
demonstration and any other information requested by EPA.

(5)	Demonstration for a Variance from a Treatment Standard (Exhibit 5A
& 5B)

(a)	Reading the Regulations

Based on its best judgment, EPA estimates that, each year, ten
facilities will seek a variance from a treatment standard.  These
facilities are expected to read the regulations at 40 CFR 268.44.

(b)	Demonstration for a Variance from a Treatment Standard

Demonstration for a Variance (Section 268.44(a)-(d))

EPA estimates that seven facilities will seek a variance from a
treatment standard, as provided under section 268.44(a)-(d).  These
seven facilities are expected to develop and submit a demonstration and
any other information requested by EPA.

Demonstration for a Site-Specific Variance (Section 268.44(h)-(m))

EPA estimates that three facilities will seek a site-specific variance
from a treatment standard, as provided under section 268.44(h)-(m).
These three facilities are expected to develop and submit a
demonstration and any other information requested by EPA.

(6)	Recordkeeping for Storage Prohibition (Exhibit 6A & 6B)

(a)	Reading the Regulations

Based on RCRAInfo, EPA estimates that there are 1,395 TSDFs in
operation.  Based on its best judgment, EPA estimates that, each year,
10 percent of these facilities (i.e, 1,395 x 0.10 = 140 TSDFs) will
store restricted hazardous wastes under 40 CFR 268.50.  These facilities
are expected to read the regulations at section 268.50.

(b)	Recordkeeping for Storage Prohibition

EPA expects that the 140 TSDFs will develop and keep records of the
contents of storage units, quantity of each hazardous waste received,
and the date that accumulation begins for each tank and container, as
applicable.  EPA estimates that each of these 140 TSDFs will perform
these tasks four times per year, or 560 times (i.e., 140 x 4 = 560).

	6(e)	Bottom Line Burden Hours and Costs

	Exhibits 8A and 8B show the aggregate annual burden and cost to both
private and State respondents for all information collection
requirements covered in this ICR. Table 2 below summarizes the annual
hour and cost burden, which can be found in these two exhibits, as well
as the number of respondents, which can be found in Table 1 above.
Exhibit 9 shows the aggregate annual burden and cost to the Federal
government for all information collection requirements covered in this
ICR. The bottom line hourly burden for the Federal government is 5,610
hours.  The bottom line cost burden for the Federal government is
$180,016 per year.

Table 2

Bottom Line Annual Hour and Cost Burden

	Number of Respondents	Total Annual Hour Burden	Total Annual Labor Cost
Total Annual Capital/Startup Costs	Total Annual O&M Costs	Total Annual
Cost

Private

188,181

1,121,176

$41,690,382

$49,079

$85,299,678

$127,039,139

State

7,529

45,161

$1,441,442

$1,867

$3,431,338

$4,874,647

Total

195,710

1,166,337

$43,131,824

$50,946

$88,731,016

$131,913,786

6(f)	Reasons for Change in Burden

	The total annual hour burden in this ICR increased by 343,343 hours,
from 822,994hours to 1,166,337 hours.  The total cost of this ICR
increased by approximately $21,374,742, from $110,539,044 to
$131,913,786.  This increase is due to the increase in the number of
respondents, from 129,584 to 195,710.  Particularly, the number of small
quantity generators increased because a better method for counting them
was used this time.  The number of land disposal facilities also
increased from 131, which came from the 2001 BRS estimate, to 464, which
came from the 2005 BRS estimate from RCRAInfo.  Consultations with
industry confirmed that the number of land disposal facilities has
increased over the last 4 to 5 years.

6(g)	Burden Statement

The annual reporting burden for this ICR is roughly 85.3 hours per
response.  The annual recordkeeping burden for this ICR is roughly 5.96
hours per response.

Burden means the total time, effort, and financial resources expended by
persons to generate, maintain, retain, disclose, or provide information
to or for a federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA’s regulations are listed in 40 CFR
Part 9 and 48 CFR Chapter 15.

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-RCRA-2007-0022, which is available for online viewing at
www.regulations.gov, or in person viewing at the RCRA Docket in the EPA
Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW,
Washington, DC.  The EPA/DC Public Reading Room is open from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for RCRA Docket is<PHONE_NUMBER>.

Use www.regulations.gov to obtain a copy of the draft collection of
information, submit or view public comments, access the index listing of
the contents of the 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 in this
document.

   Note that 40 CFR 268.7(d) references the provisions of 40 CFR
261.3(e).  However, section 268.7(d) should reference section 261.3(f),
rather than section 261.3(e).

   Based on an OMB-approved discount rate of seven percent (OMB
Circular A-94) and a required three-year retention period for LDR
records.

   Based on the supporting statement entitled, “Modifications of the
Hazardous Waste Manifest System,” EPA ICR Number 801.

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