[Federal Register Volume 77, Number 4 (Friday, January 6, 2012)]
[Rules and Regulations]
[Pages 745-749]
[FR Doc No: 2011-33846]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0944; FRL-9330-4]

Bacillus Amyloliquefaciens Strain D747; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Bacillus amyloliquefaciens strain
D747 (formerly known as Bacillus subtilis variant amyloliquefaciens
strain D747) in or on all food commodities when used in accordance with
good agricultural practices. Certis USA LLC submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Bacillus amyloliquefaciens strain D747 (formerly known as
Bacillus subtilis variant amyloliquefaciens strain D747).

DATES: This regulation is effective January 6, 2012. Objections and
requests for hearings must be received on or before March 6, 2012, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0944. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information the disclosure of which is restricted by statute.
Certain other material, such as copyrighted material, is not made
available via the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available in the
electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket Facility telephone number
is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural

producer, food manufacturer, or pesticide manufacturer. Potentially
affected entities may include, but are not limited to:
     Crop production (NAICS code 111);
     Animal production (NAICS code 112);
     Food manufacturing (NAICS code 311);
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but, rather,
provides a guide for readers regarding entities likely to be affected
by this action. Other types of entities not listed in this unit could
also be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist readers in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0944 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
March 6, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0944, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Avenue NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr. Arlington, VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of February 4, 2011 (76 FR 6465) (FRL-8858-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F7760) by Certis USA LLC, 9145 Guilford Road, Suite 175,
Columbia, MD 21046. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Bacillus subtilis variant amyloliquefaciens
strain D747 (now recognized as Bacillus amyloliquefaciens strain D747).
This notice referenced a summary of the petition prepared by the
petitioner, Certis USA LLC, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit VII.C.
    Based upon review of the data supporting the petition, EPA has
modified the nomenclature of the active ingredient, which was recently
reclassified as Bacillus amyloliquefaciens strain D747 (Refs. 1, 2, and
3). The reason for this change is explained in Unit III. A.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*'' Additionally, section 408(b)(2)(D) of FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of [a particular pesticide's] * * * residues and other
substances that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability,
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

A. Overview of Bacillus Amyloliquefaciens Strain D747

    Bacillus amyloliquefaciens strain D747 was previously identified as
Bacillus subtilis variant amyloliquefaciens strain D747 in the petition
submitted to exempt the bacterium from the requirement of a tolerance
when used as a microbial pesticide in or on all food commodities.
Bacillus subtilis and Bacillus amyloliquefaciens were considered
subtypes or variants of the same species. Now, however, Bacillus
amyloliquefaciens is taxonomically designated as a separate species.
The

taxonomic designation used in this final rule is correct.
    Certis USA, LLC, has proposed to register Bacillus
amyloliquefaciens strain D747 for control of fungi and bacteria in
greenhouses, nurseries, and shadehouses, and on outdoor agricultural
crops, ornamentals, and turfgrass. Bacillus amyloliquefaciens strain
D747 is the active ingredient in the two end-use products (EP) CX-9030
(EPA File Symbol 70051-RNI) and CX-9032 (EPA File Symbol 70051-RNT).

B. Microbial Pesticide Toxicology Data Requirements

    All mammalian toxicology data requirements supporting the petition
to exempt from the requirement of a tolerance residues of Bacillus
amyloliquefaciens strain D747 in or on all food commodities have been
fulfilled with acceptable studies. The acute oral, injection and
pulmonary toxicity/pathogenicity studies show that Bacillus
amyloliquefaciens strain D747 is not toxic, infective, or pathogenic at
the doses tested.
    1. Acute oral toxicity/pathogenicity (Office of Chemical Safety and
Pollution Prevention (OCSPP) Guideline 885.3050; Master Record
Identification Number (MRID) No. 481657-04). Bacillus amyloliquefaciens
strain D747 was administered once orally to 14 rats of both sexes (5-
weeks old) at a single dosage of 10\8\ colony-forming units (CFU) per
animal. No deaths occurred, and no abnormalities (clinical signs, body
weight) were observed, during the study or at necropsy. The test
microbe was detected at 10\3\-10\5\ CFU/g in feces 1 day after
administration of the test material, but was not detected on day 14.
The examination for internal persistence did not detect the test
microbe in any organs or tissues, such as the kidney, brain, liver,
lung, spleen, stomach, small intestine (duodenum), large intestine
(cecum), mesenteric lymph nodes, or blood, throughout the experimental
period. Fecal clearance occurred by day 14, and no viable organisms
were recovered from blood or other organs or tissues. The results of
this acceptable study demonstrated that Bacillus amyloliquefaciens
strain D747 was not infective, pathogenic, or toxic to rats when orally
dosed with 1.0 x 10\8\ CFU/animal.
    2. Acute pulmonary toxicity/pathogenicity (OCSPP Guideline
885.3150; MRID No.481657-06). Twenty male and female rats were given a
single dose of 1.0 x 10\7\ spores Bacillus amyloliquefaciens strain
D747 via a tracheal route of administration. No mortalities or clinical
effects were observed in the test animals throughout the duration of
the study. Clearance of the test material was steady, although residual
viable cells remained in the lungs and trachea at the end of the 60 day
study. This result was typical of spore forming bacteria because
bacterial spores take longer to be cleared by healthy immune systems
than the vegetative form of bacteria. This acceptable study
demonstrated that Bacillus amyloliquefaciens strain D747 was not toxic
and/or pathogenic to rats when dosed intratracheally at 1.0 x 10\7\
(CFU)/animal.
    3. Acute injection toxicity/pathogenicity (intravenous)--rat (OCSPP
Guideline 885.3200; MRID No. 481657-05). An acceptable acute injection
toxicity and pathogenicity study demonstrated that Bacillus
amyloliquefaciens strain D747 was not toxic, infective, or pathogenic
to rats that were injected with approximately 1.0 x 10\7\ CFU/animal.
    4. Bacillus amyloliquefaciens strain D747 was administered
intravenously to groups of 17 male and female rats at a dose of 1.0 x
10\7\ spores per animal. There were no mortalities, no clinical effects
from intravenous administration, and steady weight gain of treated rats
throughout the study duration. Clearance was steady though residual
viable cells remained in the liver and spleen at day 60 on study
termination, typical of spore forming bacteria administered to rats.
There was no evidence of an increase in viable counts over time that
would be indicative of a chronic infection. Since a pattern of
clearance was shown, it is assumed that the remaining viable cells were
spores that take longer to be cleared by healthy immune systems.
    5. Acute dermal toxicity (OCSPP Guideline 870.1200; MRID No.
481657-08). An acceptable 14-day acute dermal toxicity study
demonstrated that that the CX-9030 product, which contains Bacillus
amyloliquefaciens strain D747, was not toxic in rats dosed at 5,050 mg/
kg. [median lethal dose, (LD50) > 5,050 mg/kg. EPA Toxicity
Category IV.]
    6. Acute dermal irritation (OCSPP Guideline 870.2500; MRID No.:
481655-11). An acceptable dermal irritation study demonstrated that no
evidence of irritation occurred from dermal administration of 500 mg of
CX-9030 to rabbits during the 4-hour exposure and the 72-hour
observation period. The dermal irritation score for Bacillus
amyloliquefaciens strain D747 CX-9030 was 0.00 (EPA Toxicity Category
IV).
    7. Acute dermal irritation (OCSPP Guideline 870.2500; MRID No.:
481655-06). A second acceptable dermal irritation study also
demonstrated that CX-9032 product containing Bacillus amyloliquefaciens
strain D747 was non-irritating. No evidence of irritation was observed
for 72 hours following the 4 hour dermal administration of 0.5 mL
undiluted CX-9032 to the shaved skin rabbits. The dermal irritation
score for Bacillus amyloliquefaciens strain D747 CX-9032 was 0.00 (EPA
Toxicity Category IV).

