[Federal Register Volume 80, Number 114 (Monday, June 15, 2015)]
[Rules and Regulations]
[Pages 34058-34061]
[FR Doc No: 2015-14637]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0434]
RIN 1625-AA00

Safety Zone; Salvage and Recovery of CSS Georgia and Recovery and
Transit of Unexploded Ordnance, Savannah River, Savannah, GA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Savannah River, in Savannah, GA. A stationary safety zone will be
enforced around the BARGE SALONAN in the area of Buoy 52A, while the
United States Navy commences dive and salvage operations to salvage CSS
GEORGIA. A moving safety zone will be enforced while unexploded
ordnance is salvaged and transited for disposal to Tide Gate Landing,
approximately two mile transit from the salvage site. This regulation
is necessary to protect life, and property on the navigable waters of
the Savannah River due to the hazards associated with diving and
salvage operations, and hazards associated with recovery and
transportation of unexploded ordnance.

DATES: This rule is effective without actual notice from June 15, 2015
until

October 1, 2015. For the purposes of enforcement, actual notice will be
used from June 22, 2015 until October 1, 2015. The stationary zone will
be enforced during dive and salvage operations. The moving zone will be
enforced during transits of unexploded ordnance.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2015-0434]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Christopher McElvaine, Marine Safety Unit Savannah
Office of Waterways Management, Coast Guard; telephone<PHONE_NUMBER>
ext 221, email<EMAIL_ADDRESS>If you have questions
on viewing or submitting material to the docket, call Cheryl Collins,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive
notice of planned salvage operations until May 15, 2015. Publishing a
NPRM and delaying its effective date would be impracticable and
contrary to public interest because immediate action is needed to
protect the United States Navy divers, TUG LITTLE BULLY, BARGE SALONAN,
other vessels, and mariners from the hazards associated with the
salvage of CSS GEORGIA and recovery and transport of unexploded
ordnance from Savannah River.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register for the same reasons discussed
above.

B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to ensure the safety of life and vessels
on a navigable waterway of the United States during the salvage of CSS
GEORGIA and recovery and transport of unexploded ordnance from Savannah
River.

C. Discussion of the Final Rule

    The Coast Guard is establishing this safety zone to facilitate the
safe salvage of CSS GEORGIA and recovery and transport of unexploded
ordnance from the Savannah River. The salvage operations and recovery
of unexploded ordnance pose a danger to other vessels that may meet,
pass or attempt to overtake the BARGE SALONAN in the narrow waterway of
the Savannah River. This safety zone is necessary to protect the safety
of lives and persons during salvage and recovery operations.
    A moving and fixed safety zone will be established when the United
States Navy commences dive and salvage operations and during the
recovery and river transits with unexploded ordnance. During dive and
salvage operations, no vessel may pass within 100 yards of BARGE
SALONAN in approximate position 32-05'02.6 N., 081-02'21.6 W. in the
area of Buoy 52A, unless authorized by the COTP Savannah or designated
representative, and during recovery and transit of unexploded
ordnances, no other vessel may meet or pass within 500ft of the United
States Navy small boat carrying the ordnance, unless authorized by the
COTP Savannah or a designated representative.
    Entry into the safety zone is prohibited for all vessels unless
specifically authorized by the Captain of the Port (COTP) Savannah or a
designated representative. Coast Guard assets or designated
representatives will enforce this safety zone, and coordinate vessel
movements into the zone when safe to minimize the zone's impact on
vessel movements. Persons or vessels desiring to enter, transit
through, anchor in, or remain within the safety zone may contact the
Captain of the Port Savannah by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16, to request
authorization. If authorization to enter, transit through, anchor in,
or remain within the safety zone is granted by the Captain of the Port
Savannah or a designated representative, all persons and vessels
receiving such authorization must comply with the instructions of the
Captain of the Port Savannah or a designated representative. The Coast
Guard will provide notice of the safety zones by Broadcast Notice to
Mariners, and on-scene designated representatives.
    Due to fluctuations in tide and recovery operations based upon the
best available information known at the time this rule was drafted,
this rule is effective from June 22, 2015 until October 1, 2015.
However, it will only be enforced during dive and salvage operations
and transits of unexploded ordnance. The COTP Savannah or a designated
representative will inform the public through broadcast notice to
mariners of the enforcement periods for this safety zone.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The economic impact of this rule is not significant for the
following reasons: This safety zone will only be enforced during times
of diving operations and the recovery and transit of unexploded
ordnance on the Savannah River. Once salvage operations have ceased,
the safety zone will be terminated. Dive and salvage operations are
only expected to take place during day light hours and are expected to
last a few hours a day.

The receiving site for unexploded ordnance is only 14,000 feet from the
CSS GEORGIA salvage site.
    The Coast Guard has notified the Georgia Ports Authority and
Savannah Pilots Association of the needs, conditions, and effective
dates and times of the safety zone so that they may schedule arriving
and departing vessels that may be affected by this safety zone to
minimize shipping delays. The presence of other moored vessels is not
expected to impede salvage operations, and sufficient channel width is
anticipated while the dive and salvage operations are in effect so that
other vessels may transit through the area.
    Notifications of the enforcement periods of this safety zone will
be made to the marine community through broadcast notice to mariners.
Representatives of the COTP will be on-scene to coordinate the
movements of vessels seeking to enter the safety zone. These
representatives will authorize vessels to transit into the zone to the
maximum safe allowable extent during salvage operations.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
transit the Savannah River while salvage operations have commenced.
This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: (1) The
COTP Savannah may consider granting vessels permission to enter into
the moving and fixed safety zone if conditions allow for such transit
to be conducted safely, and (2) the Coast Guard will issue a broadcast
notice to mariners informing the public of the safety zone.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the creation of a temporary safety
zone. This

rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. An environmental analysis checklist supporting this
determination and a Categorical Exclusion Determination are available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add a temporary Sec.  165.T07-0434 to read as follows:

Sec.  165.T07-0434  Safety Zone; Salvage and Recovery of CSS Georgia
and Recovery and Transit of Unexploded Ordnance, Savannah River,
Savannah, GA.

    (a) Regulated area. The fixed safety zone will be centered on BARGE
SALONAN in approximate position 32-05'02.6 N., 081-02'21.6 W. in
vicinity of Buoy 52A, while moored and conducting dive and salvage
operations, extending 100 yards in all directions. The moving safety
zone will cover all waters of the Savannah River 500 feet ahead and
astern of the United States Navy small boat while loading and
transferring unexploded ordnance to the designated shore side site.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Savannah in the enforcement of the regulated area.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
safety zones unless authorized by the Captain of the Port Savannah or a
designated representative.
    (2) Persons or vessels desiring to enter, transit through, anchor
in, or remain within the safety zones may contact the Captain of the
Port Savannah by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
the safety zone is granted by the Captain of the Port Savannah or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Savannah or a designated representative.
    (3) The Coast Guard will provide notice of the regulated areas by
Broadcast Notice to Mariners and on-scene designated representatives.
    (d) Effective period. This rule is effective on June 22, 2015
through October 1, 2015. The stationary zone will be enforced during
dive and salvage operations. The moving zone will be enforced during
transits of unexploded ordnance.

    Dated: June 1, 2015.
O. Vazquez,
Lieutenant Commander, U.S. Coast Guard, Acting Captain of the Port
Savannah.
[FR Doc. 2015-14637 Filed 6-12-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Notices]
[Pages 81165-81166]
[FR Doc No: 2023-25724]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-385, OMB Control No. 3235-0441]

Proposed Collection; Comment Request; Extension: Rule 18f-3

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 18f-3 (17 CFR 270.18f-3) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) exempts from sections 18(f)(1) and
18(f)(i), a fund that issues multiple classes of shares representing
interests in the same portfolio of securities (a ``multiple class
fund'') if the fund satisfies the conditions of the rule. In general,
each class must differ in its arrangement for shareholder services or
distribution or both, must pay the related expenses of that different
arrangement, and must satisfy certain voting rights provisions.
    The rule includes one requirement for the collection of
information. A multiple class fund must prepare, and fund directors
must approve, a written plan setting forth the separate arrangement and
expense allocation of each class, and any related conversion features
or exchange privileges (``rule 18f-3 plan''). Approval of the plan must
occur before the fund issues any shares of multiple classes and
whenever the fund materially amends the plan. In approving the plan,
the fund board, including a majority of the independent directors, must
determine that the plan is in the best interests of each class and the
fund as a whole.
    The requirement that the fund prepare, and directors approve, a
written rule 18f-3 plan is intended to ensure that the fund compiles
information relevant to the fairness of the separate arrangement and
expense allocation for each class, and that directors review and
approve the information. Without a blueprint that highlights material
differences among classes, directors might not perceive potential
conflicts of interests when

they determine whether the plan is in the best interests of each class
and the fund. In addition, the plan may be useful to Commission staff
in reviewing the fund's compliance with the rule.
    The following estimates of average burden hours are made solely for
purposes of the Paperwork Reduction Act of 1995 \1\ and are not derived
from a comprehensive or even representative survey or study of the cost
of Commission rules and forms. Compliance with the information
collection requirements of rule 18f-3 is necessary to obtain the
benefit of the rule's exemption. Responses to the collection of
information requirements will not be kept confidential.
---------------------------------------------------------------------------

    \1\ 44 U.S.C. 3501 et seq.

