[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Notices]
[Pages 37000-37003]
[FR Doc No: 2019-16011]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2019-0004-N-11]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, this notice announces that FRA is forwarding
the Information Collection Requests (ICRs) abstracted below to the
Office of Management and Budget (OMB) for review and comment. The ICRs
describe the information collections and their expected burden. On May
30, 2019, FRA published a notice providing a 60-day period for public
comment on the ICRs.

DATES: Interested persons are invited to submit comments on or before
August 29, 2019.

ADDRESSES: Submit written comments on the ICRs to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW, Washington, DC 20503, Attention: FRA Desk Officer.
Comments may also be sent via email to OMB at the following address:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Information
Collection Clearance Officer, Office of Railroad Safety, Regulatory
Analysis Division, Federal Railroad Administration, 1200 New Jersey
Avenue SE, Room W33-497, Washington, DC 20590 (telephone: (202) 493-
6292); or Ms. Kim Toone, Information Collection Clearance Officer,
Office of Information Technology, Federal Railroad Administration, 1200
New Jersey Avenue SE, Room W34-212, Washington, DC 20590 (telephone:
(202) 493-6132).

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. On May 30, 2019, FRA
published a 60-day notice in the Federal Register soliciting comment on
the ICRs for which it is now seeking OMB approval. See 84 FR 25110. FRA

received no comments in response to this notice.
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30-days' notice for public comment.
Federal law requires OMB to approve or disapprove paperwork packages
between 30 and 60 days after the 30-day notice is published. 44 U.S.C.
3507(b)-(c); 5 CFR 1320.12(d); see also 60 FR 44978, 44983, Aug. 29,
1995. OMB believes the 30-day notice informs the regulated community to
file relevant comments and affords the agency adequate time to digest
public comments before it renders a decision. 60 FR 44983, Aug. 29,
1995. Therefore, respondents should submit their respective comments to
OMB within 30 days of publication to best ensure having their full
effect.
    Comments are invited on the following ICRs regarding: (1) Whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summaries below describe the ICRs that FRA will submit for OMB
clearance as the PRA requires:

    Title: Designation of Qualified Persons.
    OMB Control Number: 2130-0511.
    Abstract: The collection of information is used to prevent the
unsafe movement of defective freight cars. Railroads are required to
inspect freight cars for compliance and to determine restrictions on
the movements of defective cars; qualified inspectors are necessary to
perform this task.
    Type of Request: Extension without change of a currently approved
collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Respondent Universe: 692 Railroads.
    Frequency of Submission: On occasion.
    Total Estimated Annual Responses: 1,200.
    Total Estimated Annual Burden: 40 hours.
    Total Estimated Annual Dollar Cost Equivalent: $3,080.

    Title: Qualification and Certification of Locomotive Engineers.
    OMB Control Number: 2130-0533.
    Abstract: Section 4 of the Rail Safety Improvement Act of 1988
(RSIA), Public Law 100-342, 102 Stat. 624 (June 22, 1988), later
amended and re-codified by Public Law 103-272, 108 Stat. 874 (July 5,
1994), required FRA to issue regulations to establish any necessary
program for certifying or licensing locomotive engineers. The
collection of information is used by FRA to ensure that railroads
employ and properly train qualified individuals as locomotive engineers
and designated supervisors of locomotive engineers. The collection of
information is also used by FRA to verify that railroads have
established required certification programs for locomotive engineers
and that these programs fully conform to the standards specified in the
regulation.
    Type of Request: Extension with change (revised estimates) of a
currently approved collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Respondent Universe: 741 Railroads.
    Frequency of Submission: On occasion; annually; triennially.
    Reporting Burden: \1\
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    \1\ After an internal agency review, FRA updated the PRA
estimates.
    \2\ Throughout the tables in this document, the dollar
equivalent cost is derived from the Surface Transportation Board's
Full Year Wage A&B data series using the appropriate employee group
hourly wage rate that includes 75 percent overhead charges.

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                                                                                Total annual
          CFR section                  Respondent universe             Total annual responses         Average time per     Total annual     dollar cost
                                                                                response         burden hours   equivalent \2\
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240.9--Waivers................  741 railroads...................  2 waiver petitions..............  1 hour..............               2            $152
240.101/103--Cert. Prog:        741 railroads...................  25 amendments...................  5 minutes...........               2             152
 Amendments.
    --Cert. Prog.--New........  5 railroads.....................  5 programs......................  1 hour..............               5             380
    --Final Review............  5 railroads.....................  5 reviews.......................  1 hour..............               5             385
    --Material Modification to  741 railroads...................  10 modified programs............  10 minutes..........               2             152
     Program.
240.105(b)-(c) Written Reports/ 10 railroads....................  10 reports......................  30 minutes..........               5             575
 Determinations of DSLE
 Performance Skills.
240.109/App. C--Prior Safety    17,667 candidates...............  25 responses....................  5 minutes...........               2             116
 Conduct Data.
240.111/App C--Driver's         17,667 candidates...............  17,667 requests.................  10 minutes..........           2,945         223,820
 License Data.
    --NDR Match--notifications  741 railroads...................  177 notices + 177 requests......  5 min. + 5 min......              30           2,010
     and requests for data.
    --Written response from     741 railroads...................  20 cases/comments...............  10 minutes..........               3             174
     candidate on driver's
     license data.
240.111(g)--Notice to RR of     53,000 candidates...............  4 letters.......................  5 minutes...........              .3              19
 Absence of License.
240.111(h)--Duty to furnish     741 railroads...................  100 communications..............  5 minutes...........               8             464
 data on prior safety conduct
 as motor vehicle op.
240.113--Notice to RR           17,667 candidates...............  353 requests + 353 responses....  5 min. + 5 min......              59           4,130
 Furnishing Data on Prior
 Safety Conduct--Diff. RR.
240.119--Self-referral to EAP   53,000 locomotive engineers.....  150 self-referrals..............  5 minutes...........              13             754
 re: Active substance abuse
 disorder.
240.121--Criteria--Vision/      5 railroads.....................  5 copies........................  5 minutes...........              .4              32
 Hearing Acuity Data--New
 Railroads.
240.121--Criteria--Vision/      741 railroads...................  5 reports.......................  5 minutes...........              .4              32
 Hearing Acuity Data--Cond.
 Certification.
240.121--Criteria--Vision/      741 railroads...................  10 notifications................  15 minutes..........               3             174
 Hearing Acuity Data--Not
 Meeting Standards--Notice by
 Employee.
240.201/221--List of Qualified  741 railroads...................  741 updates.....................  5 minutes...........              62           4,712
 DSLEs.
240.201/221--List of Qualified  741 railroads...................  741 updated lists...............  5 minutes...........              62           4,712
 Loco. Engineers.
240.201/223/301--Loco.          53,000 candidates...............  17,667 certificates.............  5 minutes...........           1,472         111,872
 Engineers Certificate.
    --False entry on            N/A.............................  N/A.............................  N/A.................             N/A             N/A
     certificates.
240.207--Medical certificate    53,000 candidates...............  17,667 certificates.............  30 minutes..........           8,834       1,015,910
 showing hearing/vision         741 railroads...................  30 determinations...............  5 minutes...........               3             345
 standards are met: Written
 determinations waiving use of
 corrective device.
240.219--Denial of              17,667 candidates...............  30 letters + 30 responses.......  30 minutes..........              30           2,280
 Certification.