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    Dietary exposure to this microbial pesticide may occur, but the
complete absence of any acute oral toxicity, infectivity, and/or
pathogenicity effects, as discussed in Unit III.B., supports the
conclusion that this active ingredient is not toxic at high exposure
levels, and, therefore, establishment of a tolerance exemption for
residues of Bacillus amyloliquefaciens strain D747 is appropriate.
    1. Food. Based on the results from the toxicity studies presented
in Unit III.B., no toxicity, infectivity, pathogenicity or other
adverse effects from dietary exposure to Bacillus amyloliquefaciens
strain D747 from the proposed pesticidal uses of Bacillus
amyloliquefaciens strain D747 are expected. Bacillus species, including
Bacillus amyloliquefaciens, are commonly found in agricultural
settings, and occur naturally on fresh produce with no known adverse
effects. The Manual of Clinical Microbiology (9th edition) mentions
that dried food, such as spices, milk powder, and grains, often
contains large amounts of Bacillus spores (Ref. 3). Bacillus
amyloliquefaciens is not known to produce mammalian toxins, and no
foodborne illnesses associated with Bacillus amyloliquefaciens have
been reported.
    2. Drinking water exposure. Bacillus amyloliquefaciens is naturally
present in soils (Ref. 2); therefore, Bacillus amyloliquefaciens may
occur in surface water and possibly groundwater. According to the World
Health Organization, Bacillus species are often detected in drinking
water even after going through acceptable water treatment processes,
largely because the spores are resistant to these disinfection

processes (Ref. 4). Should this microbial pesticide be present, no
adverse effects are expected from exposure to Bacillus
amyloliquefaciens through drinking water, based on the results of
toxicity studies described in Unit III.B.

B. Other Non-Occupational Exposure

    The use sites for these products include residential gardens, as
well as agricultural sites. Based on the results of the acute toxicity
tests described in Unit III.B., the Agency believes that the potential
aggregate, non-occupational risks from exposure to Bacillus
amyloliquefaciens strain D747, when used as a microbial pesticide, are
negligible.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information concerning the cumulative effects of
[a particular pesticide's] * * * residues and other substances that
have a common mechanism of toxicity.''
    EPA has not found the microbial active ingredient to share a common
mechanism of toxicity with any other substances, and Bacillus
amyloliquefaciens strain D747 does not appear to produce any toxic
metabolites. For the purposes of this tolerance action, therefore, EPA
has assumed that Bacillus amyloliquefaciens strain D747 does not have a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the Food Quality Protection Act Safety
Factor. In applying this provision, EPA either retains the default
value of 10X or uses a different safety factor when reliable data
available to EPA support the choice of a different factor.
    Based on the acute toxicity and pathogenicity data/information
summarized in Unit III, EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to the residues of
Bacillus amyloliquefaciens strain D747. Such exposure includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. EPA has arrived at this conclusion because,
considered collectively, the data and other information (e.g., lack of
toxicity noted for oral, dermal, and inhalation routes of exposure)
available on Bacillus amyloliquefaciens strain D747 do not demonstrate
toxic, pathogenic, and/or infective potential to sensitive populations
from exposure to this microbial pest control agent. There are no
threshold effects of concern and, as a result, the provision requiring
an additional margin of safety is not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Bacillus amyloliquefaciens
strain D747.

C. Response to Comments

    Two comments were submitted. An anonymous comment was submitted
expressing opposition to granting an exemption from the requirement of
a tolerance to the applicant. (EPA-HQ-OPP-2010-0012-0019). The
commenter submitted a number of comments in the same communication that
suggested that this and other active ingredients should not be granted
exemptions. The commenter expressed concern about toxic chemical
residues on produce and on earth, and suggested that the ``Dept. of
Health'' should analyze the health effects of toxic chemicals. In the
United States, EPA is responsible for regulating pesticides under FIFRA
and the FQPA, and has analyzed the toxicity of this microbial active
ingredient. As described in Unit III.B., the results of the acute oral,
injection and pulmonary toxicity/pathogenicity studies demonstrated
that Bacillus amyloliquefaciens strain D747 is not toxic, infective or
pathogenic at the doses tested.
    Another commenter also expressed opposition to granting a tolerance
or an exemption from the requirement of a tolerance for this and other
chemicals that were listed in the same registration notice. (EPA-HQ-
OPP-2010-0905-0003). This commenter stated that the food supply must be
rigorously tested, that studies must be subjected to independent peer
review, and that only long term studies can provide data on the health
impact to these chemicals. Consistent with section 408(b)(2)(D) of
FFDCA, the testing data that were provided and evaluated by EPA for
Bacillus amyloliquefaciens strain D747, as described in Unit III.B.,
support granting this exemption.

VIII. Conclusions

    Therefore, an exemption is established for residues of Bacillus
amyloliquefaciens strain D747.

IX. References

1. Priest, F.G., M. Goodfellow, L.A. Shute, and R.C.W. Berkeley.
1987. Bacillus amyloliquefaciens sp. nov., nom. rev. International
Journal of Systematic Bacteriology, 37: 69-71.
2. Logan, N.A., and P. de Vos. 2009. Genus I. Bacillus, Pp. 21-128
In: P. de Vos, G.M. Garrity, D. Jones, N.R. Krieg, W. Ludwig, F.A.
Rainey, K.H. Schleifer, and W. Whitman (Eds.) Bergey's Manual of
Systematic Bacteriology, Volume 3, 2nd Ed. Springer, New York.

3. Murray, P.R, et al., Manual of Clinical Microbiology. Washington,
DC: ASM Press; 9th edition, 2007.
4. World Health Organization, Guidelines for Drinking-water Quality.
(2011) 4th Ed.

 X. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this final rule has been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001)
or Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 15, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.308 is added to subpart D to read as follows:

Sec.  180.308  Bacillus amyloliquefaciens strain D747; exemption from
the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the microbial pesticide, Bacillus amyloliquefaciens strain
D747 in or on all food commodities when used in accordance with good
agricultural practices.