                                        Table 1--Rule 18f-3 PRA Estimates
----------------------------------------------------------------------------------------------------------------
                                        Internal annual burden       Wage rate \1\         Internal time costs
----------------------------------------------------------------------------------------------------------------
                                            ESTIMATES FOR RULE 18F-3
----------------------------------------------------------------------------------------------------------------
Prepare and approve a written 18f-3    6 hours \3\............
 plan \2\.
Average number of responses annually   0.5 responses \3\......
 per registrant.
Total number of hours per registrant   3 hours \3\............  $484 (in-house           $936,056 (in-house
 per year \4\.                                                   attorney).               attorney).
                                                                $4,770 (fund board of    $4,612,590 (board of
                                                                 directors) \6\.          directors).\7\
Total number of registrants..........  967 \4\................
                                      --------------------------------------------------------------------------
    Total annual hour burden.........  2,901 hours \5\........  .......................  $5,548,646.\8\
----------------------------------------------------------------------------------------------------------------
 Notes:
1. The Commission's estimates of the relevant wage rates are based on salary information for the securities
  industry compiled by the Securities Industry and Financial Markets Association's Office Salaries in the
  Securities Industry 2013. The estimated figures are modified by firm size, employee benefits, overhead, and
  adjusted to account for the effects of inflation. See Securities Industry and Financial Markets Association,
  Report on Management & Professional Earnings in the Securities Industry 2013.
2. The Commission estimates that each registrant prepares and approves a rule 18f-3 plan every two years when
  issuing a new fund fund or class or amending a plan (or that 484 of all 967 registrants prepare and approve a
  plan each year).
3. This estimate assumes that each response will take 6 hours, requiring 3 hours per registrant per year (0.5
  responses per registrant x 6 hours per response = 3 hours per registrant).
4. The Commission estimates that there are approximately 6,733 multiple class funds offered by 967 registrants.
5. 967 registrants x 3 hours = 2,901 hours.
6. The estimate for the cost of board time as a whole is derived from estimates made by the staff regarding
  typical board size and compensation that is based on information received from fund representatives and
  publicly available sources. The $4,770 per hour estimate for a fund board of directors was last adjusted for
  inflation through 2019, and assumes an average of 9 board members per board.
7. This estimate assumes that two-thirds (1,934) of the internal hours are spent by in-house attorneys to
  prepare the plan (1,934 hours x $484 estimated hourly rate = $936,056 per year) and that one-third (967) are
  spent by the fund's board of directors to approve the plan (967 hours x $4,770 per hour = $4,612,590).
8. $936,056 + $4,612,590 = $5,548,646.

    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimate of the burden of the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted by January 22, 2024.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549 or send an
email to: [email protected].

    Dated: November 16, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25724 Filed 11-20-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60258-60259]
[FR Doc No: 2021-23741]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4130]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping Requirements for Microbiological Testing
and Corrective Measures for Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the procedure by which both
domestic and foreign bottled water manufacturers that sell bottled
water in the United States maintain records of microbiological testing
and corrective measures, in addition to existing recordkeeping
requirements.

DATES: Submit either electronic or written comments on the collection
of information by January 3, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 3, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-4130 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping Requirements for
Microbiological Testing and Corrective Measures for Bottled Water.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected]a.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Recordkeeping Requirements for Microbiological Testing and Corrective
Measures for Bottled Water--21 CFR 129.35(a)(3)(i), 129.80(g), and
129.80(h)

OMB Control Number 0910-0658--Extension

    The bottled water regulations in parts 129 and 165 (21 CFR parts
129 and 165) require that if any coliform organisms are detected in
weekly total coliform testing of finished bottled water, followup
testing must be conducted to determine whether any of the coliform
organisms are Escherichia coli (E. coli). The adulteration provision of
the bottled water standard (Sec.  165.110(d)) (21 CFR 165.110(d))
provides that a finished product that tests positive for E. coli will
be deemed adulterated under section 402(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)). In addition, the current
good manufacturing practice (CGMP) regulations for bottled water in
part 129 require that source water from other than a public water
system be tested at least weekly for total coliform. If any coliform
organisms are detected in the source water, bottled water manufacturers
are required to determine whether any of the coliform organisms are E.
coli. Source water found to contain E. coli is not considered water of
a safe, sanitary quality and would be unsuitable for bottled water
production. Before a bottler may use source water from a source that
has tested positive for E. coli, a bottler must take appropriate
measures to rectify or otherwise eliminate the cause of the
contamination. A source previously found to contain E. coli will be
considered negative for E. coli after five samples collected over a 24-
hour period from the same sampling site are tested and found to be E.
coli negative.
    Description of Respondents: The respondents to this information
collection are domestic and foreign bottled water manufacturers that
sell bottled water in the United States.
    FDA estimates the burden of this collection of information as
follows:

                                                    Table 1--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           21 CFR section; activity               Number of      records per    Total  annual       Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   129.35(a)(3)(i) and 129.80(h);               319               6           1,914  0.08 (5 minutes).........................             153
 bottlers subject to both source water and
 finished product testing.
Sec.   129.80(g) and (h); bottlers only                    95               3             285  0.08 (5 minutes).........................              23
 subject to finished product testing.
Sec.  Sec.   129.35(a)(3)(i) and 129.80(h);                 3               5              15  0.08 (5 minutes).........................               1
 bottlers conducting secondary testing of
 source water.
Sec.  Sec.   129.35(a)(3)(i) and 129.80(h);                 3               3               9  0.25 (15 minutes)........................               2
 bottlers rectifying contamination.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................             179
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
    The current CGMP regulations already reflect the time and
associated recordkeeping costs for those bottlers that are required to
conduct microbiological testing of their source water, as well as total
coliform testing of their finished bottled water products. We therefore
conclude that any additional burden and costs in recordkeeping based on
followup testing that is required if any coliform organisms detected in
the source water test positive for E. coli are negligible.

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23741 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Notices]
[Page 13186-13187]
[DOCID:fr18mr10-115]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61686; File No. SR-Phlx-2010-41]

Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
to Fees and Rebates for Adding and Removing Liquidity

March 10, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 1, 2010, NASDAQ OMX PHLX, Inc. (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the Exchange. Phlx has designated this
proposal as one establishing or changing a member due, fee, or other
charge imposed under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule
19b-4(f)(2) thereunder,\4\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Fee Schedule to: (i)
Increase the number of options to be included in the Exchange's current
schedule of transaction fees and rebates for adding and removing
liquidity; (ii) increase the Firm per contract transaction fee for
adding liquidity; and (iii) other clarifying technical amendments to
the Fee Schedule.
    While changes to the Fee Schedule pursuant to this proposal are
effective upon filing, the Exchange has designated these changes to be
operative for transactions settling on or after March 1, 2010.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqtrader.com/micro.aspx?id=PHLXfilings, at the
principal office of the Exchange, at the Commission's Public Reference
Room, and on the Commission's Web site at http://www.sec.gov.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to increase liquidity and to attract order
flow by increasing the number of options to be included in the
Exchange's current schedule of transaction fees and rebates for adding
and removing liquidity.
    Specifically, the Exchange proposes to add the following options:
Apple, Inc. (AAPL); Allstate Corp., (ALL), Amazon.com, Inc. (``AMZN''),
Bank of America Corporation (``BAC''); Dell, Inc. (``DELL''), Diamonds
Trust Series 1 (``DIA''), DryShips, Inc. (``DRYS''), Eastman Kodak, Co.
(``EK''), Market Vectors Gold Miners ETF (``GDX''), General Electric
Company (``GE''), Goldman Sachs Group, Inc. (``GS''), Microsoft
Corporation (``MSFT''), Qualcomm, Inc. (``QCOM''), Research In Motion
Ltd. (``RIMM''), Starbucks Corp. (``SBUX''), UltraShort Financials
ProShares (``SKF''), iShares Silver Trust (``SLV''), Semiconductor
HOLDRs (``SMH''), United States Natural Gas (``UNG''), United States
Oil Fund LP Units (``USO''), Ultra Financials ProShares (``UYG''),
WynnResorts Ltd. (``WYNN''), and Financial Select Sector SPDR
(``XLF''), collectively (``the options''). The options would be subject
to the fees and rebates for adding and removing liquidity.
    Additionally, the Exchange proposes to increase the fee for adding
liquidity assessed to Firms from its current rate of $0.35 to $0.45.
The Exchange is amending this rate to equate it to the rate assessed on
Broker-Dealers for adding liquidity.
    Currently, the Exchange assesses a per-contract transaction charge
in Standard and Poor's Depositary Receipts/SPDRs (``SPY'') \5\, the
PowerShares QQQ Trust (``QQQQ'')[supreg]; Ishares Russell 2000
(``IWM'') and Citigroup Inc. (``C'') options on five different
categories of market participants that submit orders and/or quotes that
remove, or ``take,'' liquidity from the Exchange. The per-contract
transaction charge depends on the category of market participant
submitting an order or quote to the Exchange that removes liquidity.\6\
---------------------------------------------------------------------------

