[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Notices]
[Pages 81495-81496]
[FR Doc No: 2011-33259]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2011-0230; FRL-9510-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Gasoline Distribution
Bulk Terminals, Bulk Plants, Pipeline Facilities and Gasoline
Dispensing Facilities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before January 27,
2012.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2011-0230, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2822IT, 1200 Pennsylvania Avenue NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 9, 2011 (76 FR 26900), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to both EPA and OMB within 30
days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2011-0230, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov to submit or view public comments, access the index
listing of the contents of the docket, and to access those documents in
the docket that are available electronically. Once in the system,
select ``docket search,'' then key in the docket ID number identified
above. Please note that EPA's policy is that public comments, whether
submitted electronically or in paper, will be made available for public
viewing at http://www.regulations.gov, as EPA receives them and without
change, unless the comment contains copyrighted material, Confidential
Business Information (CBI), or other information whose public
disclosure is restricted by statute. For further information about the
electronic docket, go to http://www.regulations.gov.
    Title: NESHAP for Gasoline Distribution Bulk Terminals, Bulk
Plants, Pipeline Facilities and Gasoline Dispensing Facilities
(Renewal).
    ICR Numbers: EPA ICR Number 2237.03, OMB Control Number 2060-0620.
    ICR Status: This ICR is scheduled to expire on December 31, 2011.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB Control Number. The OMB Control Numbers for the EPA
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Gasoline Distribution Bulk Terminals, Bulk
Plants, Pipeline Facilities and Gasoline Dispensing Facilities was
published on January 10, 2008 (73 FR 1916), and amended on January 24,
2011 (76 FR 4156). Potential respondents are owners or operators of any
existing or new gasoline distribution facilities that are an area
source of hazardous air pollutants (HAP) emissions.
    In addition to the initial notification and notification of
compliance status required by the General Provisions to 40 CFR part 63,
subpart A, respondents are required to submit one-time reports of start
of construction, anticipated and actual startup dates, and physical or
operational changes to existing facilities. Reports of initial
performance tests on control devices at gasoline distribution storage
tanks, loading racks, and vapor balance systems are also required and
are necessary to show that the installed control devices are meeting
the emission limitations required by the NESHAP. Annual reports of
storage tank inspections at all affected facilities are required. In
addition, respondents must submit semiannual compliance and continuous
monitoring system performance reports, and semiannual reports of
equipment leaks not repaired within 15 days or loadings of cargo tanks
for which vapor tightness documentation is not available.
    All records are to be maintained for at least five years. All
reports are to be submitted to the respondent's State or local agency,
whichever has been delegated enforcement authority by the EPA. The
information is to be used to determine whether all sources subject to
the NESHAP are achieving the standards.
    This information is being collected to assure compliance with 40
CFR part 63, subpart BBBBBB and CCCCCC, as authorized in section 112
and 114(a) of the Clean Air Act. The required information consists of
emissions data and other information that have been determined to be
private.
    Burden Statement: The annual public reporting and recordkeeping
burden for

this collection of information is estimated to average 8 hours per
response. Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.
    Respondents/Affected Entities: Gasoline Distribution Bulk
Terminals, Bulk Plants, and Pipeline Facilities; and Gasoline
Dispensing Facilities.
    Estimated Number of Respondents: 19,120.
    Frequency of Response: Initially, and semiannually.
    Estimated Total Annual Hour Burden: 60,517 hrs.
    Estimated Total Annual Cost: $6,178,409 which includes $6,068,409
in labor costs, $0 capital/startup costs, and $110,000 in operation and
maintenance (O&M) costs.
    Changes in the Estimates: There is a decrease in the labor hours in
this ICR compared to the previous ICR. A large percentage of affected
facilities are already complying with this rule as a result of their
compliance with applicable State and local rules. We have minimized or
eliminated the reporting and recordkeeping requirements under this rule
for most of those sources. There are no new or reconstructed facilities
expected within the larger, bulk segment of the industry and new
gasoline dispensing facilities are expected to be subject to NESHAP
subparts BBBBBB and CCCCCC rules. Thus, we have developed this ICR with
the expectation that only existing sources will be subject to the
reporting and recordkeeping requirements of the rule.

    Dated: December 21, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-33259 Filed 12-27-11; 8:45 am]
BILLING CODE 6560-50-P


In a recent study Lukow et al. ( 2000) tested whether T RFLP analysis ( terminal restriction fragment length polymorphism) represents an appropriate technique for monitoring highly diverse soil bacterial communities, i. e. spatial and temporal variation in bacterial commumty structure. To do this, the authors used two transgenic potato and one commercial non transgenic potato variety (' Bintje'). It was unclear whether or not the commercial potato variety ' Bintje' was the isogenic parent or control variety for the two transgenic potato lines used. The study revealed spatial and temporal effects, as well as space x time interaction effects on the structural composition of the bacterial communities where both transgenic varieties differed significantly from the non transgenic commercial variety. The authors concluded that the T RFLP technique proved to be a suitable method for monitoring highly diverse soil microbial communities for changes over space and/ or time.

EPA Response: This comment is a discussion of soil biota population differences in soils growing transgenic and nontransgenic alfalfa, potato and tobacco plants. There were reported differences in numbers and types of soil microbes and invertebrates. The significance of these differences is unclear in light of the lack of baseline " normal" soil population definitions, the great natural variability in soil biota populations, and the long established fact that that different crops ( i. e different organic nutrients) have differing soil biota associations. The USDA and EPA have allocated research funds to determine the significance of such shifts in soil biota populations.