240.227--Canadian               N/A.............................  N/A.............................  N/A.................             N/A             N/A
 Certification Data.
240.229--Joint Operations--     321 railroads...................  184 employee calls..............  5 minutes...........              15             870
 Notice--not qualified.
240.309--RR Oversight Resp.:    15 railroads....................  6 annotations...................  15 minutes..........               2             116
 Detected poor safety conduct--
 annotation.
Recordkeeping: 240.205--Data    741 railroads...................  177 records.....................  5 minutes...........              15           1,725
 to EAP Counselor.
240.209/213--Written Tests      53,000 candidates...............  17,667 test records.............  1 minutes...........             294          22,334
 Records.
240.211/213--Performance Test   53,000 candidates...............  17,667 test records.............  1 minutes...........             294          22,334
 Records.
240.215--Retaining info.        741 railroads...................  17,667 records..................  5 minutes...........           1,472         111,872
 supporting determination.
240.303--Annual operational     53,000 candidates...............  53,000 test records.............  1 minutes...........             883          67,108
 monitor observation records.
240.303--Annual operating       53,000 candidates...............  53,000 test records.............  1 minutes...........             883          67,108
 rules compliance test records.
240.305--Engineer's notice of   53,000 engineers or candidates..  100 notifications...............  5 minutes...........               8             464
 non-qualification to RR.
    --Relaying certification    1,060 engineers.................  2 letters.......................  15 minutes..........          1 hour              58
     denial or revocation
     Status to other
     certifying railroad.
240.307--Notice to engineer of  741 railroads...................  1,100 letters...................  1 hour..............           1,100          73,700
 disqualification.
240.309--Railroad annual        51 railroads....................  51 reviews......................  3...................             153          11,628
 review.
                               -------------------------------------------------------------------------------------------------------------------------
    Total.....................  741 railroads...................  217,059 responses...............  N/A.................          18,668       1,752,700
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    Total Estimated Annual Responses: 216,630.
    Total Estimated Annual Burden: 18,668.
    Total Estimated Annual Dollar Cost Equivalent: $1,752,700.

    Title: Roadway Worker Protection.
    OMB Control Number: 2130-0539.
    Abstract: On June 10, 2016, FRA amended its Roadway Worker
Protection (RWP) regulation (see 81 FR 37840) to resolve interpretative
issues that had arisen since the original 1996 promulgation of that
rule. In particular, this final rule adopted certain terms, resolved
miscellaneous interpretive issues, codified certain FRA Technical
Bulletins, adopted new requirements governing redundant signal
protections and the movement of roadway maintenance machinery over
signalized non-controlled track, and amended certain qualification
requirements for roadway workers. This final rule also deleted three
outdated incorporations by reference of industry standards in FRA's
Bridge Worker Safety Standards, and cross referenced the Occupational
Safety and Health Administration's regulations on the same point.
    Under the information collection associated with the RWP rule (49
CFR part 214), FRA collects a variety of information. To ensure
compliance with the rule's requirements, FRA collects data on affected
railroads' on-track safety programs to determine that railroads have
policies, procedures, and practices in place that protect roadway
workers from dangers in their work environment. Railroads are required
to provide on-track safety manuals to all roadway workers that they can
readily consult to determine what on-track safety procedures are
required for their work assignment. Under the regulation, railroads are
required to provide initial and recurrent training to roadway workers
on their on-track safety program. This includes training for roadway
workers who work where on-track safety for adjacent controlled tracks
is required, and the appropriate practices and procedures they must
follow. FRA collects data from railroads on training through the
records that they are required to keep. Additionally, FRA collects
information on violations of workplace safety regulations on Form FRA F
6180.119. FRA uses violation information to support actions that will
reduce or eliminate hazards to railroad workers. Specifically, FRA uses
the information that it collects under this regulation to monitor and
enforce requirements relating to the safety of roadway workers and
ensure that railroads fulfill their responsibilities to keep roadway
workers secure and free from unnecessary and avoidable hazards.
    Type of Request: Extension with change (revised estimates) of a
currently approved collection.
    Affected Public: Businesses/50,000 Roadway Workers/State Safety
Inspectors.
    Form(s): FRA F 6180.119.
    Respondent Universe: 741 Railroads.
    Frequency of Submission: On occasion.
    Reporting Burden: \3\
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    \3\ After an internal agency review, FRA updated the PRA
estimates.

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                                                                                Total annual
          CFR section                  Respondent universe             Total annual responses         Average time  per    Total annual     dollar cost
                                                                                response         burden hours     equivalent
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Form FRA F 6180.119--Part 214   350 Safety Inspectors...........  129 forms.......................  4 hours.............             516         $29,412
 Railroad Workplace Safety
 Violation Report.
214.307--Railroad On-Track      741 Railroads...................  276 programs + 325 copies.......  2 hours + 2 minutes.             563          42,788
 Safety Programs--RR Programs
 that comply with this Part +
 copies at System/Division
 Headquarters.
    --RR Notification to FRA    741 Railroads...................  276 notices.....................  20 minutes..........              92           6,992
     not less than one month
     before on-track safety
     program takes effect.
    --RR Amended on-track       741 Railroads...................  1 program.......................  4 hours.............               4             304
     safety programs after FRA
     disapproval.
    --RR Written response in    741 Railroads...................  1 written response..............  20 hours............              20           1,520
     support of disapproved
     program.

214.309--On-Track Safety        741 Railroads...................  741 provisions..................  60 minutes..........             741          56,316
 Manual--RR Provisions for
 alternative access to
 information in on-track
 safety manual.
    --RR Publication of         60 Railroads....................  100 bulletins/notices...........  60 minutes..........             100           7,600
     bulletins/notices
     reflecting changes in on-
     track safety manual.
214.311--RR Written procedure   19 Railroads....................  5 developed procedures..........  2 hours.............              10             760
 to achieve prompt and
 equitable resolution of good
 faith employee challenges.
214.317--On-Track Safety        19 Railroads....................  5 operating procedures..........  2 hours.............              10             760
 Procedures, generally, for
 snow removal, and weed spray
 equipment, tunnel niche or
 clearing by.
214.318--Procedures             741 Railroads...................  19 rules/procedures.............  2 hours.............              38           2,888
 established by railroads for
 workers to perform duties
 incidental to those of
 inspecting, testing,
 servicing, or repairing
 rolling equipment.
214.320--Roadway Maintenance    741 Railroads...................  5 requests......................  4 hours.............              20           1,520
 Machines Movement over
 signalized non-controlled
 track--RR request to FRA for
 equivalent level of
 protection to that provided
 by limiting all train and
 locomotive movements to
 restricted speed.
214.322--Exclusive Track        3 Class I Railroads.............  1,000 written authorities.......  10 minutes..........             167           9,519
 Occupancy, Electronic
 Display--Written Authorities/
 Printed Authority Copy If
 Electronic Display Fails or
 Malfunctions.
214.329--Train Approach         741 Railroads...................  26,250 written designations.....  30 seconds..........             219          16,644
 Warning--Written Designation
 of Watchmen/Lookouts.
214.336--Procedures for         100 Railroads...................  10,000 notices..................  5 seconds...........              14             798
 adjacent track movements over
 25 mph: Notifications/
 watchmen/lookout warnings.
    --Procedures for adjacent   100 Railroads...................  3,000 notices...................  5 seconds...........               4             228
     track movements 25 mph or
     less: Notifications/
     watchmen/lookout warnings.
214.339--Audible warning from   19 Railroads....................  19 written procedures...........  4 hours.............              76           5,776
 trains: Written procedures
 that prescribe effective
 requirements for audible
 warning by horn and/or bell
 for trains.
214.343/345/347/349/351/353/    50,000 roadway workers..........  50,000 records..................  2 minutes...........           1,667         126,692
 355--Annual training for all
 roadway workers (RWs)--
 Records of training.
214.503--Notifications for Non- 50,000 roadway workers..........  125 notices.....................  10 minutes..........              21           1,197
 Compliant Roadway Maintenance
 Machines or Unsafe Condition.
    --Resolution Procedures...  19 railroads....................  5 procedures....................  2 hours.............              10             760
214.505--Required               741 Railroads/200 contractors...  500 lists.......................  1 hour..............             500          38,000
 environmental control and
 protection systems for new on-
 track roadway maintenance
 machines with enclosed cabs.
    --Designations/additions    692 Class III Railroads/200       150 additions/designations......  5 minutes...........              13             988
     to list.                    contractors.
214.507--A-Built Light Weight   692 Class III Railroads/200       1,000 stickers/stencils.........  5 minutes...........              83           4,731
 on New Roadway Maintenance      contractors.
 Machines.
214.511--Required Audible       692 Class III Railroads/200       3,700 identified mechanisms.....  5 minutes...........             308          17,556
 Warning Devices for New On-     contractors.
 Track Roadway Maintenance
 Machines.
214.515--Overhead covers for    692 Class III Railroads/200       500 requests + 500 responses....  10 mins + 20 mins...             250          17,423
 existing on-track roadway       contractors.
 maintenance machines.
214.517--Retrofitting of        692 Class III Railroads/200       500 stencils/displays...........  5 minutes...........              42           2,394
 Existing On-Track Roadway       contractors.
 Maintenance Machines
 Manufactured On or After Jan.
 1, 1991.
214.523--Hi-Rail Vehicles.....  692 Class III Railroads/200       5,000 records...................  5 minutes...........             417          23,769
                                 contractors.
    --Non-complying conditions  692 Class III Railroads/200       500 tags + 500 reports..........  10 minutes + 15                  208          11,856
                                 contractors.                                                        minutes.
214.527--Inspection for         692 Class III Railroads/200       550 tags + 550 reports..........  5 minutes + 15                   183          10,431
 compliance; Repair schedules.   contractors.                                                        minutes.
214.533--Schedule of repairs;   692 Class III Railroads/200       250 records.....................  15 minutes..........              63           4,788
 Subject to availability of      contractors.
 parts.
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    Total.....................  741 railroads...................  106,482 responses...............  N/A.................           6,359         444,410
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    Total Estimated Annual Responses: 106,482.
    Total Estimated Annual Burden: 6,359 hours.
    Total Estimated Annual Dollar Cost Equivalent: $444,410.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Acting Chief Counsel.
[FR Doc. 2019-16011 Filed 7-29-19; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Proposed Rules]
[Pages 36480-36482]
[FR Doc No: 2011-15645]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 262