    \5\ SPY options are based on the SPDR exchange-traded fund
(``ETF''), which is designed to track the performance of the S&P 500
Index.
    \6\ See SR-Phlx-2010-33.
---------------------------------------------------------------------------

    The market participants are as follows: (i) Specialists, Registered
Options Traders (``ROTs''), Streaming Quote Traders (``SQTs'') \7\ and
Remote Streaming Quote Traders (``RSQTs''); \8\ (ii) customers; \9\
(iii) specialists, ROTs [sic], SQTs and RSQTs that receive Directed
Orders (``Directed Participants'' \10\ or ``Directed Specialists,
RSQTs, or SQTs'' \11\); (iv) Firms; and (v) broker-dealers.
---------------------------------------------------------------------------

    \7\ An SQT is an Exchange Registered Options Trader (``ROT'')
who has received permission from the Exchange to generate and submit
option quotations electronically through an electronic interface
with AUTOM via an Exchange approved proprietary electronic quoting
device in eligible options to which such SQT is assigned. See
Exchange Rule 1014(b)(ii)(A).
    \8\ An RSQT is an ROT that is a member or member organization
with no physical trading floor presence who has received permission
from the Exchange to generate and submit option quotations
electronically through AUTOM in eligible options to which such RSQT
has been assigned. An RSQT may only submit such quotations
electronically from off the floor of the Exchange. See Exchange Rule
1014(b)(ii)(B).
    \9\ This applies to all customer orders, directed and non-
directed.
    \10\ For purposes of this fee, a Directed Participant is a
Specialist, SQT, or RSQT that executes a customer order that is
directed to them by an Order Flow Provider and is executed
electronically on the Exchange's electronic trading platform for
options, PHLX XL II.
    \11\ See Exchange Rule 1080(l), ``* * * The term `Directed
Specialist, RSQT, or SQT' means a specialist, RSQT, or SQT that
receives a Directed Order.'' A Directed Participant has a higher
quoting requirement as compared with a specialist, SQT or RSQT who
is not acting as a Directed Participant. See Exchange Rule 1014.
---------------------------------------------------------------------------

    The per-contract transaction charges are assessed on participants
who submit proprietary quotes and/or orders that remove liquidity from
the Exchange's market in options listed on the Fee Schedule. The
Exchange also assesses a transaction charge to Firms and broker-dealers
that add liquidity.
    Additionally, the Exchange has in place a per-contract rebate
relating to transaction charges for orders or quotations that add
liquidity to the Exchange's market in options listed on the fee
schedule. The amount of the rebate depends on the category of

participant whose order or quote was executed as part of the Phlx
disseminated Best Bid and/or Offer.
    The Exchange also proposes to amend the Fee Schedule to make
technical amendments such as changing the name of the category of fees
and other clarifying amendments to make reference to other fees, and to
options affected by these fees.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \12\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \13\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members. The impact of the proposal
upon the net fees paid by a particular market participant will depend
on a number of variables, including its monthly volumes, the order
types it uses, and the prices of its quotes and orders (i.e., its
propensity to add or remove liquidity). The rate increase to Firms for
adding liquidity in the various symbols including the additional
Symbols is the same rate that is currently being assessed on Broker-
Dealers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    Accordingly, the Exchange also believes that the addition of the
options to this portion of the Fee Schedule is equitable in that it
will apply to all categories of participants in the same manner.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \14\ and paragraph (f)(2) of Rule 19b-4 \15\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \15\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2010-41 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, Station Place, 100 F Street, NE., Washington,
DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2010-41. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-Phlx-2010-41 and should be
submitted on or before April 8, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5911 Filed 3-17-10; 8:45 am]
BILLING CODE 8011-01-P


Matthews, H. B. and F. Matsumura. 1969. Metabolic fate of dieldrin in the rat. J. Agric. Food Chem. 17: 845 852 ( as cited in ATSDR, 2000; IPCS, 1989b; USEPA, 1980).

McCann, J., E. Choi, E. Yamasaki, and B. N. Ames. 1975. Detection of carcinogens as mutagens in the Salmonella/ microsome test: Assay of 300 chemicals. Proc. Natl. Acad. Sci. 72: 5135 5139 ( as cited in USEPA, 1988; GAP2000, 2000b).

McKinney, J. D., H. B. Matthews and N. K. Wilson. 1973. Determination of optical purity and prochirality of chlorinated polycyclodiene pesticide metabolites. Tetrahedron Lett. 21: 1895 1898 ( as cited in IPCS, 1989b).

Mehendale, H. M. and E. A. El Bassiouni. 1975. Uptake and disposition of aldrin and dieldrin by isolated perfused rabbit lung. Drug Metab. Dispos. 3: 543 556 ( as cited in ATSDR, 2000; IPCS, 1989b).

Mehrotra, B. D., K. S. Moorthy, S. R. Reddy, and D. Desaiah. 1989. Effects of cyclodiene compounds on calcium pump activity in rat brain and heart. Toxicology 54: 17 30 ( as cited in ATSDR, 2000).

Mehrotra, B. D., S. R. Reddy and D. Desaiah. 1988. Effect of subchronic dieldrin treatment on calmodulin regulated Ca++ pump activity in rat brain. J. Toxicol. Environ. Health 25: 461 469 ( as cited in ATSDR, 2000).

Meierhenry, E. F., B. H. Reuber, M. E. Gershwin, L. S. Hsieh and S. W. French. 1983. Deildrin induced mallory bodies in hepatic tumors of mice of different strains. Hepatology 3: 90 95 ( as cited in USEPA, 1987, 1993b).

Melnyk, L. J., M. R. Berry and L. S. Sheldon. 1997. Dietary exposure from pesticide application on farms in the agricultural health pilot study. J. Expo. Anal. Environ. Epidemiol. 7 ( 1): 61 80.

Mes, J., D. J. Davies, J. Doucet, D. Weber, and E. Mcmullen. 1993. Levels of chlorinated hydrocarbon residues in Canadian human breast milk and their relationship to some characteristics of the donors. Food Addit. Contam. 10 ( 4): 429 441.

Mick, D. L., K. R. Long, J. S. Dretchen, and D. P. Bonderman Jr. 1971. Aldrin and dieldrin in human blood components. Arch. Environ. Health 23: 177 180 ( as cited in IARC, 1974a; USEPA, 1980). 10 18 Aldrin/ Dieldrin   February 2003 Mikalsen, S. O. and T. Sanner. 1993. Intercellular communication in colonies of Syrian hamster embryo cells and the susceptibility for morphological transformation. Carcinogenesis 14: 251 257 ( as cited in GAP2000, 2000b).

Miller, T. 2000. Selected Findings and Current Perspectives on Urban Water Quality The National Water Quality Assessment ( NAWQA) Program of the U. S. Geological Survey. Paper presented to the NAWQA National Liaison Committee, June 13, 2000. 8 pp.

Miller, T. L. and W. G. Wilber. 1999. Emerging Drinking Water Contaminants: Overview and Role of the National Water Quality Assessment Program ( Ch 2.). In: Identifying Future Drinking Water Contaminants. Washington, D. C.: National Academy Press.

Mueller, W., G. Nohynek, G. Woods, F. Korte and F. Coulston. 1975a. Comparative metabolism of dieldrin 14C in mouse, rat, rabbit, rhesus monkey, and chimpanzee. Chemosphere 4( 2): 89 92 ( as cited in ATSDR, 2000; IPCS, 1989b).

Mueller, W., G. Woods, F. Korte, and F. Coulston. 1975b. Metabolism and organ distribution of dieldrin 14C in rhesus monkeys after single oral and intravenous administration. Chemosphere 2: 93 98 ( as cited in IPCS, 1989b).

Muirhead, E. E, M. Groves, R. Guy et al. 1959. Acquired hemolytic anemia, exposure to insecticides and positive Coombs test dependent on insecticide preparations. Vox Sang 4: 277 292 ( as cited in ATSDR, 2000).

Murray, H. E. and J. N. Beck. 1990. Concentrations of selected chlorinated pesticides in shrimp collected from the Calcasieu River/ Lake complex, Louisiana. Bull. Environ. Contam. Toxicol. 44: 798 804 ( as cited in ATSDR, 2000).

Nagata, K. and T. Narahashi. 1995. Multiple actions of dieldrin and lindane on the GABA A receptor chloride channel complex of rat dorsal root ganglion neurons. Pestic. Sci. 44: 1 7.

Nagata, K., B. J. Hamilton, D. B. Carter, and T. Narahashi. 1994. Selective effects of dieldrin on the GABA A receptor channel subunits expressed in human embryonic kidney cells. Brain Res. 645: 19 26.

Nagata, K. and T. Narahashi. 1994. Dual action of the cyclodiene insecticide dieldrin on the gamma aminobutyric acid receptor chloride channel complex of rat dorsal root ganglion neurons. J. Pharmacol. Exp. Ther. 269: 164 171.

Nair, A., P. Dureja, and M. K. K. Pillai. 1992. Aldrin and dieldrin residues in human fat, milk and blood serum collected from Delhi. Hum. Exp. Toxicol. 11: 43 45.