[FR Doc. 2011-33846 Filed 1-5-12; 8:45 am]
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[Federal Register: April 2, 2007 (Volume 72, Number 62)]
[Notices]
[Page 15675]
[DOCID:fr02ap07-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP97-13-030]

East Tennessee Natural Gas, LLC; Notice of Negotiated Rate

March 27, 2007.
    Take notice that on March 23, 2007, East Tennessee Natural Gas, LLC
(East Tennessee) tendered for filing as part of its FERC Gas Tariff,
Third Revised Volume No. 1, Original Sheet Nos. 26A and 26B.
    East Tennessee states that copies of its filing have been mailed to
all affected customers and interested state commissions, as well as all
parties on the official service list.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-6005 Filed 3-30-07; 8:45 am]

BILLING CODE 6717-01-P


U. S. ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES ( OPPTS) 1200 Pennsylvania Avenue, N. W. , Washington, D. C. 20460 OMB REVIEW UNDER EXECUTIVE ORDER 12866 DOCUMENTATION OF CHANGES MADE DURING OMB REVIEW Title of Action: Human Testing; Advance Notice of Proposed Rulemaking Docket #: OPP 2003 0132 FRL#: 7302 8 RIN #: 2070 AD57 This action was submitted to the Office of Management and Budget ( OMB) for review under Executive Order 12866, which is entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). According to section 6( a)( 3)( E) of the Executive Order, whenever the Agency makes publicly available a regulatory action that was reviewed under Executive Order 12866, the Agency is also required to make certain information available to the public. [ Please check the appropriate box below:]

G For this regulatory action, no substantive changes were made to the document. Accordingly, this rulemaking docket contians a copy of the information that was provided to OMB's Office of Information and Regulatory Affairs ( OIRA) for review under to the Executive Order, i. e., the text of the draft regulatory action and an assessment of the potential costs and benefits; as well as additional information required for those actions that are determined to be significant under section 3( f) of the Executive Order.

For this regulatory action, substantive changes were made to the document. Accordingly, this rulemaking docket:

1) contains a copy of the information that was provided to OMB's Office of Information and Regulatory Affairs ( OIRA) for review under to the Executive Order, i. e., the text of the draft regulatory action and an assessment of the potential costs and benefits; as well as additional information required for those actions that are determined to be significant under section 3( f) of the Executive Order; and 2) the attached information identifies any substantive changes that were made to the draft regulatory text that was submitted to OIRA, and which subsequently published.

Additional Comments: See attached document, redlined to highlight changes made during OMB review under EO 12866.

If you have any questions about this action, please call the contact: Name: Bill Jordan E Mail: jordan. william@ epa. gov Phone: 703 305 1049 RCS  OMB 7f ( 04/ 15/ 97) FILE NAME: HS ANPR 3 28 03 EO12866revisions: Redlined to show changes 1 Deliberative   Do Not Cite or Quote 2 ENVIRONMENTAL PROTECTION AGENCY 3 [ RIN: 2070 AD57] 4 [ OPP 2003 0132; FRL XXXX X] 5 Human Testing; Advance Notice of Proposed Rulemaking 6 AGENCY: Environmental Protection Agency ( EPA). 7 ACTION: Notice. 8 ____________________________________________________________ 9 SUMMARY: This notice announces EPA's plan to conduct rulemaking about criteria 10 and standards EPA would apply in deciding the extent to which it will consider or rely 11 on various types of research with human subjects to support its actions. This notice 12 also initiates the rulemaking process by requesting public comments and suggestions 13 on a broad range of issues relating to this subject. 14 DATES: Comments must be received on or before [ insert date [ ninety] days after date 15 of publication in the Federal Register]. 16 ADDRESSES: Submit your comments, identified by docket ID number OPP 2003 0132, 17 online at http:// www. epa. gov/ edocket ( EPA

s preferred method) or mailed to the Public 18 Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), 19 Environmental Protection Agency, ( 7502C), 1200 Pennsylvania Ave., NW, Washington, 20 DC, 20460 0001. For additional submission methods and detailed instructions, go to 21 Unit I. C. of the SUPPLEMENTARY INFORMATION section. 22 FOR FURTHER INFORMATION CONTACT: William L. Jordan, Mailcode 7501 C, 23 Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 24 Ave., NW., Washington, DC 20460; telephone number: 703 305 1049 fax number: 703 25 308 4776; e mail address: jordan. william@ epa. gov. 26 SUPPLEMENTARY INFORMATION: 27 This Advance Notice of Proposed Rulemaking ( ANPR) is organized into four 28 Units. Unit I contains " General Information" about the applicability of this Notice, how 29 to obtain additional information, how to submit comments in response to the request for 30 comments, and certain other related matters. Unit II provides background and historic 31 information pertaining to human subject research. Unit III describes the rulemaking 32 process, identifies relevant statutory provisions, and requests public comments and 33 suggestions on a broad range of issues related to the Agency's consideration of or 34 reliance on research with human subjects. Unit IV describes procedures followed in the 35 development of this ANPR and certain statutes and Executive Orders that the public 36 may wish to consider in preparing comments. 37 I. General Information 38 A. Does this Action Apply to Me? 39 2 This action is directed to the public in general. This action may, however, be of 40 particular interest to those who conduct testing of substances regulated by EPA. Since 41 other entities may also be interested, the Agency has not attempted to describe all the 42 specific entities that may be affected by this action. If you have any questions 43 regarding the applicability of this action to a particular entity, consult the person listed 44 under FOR FURTHER INFORMATION CONTACT. 45 B. How Can I Get Copies of This Document and Other Related Information? 46 1. Docket. EPA has established an official public docket for this action under 47 docket identification ( ID) number OPP 2003 0132. The official public docket consists of 48 the documents specifically referenced in this action, any public comments received, 49 and other information related to this action. Although a part of the official docket, the 50 public docket does not include Confidential Business Information ( CBI) or other 51 information whose disclosure is restricted by statute. The official public docket is the 52 collection of materials that is available for public viewing at the Public Information and 53 Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., 54 Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through 55 Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 56 2. Electronic access. You may access this Federal Register document 57 electronically through the EPA Internet under the " Federal Register" listings at 58 http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 59 [ insert number] is available at 60 http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr[ insert part 61 number]_ 00. html, a beta site currently under development. 62 An electronic version of the public docket is available through EPA

s electronic 63 public docket and comment system, EPA Dockets. You may use EPA Dockets at 64 http:// www. epa. gov/ edocket to submit or view public comments, access the index listing 65 of the contents of the official public docket, and to access those documents in the 66 public docket that are available electronically. Once in the system, select " search," then 67 key in the appropriate docket ID number. 68 Certain types of information will not be placed in the EPA Dockets. Information 69 claimed as CBI and other information whose disclosure is restricted by statute, which is 70 not included in the official public docket, will not be available for public viewing in 71 EPA

s electronic public docket. EPA

s policy is that copyrighted material will not be 72 placed in EPA

s electronic public docket but will be available only in printed, paper 73 form in the official public docket. To the extent feasible, publicly available docket 74 materials will be made available in EPA

s electronic public docket. When a document is 75 selected from the index list in EPA Dockets, the system will identify whether the 76 document is available for viewing in EPA

s electronic public docket. Although not all 77 docket materials may be available electronically, you may still access any of the 78 publicly available docket materials through the docket facility identified in Unit I. B. 1. 79 EPA intends to work towards providing electronic access to all of the publicly available 80 docket materials through EPA

s electronic public docket. 81 3 For public commenters, it is important to note that EPA

s policy is that public 82 comments, whether submitted electronically or on paper, will be made available for 83 public viewing in EPA