Commenter Name: Angelika Hilbeck Commenter Organization Name: Greenpeace Comment Number: 30509 113000Part2 Excerpt Number: 34 Excerpt Text: In a microcosm study, lnghain et al. ( 1999) wanted to assess potential effects of a transgenic ethanolproducing micro organism on soil biota and plant growth. In their experiments, the authors added a genetically engineered bacteria ( Klebsiella planticola ( SDF2O)) and the untransformed parental line ( SDF 15) to a sandy soil. In one half of the treatments wheat plants were grown in the soil and in the other no plants were grown. When SDF2O was added to the soil with plants, the numbers of bacteria and fungal feeding nematodes increased significantly which coincided with the death of the plants. In contrast, when SDF15 was added to the soils with plants, only the number of bacterial feeding nematodes increased but the plants did not die. When no plants were grown in the soil, the nematode community remained unchanged. The authors suspected that substrates from the plant roots may have been essential for the observed effects.. They also stressed that their results demonstrate the importance of using experimental test systems that incorporate biological interactions and include direct measurements of soil biota to assess the effects of genetically engineered micro organisms released into soils. Section 3.2 3  79 The few studies conducted to date, revealed that the observed impacts differed from case to case, were unexpected, complex and largely difficult to understand and evaluate with our little knowledge of the soil ecosystem. Or in other words, the studies support a case by case safety assessment approach and, equally important, highlight again the urgent need for developing meaningful and proven scientific technical biosafety testing guidelines involving whole organisms, multiple species and trophic interactions. The studies also allow for an optimistic view in that promising methodologies seem to emerge so that with adequate financial and scientific committment, the development of such new biosafety testing guidelines should be a feasible task in the future.

Meanwhile also some reports regarding environmental impact from the commercial production of transgenic plants have appeared. Increased and frequent use of glyphosate associated with transgenic glyphosate resistant crop production leads aside from an observed weed shift to more glyphosate tolerant species ( Progressive Farmer June 12, 2000 or http:// www. biotechjpjo net/ weed_ shift. html), apparently also to an increased frequency of Fusartuin on soybean roots ( up to 5 fold) 4 weeks after application of glyphosate herbicides ( Kremer et al. 2001). Yield levels were so far unaffected. However, a built up of the Fusarium level in the soil should be monitored. Fusarium species are responsible for a disease in soybean called ' sudden death syndrome' to which many transgenic soybean varieties are susceptible.

EPA Response: This comment is a discussion of changes in soil biota and plant health in the presence of ethanol producing microbes; a need for development of study guidelines which would include studies to address the observed effects; and glyphosate resistant plant development with an observed increase in Fusarium fungus. The USDA and EPA have allocated research funds to determine the significance of such effects on soil biota populations and plants. EPA also has commenced development of testing guidelines for protein plantincorporated protectants.

Commenter Name: Charles Benbrook Commenter Organization Name: Union of Concerned Scientists Comment Number: 30509 115000 Excerpt Number: 7 Excerpt Text: 2. No Data Are Presented on Root Exudates Nowhere in the submission does Monsanto present information on the levels of Cry 3Bb endotoxin exuded through root systems and into the soil. The lack of such information is curious, given that root exudates would presumably enhance efficacy and surely have been measured by Monsanto.

EPA should insist that data on root exudates is submitted, along with properly conducted soil assays to determine the persistence of Cry 3 Bb proteins in the soil. Information on the total flow of Cry 3Bb and NPTII proteins into the rhizosphere via roots and root exudates, and the environmental fate of these proteins, are essential to determine the possible impact on soil microbial communities.

EPA Response: EPA requires data on soil degradation of Cry proteins performed at high Cry protein doses that would Section 3.2 3  80 account for the amount of Cry protein released by continuous exudation by plant roots. In addition, it is general knowledge that microbial degradation of proteins in soil is ubiquitous. This observation was reaffirmed by the FIFRA SAP ( SAP Report No. 99 06, February 4, 2000). The data reviewed by the Agency show that the Cry protein degradation in soil occurs within days to a barely detectable background levels regardless of the Cry protein source source. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 4). Data available to date also do not show any detrimental effects on soil biota. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 5,6). These aspects will, however, be investigated over several years to provide confirmatory long term effects information.

Commenter Name: Charles Benbrook Commenter Organization Name: Union of Concerned Scientists Comment Number: 30509 115000 Excerpt Number: 11 Excerpt Text: 5. High Toxin Levels May Jeopardize Margins of Safety for Soil Organisms Monsanto reports that the maximum environmental concentration expected in the soil is 13.3 mg/ kg, based on the assumption that corn plants are tilled into the top six inches of soil when leaf tissue expression levels are peaking. Yet exposure levels are likely to be much higher for organisms that move through the soil and seek out the nutrient enriched zone within a few centimeters of roots. Moreover, plant residues and stalks worked into the soil will create an uneven distribution of Cry 3Bb in the soil profile; organisms that happen to be feeding in the vicinity of decomposing plant tissues will be exposed to relatively higher levels.

Cry 3Bb endotoxins are lethal to earthworms at 57 mg/ kg in the soil, resulting in just a 4 fold difference between the known high level concentrations in soil. Such a narrow margin of safety is not acceptable in any other regulatory context. While under " normal" conditions, a 4 fold margin of safety may spare most earthworms in fields planted to corn varieties expressing the Cry 3Bb endotoxin, many factors can enhance the vulnerability of earthworms  or other nontarget organisms  to the effects of any toxin.

Earthworms moving through " hot spots" could be exposed to lethal levels. Exposure to other insecticides or herbicides or drought stress also can make earthworms more vulnerable than normal. Tillage systems, irrigation, or soil conditions might alter their movement and feeding habits, increasing or decreasing their exposures levels.

EPA Response: The available data do not support these speculative comments. There are reports in the open literature that earthworms tested for ingestion of Cry protein do ingest Cry protein, and that Cry protein is also detected in earthworm casts. The earthworms are not affected by the Cry proteins going through their system. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 3. vii). Monsanto testing was done with purified Cry protein in order to expose the earthworms to large doses exceeding the possible soil concentration. The study referred to by the above commenter ( MRID No. 449043 16) shows that the 570mg/ kg soil was the highest concentration tested, so that the LC50 is above that concentration, not at that concentration as stated by the commenter. This study has a 10 x safety factor. The data show that no adverse effects to earthworms are expected from exposure to Cry3Bb1 protein producing corn plants. The EPA hazard evaluation procedure considers an LD50 ( not a NOEC) at 5x the environmental concentration ( EEC) as Section 3.2 3  81 indicative of no hazard to terrestrial organism populations, while in the submitted studies there was no LD50 or mortality seen at 10 x, the highest concentration tested.

Commenter Name: Charles Benbrook Commenter Organization Name: Union of Concerned Scientists Comment Number: 30509 115000 Excerpt Number: 30 Excerpt Text: 2. Impacts on Soil Health and Productivity Must Be Assessed Healthy soil is a prerequisite for profitable farming on a sustained basis. Soil quality is generally defined as the capacity of a soil to take in, store and purify water, to hold and recycle nutrients, to support a diverse and robust biotic community, and to suppress pathogens and other pests.