Nakatsugawa, T., M. Ishida, and P. A. Dahm. 1965. Microsomal epoxidation of cyclodiene insecticides. Biochem. Pharmacol. 14: 1853 ( as cited in USEPA, 1980). 10 19 Aldrin/ Dieldrin   February 2003 NCI. 1978. National Cancer Institute. Bioassays of aldrin and dieldrin for possible carcinogenicity. DHEW Publication No. ( NIH) 78 821 and 78 822. National Cancer Institute Carcinogenesis Technical Report Series, No. 21 and 22. NCI CG TR 21, NCI CG TR 22 ( as cited in ATSDR, 2000; IPCS, 1989b; USEPA, 1993a, 1993b, 1992, 1988, 1987).

Neidert, E. and P. W. Saschenbrecker. 1996. Occurrence of pesticide residues in selected agricultural food commodities available in Canada. J. AOAC Int. 79 ( 2): 549 566.

Newsome, W. H. and P. Andrews. 1993. Organochlorine pesticides and polychlorinated biphenyl congeners in commercial fish from the Great Lakes. J. AOAC Int. 76 ( 4): 707 710.

Nishimura, N., H. Nishimura., and H. Oshima. 1982. Survey on mutagenicity of pesticides by the Salmonella microsome test. Aichi Ika Daig Igak Zass 10: 305 312 ( as cited in GAP2000, 2000a, b).

Nohynek, G. J., W. F. Mueller, F. Coulston and F. Korte. 1979. Metabolism, excretion, and tissue distribution of 14C photodieldrin in non human primates following oral administration and intravenous injection. Ecotoxicol. Environ. Safety. 3: 1 9 ( as cited in IPCS, 1989b).

Nowell, L. 1999. National Summary of Organochlorine Detections in Bed Sediment and Tissues for the 1991 NAWQA Study Units. Available on the Internet at: http:// water. wr. usgs. gov/ pnsp/ rep/ bst/ Last updated October 18, 1999.

Oda, J. and W. Mueller. 1972. Identification of a mammalian breakdown product of dieldrin. Environ. Qual. Safety 1: 248 249 ( as cited in IPCS, 1989b).

Ottolenghi, A. D., J. K. Haseman, and F. Suggs. 1974. Teratogenic effects of aldrin, dieldrin and endrin in hamsters and mice. Teratology 9: 11 16 ( as cited in ATSDR, 2000; IPCS, 1989b; USEPA, 1992, 1988, 1987).

Paul, V., E. Balasubramaniam, S. Sheela, and M. S. Krishnamoorthy. 1992. Effects of endosulfan and aldrin on muscle coordination and conditioned avoidance response in rats. Pharmacol. Toxicol. 71: 254 257.

Pereira, W. E., F. D. Hostettler and J. B. Rapp. 1996. Distributions and fate of chlorinated pesticides, biomarkers and polycyclic aromatic hydrocarbons in sediments along a contamination gradient from a point source in San Francisco Bay, California. Mar. Environ. Res. 41( 3): 299 314.

Pick A, H. Joshua, M. Leffkowitz, et al. 1965. [ Aplastic anemia following exposure to aldrin.] Medicine 68: 164 167. ( Hebrew) ( as cited in ATSDR, 2000).

Polishuk, Z. W., D. Wasserman, M. Wasserman, S. Cucos, and M. Ron. 1977. Organochlorine compounds in mother and fetus during labor. Environ. Res. 13: 278 284 ( as cited in ATSDR, 2000). 10 20 Aldrin/ Dieldrin   February 2003 Probst, G. S., R. E. McMahon, L. W. Hill, D. Z. Thompson, J. K. Epp, and S. B. Neal. 1981. Chemically induced unscheduled DNA synthesis in primary rat hepatocyte cultures: A comparison with bacterial mutagenicity using 218 chemicals. Environ. Mutagen. 3: 11 32.

Radomski, J. L. and B. Davidow. 1953. The metabolite of heptachlor, its estimation, storage and toxicity. J. Pharmacol. Exp. Ther. 107: 266 ( as cited in USEPA, 1980).

Ramamoorthy, K., F. Wang, I. C. Chen, J. D. Norris, D. P. Mcdonnell, L. S. Leonard, K. W. Gaido, W. P. Bocchinfuso, K. S. Korach, and S. Safe. 1997. Estrogenic activity of a dieldrin/ toxaphene mixture in the mouse uterus, MCF 7 human breast cancer cells, and yeast based estrogen receptor assays: No apparent synergism. Endocrinology 138: 1520 1527.

Rani, M. V. U., O. S. Reddi, and P. P. Reddy. 1980. Mutagenicity studies involving aldrin, endosulfan, dimethoate, phosphamidon, carbaryl and ceresan. Bull. Environ. Contam. Toxicol. 25: 277 282 ( as cited in GAP2000, 2000a).

Richardson, A. 1971. The isolation and identification of a metabolite of HEOD ( dieldrin) from human faeces. Sittingbourne, England: Shell Research ( TLGR. 0021.71) ( as cited in IPCS, 1989b).

Richardson, A. and J. Robinson. 1971. The identification of a major metabolite of HEOD ( dieldrin) in human feces. Xenobiotica 1( 3): 213 219 ( as cited in ATSDR, 2000; IARC, 1974b; IPCS, 1989b).

Richardson, A., M. K. Baldwin and J. Robinson. 1968. Metabolites of dieldrin ( HEOD) in the urine and faeces of rats. Chem. Ind. 1968: 588 589 ( as cited in IPCS, 1989b; USEPA, 1980).

Richardson, L. A., J. R. Lane, W. S. Gardner, J. T. Peeler, and J. E. Campbell. 1967. Relationship of dietary intake to concentration of dieldrin and endrin in dogs. Bull. Environ. Contam. Toxicol. 2( 4): 207 219 ( as cited in IPCS, 1989b).

Roberts, J. W. and D. E. Camann. 1989. Pilot study of a cotton glove press test for assessing exposure to pesticides in house dust. Bull. Environ. Contam. Toxicol. 43: 717 724 ( as cited in ATSDR, 2000).

Robinson, J., M. Roberts, M. Baldwin, and A. I. T. Walker. 1969. The pharmacokinetics of HEOD ( dieldrin) in the rat. Food Cosmet. Toxicol. 7: 317 332 ( as cited in ATSDR, 2000; IPCS, 1989b; USEPA, 1980).

Robinson, J. and Roberts, M. 1968. Accumulation, distribution and elimination of organochlorine insecticides by vertebrates. In: Symposium on physicochemical and biophysical factors affecting the activity of pesticides, London, 1967. London, England: Society of Chemical Industry, pp. 106 119 ( as cited in IARC, 1974b). 10 21 Aldrin/ Dieldrin   February 2003 Rocchi, P., P. Perocco, W. Alberghini, A. Fini, and G. Prodi. 1980. Effect of pesticides on scheduled and unscheduled DNA synthesis of rat thymocytes and human lymphocytes. Arch. Toxicol. 45: 101 108 ( as cited in USEPA 1993b; GAP2000, 2000a).

Rogan, W. J. and N. B. Ragan. 1994. Chemical contaminants, pharmacokinetics, and the lactating mother. Environ. Health Perspect. 102 ( Suppl. 11): 89 95.

Sanchez Ramos, J., A. Facca, A. Basit, and S. Song. 1998. Toxicity of dieldrin for dopaminergic neurons in mesencephalic cultures. Exp. Neurol. 150: 263 271.

Savage, E. P., T. J. Keefe, H. W. Wheeler, J. D. Tessari, and M. J. Aaronson. 1984. Second national study to determine levels of hydrocarbon insecticides and polychlorinated biphenyls in human milk. Fort Collins, Colorado: Colorado State University ( as cited in Rogan and Ragan, 1994).

Savage, E. P., T. J. Keefe, J. D. Tessari, H. W. Wheeler, F. M. Applehans, E. A. Goes, and S. A. Ford. 1981. National study of chlorinated hydrocarbon insecticide residues in human milk, USA: I. Geographical distribution of dieldrin, heptachlor, heptachlor epoxide, chlordane, oxychlordane, and mirex. Am. J. Epidemiol. 113: 413 422 ( as cited in ATSDR, 2000).

Schecter, A., P. Furst, C. Kruger, H. A. Meemken, W. Groebel, and J. D. Constable. 1989. Levels of polychlorinated dibenzofurans, dibenzodioxins, PCBs, DDT and DDE, hexachlorobenzene, dieldrin, hexachlorocyclohexanes and oxychlordane in human breast milk from the United States, Thailand, Vietnam, and Germany. Chemosphere 18: 445 454 ( as cited in ATSDR, 2000).

Shah, P. V. and F. E. Guthrie. 1976. Dermal absorption, distribution, and the fate of six pesticides in the rabbit. In: Watson, D. L. and A. W. A. Brown, eds. Pesticide management and insecticide resistance. New York, London: Academic Press, pp. 547 554 ( as cited in IPCS, 1989b).

Shirasu, Y., M. Moriya, K. Kato, A. Furuhashi, and T. Kada. 1976. Mutagenicity screening of pesticides in the microbial system. Mutat. Res. 40( 1): 19 30 ( as cited in USEPA 1993b).