s electronic public docket as EPA receives them and without 84 change, unless the comment contains copyrighted material, CBI, or other information 85 whose disclosure is restricted by statute. When EPA identifies a comment containing 86 copyrighted material, EPA will provide a reference to that material in the version of the 87 comment that is placed in EPA

s electronic public docket. The entire printed comment, 88 including the copyrighted material, will be available in the public docket. Public 89 comments submitted on computer disks that are mailed or delivered to the docket will 90 be transferred to EPA

s electronic public docket. Public comments that are mailed or 91 delivered to the docket will be scanned and placed in EPA

s electronic public docket. 92 Where practical, physical objects will be photographed, and the photograph will be 93 placed in EPA

s electronic public docket along with a brief description written by the 94 docket staff. 95 C. How and To Whom Do I Submit Comments? 96 You may submit comments electronically, by mail, or through hand 97 delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID 98 number in the subject line on the first page of your comment. Please ensure that your 99 comments are submitted within the specified comment period. Comments received after 100 the close of the comment period will be marked " late." EPA is not required to consider 101 these late comments. If you wish to submit CBI or information that is otherwise 102 protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets 103 or e mail to submit CBI or information protected by statute. 104 1. Electronically. If you submit an electronic comment as prescribed in this unit, 105 EPA recommends that you include your name, mailing address, and an e mail address 106 or other contact information in the body of your comment. Also include this contact 107 information on the outside of any disk or CD ROM you submit, and in any cover letter 108 accompanying the disk or CD ROM. This ensures that you can be identified as the 109 submitter of the comment and allows EPA to contact you in case EPA cannot read your 110 comment due to technical difficulties or needs further information on the substance of 111 your comment. EPA

s policy is that EPA will not edit your comment, and any identifying 112 or contact information provided in the body of a comment will be included as part of the 113 comment that is placed in the official public docket, and made available in EPA

s 114 electronic public docket. If EPA cannot read your comment due to technical difficulties 115 and cannot contact you for clarification, EPA may not be able to consider your 116 comment. 117 i. EPA Dockets. Your use of EPA

s electronic public docket to submit comments 118 to EPA electronically is EPA

s preferred method for receiving comments. Go directly to 119 EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for 120 submitting comments. Once in the system, select " search," and then key in docket ID 121 number OPP 2003 0132. The system is an " anonymous access" system, which means 122 EPA will not know your identity, e mail address, or other contact information unless you 123 provide it in the body of your comment. 124 ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: 125 Docket ID Number OPP 2003 0132. In contrast to EPA

s electronic public docket, 126 4 EPA

s e mail system is not an " anonymous access" system. If you send an e mail 127 comment directly to the docket without going through EPA

s electronic public docket, 128 EPA

s e mail system automatically captures your e mail address. E mail addresses that 129 are automatically captured by EPA

s e mail system are included as part of the comment 130 that is placed in the official public docket, and made available in EPA

s electronic 131 public docket. 132 iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you 133 mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be 134 accepted in WordPerfect or ASCII file format. Avoid the use of special characters and 135 any form of encryption. 136 2. By mail. Send your comments to: Public Information and Records Integrity 137 Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency 138 ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC, 20460 0001, Attention: 139 Docket ID Number OPP 2003 0132. 140 3. By hand delivery or courier. Deliver your comments to: Public Information and 141 Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental 142 Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, 143 VA., Attention: Docket ID Number OPP 2003 0132. Such deliveries are only accepted 144 during the docket

s normal hours of operation as identified in Unit I. A. 1. 145 D. How Should I Submit CBI To the Agency? 146 Do not submit information that you consider to be CBI electronically through 147 EPA

s electronic public docket or by e mail. You may claim information that you submit 148 to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI 149 on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify 150 electronically within the disk or CD ROM the specific information that is CBI). 151 Information so marked will not be disclosed except in accordance with procedures set 152 forth in 40 CFR part 2. 153 In addition to one complete version of the comment that includes any information 154 claimed as CBI, a copy of the comment that does not contain the information claimed 155 as CBI must be submitted for inclusion in the public docket and EPA

s electronic public 156 docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the 157 outside of the disk or CD ROM clearly that it does not contain CBI. Information not 158 marked as CBI will be included in the public docket and EPA