Soil quality can and has been degraded through erosion, excessive tillage, compaction, use of broadspectrum insecticides and soil fumigants, depletion of nutrients, and the build up of salt and other minerals. Research over 50 years has documented the significant and largely irreversible impacts of soil loss and degradation on average attainable corn yields ( NRC, 1993). Plus, recent work by soil ecologists is beginning to explain the many ways that soil microbial communities can impact plant growth and development, and perhaps even more important, contribute to the microbial biocontrol of soil borne pathogens and microarthropods.

Kerry has highlighted the impact of plant root exudates on nematode populations " by influencing both the dynamics of the nematode host and structure and dynamics of the community of antagonists and parasites in the rhizosphere" ( Kerry, 2000). He stresses that little is known about how root exudates impact soil microbial communities, as well as microbial biocontrol processes. Introduction of Cry 3Bb corn hybrids will add another layer of complexity for soil ecologists.

A key 1998 study in Nature by van der Heijden and colleagues showed that the diversity of mycorrhizal fungi plays a key role in determining the productivity of soil ecosystems ( van der Heijden et al., 1999). An overview by Read in the same issue speculates that greater fungal biodiversity expands the range of mechanisms through which microbial interactions can help plants deal with various sources of stress and competition ( Read, 1999).

EPA Response: The Bt crops are a very likely beneficial solution to the soil quality problems caused by long term use of chemical additives in agriculture as quoted by this commenter.

Commenter Name: Charles Benbrook Commenter Organization Name: Union of Concerned Scientists Comment Number: 30509 115000 Excerpt Number: 31 Excerpt Text: Persistence of Cry3Bb Toxins in the Soil Must Be Measured Section 3.2 3  82 A disadvantage of foliar Bt products has always been a constraint on their commercial development  foliar Bt sprays break down quickly when exposed to sunlight, and become inactive within 48 hours to a few days. Engineering Bt into plant tissues helps solve this problem. Varieties like Cry 3Bb corn that express Bt in roots, and presumably as well through root exudates, will assure even slower breakdown of Bt proteins.

Important work by Stotzky and colleagues reported in Nature shows that Bt proteins are exuded from the roots of Bt corn and can bind with clay soil particles or humic acid and remain active for over 120 days in the soil ( Saxena et al., 1999). This work needs to be repeated with Cry3Bb corn varieties to document the extent to which they exude Cry3Bb protein toxin and whether it too binds to soil particles.

Stotzky's team has shown that Bt proteins can bind to clay particles and humic acids and become very stable in the soil ( Saxena et al., 1999). In some farming systems and on certain soils, bound Bt may move off fields with eroding soil and enter streams, ponds and lakes, and aquatic ecosystems. Understanding the environmental fate and movement of such bound Cry 3Bb endotoxins will require careful field research.

If approved, Monsanto's Cry3Bb corn could be adopted widely within a few years on millions of acres ( Gray, 2000). It will deliver into the root zone concentrations of Cry3Bb toxins that are orders of magnitude above what occurs naturally, possibly triggering serious effects on soils, soil food webs, and soil borne pest dynamics.

EPA Response: EPA receives data on soil degradation of Cry proteins performed at high Cry protein doses that would account for the amount of Cry protein released by continuous exudation by plant roots. In addition, it is general knowledge that microbial degradation of proteins in soil is ubiquitous. This observation was reaffirmed by the FIFRA SAP ( SAP Report No. 99 06, February 4, 2000). The authors of the studies quoted above have also shown that Cry proteins adsorbed to soil minerals are quickly metabolized by soil microbes upon elution. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 4) The data reviewed by the Agency show that the Cry protein degradation in soil occurs within days to a barely detectable background level. Data available to date also do not show any detrimental effects on the soil biota. These aspects will, however, be investigated over the life of the limited MON863 corn registration to provide confirmatory long term soil biota effects information.

Commenter Name: Charles Benbrook Commenter Organization Name: Union of Concerned Scientists Comment Number: 30509 115000 Excerpt Number: 36 Excerpt Text: When the first Bt transgenic plant applications were reviewed, there was little evidence that antibiotic marker genes might trigger resistance problems. Now the transfer of antibiotic marker genes in plant cells to soil bacteria has been demonstrated ( Gerbhard and Smalla, 1998). In a key article in the journal Applied and Environmental Microbiology, Gebhard and Smalla hypothesize that:

"  the introduction of bacterial genes into the plant genome leads to a higher probability of gene transfer from plants to bacteria due to the presence of homologous sequences. However, until now, there has been a Section 3.2 3  83 lack of clear experimental evidence that successful gene transfer from plants to bacteria can occur at all." ( Gebhard and Smalla, 1998).

EPA Response: The above quoted transfer of genes appears to be a laboratory phenomenon under conditions deliberately created to favor such gene transfer. There is no evidence of this occurring in agricultural fields. This aspect is, however, among the research items to be investigated by USDA and EPA funded research projects.

Commenter Name: Charles Benbrook Commenter Organization Name: Union of Concerned Scientists Comment Number: 30509 115000 Excerpt Number: 38 Excerpt Text: Also contrary to conventional wisdom, genes that confer antibiotic resistance have been shown to move readily between people and from bacteria in the gut of farm animals to people ( Tschape, 1994). A team in Denmark has shown that indigenous soil bacteria can serve as a sink for plasmid borne antibiotic resistance traits from E. coli entering agricultural soils from animal manure or other wastes ( Sorensen et al., 1999).

Until recently it was also thought that foreign DNA, such as the gene constructs in Cry 3Bb corn, would pass through the mammalian digestive without being activated and without consequence. The transfer of foreign DNA in food into the blood and organ systems in mice has now been demonstrated ( Schubbert et al., 1997). In addition some of the transgenic DNA was found to covalently bind to mouse DNA, in effect becoming a part of the mouse genome. The authors modestly summed up this article by stating  " The medical and evolutionary implications of these observations may be considerable" ( Schubbert et al., 1997).

EPA Response: The above quoted research is confined to bacteria host interactions. The reported incorporation of antibiotic resistance genes into mammalian DNA has not been verified. This issue is among the research items to be clarified by USDA and EPA funded research projects.