Simmon, V. F. and K. Kauhanen. 1978. Stanford research report. In vitro microbiological mutagenicity assays of aldrin. Stanford, CA: Stanford Research International, p. 15 ( as cited in USEPA, 1992).

Simmon, V. F., K. Kauhanen and R. G. Tardiff. 1977. Mutagenic activity of chemicals identified in drinking water. Develop. Toxicol. Environ. Sci. 2: 249 258 ( as cited in USEPA, 1992).

Sina, J. F., C. L. Bean, G. R. Dysart, V. I. Taylor and M. O. Bradley. 1983. Evaluation of the alkaline elution/ rat hepatocyte assay as a predictor of carcinogenic/ mutagenic potential. Mutat. Res. 113: 357 391( as cited in GAP2000, 2000a). 10 22 Aldrin/ Dieldrin   February 2003 Sittig, M. 1991. Handbook of toxic and hazardous chemicals and carcinogens, 3rd ed., vol. 1. Park Ridge, NJ: Noyes Publications, pp. 6 64, 598 601.

Skalsky, H. L. and F. E. Guthrie. 1978. Binding of insecticides to human serum proteins. Toxicol. Appl. Pharmacol. 43: 229 ( as cited in USEPA, 1980).

Song, J. and W. E. Harville. 1964. Carcinogenicity of aldrin and dieldrin in mouse and rat liver. Fed. Proc. Fed. Am. Soc. Exp. Biol. 23: 336 ( as cited in USEPA, 1987, 1993b).

Soto, A. M., K. L. Chung, and C. Sonnenschein. 1994. The pesticides endosulfan, toxaphene and dieldrin have estrogenic effects on human estrogen sensitive cells. Environ. Health Perspect. 102: 380 383.

Soto, A. R. and W. B. Deichmann. 1967. Major metabolism and acute toxicity of aldrin, dieldrin and endrin. Environ. Res. 1: 307 322 ( as cited in USEPA, 1992).

Spiotta, E. J. 1951. Aldrin poisoning in man. Arch. Ind. Hyg. Occup. Med. 4: 560 566 ( as cited in USEPA, 1992).

Stacey, C. I. and T. Tatum. 1985. House treatment with organochlorine pesticides and their level in milk ! Perth, Western Australia. Bull. Environ. Contam. Toxicol. 35: 202 208 ( as cited in ATSDR, 2000).

Stevenson, D. E., E. F. Walborg, Jr., D. W. North, R. L. Sielken, Jr., C. E. Ross, A. S. Wright, Y. Xu, L. M. Kamendulis, and J. E. Klaunig. 1999. Monograph: Reassessment of human cancer risk of aldrin/ dieldrin. Toxicol. Lett. 109: 123 186.

Stevenson, D. E., J. P Kehrer, K. L. Kolaja, E. F. Walborg, Jr., and J. E. Klaunig. 1995. Effect of dietary antioxidants on dieldrin induced hepatotoxicity in mice. Toxicol. Lett. 75: 177 183.

Stevenson, D. E., E. Thorpe, P. F. Hunt, and A. I. T. Walker. 1976. The toxic effects of dieldrin in rats: re evaluation of data obtained in a two year feeding study. Toxicol. Appl. Pharmacol. 36: 247 254 ( as cited in USEPA, 1987).

Strachan, W. M. J. 1988. Toxic contaminants in rainfall in Canada, 1984. Environ. Toxicol. Chem. 7: 871 878 ( as cited in ATSDR, 2000).

Strassman, S. C. and F. W. Kutz. 1977. Insecticide residues in human milk from Arkansas and Mississippi, 1973 74. Pestic. Monit. J. 10: 130 133 ( as cited in ATSDR, 2000).

Sundaram, K. S., V. N. Damodaran, and T. A. Venkitasubramanian. 1978a. Absorption of dieldrin through monkey and dog skin. Indian J. Exp. Biol. 16: 101 103 ( as cited in ATSDR, 2000; IPCS, 1989b). 10 23 Aldrin/ Dieldrin   February 2003 Sundaram, K. S., V. N. Damodaran and T. A. Venkitasubramanian. 1978b. Absorption of dieldrin through skin. Indian J. Exp. Biol. 16: 1004 1007 ( as cited in ATSDR, 2000).

Suskind, R. R. 1959. The cutaneous appraisal of several fabrics treated with dieldrin. The Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH ( as cited in ATSDR, 2000).

Swenberg, J. A. 1981. Utilization of the alkaline elution assay as a short term test for chemical carcinogens. In: Short term tests for chemical carcinogens. New York, NY: Springer Verlag, pp. 48 58 ( as cited in GAP2000, 2000b).

Swenberg, J. A., G. L. Petzold, and P. R. Harbach. 1976. In vitro DNA damage/ alkaline elution assay for predicting carcinogenic potential. Biochem. Biophys. Res. Commun. 72: 732 738 ( as cited in Gap2000, 2000b).

Takei, G., S. M. Kanahikaua, and G. H. Leong. 1983. Analysis of human milk samples collected in Hawaii for residues of organochlorine pesticides and polychlorobiphenyls. Bull. Environ. Contam. Toxicol. 30: 606 613 ( as cited in ATSDR, 2000).

Tennekes, H. A., L. Edler, and H. W. Kunz. 1982. Dose response analysis of the enhancement of liver tumor formation in CF 1 mice by dieldrin. Carcinogenesis 3: 941 945 ( as cited in USEPA, 1987).

Tennekes, H. A., A. S. Wright, K. M. Dix, and J. H. Koeman. 1981. Effects of dieldrin, diet, and bedding on enzyme function and tumor incidence in livers of male CF 1 mice. Cancer Res. 41: 3615 3620 ( as cited in USEPA, 1993b).

Tennekes, H. A., A. S. Wright and K. M. Dix. 1979. The effects of dieldrin, diet, and other environmental components on enzyme function and tumor incidence in livers of CF 1 mice. Arch. Toxicol. 2: 197 212 ( as cited in USEPA, 1987).

Tepper, J. S., V. C. Moser, D. L. Costa, M. A. Mason, N. Roache, Z. Guo, and R. S. Dyer. 1995. Toxicological and chemical evaluation of emissions from carpet samples. American Industrial Hygiene Association Journal 56 ( 2): 158 170.

Thorpe, E. and A. I. T. Walker. 1973. The toxicology of dieldrin ( HEOD). Part II. Comparative long term oral toxicology studies in mice with dieldrin, DDT, phenobarbitone, beta BHC and gamma BHC. Food Cosmet. Toxicol. 11: 433 441 ( as cited in USEPA, 1987, 1993b).

TOXLINE. 2000a. Abstracts of: Deichmann, W. B., W. E. MacDonald and D. A. Cubit. 1975. Dieldrin and DDT in the tissues of mice fed aldrin and DDT for seven generations. Arch. Toxicol. 34( 3): 173 182. Retrieved Oct. 4, 2000. Bethesda, MD: National Library of Medicine, Specialized Information Services Division, Toxicology and Environmental Health Information Program, TOXLINE database. 10 24 Aldrin/ Dieldrin   February 2003 TOXLINE. 2000b. Abstract of: Hunter, C. G., J. Robinson and M. Roberts. 1969. Pharmoacodynamics of dieldrin ( HEOD). Ingestion by human subjects for 18 to 24 months, and postexposure for eight months. Arch. Environ. Health 18( 1): 12 21. Retrieved Oct. 4, 2000. Bethesda, MD: National Library of Medicine, Specialized Information Services Division, Toxicology and Environmental Health Information Program, TOXLINE database.

TOXLINE. 2000c. Abstracts of: Wright, A. S., C. Donninger, R. D. Greenland, K. L. Stemmer and M. R. Zavon. 1978. The effects of prolonged ingestion of dieldrin on the livers of male rhesus monkeys. Ecotoxicol. Environ. Safety 1( 4): 477 502. Retrieved Oct. 2, 2000. Bethesda, MD: National Library of Medicine, Specialized Information Services Division, Toxicology and Environmental Health Information Program, TOXLINE database.

Treon, J. F., E. E. Larson, and J. Cappel. 1957. The toxic effects sustained by animals subjected to the inhalation of air containing products of the sublimation of technical aldrin at various temperatures. The Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH ( as cited in ATSDR, 2000).

Treon, J. F. and F. P. Cleveland. 1955. Toxicity of certain chlorinated hydrocarbon insecticides for laboratory animals, with special reference to aldrin and dieldrin. Agric. Food Chem. 3: 402 408 ( as cited in IPCS, 1989b; USEPA, 1987, 1992,1993a, and 1993b).

Treon, J. F., J. Boyd, G. Berryman, et al. 1954. Final report on the effects on the reproductive capacity of three generations of rats being fed on diets containing aldrin, dieldrin or DDT. The Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH ( as cited in ATSDR, 2000).

Treon, J. F., L. Hartman, T. Gahegen, et al. 1953. The immediate and cumulative toxicity of aldrin, dieldrin and DDT when maintained in contact with the skin of rabbits. The Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH ( as cited in ATSDR, 2000).