s electronic public docket 159 without prior notice. If you have any questions about CBI or the procedures for claiming 160 CBI, please consult the person listed under FOR FURTHER INFORMATION 161 CONTACT." 162 E. What Should I Consider as I Prepare My Comments for EPA? 163 You may find the following suggestions helpful for preparing your comments: 164 1. Explain your views as clearly as possible. 165 2. Describe any assumptions that you used. 166 3. Provide copies of any technical information and/ or data you used that support 167 5 your views. 168 4. If you estimate potential burden or costs, explain how you arrived at the estimate 169 that you provide. 170 5. Provide specific examples to illustrate your concerns. 171 6. Offer alternative ways to improve the notice or collection activity. 172 76. Make sure to submit your comments by the deadline in this notice. 173 87. To ensure proper receipt by EPA, be sure to identify the docket control number 174 assigned to this action in the subject line on the first page of your response. You 175 may also provide the name, date, and Federal Register citation. 176 II. Introduction 177 A. Background on Federal Standards for Conducting Human Research 178 Over the years, scientific research with human subjects has provided much 179 valuable information to help characterize and control risks to public health, but its use 180 has also raised particular ethical concerns for the welfare of the human participants in 181 such research as well as scientific issues related to the role of such research in 182 assessing risks. Society has responded to these concerns by defining general 183 standards for conducting human research. In the United States, the National 184 Commission for the Protection of Human Subjects of Biomedical and Behavioral 185 Research issued in 1979 The Belmont Report: Ethical Principles and Guidelines for the 186 Protection of Human Subjects of Research. This document can be found on the web at 187 http:// ohsr. od. nih. gov/ mpa/ belmont. php3 188 http:// ohrp. osophs. dhhs. gov/ humansubjects/ guidance/ belmont. htm. 189 For most federal agencies in the United States, the principles of the Belmont 190 Report are implemented through the Common Rule, which was developed 191 cooperatively by some 17 departments and agencies, including EPA, and which guides 192 all research with human subjects conducted or supported by these departments and 193 agencies of the federal government. The Common Rule as promulgated by EPA ( 40 194 CFR Part 26) has guided human research conducted or supported by EPA since it was 195 put in place in 1991. 196 More broadly, the international medical research community has developed and 197 maintains ethical standards documented in the Declaration of Helsinki, first issued by 198 the World Medical Association in 1964 and revised several times since then. These 199 standards apply to diagnostic and therapeutic medical research on matters relating to 200 the diagnosis and treatment of human disease, and to research that adds to 201 understanding of the causes of disease and the biological mechanisms that explain the 202 relationships between human exposures to environmental agents and disease. 203 In addition, many public and private research and academic institutions and 204 private companies, both in the United States and in other countries, including non 205 federal U. S. and non U. S. governmental organizations, have their own specific policies 206 related to the protection of human participants in research. 207 Much of the scientific research supporting EPA's actions, including a significant 208 6 portion of the research with human subjects submitted to the Agency or retrieved by the 209 Agency from published sources, is conducted by this broader research community, 210 without direct participation or support by the U. S. government. Such research, referred 211 to here as " third party" research, while it may be governed by specific institutional 212 policies intended to protect research participants or may fall within the scope of the 213 Declaration of Helsinki, is not subject to the Common Rule. In general, EPA can not 214 readily determine whether such policies are consistent with or as protective of human 215 subjects as the Common Rule, nor the extent to which such policies or standards have 216 been followed in the conduct of any particular study. Thus even well conducted third 217 party human studies may raise difficult questions for the Agency when it seeks to 218 determine their acceptability for consideration. 219 B. Human Research Issues in EPA's Pesticide Program 220 Questions about the Agency's consideration of and reliance on third party 221 human research studies have arisen most notably, but not exclusively, in EPA's 222 pesticides program. Under the Federal Insecticide, Fungicide and Rodenticide Act 223 ( FIFRA), EPA may require pesticide companies to conduct studies with human 224 subjects, for example, to measure potential exposure to pesticide users or to workers 225 and others who re enter areas treated with pesticides, and to evaluate the 226 effectiveness of pesticide products intended to repel insects and other pests from 227 human skin. In addition, EPA sometimes encourages other research with human 228 subjects, including tests of the potential for some pesticides   generally those designed 229 for prolonged contact with human skin   to irritate or sensitize human skin, and tests of 230 the metabolic fate of pesticides in the human system. These latter studies typically 231 precede monitoring studies of agricultural workers and others to protect them from 232 exposure to potentially dangerous levels of pesticide residues. 233 In addition to these kinds of research which have been required or encouraged 234 by EPA, other kinds of human studies involving human subjects intentionally exposed 235 to with pesticides have occasionally been submitted to the agency voluntarily. Among 236 these voluntarily submitted studies have been tests involving intentional dosing of 237 human subjects to establish a No Observed Adverse Effect Level ( NOAEL) or No 238 Observed Effect Level ( NOEL) for systemic toxicity of certain pesticides to humans. 239 Before passage of the Food Quality Protection Act in 1996, submission of such studies 240 was rare. EPA considered and relied on human NOAEL/ NOEL studies in a few 241 regulatory decisions on pesticides made prior to 1996. Since the passage of FQPA, 242 submission of these types of studies to the Office of Pesticide Programs has increased; 243 the Agency has received some twenty studies of this kind since 1996. 244 In response to concerns about human testing expressed in a report of a non 245 governmental advocacy organization, the Environmental Working Group, in July, 1998, 246 the Agency began a systematic review of its policy and practice. In a press statement 247 on July 28, 1998, EPA noted that it had not relied on any such studies in any final 248 decisions made under FQPA; this remains true today. 249 In further response to growing public concern over pesticide research with 250 human subjects, EPA convened an advisory committee under the joint auspices of the 251 EPA Scientific Advisory Board ( SAB) and the FIFRA Scientific Advisory Panel ( SAP) to 252 7 1 The Agency's press release on this subject is on the web at http:// yosemite. epa. gov/ opa/ admpress. nsf/ b1ab9f485b098972852562e7004dc686/ c232a45f54737 17085256b2200740ad4? OpenDocument In early 2002 various parties from the pesticide industry filed a petition with the U. S. Court of Appeals for the District of Columbia for review of EPA's December 2001press release. These parties argued that the Agency's interim approach constituted a " rule" promulgated in violation of the procedural requirements of the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act. The court has denied motions concerning emergency relief and other matters, briefs have been filed, and oral argument of the merits of the case is scheduled for March 2003. [ Folded UNCHANGED into the text.] address issues of the scientific and ethical acceptability of such research. This 253 advisory committee, known as the Data from Testing of Human Subjects Subcommittee 254 ( DTHSS), met in December 1998 and November 1999, and completed its report in 255 September, 2000. Their report is available in the Docket cited above in this notice, and 256 on the web at: http:// www. epa. gov/ science1/ pdf/ ec0017. pdf 257 The DTHSS advisory committee heard many comments at their two public 258 meetings, and further comments have been submitted in response to their published 259 report. No clear consensus 260 emerged from the advisory committee process on the acceptability of NOAEL or NOEL 261 studies of systemic toxicity of pesticides to human subjects, and significant differences 262 of opinion remain on both their scientific merit and ethical acceptability. A vigorous 263 public debate continues about the extent to which EPA should accept, consider, or rely 264 on third party intentional dosing human toxicity studies with pesticides. 265 C. EPA's Current Agency wide Focus on Human Research Issues 266 EPA is now interested in addressing these issues more broadly, and in all 267 Agency programs. In December, 2001, EPA asked the advice of the National Academy 268 of Sciences ( NAS) on the many difficult scientific and ethical issues raised by this 269 debate, and also stated the Agency's interim approach on third party intentional dosing 270 human subjects studies. 1 The Agency's press release on this subject is on the web at 271 http:// yosemite. epa. gov/ opa/ admpress. nsf/ b1ab9f485b098972852562e7004dc686/ c232 272 a45f5473717085256b2200740ad4? OpenDocument. At that time the Agency 273 committed that when it receives the NAS report, " EPA will engage in an open and 274 participatory process involving federal partners, interested parties and the public during 275 its policy development and/ or rule making regarding future acceptance, consideration 276 or regulatory reliance on such human studies." Since making that commitment, EPA 277 has decided to initiate a rulemaking process by issuing this notice. 278 In early 2002 various parties from the pesticide industry filed a petition with the 279 U. S. Court of Appeals for the District of Columbia for review of EPA's December 2001 280 press release. These parties argued that the Agency's interim approach constituted a 281 " rule" promulgated in violation of the procedural requirements of the Administrative 282 Procedure Act and the Federal Food, Drug, and Cosmetic Act. The court has denied 283 motions concerning emergency relief and other matters, briefs have been filed, and oral 284 8 argument of the merits of the case occurred on March 17, 2003. 285 Under a contract with EPA, the NAS has convened a committee to provide the 286 requested advice. The committee met in December 2002, and again in January and 287 March 2003. The membership, meeting schedule, and other information about the work 288 of this committee can be found on the NAS website at: 289 http:// www4. nas. edu/ webcr. nsf/ 5c50571a75df494485256a95007a091e/ 9303f725c1590 290 2f685256c44005d8931? OpenDocument& Highlight= 0, EPA. 291 The committee's final report is due in December 2003. 