[EPA-HQ-RCRA-2001-0032; FRL-9321-7]

Hazardous Waste Manifest Printing Specifications Correction Rule

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing a minor
change to the Resource Conservation and Recovery Act (RCRA) hazardous
waste manifest regulations that affects those entities that print the
hazardous waste manifest form in accordance with EPA's specifications.
Specifically, this action proposes to amend the current printing
specification regulation to indicate that red ink, as well as other
distinct colors, or other methods to distinguish the copy distribution
notations from the rest of the printed form and data entries are
permissible. This proposed change would afford authorized manifest form
printers

greater flexibility in complying with the Federal hazardous waste
manifest printing specifications.

DATES: Written comments must be received by July 22, 2011.

ADDRESSES: Submit your comments identified by Docket ID No. EPA-HQ-
RCRA-2001-0032 by one of the following methods:
     http://www.regulations.gov: follow the on-line
instructions for submitting comments.
     E-mail: RCRA<EMAIL_ADDRESS>and<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-RCRA-2001-0032.
     Fax:<PHONE_NUMBER>. Attention Docket ID No. EPA-HQ-RCRA-
2001-0032.
     Mail: RCRA Docket (28221T), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Attention
Docket ID No. EPA-HQ-RCRA-2001-0032. Please include a total of two
copies of your comments.
     Hand Delivery: Please deliver two copies to the EPA Docket
Center, EPA West Building, Room 3334, 1301 Connecticut Ave., NW.,
Washington, DC. Such deliveries are only accepted during the Docket's
normal hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2001-0032. EPA's policy is that all comments received will be included
in the public docket without change and be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are within the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the HQ-Docket Center,
Docket ID No. EPA-HQ-RCRA-2001-0032, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The 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 Public Reading Room is (202)
566-1744, and the telephone number for the RCRA Docket is (202) 566-
0270. A reasonable fee may be charged for copying docket materials.

FOR FURTHER INFORMATION CONTACT: For more information on this
rulemaking, contact Bryan Groce or Richard LaShier, U.S. Environmental
Protection Agency, Office of Resource Conservation and Recovery (MC:
5304P), 1200 Pennsylvania Ave., NW., Washington, DC 20460; Phone for
Bryan Groce:<PHONE_NUMBER>, Phone for Richard LaShier: (703) 308-
8796; or e-mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Why is EPA issuing this proposed rule?

    EPA is proposing a minor amendment that would change the Federal
printing specifications applicable to those entities that print the
hazardous waste manifest form. This proposed rule would change only the
printing specification in 40 CFR 262.21(f)(4) that currently requires
that certain copy distribution notations appearing in the margins of
the form must be printed only in red ink. In the ``Rules and
Regulations'' section of this Federal Register, EPA is making this
change as a Direct Final rule without a prior proposed rule, because we
view this as a non-controversial action and anticipate no adverse
comment. We have explained our reasons for this proposed action in the
preamble to the Direct Final rule. If we receive no adverse comment on
this minor change we are publishing today, we will not take further
action on this proposed rule. If, however, we receive adverse comment,
we will publish a timely withdrawal in the Federal Register to notify
the public that the regulatory amendment in the Direct Final rule will
not take effect, and the reasons for such a withdrawal. If the Direct
Final rule in the Rules and Regulations section of this Federal
Register is withdrawn, all comments will be addressed in a subsequent
final action on the proposed rule. We do not intend to institute a
second comment period on this action. Any parties interested in
commenting must do so at this time.
    The regulatory text for this proposal is identical to that for the
Direct Final rule published in the Rules and Regulations section of
this Federal Register. For further information, please see the
information provided in the ADDRESSES section of this Federal Register.

II. Does this action apply to me?

    Entities potentially affected by this action are the hazardous
waste manifest printers subject to 40 CFR 262.21(f) of the RCRA
hazardous waste regulations. States are not affected by the changes to
the printing specifications unless they should opt to print manifests.
No states are currently printing these forms.

III. Statutory and Executive Order Reviews

    For a complete discussion of all the administrative requirements
applicable to this action, see the discussion in the ``Statutory and
Executive Order Reviews'' section to the preamble for the Direct Final
rule that is published in the Rules and Regulations section of this
Federal Register.

A. Regulatory Flexibility Act.

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, a small entity is defined as: (1) A small business as defined
by the Small Business

Administration's (SBA) regulations at 13 CFR 121.201; (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of today's Direct Final rule
on small entities, I certify that this proposed rule will not have a
significant economic impact on a substantial number of small entities.
This action proposes only a minor change to the manifest printing
specifications, and the effect of this proposed change would make it
easier for printers to comply with the manifest printing specification
by providing additional options. Therefore, this proposed rule would
not impose any new burden or costs on printers or users of the
manifest, including printers and users who are small entities as
defined by the RFA. Since the rule would not have any significant
adverse economic impact on small entities, the RFA does not require EPA
to perform a regulatory flexibility analysis.

List of Subjects in 40 CFR Part 262

    Environmental protection, Exports, Hazardous materials
transportation, Hazardous waste, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.