Treon, J. F, T. Gahegen, and J. Coomer. 1952. The immediate toxicity of aldrin, dieldrin and compound 49 RL 5, a possible contaminant of impure aldrin. The Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH.

Treon, J. F., F. R. Dutra, F. E. Shaffer, et al. 1951a. The toxicity of aldrin, dieldrin, and DDT when fed to rats over the period of six months. The Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH ( as cited in ATSDR, 2000).

Treon, J. F. Dutra, F. R., Shaffer, F. E. et al. 1951b. The toxicity of aldrin and dieldrin when fed to dogs for variable periods. The Kettering Laboratory in the Department of Preventive Medicine 10 25 Aldrin/ Dieldrin   February 2003 and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH ( as cited in ATSDR, 2000).

Trepanier, G., F. Marchessault, J. Bansal, and A. Chagon. 1977. Cytological effects of insecticides on human lymphoblastoid cell line. In Vitro. 13: 201 ( as cited in USEPA 1993b).

Trotter, W. J. and R. Dickerson. 1993. Pesticide residues in composited milk collected through the U. S. Pasteurized Milk Network. J. AOAC Int. 76 ( 6): 1220 1225.

USEPA. 2001a. Analysis of national occurrence of the 1998 Contaminant Candidate List regulatory determination priority contaminants in public water systems. Office of Water. EPA report 815 D 01 002. 77 pp.

USEPA. 2001b. Occurrence of unregulated contaminants in public water systems: An initial assessment. Office of Water. EPA report 815 P 00 001. Office of Water. 50 pp.

USEPA. 2000 ( Section 4). U. S. Environmental Protection Agency. Water Industry Baseline Handbook, Second Edition ( Draft). March 17, 2000.

USEPA. 2000a ( Section 3). U. S. Environmental Protection Agency. What is the Toxic Release Inventory? Available on the Internet at: http:// www. epa. gov/ tri/ general. htm Last modified February 28, 2000.

USEPA. 2000b. U. S. Environmental Protection Agency. TRI Explorer: Geographic Report. Available on the Internet at: http:// www. epa. gov/ triexplorer/ geography. htm. Last modified May 5, 2000.

USEPA. 2000c. U. S. Environmental Protection Agency. The Toxic Release Inventory ( TRI) and Factors to Consider when Using TRI Data. Available on the Internet at: http:// www. epa. gov/ tri/ tri98/ 98over. pdf Last modified August 11, 2000. Link to site at: http:// www. epa. gov/ tri/ tri98 USEPA. 1999. U. S. Environmental Protection Agency. Superfund Hazardous Waste Site Basic Query Form. Available on the Internet at: http:// www. epa. gov/ superfund/ sites/ query/ basic. htm Last modified December 1,1999.

USEPA. 1999a. U. S. Environmental Protection Agency. Suspension of unregulated contaminant monitoring requirements for small public water systems; Final Rule and Proposed Rule. Fed. Reg. 64( 5): 1494  1498. January 8.

USEPA. 1999b. U. S. Environmental Protection Agency. Revisions to the unregulated contaminant monitoring regulation for public water systems; Final Rule. Fed. Reg. 64( 180): 50556  50620. September 17. 10 26 Aldrin/ Dieldrin   February 2003 USEPA. 1999c. U. S. Environmental Protection Agency. A Review of Contaminant Occurrence in Public Water Systems. EPA Report/ 816 R 99/ 006. Office of Water. 78 pp.

USEPA. 1998. U. S. Environmental Protection Agency. Announcement of the Drinking Water Contaminant Candidate List; Final Rule. Fed. Reg. 63( 274): 10273. March 2.

USEPA. 1997. U. S. Environmental Protection Agency. Announcement of the Draft Drinking Water Contaminant Candidate List; Notice. Fed. Reg. 62( 193): 52193. October 6.

USEPA. 1997. U. S. Environmental Protection Agency. Exposure factor handbook. Office of Research and Development. Washington, D. C. EPA/ 600/ P 95/ 002Fa.

USEPA. 1996/ 1999. U. S. Environmental Protection Agency. Proposed Cancer Guidelines. Available on the Internet at: http:// www. epa. gov/ ORD/ WebPubs/ carcinogen / carcin. pdf.

USEPA. 1993 ( Section 9). U. S. Environmental Protection Agency. IRIS document for aldrin. Available on the Internet at: http:// www. epa. gov/ ngispgm3/ iris/ index. html.

USEPA. 1993a ( Sections 7 and 8). U. S. Environmental Protection Agency. IRIS document for aldrin. Available on the Internet at: http:// www. epa. gov/ ngispgm3/ iris/ index. html.

USEPA. 1993b. U. S. Environmental Protection Agency. IRIS document for dieldrin. Available on the Internet at: http:// www. epa. gov/ ngispgm3/ iris/ index. html.

USEPA. 1992 ( Section 4). U. S. Environmental Protection Agency. Drinking Water; National Primary Drinking Water Regulations   Synthetic Organic Chemicals and Inorganic Chemicals; National Primary Drinking Water Regulations Implementation. Fed. Reg. 57( 138): 31776  31849. July 17.

USEPA. 1992 ( Sections 1, 2, 3, 6, 7, 8). U. S. Environmental Protection Agency. Aldrin drinking water health advisory. Washington, DC: USEPA Office of Water.

USEPA. 1991. National Primary Drinking Water Regulations  Synthetic Organic Chemicals and Inorganic Chemicals; Monitoring for Unregulated Contaminants; National Primary Drinking Water Regulations Implementation; National Secondary Drinking Water Regulations; Final Rule. Fed. Reg. 56( 20): 3526  3597. January 30.

USEPA. 1988 ( Section 5). U. S. Environmental Protection Agency. Recommendations for and documentation of biological values for use in risk assessment. Environmental Criteria and Assessment Office. Office of Health and Environmental Assessment. Office of Research and Development. Cincinnati, Ohio. EPA/ 600/ 6 87/ 008.

USEPA. 1988 ( Sections 1, 2, 3, 6, 7, 8, 9). U. S. Environmental Protection Agency. Dieldrin health advisory. Washington, DC: USEPA Office of Water. 10 27 Aldrin/ Dieldrin   February 2003 USEPA. 1987 ( Section 4). U. S. Environmental Protection Agency. National Primary Drinking Water Regulations Synthetic Organic Chemicals; Monitoring for Unregulated Contaminants; Final Rule. Fed. Reg. 52( 130): 25720. July 8.

USEPA. 1987 ( Sections 6, 7, 8, 9). U. S. Environmental Protection Agency. Carcinogenicity assessment of aldrin and dieldrin. Document no. EPA 600/ 6 87/ 006, August 1987. Washington, DC: USEPA Office of Health and Environmental Assessment, Carcinogenesis Assessment Group.

USEPA. 1987a ( Section 1). U. S. Environmental Protection Agency. Integrated Risk Information System ( IRIS): Dieldrin. Cincinnati, OH.

USEPA. 1987b ( Section 1). U. S. Environmental Protection Agency. Carcinogenicity assessment of Dieldrin and Aldrin. ( CAG).

USEPA. 1986 ( Section 1). U. S. Environmental Protection Agency. Integrated Risk Information System ( IRIS): Aldrin. Cincinnati, OH.

USEPA. 1986 ( Sections 7, 8, 9). U. S. Environmental Protection Agency. Guidelines for carcinogen risk assessment. Fed. Reg. 51( 185): 33992 34003. September 24.

USEPA. 1980. U. S. Environmental Protection Agency. Ambient water quality criteria for aldrin/ dieldrin. Document no. EPA 440/ 5 80 019. Washington, DC: USEPA Office of Water, Office of Water Regulations and Standards, Criteria and Standards Division.

USGS. 2000. U. S. Geological Survey. Pesticides in Stream Sediment and Aquatic Biota. USGS Fact Sheet FS 092 00. 4 pp.

USGS. 1999 ( Section 4). U. S. Geological Survey. The Quality of Our Nation's Waters: Nutrients and Pesticides. U. S. Geological Survey Circular 1225. Reston, VA: United States Geological Survey. 82 pp.

USGS. 1999a ( Section 4). U. S. Geological Survey. The Quality of Our Nation's Waters: Nutrients and Pesticides. U. S. Geological Survey Circular 1225. Reston, VA: United States Geological Survey. 82 pp.

USGS. 1999b ( Section 4). U. S. Geological Survey. Pesticides Analyzed in NAWQA Samples: Use, Chemical Analyses, and Water Quality Criteria. PROVISIONAL DATA  SUBJECT TO REVISION. Available on the Internet at: http:// water. wr. usgs. gov/ pnsp/ anstrat/ Last modified August 20, 1999.

USGS. 1998. U. S. Geological Survey. Pesticides in Surface and Ground Water of the United States: Summary of Results of the National Water Quality Assessment Program ( NAWQA). PROVISIONAL DATA  SUBJECT TO REVISION. Available on the Internet at: http:// water. wr. usgs. gov/ pnsp/ allsum/ Last modified October 9, 1998. 10 28 Aldrin/ Dieldrin   February 2003 van Raalte, H. G. S. 1977. Human experience with dieldrin in perspective. Ecotox. Environ. Saf. 1: 203 210 ( as cited in ATSDR, 2000). van Ravenzwaay, B. and W. Kunz. 1988. Quantitative aspects of accelerated nuclear polyploidization and tumour formation in dieldrin treated CF 1 mouse liver. Br. J. Cancer 58: 52 56 ( as cited in GAP2000, 2000b).