292 Notwithstanding these many recent developments concerning human studies, 293 some things have not changed. EPA remains committed to full compliance with the 294 Common Rule for all research with human subjects conducted or supported by the 295 Agency. The Agency is proud of its record in this regard, and proud of the scientific 296 quality of the research performed in its own laboratories and with various partners. 297 This body of research has provided many important insights and has contributed 298 significantly to the protection of human health. The Agency will continue to conduct 299 and support such research, and to consider and rely on its results in Agency actions. 300 EPA also remains committed to scientifically sound assessments of the hazards of 301 environmental agents, taking into consideration available, relevant, and appropriate 302 scientific research. 303 III. EPA's Rulemaking Process and Request for Public Comment 304 EPA intends to undertake notice and comment rulemaking on the subject of its 305 consideration of or reliance on research involving human subjects. The Agency will 306 particularly focus on third party intentional dosing human studies, but recognizes that 307 the principles applicable to third party studies may also be relevant to studies 308 conducted or supported by the federal government. The first step in this process is this 309 advance notice of proposed rulemaking which calls for comments and suggestions from 310 all interested parties. The next step the Agency would expect to undertake would be to 311 issue a proposed rule for public comment. In developing any proposed rule EPA will 312 consider the advice in the National Academy of Sciences committee report, along with 313 comments received in response to this notice. Comments received on any proposed 314 rule would then be taken into consideration in developing a final rule or policy. 315 In general, the Agency expects that any rule or policy coming out of this process 316 may do one or more of the following: 317 ° Specify, if and to the extent determined by EPA to be appropriate, thatwhether 318 EPA would not accept, consider, or rely on results from particular types of 319 studies involving intentional dosing of human subjects or from human studies 320 with particular characteristics; 321 ° Establish minimum standards relating to the protection of human subjects which 322 would be required to be met in the design and conduct of a study with human 323 9 subjects not otherwise precluded from consideration, in order for EPA to accept, 324 consider, or rely on the results of the study; 325 ° Establish procedures for ensuring that any minimum standards for the conduct of 326 third party research with human subjects had been adhered to in the conduct of 327 any such study that EPA intended to accept, consider, or rely on. 328 A. Legal Authority 329 Section 25( a) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) 330 gives the Administrator authority to " prescribe regulations to carry out the purposes of 331 [ FIFRA]." Such a rule would implement EPA's authority to require data in support of 332 registration of pesticides ( see, for example, FIFRA sections 3( c)( 1)( F) and 3( c)( 2)( B)) 333 and to interpret the provision making it unlawful for any person " to use any pesticide in 334 tests on human beings unless such human beings ( i) are fully informed of the nature 335 and purposes of the test and of any physical and mental health consequences which 336 are reasonably foreseeable therefrom, and ( ii) freely volunteer to participate in the 337 test." ( FIFRA sec. 12( a)( 2)( P)). In addition, section 408( e)( 1)( C) of the Federal Food, 338 Drug and Cosmetic Act ( FFDCA) authorizes the Administrator to issue a regulation 339 establishing " general procedures and requirements to implement this section." 340 The Clean Air Act gives EPA general rulemaking authority in 42 U. S. C. 7601( a). 341 The Clean Water Act, 33 U. S. C. sec. 1361, authorizes the Administrator to promulgate 342 regulations necessary to carry out the Agency's functions under that Act. Section 42 343 U. S. C. 9615 in the Comprehensive Environmental Response, Compensation, and 344 Liability Act authorizes the President to establish regulations to implement the statute; 345 this authority has been delegated to EPA by Executive Order 12580. The Emergency 346 Planning and Community Right to Know Act also contains a general rulemaking 347 provision, 42 U. S. C. 11048, authorizing the Administrator to promulgate rules 348 necessary to carry out the Act. The Resource Conservation and Recovery Act 349 specifically authorizes the Administrator to prescribe regulations necessary to carry out 350 EPA's functions under the Act, 42 U. S. C. 6912. The Safe Drinking Water Act contains 351 similar language, authorizing the Administrator to prescribe such regulations " as are 352 necessary and appropriate" to carry out EPA's functions under the Act, 42 U. S. C. 300j 353 9. In addition, EPA has authority under 5 U. S. C. 301 and 42 U. S. C. 300v 1( b). 354 B. Request for Comments 355 Neither this notice nor the specific questions presented below for public 356 comment are intended to indicate that EPA now favors any particular policy approaches 357 regarding the Agency's consideration of or reliance on third party intentional dosing 358 human studies. Similarly, neither this notice nor the specific questions presented 359 below for public comment are intended to indicate that EPA has decided on a particular 360 scope for any potential future rulemaking. Nor is this notice intended to impede or 361 otherwise delay any Agency assessments or actions. Rather, this notice is designed to 362 encourage public input from all interested parties on a broad range of issues that could 363 help inform any rule or policy that EPA eventually promulgates or issues, respectively. 364 The Agency fully appreciates the number, the range, and the 365 10 interconnectedness of the scientific and ethical concerns raised especially by 366 intentional dosing human studies of the wide range of environmental agents addressed 367 by EPA's programs. Reflecting the breadth of issues that have been raised in the 368 course of the public debate to this point, the Agency has identified a number of specific 369 questions on which it particularly invites comment. These questions are intended to 370 help organize and focus the discussion, but not to constrain it. Commenters should 371 feel free to address any other relevant topics as well. 372 4. Applicability of Existing Standards 373 a. Is it appropriate to use a standard intended to guide the conduct of research, 374 ( e. g., the Common Rule, Declaration of Helsinki, or the Nuremberg Code) to 375 assess the acceptability for review of completed research? 376 b. Is it appropriate to use a standard intended to guide the conduct of 377 therapeutic or diagnostic medical research or to clarify causes of disease, such 378 as the Declaration of Helsinki, to assess the acceptability for review of other 379 kinds of research without diagnostic or therapeutic intent, conducted with healthy 380 subjects? 381 c. Should the Agency apply a differentthe same standard of acceptability 382 dependingindependent onf the type of substance tested ( e. g., pharmaceutical, 383 pesticide, pathogen, or environmental contaminant)? If sonot, how might the 384 differing standards be applied when a single substance has multiple uses, e. g., 385 as both a pesticide and a drug? 386 d. Does it matter who maintains a standard, or by what process it is maintained? 387 For example, would it be appropriate for EPA to accept and apply a standard 388 maintained by a private, non governmental organization, and subject to change 389 without public notice and comment or U. S. Government endorsement, as is the 390 Declaration of Helsinki? 391 e. Should the Agency extend the requirements of the Common Rule to the 392 conduct of third party research with human subjects intended for submission to 393 EPA? What are the advantages and disadvantages of conducting a rulemaking 394 or undertaking other Agency action for this purpose alone, as opposed to one 395 with a broader scope? 396 5. Should the standard of acceptability vary depending on the research design? 397 a. Should the Agency apply a differentthe same standard of acceptability 398 dependingindependent onf whether the research design involves intentional 399 exposure? For example, should the same standard apply to research involving 400 intentional exposures to human subjects, to research designed to follow up 401 accidental exposure, and to studies of individuals occupationally or incidentally 402 exposed? 403 b. Should the Agency apply a differentthe same standard of acceptability 404 dependingindependent onf the level of exposure of the human subjects? For 405 11 example, whendoes it matter if the level of exposure to a chemical is below the 406 Reference Dose or other established health standard designed to protect the 407 general public? Should the same standard apply if intentional exposure to an 408 environmental pollutant occurs at ambient levels, or at elevated levels? If 409 research involves intentional exposure to a pesticide, does it matter if exposure 410 results from use of the pesticide in conformity with approved label directions, or 411 if the level of exposure is below the Reference Dose or other established health 412 standard designed to protect the general public?? 413 c. Should the Agency apply a differentthe same standard of acceptability 414 dependingindependent onf the pathway of exposure? For example, should the 415 same standard apply when exposure is oral, or dermal, or by inhalation? 416 d. Should the Agency apply a differentthe same standard of acceptability 417 dependingindependent onf the effects being evaluated? For example, should 418 the same standard apply to a study of localized skin irritation or dermal 419 sensitization that applies to a study of systemic dermal toxicity? Should the 420 same standard apply to a study measuring transitory changes in blood chemistry 421 or levels of a substance in urine that applies to studies measuring longer lasting 422 changes? Should the same standard apply to a study of localized skin irritation 423 that applies to a study of systemic dermal toxicity? Should the same standard 424 apply to studies measuring organoleptic effects, such as taste or smell, that 425 applies to studies of toxic effects? Should the same standard apply to 426 measurements of toxic effects and to measurements through genomic or 427 proteomic assessments? 428 e. Should conduct of research in compliance with the provisions of the Common 429 Rule or another standard for the protection of human subjects be accepted as 430 evidence of its ethical acceptability? 