    Dated: June 15, 2011.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste & Emergency Response.
[FR Doc. 2011-15645 Filed 6-21-11; 8:45 am]
BILLING CODE 6560-50-P


OECD HPV FORM Summary of Responses to the OECD Request for Available Data on HVP Chemicals 0. General Information Name of Sponsor country United States of America Contact point ( name, address, telephone and telefax)

Name of Lead organisation 1. Chemical Identity * 1.1 CAS number 123 38 6 * 1.2 Name ( give the name supplied by the OECD)

Propionaldehyde 1.3 Common Synonyms Propanal Propylaldehyde Propyl Aldehyde Methylacetaldehyde Propionic Aldehyde Propyic Aldehyde UN 1275 OHS19740 1.4 Empirical formula C3H6O O * 1.5 Structural formula CH3 CH2 CH 1.6 Purity of industrial product 1.6.1 Degree of purity ( percentage by weight/ volume)

1.6.2 Identify of major impurities 1.6.3 Essential additives ( stabilizing agents, inhibitors, other additives), if applicable 2 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 2 . Physical Chemical Data * 2.1 Melting or Decomposition Point  80o Centigrade Method ( e. g. OECD, other):

GLP: YES [ ] NO [ X]

Comments: Freezing point Reference: Union Carbide Chemicals and Plastics Co. Solvents & Coatings Materials Division Material Safety Data Sheet 2.2 Boiling Point ( including temperature of decomposition, if relevant).

48oC at 760 mm Hg kPa Method ( e. g., OECD, other):

GLP: Yes [ ] No [ X]

Comments:

Reference: Union Carbide Chemicals and Plastics Co. Solvents & Coatings Materials Division Material Safety Data Sheet * 2.3 Vapour pressure 258 mm Hg at 20oC k p a at 25oC ( calculated) 3 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Method ( e. g. OECD, other):

GLP YES [ ] NO [ X] Comments:

Reference: Union Carbide Chemicals and Plastics Co. Solvents & Coatings Materials Division Material Safety Data Sheet 2.4 Partition coefficient n Octanol/ water log Pow = 0.83 at 23oC Method: calculated [ X]  measured [ ]

GLP: YES [ ] NO [ X]

Analytical Method:

Comments ( e. g., is the compound surface active or dissociative?):

Reference: Verschuern, K. ( 1983) Handbook of Environmental Data on Organic Chemicals, 2nd Ed., Van Nostrand Reinhold, NY.

* 2.5 Water solubility 22% at 20oC Method ( e. g., OECD, others):

GLP: YES [ ] NO [ X]

Analytical Method:

Comments ( e. g., the detection limit for insoluble substances): 4 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Reference: Union Carbide Chemicals and Plastics Co. Solvents & Coatings Materials Division Material Safety Data Sheet 2.6 Flash point ( liquids)

< 18oC closed cup [ X]; < 18oC open cup [ X]

Method ( e. g., OECD, other including reference to the standard used): Tag GLP: YES [ ] NO [ X]

Comments:

Reference: Union Carbide Chemicals and Plastics Co. Solvents & Coatings Materials Division Material Safety Data Sheet 2.7 Flammability ( solid/ gases)

Method ( e. g., OECD, others):

GLP: YES [ ] NO [ X]

Test results: Lower Flammable Limit Air 2.6% Upper Flammable Limit Air 17.0%

Comments:

Reference: Union Carbide Chemicals and Plastics Co. Solvents & Coatings Materials Division Material Safety Data Sheet 2.8 pH in water 5 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 pH 7.5 at 85 mg/ l ( water) pKa Method ( e. g., OECD, other):

GLP: YES [ ] NO [ X]

Comments: Initial pH in Fathead Minnow acute toxicity study References: Waggy, G. T. and J. R. Payne ( 1974) " Environmental Impact Analysis  Acute Aquatic Toxicity Testing". Project Report 910F44, Union Carbide Corporation, South Charleston Technical Center, South Charleston, WV.

2.9 Other data e. g., relative density, surface tension ( of aquous solution), fat solubility, explosivity, oxidising properties and particle size distribution Comments: Henrys Law Constant H= 3.32 atms/ mole fraction ( Calculated)

References: Fed. Reg. 59: 78 April 2nd, February, 1994., p19610 3. Source of Exposure * 3.1 Production levels expressed as tonnes per annum 150 to 175. The estimated annual production of propionaldehyde in the United States is in the order of 275 million pounds. Worldwide, it is estimated that 405 million pounds of this aldehyde are produced annually.

Information on production levels should be provided in ranges ( e. g., 100 1000 tonnes, ect.) per responder or country and the date for which those ranges apply should be given.

3.2 Processes See attached Figure 1 Describe sources of potential human or environmental exposure including workplace concentrations and emission data ( in % release), if available, for both manufacturing and user areas. 6 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Typically, propionaldehyde is manufactured by the catalytic hydroformylation of ethylene with carbon monoxide and hydrogen ( Oxo Process). The reaction is carried out under high pressure in closed systems. Crude propionaldehyde is stripped of dissolved gasses and heavy residuals by gas stripping in pressured columns and stored for downstream derivatives production. Characteristically, propionaldehyde production units are designed to vent possible emissions from reactors, columns and storage tanks to the plant fuel system. In addition other steps are taken to reduce emissions. Union Carbide, for instance, operates their " Oxo" unit under the " New Source Performance Standards ( NSPS)" rule which requires fugitive emissions monitoring of all size valves on a quarterly basis and all pumps and compressors on a monthly basis. In Figure 1 a block diagram of a typical manufacturing unit is shown.

Propionaldehyde is stored in pressured tanks or tanks equipped with internal floating roofs in order to minimize losses by evaporation. Field storage tanks are either pressure storage tanks or blanketed with nitrogen over floating roofs. Propionaldehyde inventories are purposely maintained at the lowest workable level to insure quality is maintained. Processes which use propionaldehyde as a reactive intermediate are conducted in closed manufacturing systems designed to prevent exposure of personnel to the aldehyde and other potential monomers. Figure 2 is a block diagram illustrating a typical manufacturing and distribution plan.

Distribution:

For internal plant uses, propionaldehyde typically is transported by pipeline. We are not aware of any manufacturing process in which this volatile aldehyde would be handled in open containers. Tank cars ( rail cars) and tank trucks are used for shipment to domestic customers. In loading these transport vehicles, vapor is collected from the closed tank, routed to a vent collection system and incinerated.

Fugitive Emissions: 7 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 In the United States, for the year 1990, there were 18 facilities which reported environmental release information under provisions of the Super Fund Amendment Reauthorization Act ( SARA). These were facilities either which manufactured or processed 25,000 pounds or more, or used more than 10,000 pounds of propionaldehyde. The toxic release inventory indicates that these facilities collectively released 988,986 pounds of propionaldehyde into the air and 34,885 pounds to other segments of the environment. In 1992, TRI reports were received from 22 submitters which collectively released 689,640 pounds to the air and 63949 pounds to other segments of the environment representing a total decrease of   25%

Workplace Monitoring:

In typical propionaldehyde operations, monitoring is conducted to assure that worker exposure is maintained well within acceptable exposure limits. No formal exposure standards have been established for this aldehyde, however, personnel monitoring within the Union Carbide production facility indicate that the 8 hour time weighted average ( TWA) exposures are low. In the 17 year period between 1975 and 1992, a total of 73 personnel samples have been taken within the " Oxo" production unit. Of these, 62 (  85%) were below the detection limit of 0.01 ppm. The maximum TWA measured over this interval was 26 ppm and the geometric mean for all 73 TWA determinations was   0.2 ppm. In the same time frame 16 TWA determinations were made within the In Plant Distribution Department. Of these 8 ( 50%) were below the detection limit of 0.01 ppm. In one or two instances excursions in the range of 100 ppm were determined, but the geometric mean for all 16 samples was still in the range of 1 ppm. We believe that these low personnel exposures are typical of the industry as a whole. Considering the low concentrations of propionaldehyde measured within the production unit, air concentrations at the fence line and within the surrounding community must be extremely low.