Commenter Name: Scott Black Commenter Organization Name: The Xerces Society Comment Number: 30509 L03 Excerpt Number: 5 Excerpt Text: Monsanto reports that the maximum environmental concentration expected in the soil is 13.3 mg/ kg, based on the assumption that corn plants are tilled into the top six inches of soil when leaf tissue expression levels are peaking. Yet exposure levels are likely to be much higher for organisms that move through the soil and seek out the nutrient enriched zone within a few centimeters of roots.

EPA Response: The available data do not support these comments. The calculations for soil concentration in the top 6" were done by standard, published EPA procedures. Monsanto testing was done with purified Cry protein in order to expose the earthworms to large doses far exceeding the possible soil concentration. The study has a 10 x safety factor. Also, no adverse or reproductive effects were noted in springtail studies Section 3.2 3  84 conducted with 50% leaf tissue. The EPA hazard evaluation procedure considers an LD50 ( not a NOEC) at 5x the environmental concentration ( EEC) as indicative of no hazard to terrestrial organism populations, while in the submitted earthworm studies there was no LD50 or mortality seen at 10x, the highest concentration tested.

Commenter Name: Scott Black Commenter Organization Name: The Xerces Society Comment Number: 30509 L03 Excerpt Number: 10 Excerpt Text: Research over 50 years has documented the significant and largely irreversible impacts of soil loss and degradation on average attainable corn yields ( NRC, 1993). Plus, recent work by soil ecologists is beginning to explain the many ways that soil microbial communities can impact plant growth and development, and perhaps even more important, contribute to the microbial biocontrol of soil borne pathogens and microarthropods. Kerry has highlighted the impact of plant root exudates an nematode populations " by influencing both the dynamics of the nematode host and structure and dynamics of the community of antagonists and parasites in the rhizosphere" ( Kerry, 2000). He stresses that little is known about how root exudates impact soil microbial communities, as well as microbial biocontrol processes.

EPA Response: The Bt crops are a very likely beneficial solution to the soil quality problems caused by long term use of chemical additives in agricultural soils quoted by this commenter.

Commenter Name: Scott Black Commenter Organization Name: The Xerces Society Comment Number: 30509 L03 Excerpt Number: 11 Excerpt Text: Persistence of Cry3Bb Toxins in the Soil Must Be Measured The EPA needs to study Cry3Bb corn varieties to document the extent to which they exude Cry3Bb protein toxin and whether it binds to soil particles. Work by Stotzky and colleagues reported in Nature shows that Bt proteins are exuded from the roots of Bt corn and can bind with clay soil particles or humic acid and remain active for over 120 days in the soil ( Saxena et al., 1999). In some fanning systems and on certain soils, bound Bt may move off fields with eroding soil and enter streams, ponds and lakes, and aquatic ecosystems. Understanding the environmental fate and movement of such bound Cry 3Bb endotoxins will require careful field research.

EPA Response: EPA requires data on soil degradation of Cry proteins performed at high Cry protein doses that would account for the amount of Cry protein released by continuous exudation by plant roots. In addition, it is general knowledge that microbial degradation of proteins in soil is ubiquitous. This observation was reaffirmed by the FIFRA SAP ( SAP Report No. 99 06, February 4, 2000). The authors of the studies quoted above have also shown that Cry proteins adsorbed to soil minerals are quickly metabolized by soil Section 3.2 3  85 microbes upon elution. The data reviewed by the Agency show that the Cry protein degradation in soil occurs within days to a barely detectable background levels regardless of the Cry protein source source. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 4). Data available to date also do not show any detrimental effects on soil biota. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 5,6). These aspects will, however, be investigated over several years to provide confirmatory long term effects information.

Commenter Name: Lincoln Brower Commenter Organization Name: Sweet Briar College Comment Number: 30509B 084000 Excerpt Number: 2 Excerpt Text: In many respects, the potential for biodiversity damage that may ensue from a corn varietal that secretes Bt toxins in its roots seems even greater to me ....... affecting the biological integrity of the soil ecosystem in some of the richest and most biodiverse soils on this planet. Gene stacking seems particularly troublesome and fraught with long term toxicological uncertainty.

EPA Response: EPA requires data on soil degradation of Cry proteins performed at high Cry protein doses that would account for the amount of Cry protein released by continuous exudation by plant roots. In addition, it is general knowledge that microbial degradation of proteins in soil is ubiquitous. This observation was reaffirmed by the FIFRA SAP ( SAP Report No. 99 06, February 4, 2000). Several studies have also shown that Cry proteins adsorbed to soil minerals are quickly metabolized by soil microbes upon elution. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 4). The data reviewed by the Agency show that the Cry protein degradation in soil occurs within days to a barely detectable background levels regardless of the Cry protein source source. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 4). Data available to date also do not show any detrimental effects on soil biota. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 5,6). These aspects will, however, be investigated over several years to provide confirmatory long term effects information.

Commenter Name: Dennis Ward Commenter Organization Name: Monsanto Comment Number: 30509B 086000 Excerpt Number: 25 Excerpt Text: 1. ENVIRONMENTAL FATE AND ECOSYSTEM IMPACTS Comment or Question: There is a lack of empirical data showing the concentrations of Cry3Bbl within the soil profile due to root exudation and plant decomposition, and a lack of data on soil fate, persistence and the potential for off field movement to streams, ponds, lakes and aquatic ecosystems.

Scientific Background: A recent EPA Scientific Advisory Panel ( SAP) report [ Footnote 2: SAP Report # 2000 07b, March 12, 2001] discussed the issue of root exudation from Bt corn and provided the following ( verbatim) comments: " The panel agreed that for the purpose of risk assessment, the principal issues are the amount of Cry protein that enters the soil over time and the length of time that the protein persists in a biologically active form. The mechanism by which Cry proteins enter the soil, for example by secretion, shedding of root hairs, degradation of biomass, pollen, etc., were to be considered of secondary importance, Section 3.2 3  86 and although relevant, knowledge of these might not be necessary for completing a risk assessment."