431 f. Should the Agency apply a different standard of acceptability toconsider 432 whether research which ishas been performed consistent with an EPA guideline 433 for data development in determining its acceptability? For example, EPA has 434 published guidelines for certain kinds of human studies currently required for 435 pesticide registration; should conduct of a required study in full compliance with 436 an EPA guideline be accepted as evidence of its acceptability? 437 g. Should the Agency apply a differentthe same standard of acceptability 438 dependingindependent onf a study's statistical power? 439 h. Should the Agency apply a differentthe same standard of acceptability 440 depending on whether or not a human study design is able to measure the same 441 endpoints in humans that have been observed in animal testing of the same 442 substance? For example, if the most sensitive adverse effects shown in animal 443 studies have been detected through histopathological evaluation of brain tissue, 444 is subsequent research involving intentional exposure of human subjects 445 acceptable? 446 i. Should the Agency apply a differentthe same standard of acceptability to 447 12 intentional dosing studies dependingindependent onf whether there are 448 alternative methods of obtaining data of comparable scientific merit that would 449 not require deliberate exposure of humans? If not, to what extent, if any, should 450 the cost of the alternate method be a factor? 451 j. Should What special considerations, if any, should the Agency apply a 452 different standard of acceptability to studies involving children as test 453 subjects? in judging the acceptability of studies when some or all of the subjects 454 are from populations likely to be vulnerable to coercion or undue influence, such 455 as children, prisoners, pregnant women, mentally disabled persons, or 456 economically or educationally disadvantaged persons? 457 3. Should the standard of acceptability vary depending on the provenance of the 458 research? 459 a. Should the Agency apply a differentthe same standard of acceptability 460 depending onwithout regard to who or what organization sponsors or supports 461 the research? Since 1991, human research conducted or supported by the US 462 government has been subject to the Common Rule. Should the same standard 463 apply to research conducted or supported by others? Should a single standards 464 differ when apply independent of whether the sponsor is a commercial 465 enterprise, or a non profit organization, another government in the United States 466 ( such as state, tribal, or local), or the government in another country? Should 467 the same standard differ depending onapply without regard to the test sponsor's 468 interest in a regulatory matter that could be affected by EPA's consideration of 469 the data? 470 b. Should the Agency apply a differentthe same standard of acceptability 471 dependingindependent onf who or what organization conducts the research? 472 For example, a research organization   public or private   holding a " Federal Wide 473 Assurance" from the Department of Health and Human Services's Office of 474 Human Research Protections usually promises to comply with the Common Rule 475 in all its human research, without regard to the identity of the sponsor or 476 supporter of the research. Should third party work conducted by a research 477 organization holding a Federal Wide Assurance be assessed by a differentthe 478 same standard thanthat applies to other third party human research? 479 c. Should the Agency apply a differentthe same standard of acceptability 480 depending onwithout regard to where the research was conducted? For 481 example, does it matter whether research is conducted entirely in the United 482 States or partially in the United States? If it is conducted outside the United 483 States, does it matter in what country it is conducted? What are the advantages 484 and disadvantages of judging the acceptability of human studies based on a 485 single uniform standard versus prevailing local standards ( e. g., in different 486 countries)? 487 d. Should the Agency apply a differentthe same standard of acceptability 488 depending onwithout regard to the reasons the research was conducted? If not, 489 how might the Agency determine intent? 490 13 e. Should the Agency apply a differentthe same standard of acceptability to 491 submitted research depending onwithout regard to who submitted it? For 492 example, should the same standard apply to submissions from regulated 493 industry, from public interest groups, from the public, or from other 494 governments? Should the Agency apply a differentthe same standard of 495 acceptability dependingindependent onf whether the study was submitted 496 voluntarily, or in response to a particular regulatory requirement of EPA? 497 f. Should the Agency apply a differentthe same standard of acceptability to 498 human research which is not submitted, but which the Agency obtains at its own 499 initiative from the scientific literature or other sources, dependingindependent 500 onf how or where EPA obtains it? 501 4. Should the standard of acceptability vary depending on EPA's potential use of 502 the data? 503 a. Should the Agency apply a differentthe same standard of acceptability 504 depending on independent of whether the results of the study would support a 505 more or less stringent regulatory position? For example, should the same 506 standard apply whether the data indicate that the substance tested is more risky 507 or less risky than is indicated by other available data? 508 b. Should the Agency apply a differentthe same standard of acceptability 509 depending onwithout regard to how EPA intends to use the results   e. g., to 510 reduce or remove the usualtraditional tenfold interspecies uncertainty factor, to 511 provide an endpoint for use in calculating a Reference Dose or Reference 512 Concentration for the test substance, to provide a dose response function for 513 use in quantitative risk assessment, or for some other purpose? 514 5. Should the standard of acceptability vary depending on EPA's assessment of the 515 risks and benefits of the research to the subjects or to society? 516 a. Should the Agency apply a standard of acceptability based on a comparison 517 of the anticipated benefits of the research in relation to the risks to human 518 subjects, provided the risks are minimized and informed consent is obtained? 519 ab. Should the Agency independently considerassess the risks of the research 520 to the subjects and the benefits of the research to the research subjects or to 521 society, or should it defer to the judgment of Institutional Review Boards or 522 similar oversight panels? 523 bc. If EPA were to assess independently the risks and benefits of research to 524 thehuman research subjects or to society, on what range of information should it 525 base its assessment? How might EPA obtain information relevant to such an 526 assessment? 527 6. How should the Agency implement standards of acceptability? 528 a. To what extent and how should the submitter of research with human subjects 529 14 to EPA be required to document or otherwise demonstrate compliance with 530 appropriate standards for the protection of human research subjects   e. g., fully 531 informed and fully voluntary participation, and independent oversight of research 532 design and conduct by an Institutional Review Board or comparable entity? 533 b. How should the Agency determine compliance with an appropriate standard 534 for human research data which is not submitted, but which it obtains from the 535 scientific literature or other sources? 536 c. To what extent should new standards be applied to research which has 537 already been conducted, or is underway? Should a different standard be 538 applied to such research? Does fairness require a period of transition to any 539 new rule or standards of acceptability, or do other considerations override that 540 factor? 541 d. Should the Agency apply a differentthe same standard of acceptability to 542 research already submitted to or obtained by EPA and to research newly 543 submitted to or obtained by EPA? Should previous submitters be allowed time to 544 submit supplemental information to demonstrate compliance with any new Does 545 it matter if the submitted research was conducted for the specific regulatory 546 purpose at hand or for other purposes ( even though the study was conducted 547 after EPA issued a policy on human testing)? Does fairness require a period of 548 transition to any new rule or standards of acceptability, or do other 549 considerations override that factor? 550 e. Is rulemaking needed at all? Would it be better to address the issues 551 surrounding acceptance of human research, or some of them, by other means, 552 such as policy statements or internal guidelines? 553 IV. Statutory and Executive Order Reviews 554 Under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 555 51735, October 4, 1993), it has been determined that this advance notice of proposed 556 rulemaking is a " significant regulatory action" under section 3( f) of the Executive Order. 557 The Agency therefore submitted this document to OMB for the 10 day review period 558 afforded under this Executive Order. Any changes made in response to OMB 559 comments during that review have been documented in the public docket as required 560 by the Executive Order. 561 Since this advance notice of proposed rulemaking does not impose any 562 requirements, and instead seeks comments and suggestions for the Agency to consider 563 in developing a subsequent notice of proposed rulemaking, the various other review 564 requirements that apply when an agency imposes requirements do not apply to this 565 action. 566 As part of your comments on this advance notice of proposed rulemaking you 567 may include any comments or information that you have regarding these requirements. 568 In particular, any comments or information that would help the Agency to assess the 569 15 potential impact of a rule on small entities pursuant to the Regulatory Flexibility Act 570 ( RFA) ( 5 U. S. C. 601 et seq.); to consider voluntary consensus standards pursuant to 571 section 12( d) of the National Technology Transfer and Advancement Act of 1995 572 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note); or to consider 573 environmental health or safety effects on children pursuant to Executive Order 13045, 574 entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 575 FR 19885, April 23, 1997). The Agency will consider such comments during the 576 development of any subsequent notice of proposed rulemaking as it takes appropriate 577 steps to address any applicable requirements. 578 List of Subjects 579 Environmental protection, protection of human research subjects 580 Dated:__________________ 581 ________________________________________ 582 Administrator. 583 [ FR Doc. 01?????? Filed ???? 01; 8: 45 am] BILLING CODE 6560 50 S 584