In addition, area monitors are used in manufacturing areas to detect leaks and alert operating personnel to any unusual conditions which might result in episodic release of the aldehyde to the environment. Personnel protective equipment is maintained and available for immediate use in the event of unforeseen emergency situations. 8 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Reference:

* 3.3 Information concerning Uses ( including catagories and types of uses expressed in percentage terms Examples of use catagories are dyestuffs, intermediates, solvents, adhesives, building material agents, detergents, cleaning agents, fertilisers, plastic agents, surface treatment agents, etc. Types of uses are divided into three: industrial use ( open system and closed system), public use and export Of the total production volume, it is believed that greater than 99% is used as an internal plant chemical intermediate. The major uses of propionaldehyde is as a reactive intermediate in the manufacture of npropanol propionic acid, 2 methyl pentanol, trimethyolethane polyols, polyethylene additives, fragrance chemicals and fungicides. Propionaldehyde, being a reactive chemical intermediate, is not directly used in products reaching the consumer. Because of its reactive nature and volatility, residual concentration of propionaldehyde in consumer products is very low.

3.4 Options for disposal Mode of disposal ( e. g., incineration, release to sewage system) for each category and type of use, if appropriate; recycling possibility  Incineration in the event of a spill

3.5 Other remarks Reference:  None

4.0 Environmental Fate and Pathways 9 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Reporting of studies should give the test method, test conditions ( lab versus field studies), test results ( e. g., % degradation in specified time period) and reference. Information on breakdown products ( treatment and stable) should be provided when available.

4.1 Degradability ( biotic and abiotic) Photooxidation Test substance: Propionaldehyde In the case of poorly soluble chemicals, treatment given ( nature, concentration, ect.):

Test method ( e. g., OECD, ISO, others):

GLP YES [ ] NO [ X]

Test results: T1/ 2 in air = 5.8 hours Comments: Calculated Reference: Software " Atmospheric Oxidation Program" ( AOP) v. 1.43 developed by the Syracuse Research Corporation, an adaptation of the " Atkinson estimation methodology" for estimating hydroxyl radical and ozone reaction rates with organic compounds in air and based on the following two published references 1. Int. J. Chem. Kinet. 19: 799 828 ( 1987). 2. Env. Toxic Chem. 7: 435 42 ( 1988).

4.1.1 Biodegradability Test substance: Propionaldehyde Test type, aerobic [ ], anaerobic [ X] 10 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Test medium: water, water sediment, soil, sewage treatment Unacclimated domestic treatment plant water In the case of poorly soluble chemicals, treatment given ( nature, concentration, ect.):

Test method ( e. g., OECD, ISO, others):

GLP YES [ ] NO [ X]

Test results: BOD/ COD( theoritical) X100 = 70% ( 5 days); 83% ( 10 days); 80% ( 15 days); 95% ( 20 days)

Comments:

Reference: Waggy, G. T. and J. R. Payne ( 1974) " Environmental Impact Analysis  Product Biodegradability Testing". Project Report 910F44, Union Carbide Corporation, South Charleston Technical Center, South Charleston, WV.

4.1.2 Sewage Treatment Information on treatability of the substance  No data submitted 4.1.3 Stability in air ( e. g., photodegradability) and in water ( e. g., hydrolysis)

Test substance: Propionaldehyde Test method or estimation method ( e. g., OECD, others):

 No data submitted

4.1.4 Identification of main mode of degradability in actual use  No data submitted  11 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 4.2 Bioaccumulation Test substance: Propionaldehyde Test method ( e. g., OECD, other):  No data submitted

4.3 Transport and distribution between environmental compartments including estimate environmental concentrations and distribution pathways  No data submitted  4.4 Monitoring data ( environment)  No data submitted

5. Ecotoxicological Data 5.1 Toxicity to fish 5.1.1 Results of acute tests Test substance: Propionaldehyde Test species: 1) Poecilia reticulata ( Guppy) 2) Pimephales promelas ( Fathead Minnow)

Test method ( e. g., OECD, others):

1) o Type of test: static [ ], semi static [ X], flow through [ ] 2) o Type of test: static [ X], semi static [ ], flow through [ ] o Other ( e. g., field test) [ ]

GLP YES [ ] NO [ X]

Test results:

LC50 or EC50  values after 24, 48, 72 and 96 hours and method used to calculate these values 12 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 1) LC50 = 15 mg/ l ( 14 Day) [ log LC50 2.41 when LC50 in units of umoles/ liter]

2) LC50 = 85 mg/ l ( 24 hours); 16 mg/ l ( 48 hours); 14 mg/ l ( 96 hours).

Comments:

Reference: 1) Deneer, J. W., Seinen, W. and J. L. M. Hermens ( 1988) " The Acute Toxicity of Aldehydes to the Guppy". Aqu. Tox. 12: 185 192. 2) Waggy, G. T. and J. R. Payne ( 1974) " Environmental Impact Analysis  Acute Aquatic Toxicity Testing". Project Report 910F44, Union Carbide Corporation, South Charleston Technical Center, South Charleston, WV.

5.1.2 Results of long term tests e. g., prolonged toxicity, early life stage  No data submitted

Test substance: Propionaldehyde * 5.2 Toxicity to daphnids 5.2.1 Results of acute tests Test substance: Propionaldehyde Test species: Daphnia magna Test method ( e. g., OECD, others):

GLP YES [ X] 13 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 NO [ ]

Test results:

EC50  values after 24 and 48 hours, and method used to calculate these values 24 Hour EC50 = 200 mg/ l ( 95% Confidence interval 176 to 234 mg/ l) 48 Hour EC50 = 125 mg/ l ( 95% Confidence interval 106 to 147 mg/ l)

Comments:

Reference: Union Carbide Corporation, Union Carbide Technical Center, South Charleston , WV. Acute Toxicity of Propionaldehyde to Daphnia magna. Environmental Products Testing Study No. 920420002. Draft dated June, 1992.

5.2.2 Results of long term tests e. g., reproduction  No Data Submitted

Test substance: Propionaldehyde * 5.3 Toxicity to algae Test substance: Propionaldehyde Test species: Selenastrum capricornutum Test method ( e. g., OECD, others): 4 day old algal culture maintained in controlled temperature environmental chamber at pH 7.5 under static conditions. The cultures were maintained for 96 hours at propionaldehyde concentrations of 3.13, 6.25, 12.5, 25, 50, 100, 200 and 400 mg/ L.

GLP YES [ X] NO [ ]

Test results: 14 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 EC50 ( duration, e. g. 24, 48, 72 hours) 24 Hour EC50 = 290 mg/ L ( 95% confidence interval 210 to 480) 48 Hour EC50 = 133 mg/ L 72 Hour EC50 = 58 mg/ L ( 95% confidence interval 29 to 134) 96 Hour EC50 = 40 mg/ L ( 95% confidence interval 20 to 80)

Maximum concentration at which no effect was observed within the period of the test. 25 mg/ L  96 hour Minimum concentration at which no effect was observed within the period of the test.

Comments:

Reference:

Union Carbide Corporation, Union Carbide Technical Center, South Charleston , WV. Acute Toxicity of Propionaldehyde to Selenastrum capricornutum Environmental Products Testing Study No. 920420001. Draft dated June, 1992.