Verschueren, K. 1983. Handbook of environmental data on organic chemicals, 2nd ed. New York, NY: Van Nostrand Reinhold, pp. 168 173, 513 518.

Versteeg, J. P. J. and K. W. Jager. 1973. Long term occupational exposure to the insecticides aldrin, dieldrin, endrin, and telodrin. Br. J. Ind. Med. 30: 201 202 ( as cited in ATSDR, 2000).

Virgo, B. B. and G. D. Bellward. 1977. Effects of dietary dieldrin on offspring viability, maternal behavior, and milk production in the mouse. Res. Commun. Chem. Pathol. Pharmacol. 17: 399 409 ( as cited in ATSDR, 2000; IPCS, 1989b).

Virgo, B. B. and G. D. Bellward. 1975. Effects of dietary dieldrin on reproduction in the Swiss Vancouver ( SWV) mouse. Environ. Physiol. Biochem. 5: 440 450 ( as cited in ATSDR, 2000; IPCS, 1989b).

Wade, M. G., D. Desaulniers, K. Leingartner, and W. G. Foster. 1997. Interactions between endosulfan and dieldrin on estrogen mediated processes in vitro and in vivo. Reprod. Toxicol. 11: 791 798.

Wade, M. H., J. E. Trosko, and M. Schindler. 1986. A flourescence photobleaching assay of gap junction mediated communication between human cells. Science 232: 525 528 ( as cited in GAP2000, 2000b).

Wade, M. J., J. W. Moyer, and C. H. Hine. 1979. Mutagenic action of a series of epoxides. Mutat. Res. 66( 4): 367 371 ( as cited in USEPA, 1993b; GAP2000, 2000b).

Wagner, S. R. and F. E. Greene. 1978. Dieldrin induced alterations in biogenic amine content of rat brain. Toxicol. Appl. Pharmacol. 43: 45 55 ( as cited in ATSDR, 2000).

Walker, A. I. T., E. Thorpe, and D. E. Stevenson. 1972. The toxicology of dieldrin ( HEOD). I. Long term oral toxicity studies in mice. Food Cosmet. Toxicol. 11: 415 432 ( as cited in USEPA, 1987, 1988, and 1993b).

Walker, A. I. T., E. Thorpe, J. Robinson and M. K. Baldwin. 1971. Toxicity studies on the photoisomerisation product of dieldrin. Meded. Fac. Landbouwwet. Rijksuniv. Gent. 36( 1): 398 409 ( as cited in IARC, 1974b; IPCS, 1989b).

Walker, A. I. T., D. E. Stevenson, J. Robinson, E. Thorpe, and M. Roberts. 1969. The toxicology and pharmacodynamics of dieldrin ( HEOD): Two year oral exposures of rats and dogs. Toxicol. Appl. Pharmacol. 15: 345 373 ( as cited in ATSDR, 2000; IPCS, 1989b; USEPA, 1980). 10 29 Aldrin/ Dieldrin   February 2003 Wallace, J. C., L. P. Brzuzy, S. L. Simonich, S. M. Visscher, and R. A. Hites. 1996. Case Study of organochlorine pesticides in the indoor air of a home. Environ. Sci. Technol. 30 ( 9): 2715 2718.

Walton, M. S. V. Beck Bastone and R. L. Baron. 1971. Subchronic toxicity of photodieldrin, a photodecomposition product of dieldrin. Toxicol. Appl. Pharmacol. 20( 1): 82 88 ( as cited in IPCS, 1989b).

Warnick S. L. and J. E. Carter. 1972. Some findings in a study of workers occupationally exposed to pesticides. Arch. Environ. Health 25: 265 270 ( as cited in ATSDR, 2000).

Weisgerber, I., J. Kohli, R. Kaul, W. Klein and F. Korte. 1974. Fate of aldrin 14C in maize, wheat and soils under outdoor conditions. J. Agric. Food Chem. 22( 4): 609 612 ( as cited in HSDB, 2000a; IPCS, 1989b).

Winteringham, F. P. W. and J. B. Barnes. 1955. Comparative response of insects and mammals to certain halogenated hydrocarbons used as pesticides. Physiol. Rev. 35: 701 ( as cited in USEPA, 1980).

Witherup, S., K. L. Stemmer, J. L. Roberts, et al. 1961. Prolonged cutaneous contact of wool impregnated with dieldrin. The Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati. Cincinnati, OH ( as cited in ATSDR, 2000).

Wolff, T., E. Deml and H. Wanders. 1979. Aldrin epoxidation, a highly sensitive indicator specific for cytochrome P 450 dependent monooxygenase activities. Drug Metab. Dispos. 7: 301 305 ( as cited in ATSDR, 2000).

Wong, D. T. and L. C. Terriere. 1965. Epoxidation of aldrin, isodrin, and heptachlor by rat liver microsomes. Biochem. Pharmacol. 14: 375 377 ( as cited in ATSDR, 2000; IARC, 1974a; USEPA, 1980).

Woolley, D., L. Zimmer, D. Dodge, and K. Swanson. 1985. Effects of lindane type insecticides in mammals: Unsolved problems. Neurotoxicity 6: 165 192 ( as cited in ATSDR, 2000).

Wright, A. S., C. Donninger, R. D. Greenland, K. L. Stemmer and M. R. Zavon. 1978. The effects of prolonged ingestion of dieldrin on the livers of male rhesus monkeys. Ecotoxicol. Environ. Saf. 1( 4): 477 502 ( as cited in IPCS, 1989b; TOXLINE, 2000a).

Wright, A. S., D. Potter, M. F. Wooder, C. Donninger, R. D. Greenland. 1972. The effects of dieldrin on the subcellular structure and function of mammalian liver cells. Food Cosmet. Toxicol. 10: 311 332 ( as cited in ATSDR, 2000).

Yess, N. J., E. L. Gunderson, and R. R. Roy. 1993. U. S. Food and Drug Administration monitoring of pesticide residues in infant foods and adult foods eaten by infants/ children. J. AOAC Int. 76 ( 3): 492 507. 10 30 Aldrin/ Dieldrin   February 2003 Zabik, M. E., M. J. Zabik, A. M. Booren, S. Daubenmire, M. A. Pascall, R. Welch, and H. Humphrey. 1995. Pesticides and total polychlorinated biphenyls residues in raw and cooked walleye and white bass harvested from the Great Lakes. Bull. Environ. Contam. Toxicol. 54 ( 3): 396 402.