Monsanto has submitted a soil degradation study for Cry3Bbl protein in support of corn event MON 863 registration. [ Footnote 3: Monsanto report MSL 16440; MRID 451568 04] The design of this study employed. exaggerated doses to simulate worst case soil deposition from the variety of potential mechanisms identified by the SAP. Cry3Bb1 protein was added to the soil as plant material at levels exceeding the upper estimates of the amount of plant tissue and Cry3Bb I protein that might possibly enter the soil through tillage of Bt crops or through decay of corn roots. In fact, the plant tissue used contained the highest level of Cry3Bbl protein found in any tissue at the peak time of Cry protein production. The study included two exaggerated dose levels of Cry3Bbl protein in soil ( 52.4 ug/ g soil and 174.5 ug/ g), representing 3% and 10% tissue by weight of soil, respectively. These doses greatly exceed the amount of protein that can reach soil ( at any one time) via any conceivable mechanism, including exudation. Since the average level of Cry3Bb1 in root tissue is 41 ug/ g tissue, [ Footnote 4: Monsanto report MSL 17181; MRID 454240 01] a total of 4.26 gram of fresh corn root tissue would have to be mixed with ( or decay into) each gram of soil in the root zone, an obvious impossibility in an agricultural field. Thus, the dose of CrY3] 3b1 protein used in this study exceeds all possible estimates of Cry3Bb1 protein in. the root zone, even if exudation were to provide an additional source of Cry3Bb1 protein to the soil.

EPA Response: At the present time EPA is following the EPA Scientific Advisory Panel ( SAP Report # 2000 07b, March 12, 2001) approach evaluating the persistence of Cry proteins in soil. The amounts of Cry protein in soil, however, will be evaluated over the life of the limited MON863 registration to provide confirmatory long term soil biota effects information.

Commenter Name: Dennis Ward Commenter Organization Name: Monsanto Comment Number: 30509B 086000 Excerpt Number: 26 Excerpt Text: The results of this study showed that Cry3Bb1 protein degrades rapidly in soil. The calculated DT50 ( time to 50% degradation) was 2.4 to 2.8 days, and the calculated DT90 ( time to 90% degradation) was 7.9 to 9.2 days. There was no detection of Cry3Bbl, by either ELISA or insect bioassay, in any soil sample incubated for over 21 days.

Comment or Question: The concentration of MON 863 in the area immediately adjacent to the root or other plant material in soil will be higher than the worst case prediction of 13.3 mg Cry3Bb1 protein/ kg soil.

Scientific Background: The Cry3Bb1 protein, as engineered into MON 863, contains no secretory peptide sequences and has no known chemical mechanisms for exudation. As such, any protein in the root zone is expected to be present by adventitious mechanisms such as damage to roots. In addition, soil degradation experiments demonstrate that Cry3Bb1 has a short half life ( DT50, 2.4 2.8 days) in soil. Monsanto calculated a conservative exposure level of 13.3 mg Cry3Bb1 protein/ kg soil based on a worst case assumption that the entire aboveground mass of a corn plant could be incorporated into the top six inches of soil at the time of maximum Cry3Bb1 expression. Given that Cry3Bbl protein is not likely to be secreted into the root zone and that this protein has a short half life, there is no reason to believe that Section 3.2 3  87 exposure will approach, far less exceed, the conservative estimate of 13.3 Cry3Bb1 mg protein/ kg soil. Furthermore, NOEC levels for specific soil organisms had significant safety margins beyond this conservative exposure.

EPA Response: The current EPA view is that the soil persistence and degradation data, together with the soil invertebrate testing at artificially high doses of Cry protein, show that no hazard to soil biota is expected. The accumulation of residual amounts of Cry protein in agricultural field soil, however, will be evaluated over the life of the limited MON863 corn registration to provide confirmatory long term soil biota effects information.

Commenter Name: Dennis Ward Commenter Organization Name: Monsanto Comment Number: 30509B 106000 Excerpt Number: 6 Excerpt Text: Comment or Question: Studies have not been conducted to determine the persistence of Cry3Bb1 protein in soil under field conditions.

Scientific Background: Monsanto has submitted a soil degradation study for Cry3Bb1 protein using fieldcollected soil that indicates the protein will dissipate rapidly under field conditions. { Footnote 8: Monsanto report MSL 16440; MRID 451568 04] The design of this study employed exaggerated doses to simulate worst case soil deposition from the variety of potential mechanisms, including potential secretion, shedding of root hairs, degradation of biomass and pollen deposition. The study showed that Cry3Bb1 protein degrades rapidly in soil. The calculated DT50 ( time to 50% degradation) was 2.4 to 2.8 days, and the calculated DT90 ( time to 90% degradation) was 7.9 to 9.2 days. There was no detection of Cry3Bbl, by either ELISA or insect bioassay, in any sample incubated for over 21 days.

In the soil fate study, Cry3BbI protein was added to the soil as plant material at levels exceeding the upper estimates of the amount of plant tissue and Cry3BbI protein that might possibly enter the soil through tillage of Bt crops or through decay of corn roots. In fact, the plant tissue used contained the highest level of Cry3Bb1 protein found in any tissue at the peak time of crystal protein production. The study included two exaggerated dose levels of Cry3BbI protein in soil ( 52.4 pg/ g and 174.5 pg/ c, soil), representing 3% and 10% tissue by weight of soil, respectively. These doses greatly exceed the amount of protein that can reach soil at any one time via any conceivable mechanism, including exudation. Since the average level of Cry3Bb I in root tissue is 41 ug/ g tissue, [ Footnote 9: Monsanto report MSL 17181; MRID 454240 01] a total of 4.26 gram of fresh corn root tissue would have to be mixed with ( or decay into) each gram of soil in the root zone, an obvious impossibility in an agricultural field. Thus, the dose of Cry3Bb1 protein used in this study exceeds all possible estimates, of Cry3Bb1 protein in the root zone and provides a conservative estimate of Cry3Bb1 degradation in soil.