5.4 Toxicity to other aquatic organisms Test substance: Propionaldehyde Test species: Aedes aegypti larvae ( mosquito)

Test method ( e. g., OECD, others): o Type of test: static [ X], semi static [ ], flow through [ ] o Other ( e. g., field test) [ ]

GLP YES [ ] NO [ X]

Test results:

LC50 or EC50 values ( acute) LC50 = 0.25% ( w/ v) 15 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Maximum concentration at which no effect was observed within the period of the test ( prolonged test). Minimum concentration at which no effect was observed within the period of the test ( prolonged test)

Comments: No details given as to concentrations used.

Reference: Kramer, V. C., Schnell, D. J. and K. W. Nickerson ( 1983) " Relative Toxicity of Organic Solvents to Aedes aegypti Larvae". J. Invert. Path. 42: 285 287.

5.5 Toxicity to bacteria Test substance: Propionaldehyde Test species: Sewage Microorganisms Single species tests such as " Microtox Photobacterium luminescence test" and tests on overall processes such as nitrification or soil respiration are included in this item.

Test method ( e. g., OECD, others):

oType of test Median inhibition concentration ( IC50) when resulting turbidity is at 50% of the control after a6 hour incubation at 23oC [ ]. oOther ( e. g., field observation) [ ]

GLP YES [ ] NO [ X]

Test results: IC50 = 207 mg/ l Comments: 16 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Reference: Waggy, G. T. and R. L. Blessing ( 1987) " Environmental Impact Analysis  Acute Aquatic Toxicity Testing". File NO: 35269, Union Carbide Corporation, South Charleston Technical Center, South Charleston, WV.

* 5.6 Toxicity to terrestrial organisms 5.6.1 Toxicity to soil dwelling organisms  No data submitted

Test substance: Propionaldehyde 5.6.2 Toxicity to plants Test substance: Propionaldehyde Test species: Lactuca sativa ( Great Lakes Lettuce)

Test method ( e. g., OECD, others): Seed Germination GLP YES [ ] NO [ X]

Test results:

EC50 for 7 and 14 days or LC50 13.7 mM propionaldehyde solution produced 50% inhibition of germination.

Maximum concentration at which no effect was observed within the period of the test. Minimum concentration at which no effect was observed within the period of the test.

Comments:

Reference: Reynolds, T. ( 1977) " Comparative Effects of Aliphatic Compounds on Inhibition of Lettuce Fruit Germination". Ann. Bot. 41: 637 648. 17 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 5.6.3 Toxicity to birds  No data submitted

Test substance: Propionaldehyde 5.7 Biological Effects Monitoring ( including biomagnification)

 No data submitted

Studies on variation of predominant species in certain ecosystems and monitoring of biological effects ( e. g., thinning of eggshell) etc. are included.

Test substance: Propionaldehyde 5.8 Biotransformation and kinetics in environmental species  No data submitted

Under this item, studies on absorption, distribution, metabolism and excretion etc. should be given.

6.0 Toxicological Data ( oral, dermal and inhalation, as appropriate)

Where observation on humans are available, e. g., irritation, these should be entered in the appropriate " Comments" section.

* 6.1 Acute toxicity 6.1.1 Acute oral toxicity Test substance: Propionaldehyde Test species/ strain: 1) Male albino rats 2) Rat 3) Male & Female Sprague Dawley Test method ( e. g., OECD, EC, limit test): Gavage 1) GLP YES [ ] 2) GLP YES [ ] 3) GLP YES [ X] 18 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 NO [ X] NO [ X] NO [ ]

Test results: LD50 or other measure of acute toxicity ( e. g. in case of fixed dose test)

1) Oral LD50  1.41 g/ Kg ( 95% confidence interval of 0.96 to 2.98) 2) Oral LD50  0.8 to 1.6 g/ Kg 3) Oral LD50  Males 2g/ Kg killed 2 of 3; Females LD50 = 1.7 mg/ Kg ( 95% Confidence interval 1.4 to 2.0 g/ Kg)

Comments: 1) Administered as a 20% dispersion using a nonionic surfactant ( 1% TERGITOL " 7") as a dispersion agent. Five animals used per dosage group. 3) Administered as an aqueous dilution at a dosage volume of 1ml/ 100g body weight. Rats observed for 14 days after dose administration. Study conducted under EPA TSCA Health Effects Test Guidelines.

Reference: 1) Union Carbide Corporation, Mellon Institute of Industrial Research Report 14 24 dated February 16, 1951.

2) Brabec, M. J. ( 1981) " Chapter 37: Aldehydes and Acetals in Patty's Industrial Hygiene and Toxicology, 3rd revised edition. Vol. 2A., Clayton, G. D. and F. E. Clayton, Eds. John Wiley & Sons, New York. p. 2643.

3) Union Carbide Corporation, Bushy Run Research Center Report 92U1030, Draft dated June 3, 1992.

6.1.2 Acute inhalation toxicity 19 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Test substance: Propionaldehyde Test species/ strain: 1) Rats 2) Male mature rats 3) B6C3F1 & Swiss Webster mice 4) Fischer 344 rats Test method ( e. g., OECD, EC, limit test):

GLP YES [ ]

Test results:

LC50: 1) 26000 ppm ( 0.5 hours)

Comments:

2) Dynamically generated substantially saturated vapor killed 6 of 6 rats in 10 minutes, 2 of 6 rats in 5 minutes, and 0 of 5 in 2 minutes. Exposure to a measured concentration of 16000 ppm for 2.5 hours killed 6 of 6 rats, 8000 ppm killed 5 of 6 rats in 4 hours and 4000 ppm 0 of 6 rats in 4 hours.

3) The vapor concentration required to elicit a 50% decrease in respiratory rate ( RD50) of B6C3F1 mice was 2078 ppm ( 95% confidence interval 1803 to 2402), and in Swiss Webster mice was 2052 ppm ( 95% confidence interval 1625 to 3040).

4) The vapor concentration required to elicit a 50% decrease in respiratory rate ( RD50) of Fischer 344 rats was 6789 ppm ( 95% confidence interval 3903 to 15466 ppm).

Reference: 1) Brabec, M. J. ( 1981) " Chapter 37: Aldehydes and Acetals 20 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 in Patty's Industrial Hygiene and Toxicology, 3rd revised edition. Vol. 2A., Clayton, G. D. and F. E. Clayton, Eds. John Wiley & Sons, New York. p. 2643.

2) Union Carbide Corporation, Mellon Institute of Industrial Research Report 15 55 dated June 30, 1952.

3) Steinhagan, W. H. and C. S. Barrow ( 1984) Toxicol. Appl. Pharmacol. 72: 495 503.

4) Babiuk, C. Steinhagan, W. H. and C. S. Barrow ( 1985) Toxicol. Appl. Pharmacol. 79: 143 149.

6.1.3 Acute dermal toxicity Test substance: Propionaldehyde Test species/ strain: 1) New Zealand White Rabbits 2) Guinea Pig Test method ( e. g., OECD, limit test):

1) Application of undiluted test material for 24 hours to the skin under an occlusive dressing. 2) No details given 3) EPA TSCA Health Effects Test Guidelines 1) GLP YES [ ] 2) GLP YES [ ] 3) GLP YES [ X] NO [ X] NO [ X] NO [ ]

Test results:

LD50: 21 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 1) 5.0 ml/ Kg ( 95% confidence interval 3.4 to 7.5) 2) 10 to 20 g/ Kg 3) Males: 2.0 g/ Kg killed 1 of 3. Females: LD50 = 2.5 g/ Kg ( 95% Confidence interval 1.8 to 3.4 g/ Kg)

Comments: 1) Erythema and desquamation at the site of contact, pale and mottled livers and kidneys and congested lungs in victims. 3) 24 Hour occluded application of undiluted test material to clipped skin with a 14 day observation period after application.