Zhong Xiang, L., T. Kavanagh, J. E. Trosko, and C. C. Chang. 1986. Inhibition of gap junctional intercellular communication in human teratocarcinoma cells by organochlorine pesticides. Toxicol. Appl. Pharmacol. 83: 10 19 ( as cited in GAP2000, 2000a, b). A1 Aldrin/ Dieldrin   February 2003 Abbreviations and Acronyms ACGIH  American Conference of Governmental Industrial Hygienists ADI  Acceptable Daily Intake AI  active ingredient ATSDR  Agency for Toxic Substances and Disease Registry BCF  bioconcentration factor BCH  bicycloheptadiene BTFs  biotransfer factors CASRN  Chemical Abstract Service Registry Number CCL  Contaminant Candidate List CERCLA  Comprehensive Environmental Response, Compensation & Liability Act CI  Confidence Interval CMR  Chemical Monitoring Reform CNS  central nervous system CWSs  community water systems DBCP  dibromochloropropane 2,3 DHBA  2,3 dihydroxybenzoic acid DMPC  dimyristoylphosphatidylcholine DNA  deoxyribonucleic acid DPH  1,6 diphenyl 1,3,5 hexatriene DPH PA  propionic acid deriative of DPH DRG  dorsal root ganglion EEG  electroencephalogram EMAP  Environmental Monitoring Assessment Program EPA  Environmental Protection Agency EPCRA  Emergency Planning and Community Right to Know Act F  female FDA  Food and Drug Administration FIFRA  Federal Insecticide, Fungicide, and Rodenticide Act FSH  follicle stimulating hormone GABA  gamma aminobutyric acid GAD ir  glutamate decarboxylase immunoreactive GC/ MS  gas chromotography/ mass spectometry gd  gestation day GI  gastrointestinal tract G6P  glucose 6 phosphatase deficient GW  ground water A2 Aldrin/ Dieldrin   February 2003 HazDat  Hazardous Substance Release and Health Effects Database HCCPD  hexachlorocyclopentadiene HRL  Health Reference Level HSDB  Hazardous Substances Data Bank IARC  International Agency for Research on Cancer IC 50  IOC  inorganic contaminant IPCS  International Programme on Chemical Safety IRIS  Integrated Risk Information System IUPAC  International Union of Pure and Applied Chemistry LD 50  lethal dose LH  Lutenizing hormone LOAEL  lowest observed adverse effect level M  male MCLG  Maximum Contaminant Level Goal MDA  malondialdehyde MDL  Method Detection Limit MMT  methylcyclopentadienyl manganese tricarbonyl MRL  Minimum Reporting Level mRNA  messenger ribonucleic acid MW  molecular weight NADPH  nicotine adenine dinucleotide phosphate NAS/ OW  National Academy of Sciences/ Office of Water NAWQA  National Water Quality Assessment Program NCOD  National Drinking Water Contaminant Occurrence Database NDWAC  National Drinking Water Advisory Council NOAA  National Oceanic and Atmospheric Administration NOAEL  no observed adverse effect level NPDWR  National Primary Drinking Water Regulation NPL  National Priorities List NTNCWSs  non purchased non transient non community water systems OH8dG  8 hydroxy 2' deoxyguanosine PB  phenobarbital PES  prostaglandin endoperoxide synthase PGG 2  prostaglandin G 2 PHG 2  prostaglandin H 2 ppd  postpartum day ppm  part per million A3 Aldrin/ Dieldrin   February 2003 PWS  Public Water System q1*  geometric mean R2 ARS  Round 2 states RBCs  red blood cells RCRA  Resource Conservation and Recovery Act RfD  Reference Dose ROS  reactive oxygen species RSD  risk specific dose R2 X  Round 2 cross section SARA Title III  Superfund Amendments and Reauthorization Act SCE  sister chromatid exchanges SDWA  Safe Drinking Water Act SDWIS/ FED  Safe Drinking Water Information System ( Federal version) SMRs  standardized mortality ratios SOC  synthetic organic compound 35S TBPS  t 35S butyl bicyclophosphorothionate SW  surface water TE 50  median effective time TH ir  tyrosine hydroxylase immunoreactive TRI  Toxic Release Inventory UCM  Unregulated Contaminant Monitoring UCMR  Unregulated Contaminant Monitoring Regulation/ Rule UDPGA  uridine diphosphoglucuronic acid UDS  unscheduled DNA synthesis URCIS  Unregulated Contaminant Monitoring Information System USDA  United States Department of Agriculture USEPA  United States Environmental Protection Agency USGS  United States Geological Survey UV  ultraviolet VOC  volatile organic compound atm  atmospheres atm m3/ mol  atmospheres cubic meter per mole oC  degrees Celsius cm  centimeters cm2  square centimeters g  grams g/ cc  grams per cubic centimeter kg  kilograms A4 Aldrin/ Dieldrin   February 2003 kg/ day  kilograms per day kg/ ha  kilograms per hectare L/ day  liters per day lbs  pounds M  molar m  meter mg/ cm2  milligrams per square centimeter mg/ day  milligrams per day mg/ kg  milligrams per kilogram mg/ kg bw  milligrams per kilogram per body weight mg/ kg bw/ day  milligrams per kilogram per body weight per day mg/ kg bw/ week  miiligrams per kilogram per body weight per week mg/ L  milligrams per liter mg/ m3  milligrams per cubic meter mL  milliliter mm Hg  millimeters of mercury ng/ g  nanograms per gram ng/ L  nanograms per liter ng/ m3  nanograms per cubic meter ng/ mL  nanograms per milliliter nM  nanomolar nm  nanometers nmol/ mL  nanomole per milliliter pM  pico molar ppb  parts per billion : g  micrograms : g/ cm2  micrograms per square centimeter : g/ g  micrograms per gram : g/ L  micrograms per liter : g/ m2  micrograms per square meter : g/ m3  micrograms per cubic meter : M  micro molar B1 Aldrin/ Dieldrin   February 2003 APPENDIX A: Round 2 Aldrin Occurrence Aldrin Occurrence in Public Water Systems in Round 2, UCM ( 1993) results STATE TOTAL UNIQUE PWS # GW PWS # SW PWS % PWS with detections % GW PWS with % SW PWS with detections % PWS > HRL % GW PWS > HRL % SW PWS > HRL 99% VALUE ( µ g/ L)

Tribes ( 06) 26 25 1 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.50 AK 34 24 10 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 AL 16 11 5 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 0.68 AR 536 431 105 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 AZ CA CO 750 538 212 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 CT 70 35 35 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 IN KY 366 184 182 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 2.00 LA 1,363 1,295 68 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.01 MA 56 29 27 17.86% 17.24% 18.52% 17.86% 17.24% 18.52% 4.40 MD 726 669 57 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 1.00 ME MI 2,650 2,570 80 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 MN 1,264 1,234 30 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 MO 378 280 98 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.10 MS 12 11 1 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 NC 536 490 46 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 ND 296 258 38 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.01 NH 593 560 33 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 NJ NM 720 691 29 0.14% 0.14% 0.00% 0.14% 0.14% 0.00% < 1.00 OH 1,029 882 147 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 30.00 OK 98 76 22 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 OR 1,152 999 153 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 PA 68 57 11 5.88% 7.02% 0.00% 5.88% 7.02% 0.00% 0.10 RI 24 15 9 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.20 SC 939 841 98 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 SD TN 7 2 5 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 TX 427 122 305 0.23% 0.82% 0.00% 0.23% 0.82% 0.00% < 0.20 VT 401 349 52 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 WA 586 517 69 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 WI TOTAL 15,123 13,195 1,928 0.21% 0.17% 0.52% 0.21% 0.17% 0.52% < 1.00 20 STATES 12,221 10,569 1,652 0.10% 0.07% 0.30% 0.10% 0.07% 0.30% < 2.00 19 STATES1 12,165 10,540 1,625 0.02% 0.02% 0.00% 0.02% 0.02% 0.00% < 2.00 1. Massachusetts data not included in " 19 States" summary statistics for Aldrin.

PWS= Public Water Systems; GW= Ground Water ( PWS Source Water Type); SW= Surface Water ( PWS Source Water Type); MRL= Minimum Reporting Limit ( for laboratory analyses).

The Health Reference Level ( HRL) is the estimated health effect level as provided by EPA for preliminary assessment for this work assignment.

"% > HRL" indicates the proportion of systems with any analytical results exceeding the concentration value of the HRL.

The Health Reference Level ( HRL) used for Aldrin is 0.002 µ g/ L. This is a draft value for working review only.

The highlighted States are part of the SDWIS/ FED 20 State Cross Section. B2 Aldrin/ Dieldrin   February 2003 APPENDIX B: Round 2 Dieldrin Occurrence Dieldrin Occurrence in Public Water Systems in Round 2, UCM ( 1993) results STATE TOTAL UNIQUE PWS # GW PWS # SW PWS % PWS > MRL % GW PWS > MRL % SW PWS > MRL % PWS > HRL % GW PWS > HRL % SW PWS > HRL 99% VALUE ( µ g/ L)

Tribes ( 06) 25 24 1 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.10 AK 16 12 4 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 AL 4 4 0 100.00% 0.00% 0.00% 100.00% 100.00% 0.00% 0.10 AR 536 431 105 0.19% 0.00% 0.95% 0.19% 0.00% 0.95% < 0.00 AZ CA CO 749 537 212 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 CT 70 35 35 1.43% 0.00% 2.86% 1.43% 0.00% 2.86% < 0.00 IN KY 44 20 24 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.21 LA 1,363 1,295 68 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.07 MA 55 28 27 18.18% 17.86% 18.52% 18.18% 17.86% 18.52% 4.40 MD 725 668 57 0.97% 0.90% 1.75% 0.97% 0.90% 1.75% < 1.00 ME MI 2,650 2,570 80 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 MN 1,264 1,234 30 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 MO 378 280 98 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.10 MS 12 11 1 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 NC 522 475 47 0.38% 0.42% 0.00% 0.38% 0.42% 0.00% < 0.00 ND 296 258 38 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.01 NH 593 560 33 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 NJ NM 716 687 29 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.20 OH 1,029 883 146 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 20.00 OK 98 76 22 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 OR 1,148 995 153 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 PA 67 56 11 7.46% 8.93% 0.00% 7.46% 8.93% 0.00% 0.10 RI 15 6 9 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.30 SC 939 841 98 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 SD TN 7 2 5 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 TX 427 122 305 0.23% 0.82% 0.00% 0.23% 0.82% 0.00% < 0.20 VT 395 343 52 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 WA 582 515 67 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% < 0.00 WI TOTAL 14,725 12,968 1,757 0.21% 0.18% 0.46% 0.21% 0.18% 0.46% < 0.30 20 STATES 11,843 10,357 1,486 0.18% 0.14% 0.47% 0.18% 0.14% 0.47% < 1.00 19 STATES 11,788 10,329 1,459 0.09% 0.09% 0.14% 0.09% 0.09% 0.14% < 1.00 1. Massachusetts data not included in " 19 States" summary statistics for Dieldrin.

PWS= Public Water Systems; GW= Ground Water ( PWS Source Water Type); SW= Surface Water ( PWS Source Water Type); MRL= Minimum Reporting Limit ( for laboratory analyses).

The Health Reference Level ( HRL) is the estimated health effect level as provided by EPA for preliminary assessment for this work assignment.

"% > HRL" indicates the proportion of systems with any analytical results exceeding the concentration value of the HRL.

The Health Reference Level ( HRL) used for Dieldrin is 0.002 µ g/ L. This is a draft value for working review only. The highlighted States are part of the SDWIS/ FED 20 State Cross Section.