EPA Response: The accumulation of residual amounts of Cry protein in agricultural field soil will be evaluated over the life of the limited MON863 corn registration to provide confirmatory long term soil biota effects information. Section 3.2 3  88 Commenter Name: Lance Meinke Commenter Organization Name: NCR 46 Memebers Comment Number: OPP02 0016 Excerpt Number: 15 Excerpt Text:  Unlike ECB, corn rootworm populations can be scouted the previous year to determine whether or not management efforts, including transgenics, are needed in a specific field. Scouting techniques and thresholds are available for continuous corn, extended diapause of northern corn rootworms, and western corn rootworm oviposition in soybean. These methodologies would enable the use of transgenic varieties in a prescriptive, pest management approach.  The majority of corn acreage " at risk" from corn rootworm, is treated with insecticides in contrast to prevailing grower tolerance of ECB infestations throughout much of the Corn Belt. Farmers will expect the option of protecting corn roots from corn rootworms if refuge areas are a required part of an IRM plan. Currently, either the larval or adult stage is targeted when insecticides are applied to control corn rootworms and manage root injury. Soil insecticides or seed treatments targeted at larvae are typically used at planting to reduce larval injury and the probability that plant lodging will occur. However, because placement of these products is restricted to the seed furrow or a narrow band over the row, roots growing outside of the insecticide treated zone will often produce many adults ( goal: protection of nodal roots near the plant stem, not rootworm population management). Unlike the larval control strategy, the goal of adult control programs is to greatly suppress beetle densities ( population management) with broadcast insecticide treatments to corn foliage and reduce oviposition so that larval densities the following year will not cause economic loss. Use of the adult management strategy would significantly reduce beetle production from a refuge.

EPA Response: The above commenter discusses the current control strategies for corn rootworm larvae and adults. No request for a response from EPA is apparent. Insect resistance management issues are addressed in a separate section Commenter Name: Clifford Habig Commenter Organization Name: Exponent, Inc. Comment Number: OPP02 0017 Excerpt Number: 6 Excerpt Text: Environmental fate and expression can be incorporated into a field program, including sampling of soil and plants, and specific plant parts at various time points during the growing season, and can therefore compliment laboratory studies on the degradation of PIP products. However, incorporating environmental fate and expression analyses into a field study program ( or laboratory testing on environmental fate and expression) needs to include considerations of a practical nature, such as currently available analytical methods, the limits of detection and quantification of those methods, and the utility of continued sampling and analyses once soil concentrations fall below levels of detection/ quantification for two or three consecutive sampling time points.

EPA Response: Section 3.2 3  89 The commenter's suggestions on the protocol parameters for long term field sampling for residual soil Cry protein determination have been considered and generally accepted as valid by the EPA.

Commenter Name: Monsanto Commenter Organization Name: Monsanto Comment Number: OPP02 0021 Excerpt Number: 6 Excerpt Text: Question 4: Soil Degradation/ Accumulation of Cry3Bb1 A) The Panel is requested to comment on the advisability of testing additional soil types and for having soil persistence studies for up to 3 years.

Response: Monsanto believes that this laboratory soil degradation study demonstrates that Cry3Bb1 protein has the propensity to degrade rapidly in soils, and is sufficient for preliminary fate assessment. Monsanto will provide supplemental post registration studies with soils of soils of higher clay and silt content, as well as field persistence studies.

EPA has reviewed a soil degradation study on a sandy loam soil, which contained 61% sand, 28% silt, 10% clay and 2.3% organic matter. The study showed a DT50 of 2.4 days by insect bioassay, and 2.8 days by enzyme linked immunosorbent assay ( ELISA). The DT90 was 7.9 days by insect bioassay and 9.2 days by ELISA. [ Footnote 17: Martin, J. W., M. J. McKee, S. Dubelman and Y. A. Dudin ( 2000). Aerobic Soil Degradation of the B. t. Protein 11098 as a Component of Insect Protected Corn. Report MSL 16440, an unpublished study conducted by Monsanto Company. MRID 451568 04.]

EPA Response: The accumulation of residual amounts of Cry protein in agricultural field soil will be evaluated over the life of the limited MON863 registration to provide confirmatory long term soil biota effects information. Commenter Name: Monsanto Commenter Organization Name: Monsanto Comment Number: OPP02 0021 Excerpt Number: 7 Excerpt Text: B) What soil types would need to be tested and what duration is needed for soil persistence studies?

Response: Monsanto will provide supplemental post registration studies with soils of higher clay and silt content. Given the rapid dissipation of the Cry3Bbl protein in the laboratory soil degradation study, Monsanto suggests that the duration of post registration field persistence studies follow a tiered design ( i. e., a one year study would be adequate unless Cry3Bb1 protein persistence were observed in soil).

EPA Response: Additional field studies will be conducted that include the incorporation of all non harvested plant tissue in a variety of soil types particularly areas high in clay ( 26% already tested) and humic acids. These studies will be conducted for at least one growing season after harvest and continue until no Cry3Bb1 protein is detected. In addition the persistence of the Cry3Bb1 protein under less than optimum conditions ( e. g., high Section 3.2 3  90 or low temperatures; high or low soil moisture content) will be examined. Soil in fallow fields after at least three seasons of MON 863 corn cultivation will also be tested. These studies, in addition to ELISA, will include an insect bioassay utilizing a known sensitive species such as the Colorado potato beetle.

Commenter Name: Monsanto Commenter Organization Name: Monsanto Comment Number: OPP02 0021 Excerpt Number: 8 Excerpt Text: C) Are these studies truly expressing the time to 50% or 90% degradation of Bt protein in soil or whether they are only determining the level of detection of Cry3Bbl protein in soil? Discuss the acceptability of these studies for a preliminary risk assessment to evaluate the fate of Cry3Bbl in soil.

Response: The two detection methods used in Monsanto's soil degradation study, an insect bioassay and an ELISA method, yielded nearly identical DT50 and DT90 values, suggesting that these values are robust, and that either method can be used in such studies.

The soil degradation study was performed by dosing soils with exaggerated quantities of tissues containing Cry3Bbl protein, and using both insect bioassay and ELISA methods. Soil samples collected at the various sampling intervals showed Cry3Bbl protein residues declining exponentially as a function of sampling time, but well above the detection limit of both methods used to quantify Cry3Bbl protein residues in soil. The DT50 and DT90 values were calculated primarily based on detectable responses at the various sampling intervals, and method detection limits were not an obstacle to proper determination of DT50 and DT90 values. Insect bioassay methods have been frequently used to measure soil bound Bt protein residues. [ Footnote 18: Saxena, D., S. Flores and G. Stotsky ( 2002). Bt Toxin is Released in Root Exudates from 12 Transgenic Corn Hybrids Representing Three Transformation Events. Soil Biol. Biochem. 34: 133 137.]

EPA Response: An insect bioassay and an ELISA method, the two methods for detection of Cry protein in soils used in Monsanto's soil degradation studies, are currently acceptable to EPA. Bt Cry proteins adsorbed to clay and humic acid are detectable by the insect bioassay method.