Reference: 1) Union Carbide Corporation, Mellon Institute of Industrial Research Report 15 55 dated June 30, 1952.

2) Brabec, M. J. ( 1981) " Chapter 37: Aldehydes and Acetals in Patty's Industrial Hygiene and Toxicology, 3rd revised edition. Vol. 2A., Clayton, G. D. and F. E. Clayton, Eds. John Wiley & Sons, New York. p. 2643.

3) Union Carbide Corporation, Bushy Run Research Center Report 92U1030, Draft dated June 3, 1992.

6.2 Corrosiveness/ Irritation 6.2.1 Skin Irritation Test substance: Propionaldehyde Test species/ strain: 1) New Zealand White Rabbits 2) Guinea Pig 3) New Zealand White Rabbits Test method ( e. g., OECD, others):

1) 0.01 ml undiluted test substance applied to the uncovered clipped skin of the abdomen. 22 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 3) EPA TSCA Health Effects Test Guidelines. 4 Hour occluded application of o. 5 ml undiluted test material with 14 day observation period.

1) GLP YES [ ] 2) GLP YES [ ] 3) GLP YES [ X] NO [ X] NO [ X] NO [ ]

Test results: give maximum scores after ...... hrs 1) Marked erythema on 1 of 5 rabbits. 2) Severe irritation 3) Moderate to severe irritation with superficial necrosis. Irritation persisting on 4 of 6 rabbits at 14 days Comments:

1) Instillation of .02 ml of undiluted test material into the inferior conjunctival sac of rabbit eyes produced severe injury, 0.005 ml instilled in an identical manner produced moderate damage.

3) Instillation of 0.1 ml into the inferior conjunctival sac of rabbit eyes produced mild transient corneal injury, iritis with moderate to severe conjunctival irritation and resolution of injury in all eyes by 10 days. 0.01 Ml produced minor transient corneal injury, iritis and moderate to severe conjunctival injury with complete resolution in 7 days.

Reference: 1) Union Carbide Corporation, Mellon Institute of Industrial Research Report 15 55 dated June 30, 1952.

2) Brabec, M. J. ( 1981) " Chapter 37: Aldehydes and Acetals in Patty's Industrial Hygiene and Toxicology, 3rd revised edition. Vol. 2A., Clayton, G. D. and F. E. Clayton, Eds. John Wiley & Sons, New York. p. 2643. 23 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 3) Union Carbide Corporation, Bushy Run Research Center Report 92U1030, Draft dated June 3, 1992.

6.3 Skin sensitisation  No data submitted

Test substance: Propionaldehyde * 6.4 Repeated dose toxicity Test substance: Propionaldehyde Test species/ strain: 1) Alderley Park specific pathogen free rats 2) CD Male & Female Rats Test method ( e. g., OECD, others):

1) Propionaldehyde liquid injected at a known rate into a metered stream of air by means of a controlled, fluid free atomizer. 2) OECD Screening Information Data Set Combined Repeated Dose/ Reproductive Protocol 1) GLP YES [ ] 2) GLP YES [ X] NO [ X] NO [ ]

Test results:

1) Four males and 4 females which received six, 6 hour exposures to 1300 ppm did not gain weight. Histological examination of tissues at necropsy revealed liver cell vacuolation. Four males and 4 females which received 20, 6 hour exposures to 90 ppm demonstrated no toxic signs and organs were normal at necropsy.

2) Male and female rats ( 15 per exposure group) were exposed to propionaldehyde by inhalation at air concentrations of 0, 150, 750 or 1500 ppm. Exposures were conducted 6 hours per day, 7 days per week. Males received 52 consecutive daily exposures, while females were exposed for 2 weeks prior to mating, during a 14 day ( maximum) mating period and 24 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 through day 20 of gestation. No differences were observed between means of all three male exposure groups and controls with respect to body weight, body weight gain, clinical observations and food consumption. In females no exposure related clinical signs were noted, however, body weight gain and food consumption were significantly reduced in animals of this sex in the intermediate and high exposure groups during the first week of exposure and in the high exposure group during the first half of gestation. Food consumption was also slightly reduced in the females of the high and intermediate exposure groups either throughout, or during part of, gestation. Elevated erythrocyte count with accompanying increases in hemoglobin concentrations and hematocrit values and an increase in monocytes were noted in the males exposed to 1500 ppm. Kidney weights, as a percent of body weight were also slightly increased in males exposed to 1500 ppm. No exposure related increases in the incidence of gross lesions was apparent in either sex. The only exposure related finding upon microscopic examination of tissues was on the olfactory epithelium in the anterior 2 sections of the nasal cavities of both male and female rats. Vacuolization was primarily evident in the low and intermediate exposure groups with atrophy seen in the intermediate and high exposure groups. The injury appeared to be somewhat diminished in females possibly a result of a 6 day recovery period.

Dose or concentration at which no toxic effects were observed:

1) 90 ppm 2) No NOEL established for nasal lesions. 150 ppm for other manifestations of systemic toxicity Comments:

Reference:

1) Gage, J. C. ( 1970) Brit. J. Indust. Med. 27: 1 18. 2) Union Carbide Corporation, Bushy Run Research Center Report 91U0086 Draft dated June 17, 1992. 25 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 * 6.5 Genetic toxicity 6.5.1 Bacterial test Test substance: Propionaldehyde Test species/ strain: 1) S. typhinurium strains TA 100, TA 1535, TA 1537 & TA 98. 2) S. typhinurium strains TA 98, TA 100, TA 1535 & TA 1537 3) S. typhinurium strain TA 1535 4) S. typhinurium strain TA 98, TA 100 & TA 102 Test method ( e. g., OECD, others):

Bacterial Forward Gene Mutation Assay in Salmonella typhinurium ( Ames Test)

GLP YES [ ] NO [ X]

Test results:

Minimum concentration of test substance at which toxicity to bacteria was observed:

with metabolic activation: without metabolic activation:

Concentration of test compound resulting in precipitation:

Genotoxic effects: + ?  1) with metabolic activation: [ ] [ ] [ X] without metabolic activation: [ ] [ ] [ X] 26 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 + ?  2) with metabolic activation: [ ] [ ] [ X] without metabolic activation: [ ] [ ] [ X]

+ ?  3) with metabolic activation: [ ] [ ] [ X] without metabolic activation: [ ] [ ] [ X] + ?  4) with metabolic activation: [ ] [ ] [ X]

Comments:

1) Five concentrations used ranging between 100 and 10000 ug/ plate. Both rat liver S9 and Hamster liver S9 used for metabolic activation system 3) Six concentrations ranging between 0.01 and 2.5 umol/ plate.

4) No plate counts given. Tested at concentrations between 0.13 nmoles and 0.13 mmoles per plate.

Reference:

1) Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B. and E. Zeiger ( 1986) Environ. Mut. 8( suppl. 7): 1 119.

2) Florin, I., Rutberg, L., Curvall, M. and C. R. Enzell ( 1980) Toxicol. 18: 219 232.

3) Pool, B. L. and M. Wiessler ( 1981) Carcinogenesis 2( 10): 991 997.

4) Aeschbacher, H. U., Wolleb, U., Loliger, J., Spadone, J. C. and R. Liardon ( 1989) " Contribution oc Coffee Aroma Constituents to the Mutagenicity of Coffee". Fd. Chem. Toxic. 27: 227 232.

6.5.2 Non bacterial in vitro test 27 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Test substance: Propionaldehyde Type of cell used: 1) CHO V79 HGPrt locus and Na+/ K+ locus as resistance to Ouabain.