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50887-50888]
[FR Doc No: 2023-16326]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4681-DR; Docket ID FEMA-2023-0001]

Havasupai Tribe; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Havasupai Tribe (FEMA-4681-DR), dated December 30, 2022, and
related determinations.

DATES: This change occurred on June 20, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Maona N.
Ngwira, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Benigno B. Ruiz as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used

for reporting and drawing funds: 97.030, Community Disaster Loans;
97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster
Legal Services; 97.034, Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant; 97.048, Disaster Housing
Assistance to Individuals and Households In Presidentially Declared
Disaster Areas; 97.049, Presidentially Declared Disaster
Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidentially Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-16326 Filed 8-1-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25562-25563]
[FR Doc No: 2022-09247]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2021-1161]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Flight and
Duty Limitations and Rest Requirements--Flightcrew Members

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on December 20, 2021. The collection involves reporting
exceeded flight duty periods and flight times, including scheduled
maximum and actual flight duty periods and flight times, basic flight
information (e.g., city pairs, departure times, flight number), and
reason for exceedance. Reporting and recordkeeping are required any
time a certificated air carrier has exceeded a maximum daily flight
time limit or a maximum daily Flight Duty Period (FDP) limit. It is
also required for the voluntary development of a Fatigue Risk
Management System (FRMS), and for fatigue training. The information is
necessary to monitor trends in exceedance and possible underlying
systemic causes requiring operator action, and to determine whether
operator is scheduling realistically.

DATES: Written comments should be submitted by May 31, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Chester Piolunek, Jr. by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a)

Whether the proposed collection of information is necessary for FAA's
performance; (b) the accuracy of the estimated burden; (c) ways for FAA
to enhance the quality, utility and clarity of the information
collection; and (d) ways that the burden could be minimized without
reducing the quality of the collected information.
    OMB Control Number: 2120-0751.
    Title: Flight and Duty Limitations and Rest Requirements--
Flightcrew Members.
    Form Numbers: None.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on December 20, 2021 (86 FR 72026). The FAA collects
reports from air carriers conducting passenger operations certificated
under 14 CFR part 121 as prescribed in 14 CFR part 117 Flightcrew
Member Duty and Rest Requirements, Sec. Sec. Sec.  117.11, 117.19, and
117.29. Air carriers are required to submit a report of exceeded flight
duty periods and flight times, including scheduled maximum and actual
flight duty periods and flight times, basic flight information (e.g.,
city pairs, departure times, flight number), and reason for exceedance.
The purpose for the reports is to notify the FAA that the certificate
holder has extended a flight time and/or FDP limitation. This
information enables FAA to monitor trends in exceedance and possible
underlying systemic causes requiring operator action as well as
determine whether operators are scheduling realistically. Additionally,
if air carriers choose to develop a Fatigue Risk Management System
(FRMS) under Sec.  117.7 they are required to collect data specific to
the need of the operation for which they will seek an FRMS
authorization. It results in an annual recordkeeping and reporting
burden when carriers adopt the system because they need to report the
related activities to the FAA. Each air carrier is also required to
develop specific elements and incorporate these elements into their
training program (Sec.  117.9). Once the elements have been
incorporated, the air carrier must submit the revised training program
for approval.
    Respondents: 47 Air Carriers.
    Frequency: On Occasion.
    Estimated Average Burden per Response: Varies by Requirement.
    Estimated Total Annual Burden: 30,954 Hours.

    Issued in Washington, DC, on April 26, 2022.
Sandra L. Ray,
Aviation Safety Inspector, AFS-260.
[FR Doc. 2022-09247 Filed 4-28-22; 8:45 am]
BILLING CODE 4910-13-P


  DATE \@ "dddd, MMMM dd, yyyy"  Friday, February 17, 2012

OSHA Quick Card

Top/Side Handler Safety

As a worker in the Longshore Industry you and your

co-workers are exposed to the risk of being struck by

top/side handlers working on the marine terminal.  Always be aware of traffic patterns and moving vehicles in order to avoid accidents and injuries.

Tips to Avoid Top Handler and Semi Tractor Accidents

All drivers:

Use caution when approaching a gap in the stack where Top/side handlers may be operating.

Yield the right of way to top/side handlers that are backing up and provide a wide berth or stop to allow the top/side handlers to back across the travel lane.

Obey all speed and traffic regulations (1917.44(d)) and

ensure installed safety devices are operational. (1917.43 (c)(5)).

Be aware that there may be pedestrians working in your area and make eye or radio contact if possible.

Be prepared to STOP!

Things to remember about Top/Side Handlers  working in deep piles:

They cannot be seen until they emerge from the pile and have to back across transit lanes to load containers onto chassis and bomb carts.

Top/Side handler operators:

Always back slowly, smoothly and predictably out of the stacks and do not cut across, between, or through bays.

Ensure that the container being lifted does not strike other containers while backing out the pile.

Semi tractor operators:

 Always use caution whenever approaching a gap in a stack or bay. A top/side handler may be working and back into the travel lane.

Stay back one container length while waiting to receive a container.

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