Commenter Name: Monsanto Commenter Organization Name: Monsanto Comment Number: OPP02 0021 Excerpt Number: 9 Excerpt Text: D) What if any difference would it make in the values of these ELISA based studies if clay particles to which Cry3Bbl protein might bind are present in the soil being tested that measures should be taken to ensure that the test is not measuring inactive protein fragments?

Response: The ELISA method quantifies the total amount of Cry3Bbl protein, active and inactive, free or soil bound, present in soil samples. Inactive Cry3Bbl protein may consist of small protein fragments that are not biologically active against insects and consequently ELISA quantification may potentially exaggerate the amount of Cry3Bbl protein residue present in soil. Monsanto believes that the insect Section 3.2 3  91 bioassay and ELISA based DT50 and DT90 values obtained in the soil degradation studies provide a conservative estimate of the soil fate of the Cry3Bbl protein derived from corn containing event MON 863.

Clay and silt particles were present in the soil used to determine DT50 and DT90 values for Cry3Bb1 protein ( 10% clay, 28% silt). Monsanto acknowledges that soils with higher silt and clay content should be tested to verify that the rapid degradation pattern is not adversely affected by the presence of additional silt and clay. The ELISA method quantifies the total amount of Cry3Bb1 protein, active and inactive, present in soil samples. The insect bioassay method quantifies only toxicologically active Cry3BbI protein. Toxicologically active protein can be free or soil bound. Inactive protein may consist of small protein fragments that are not biologically active against insects, but may theoretically still contain the immunophoric sequence detected by the ELISA method. The ELISA method was used in the soil degradation studies because it is more sensitive than the most sensitive insect bioassay method ( Colorado potato beetle) currently available for determination of Cry3Bb1 protein residues in soil. The ELISA method could therefore, provide data for longer sampling intervals ( i. e., when most of the Cry3Bb1 protein had already degraded to levels below insect toxicity thresholds). Indeed, in the cited study, the insect bioassay provided quantitative data for the first four sampling points, and the ELISA method provided quantitative data for six sampling intervals, extending the limits of qualification for two additional weeks of sample incubation. As mentioned above, the DT50 and DT90 values were almost identical by both methods ( DT50 of 2.4 days by insect bioassay, and 2.8 days by ELISA; DT90 of 7.9 days by insect bioassay and 9.2 days by ELISA). This suggests that the ELISA method also quantifies mostly active Cry3Bb1 protein. However, if the ELISA method were assumed to quantify both active and inactive protein, then it would potentially exaggerate the amount of Cry3Bb1 protein residue present in soil. In such case, Cry3Bbl protein degradation may be even faster ( less risk) than indicated by the ELISA derived DT50 and DT90 values. Monsanto believes that the insect bioassay and ELISA based DT50 and DT90 values obtained in the soil degradation studies provide a conservative estimate of the soil fate of the Cry3Bb1 protein derived from corn containing event MON 863.

EPA Response: An insect bioassay and an ELISA method, the two methods for detection of Cry protein in soils used in Monsanto's soil degradation studies, are currently acceptable to EPA. Bt Cry proteins adsorbed to clay and humic acid are detectable by the insect bioassay method.

Commenter Name: N/ A Commenter Organization Name: Center for Science in the Public Interest Comment Number: OPP02 0028 Excerpt Number: 8 Excerpt Text: 6. Monsanto has not conducted studies of tile persistence of Cry3Bb1 in the soil under field conditions. The recent Bt reassessment Scientific Advisory Panel ( SAP) stated that it is important to determine the persistence of Bt protein in the soil under field conditions. Monsanto should conduct soil persistence experiments for Cry3Bb1 under field conditions and measure Cry3Bb1 concentrations both close to and distant from MON 863 corn roots.

EPA Response: Additional field studies will be conducted that include the incorporation of all non harvested plant tissue in Section 3.2 3  92 a variety of soil types particularly areas high in clay ( 26% already tested) and humic acids. These studies will be conducted for at least one growing season after harvest and continue until no Cry3Bb1 protein is detected. In addition the persistence of the Cry3Bb1 protein under less than optimum conditions ( e. g., high or low temperatures; high or low soil moisture content) will be examined. Deep and shallow soils, as well as soil close to, and away from roots will be examined. It is understood, however, that soil taken from the root zone will likely be contaminated by exudates from fine roots damaged during the soil collection process. Soil in fallow fields after at least three seasons of MON 863 corn cultivation will also be tested. These studies, in addition to ELISA, will include an insect bioassay utilizing a known sensitive species such as the Colorado potato beetle.

Commenter Name: N/ A Commenter Organization Name: Center for Science in the Public Interest Comment Number: OPP02 0028 Excerpt Number: 20 Excerpt Text: Monsanto has determined that Cry3Bb1 degrades at a rate of about 50% in less than three days in soil under laboratory conditions after a single incorporation of finely ground MON 863 leaves. However, the Bt reassessment SAP recommended that the rate of degradation of Cry proteins should be determined under field conditions ( 18). EPA should require Monsanto to determine the rate of degradation of MON 863 in the field for at least one growing season including sufficient time after harvest to determine how quickly Cry3 Bb1 degrades.

Furthermore, single incorporation studies to determine the fate of Cry toxins were considered insufficient by the Bt reassessment SAP because actual deposition likely occurs on a continuous basis both from root biomass, as well as through possible exudation of Cry3Bb1 through the roots. If exudation occurs at a sufficient rate, it is possible that the concentration of Cry3Bb1 in the soil could increase, at least through the growing season, because breakdown of Cry proteins may be slowed by binding onto clay particles.

Conducting field degradation studies is important because Monsanto reported that expression of MON 863 is high in the root tip ( 20). Corn in particular is noted for its ability to exude proteins through the root cap ( 18), so there is particular concern that MON 863 corn may exude Cry3Bb1. In addition, Monsanto calculated the average concentration of Cry3Bb I in the soil based on even distribution of a single incorporation of corn plant residue to a depth of six inches. That concentration was used as a soil EEC to determine the Cry3Bb1 concentration used in non target soil organism toxicity tests. Due to root growth and possible exudation, Monsanto likely underestimates the actual concentration of Cry3Bbl that soil organisms will encounter. While a single incorporation of Bt plant material would expose soil organisms to steadily decreasing amounts of Cry3Bbl, actual exposure during the growing season will be continuous. When the primary exposure to Cry3Bb1 is ingestion of root material or root exudates by herbivores or detritovors, or indirectly by their predators or parasites, exposure to higher concentrations of Cry3Bb1 than estimated by Monsanto can occur.