Test method ( e. g., OECD, others):

GLP YES [ ] NO [ X]

Test results:

Lowest Concentration producing cell toxicity:

with metabolic activation: without metabolic activation: Approximately 30 mM Genotoxic effects: + ?  with metabolic activation: [ ] [ ] [ ] without metabolic activation: [ X] [ ] [ ]

Comments: 1) Propionaldehyde induced a dose dependent increase in the mutation frequency either at the HGPrt locus, with thioguanine as the selective agent, or at the Na+/ K+ locus, with ouabain as the selective agent.

Reference: Brumbilla, G., Cajelli, E., Cunonero, R., Martelli, A. and A. M. Marinari ( 1989) " Mutagenicity in V79 Chinese Hamster Cells of n Alkanals Produced by Lipid Peroxidation" Mutagenesis 4: 277 279.

6.5.3 Non bacterial test in vivo Test substance: Propionaldehyde 28 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Test species/ strain: Male & Female Swiss Webster Mice Test method ( e. g., OECD, others):

Mouse Bone Marrow Micronucleus Test conducted in accordance with OECD Guidelines C( 81) 30( Final).

GLP YES [ X] NO [ ]

Test results:

Lowest dose producing toxicity: The IP LD50 for combined sexes was determined as 960 mg/ Kg body weight. Mice, 5 per sex per dose, received propionaldehyde by IP injection at either 0%, 25%, 50% or 80% of the LD50 ( 0, 240, 480 or 768 mg/ Kg). No significant increases in the incidences of micronucleated PCEs were observed at 240 and 480 mg/ Kg or in the 768 mg/ Kg females. Increases in the incidence of micronucleated PCEs were observed in males receiving 768 mg/ Kg at 24 and 48 hours, but not at 12 hours. There was no evidence that the increases in male mice were dose related and they were not considered biologically significant.

Effect on Mitotic Index or P/ N Ratio:

PCE/ NCE = 58% of Controls at 48 hours after injection in high dose females.

Genotoxic effects: + ?  [ ] [ ] [ X]

Comments:

Reference: 2) Union Carbide Corporation, Bushy Run Research Center Report 92U1011 Draft dated June 4, 1992. 29 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 6.6 Carcinogenicity  No data submitted

Test substance: Propionaldehyde Test species/ strain:

* 6.7 Reproductive and Developmental toxicity 6.7.1 Reproductive toxicity Test substance: Propionaldehyde Test species/ strain: CD Rats Test method ( e. g., OECD, others): OECD Screening Information Data Set Combined Repeated Dose/ Reproductive Protocol GLP YES [ X] NO [ ]

Test results:

Male and female rats ( 15 per exposure group) were exposed to propionaldehyde by inhalation at air concentrations of 0, 150, 750 or 1500 ppm. Exposures were conducted 6 hours per day, 7 days per week. Males received 52 consecutive daily exposures, while females were exposed for 2 weeks prior to mating, during a 14 day ( Maximum) mating period and through day 20 of gestation. Females were allowed to litter and the offspring body weight, viability, disposition were monitored from birth until postnatal day 4. On day 4 of lactation, necropsies were performed on the adult females and the offspring were examined externally and sacrificed without pathologic evaluation. No significant effects of exposure were noted on any reproductive parameter assessed. Litter size and viability were similar among exposure groups and the control. Pup body weights on postnatal day 0 and 4 were not 30 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 affected by exposure, although the body weight gain of pups from the high exposure group mothers for that period was slightly depressed.

NOEL for P generation: No NOEL established for nasal lesions, 150 ppm for evidence of systemic toxicity. NOEL for F1 generation NOEL for F2 generation Maternal and Paternal general toxicity: Nasal lesions  150 ppm. Signs of systemic toxicity  750 ppm Reproductive toxicity observed in parental animals ( fertility, gestation, reproductive organtoxicity, etc.): > 1500 ppm Reproductive toxicity observed in offspring ( weights of litter, postnatal growth, viability, etc.): > 1500 ppm Comments:

Reference: Union Carbide Corporation, Bushy Run Research Center Report 91U0086 Draft dated June 17, 1992.

6.7.2 Teratogenicity/ Developmental toxicity Test substance: Propionaldehyde Test species/ strain: Sprague Dawley rats.

Test method ( e. g., OECD, others): Intraamniotic injection on day 13 of gestation. GLP YES [ ] NO [ X]

Test results:

NOEL for maternal animals NOEL for offspring 100 ug/ fetus Maternal general toxicity Pregnancy and litter data Foetal data ( live/ dead, sex, external defects, soft tissue and skeletal defects) 31 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Comments: Increased incidence of dead or resorbed fetuses at 1000 ug/ fetus. No increased incidence of maleformed fetuses up to the highest concentration tested, 1000 ug/ fetus.

Reference: Slott, V. L. and B. F. Hales ( 1985) Teratology 32: 65 72.

6.8 Specific toxicities ( Neurotoxicity, immunotoxicity etc.)

6.9 Toxicodynamics, toxico kinetics 1) The retention of propionaldehyde vapor in the respiratory tract dog was approximately 75 to 80% of the inhaled dose at air concentrations between 100 and 400 ppm ( 250 mg/ m3 to 1000 mg/ m3). Retentions of 75% to 80% were also measured in the dog at tital volumes ranging from approximately 110 to 200 ml.

Egle, J. L. ( 1972) " Retention of Inhaled Formaldehyde, Propionaldehyde and Acrolein in the Dog". Arch. Environ. Health 25: 119 124.

2) The activity of the liver cytosolic propionaldehyde dehydro genase was 9.4 nmoles NADH/ min/ mg protein in control mice and 19 nmoles NADH/ min/ mg protein in pregnant mice at an initial propionaldehyde concentration of 5 mM. Mitochondrial activity was 34.1 and 33.0 nmoles NADH/ min/ mg protein at a concentration of 5 mM, and 12.95 and 12.45 nmoles NADH/ min/ mg protein at a concentration of 50 uMin in control and pregnant mice respectively. The apparent Km value for the enzyme using propionaldehyde as a substrate was approximately 0.36 mM in control mice and 0.37 mM in pregnant mice. Values using acetaldehyde were 0.59 and 0.56 mM, respectively.

Reference: 32 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Petersen, D. R., Panter, S. S. and A. C. Collins ( 1977) " Ethanol and Acetaldehyde Metabolism in the Pregnant Mouse". Drug Alc. Depend. 2: 409 420.

7. Experience with Human Exposure ( give full description of study design, effects of Accidental or Occupational Exposure, epidemiology)

Odor threshold of aqueous solutions for normal individuals, 145 ppb, for anosmic individuals, 656 ppb.

Amoore, J. E., Forrester,, L. J. and P. Pelosi ( 1976) " Specific Anosmia to Isobutyraldehyde: The Malty Primary Odor". Chem. Senses Flavor 2: 17 25.

7.1 Biological Monitoring ( including clinical studies, case reports, etc.)

No Data Available 8. Recommended Precautions, Classification ( use and/ or transporation) and Safety Data Sheets.

See attached Material Safety Data Sheets 9. Availability and references( s) for existing review( s)

Available 10 Name of responder Tipton R. Tyler, Ph. D., D. A. B. T. Associate Director of Applied Toxicology Union Carbide Corporation ( P 2) 39 Old Ridgebury Road Danbury, Connecticut 06817 0001 33 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 ( 203) 794 5389 34 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Appendix I Flow Diagram of Propionaldehyde Production Facility 35 OECD HPV FORM PROPIONALDEHYDE/ REVISION 35 EXHVA/ 90.16 Appendix II Union Carbide Material Safety Data Sheet for Propionaldehyde