Finally, while not a current requirement, EPA should require testing of the impact of Cry3Bb1 on soil microbes. Soil microbes are vital for maintaining the properties of soil responsible for crop productivity and such environmentally critical issues as water conservation. Data was generated on microbial impact for currently registered Bt crops, and the Bt reassessment SAP recognized the importance of evaluating Section 3.2 3  93 possible impact of transgenic pesticidal crops on soil microorganisms and encouraged additional effort in evaluating such impacts. Unfortunately, EPA has not developed guidelines to assess impact on soil microorganisms so it is not clear what testing should be conducted to assess impact on soil microbes.

EPA Response: Additional field studies will be conducted that include the incorporation of all non harvested plant tissue in a variety of soil types particularly areas high in clay ( 26% already tested) and humic acids. These studies will be conducted for at least one growing season after harvest and continue until no Cry3Bb1 protein is detected. In addition the persistence of the Cry3Bb1 protein under less than optimum conditions ( e. g., high or low temperatures; high or low soil moisture content) will be examined. During the growing season deep and shallow soils, as well as soil close to, and away from roots will be examined. It is understood, however, that soil taken from the root zone will likely be contaminated by exudates from fine roots damaged during the soil collection process. Soil in fallow fields after at least three seasons of MON 863 corn cultivation will also be examined. These studies, in addition to ELISA, will include an insect bioassay utilizing a known sensitive species such as the Colorado potato beetle.

Data on soil degradation of CryBb proteins currently at EPA was obtained at high Cry protein doses that would account for the amount of Cry protein released by continuous exudation by plant roots. In addition, it is general knowledge that microbial degradation of proteins in soil is ubiquitous. This observation was reaffirmed by the FIFRA SAP ( SAP Report No. 99 06, February 4, 2000). Several studies have also shown that Cry proteins adsorbed to soil minerals are quickly metabolized by soil microbes upon elution. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 4). The data reviewed by the Agency show that the Cry protein degradation in soil occurs within days to a barely detectable background levels regardless of the Cry protein source source. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 4). Data available to date also do not show any detrimental effects on soil biota. ( USEPA. 2002. MON 863 BRAD Section C. I. B. 5,6). These aspects of soil accumulation and runoff of Cry proteins will, however, be investigated over several years to provide confirmatory long term effects information.


Comment Info: =================

General Comment:Supplemental Material Document Title: Memo: Guidelines for Assignment for reduced freeboards for dredgers, DR-68: 08/04/2010 from F. Kersbergen, Inspectie Verkeer en Waterstaat 1 page


[Federal Register Volume 76, Number 151 (Friday, August 5, 2011)]
[Rules and Regulations]
[Pages 47424-47427]
[FR Doc No: 2011-19866]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0631; Directorate Identifier 2011-NM-134-AD;
Amendment 39-16759; AD 2011-16-01]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Model FALCON 7X
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above that would supersede an existing AD. This AD
results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as:

    Recently, a Dassault Aviation Falcon 7X aeroplane experienced an
uncontrolled pitch trim runaway during descent. The crew succeeded
in recovering a stable situation and performed an uneventful
landing.
    This condition, if occurring again, could lead to a loss of
control of the aeroplane.
* * * * *

    This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective August 22, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in the AD as of August 22, 2011.
    We must receive comments on this AD by September 19, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; phone: 425-227-
1137; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On June 16, 2011, we issued AD 2011-12-51, Amendment 39-16735 (76
FR 37251, June 27, 2011). To address an unsafe condition, that AD
prohibited operation of the affected airplanes. That AD corresponds to
Emergency Airworthiness Directive 2011-0102-E, dated May 26, 2011,
issued by the European Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, to
correct an unsafe condition for the specified products.
    Since we issued AD 2011-12-51, we have been advised of the
development of new modifications that will address the unsafe
condition. We have determined that these modifications are necessary to
allow these airplanes to resume operation. The EASA issued Emergency AD
2011-0114-E, dated June 16, 2011, to supersede AD 2011-0102-E. The EASA
subsequently revised that AD with EASA AD 2011-0114R1, dated June 23,
2011. The EASA subsequently revised that AD with EASA AD 2011-0114R2,
dated July 7, 2011 (referred to after this as ``the MCAI''), which
states:

    Recently, a Dassault Aviation Falcon 7X aeroplane experienced an
uncontrolled pitch trim runaway during descent. The crew succeeded
in recovering a stable situation and performed an uneventful
landing.
    This condition, if occurring again, could lead to a loss of
control of the aeroplane.
    To address this potential unsafe condition, pending
investigations by the manufacturer, EASA issued emergency AD 2011-
0102-E (which corresponds to FAA AD 2011-12-51) which prohibited
further flights from its effective date.
    The initial results of the investigations show that there was a
production defect in the Horizontal Stabilizer Electronic Control
Unit (HSECU) which could have contributed to the cause of the event.
There are two different HSECU part numbers (P/N) in use: P/N 051244-
02 is not affected by this production defect and P/N 051244-04 is
potentially affected by this production defect. The aeroplane that
experienced the uncontrolled pitch trim runaway event was equipped
with a HSECU P/N 051244-04. Investigations are continuing to confirm
this cause.
    In the meantime, to allow re-starting flight operations and
providing protection against further pitch trim runaway events,
Dassault Aviation have developed two modifications (M1235 and M1236)
which are implemented through accomplishment of Dassault Aviation
Service Bulletin (SB) F7X-211.
    Furthermore, the flight envelope must be restricted, compared to
the original certified flight envelope. Dassault Aviation have
developed the corresponding Aircraft Flight Manual (AFM) limitations
and a placard, to be installed in the cockpit (part of the
instructions of SB F7X-211) to remind the flight crew of the
limitations. In addition, modified operational procedures have been
developed for in-flight activation of the new protection.
    A Certification Maintenance Requirement (CMR), to repetitively
test the new Horizontal Stabilizer Trim Actuator (HSTA) electric
motors reversion relays (installed with M1235 and M1236), has been
developed and must be introduced into chapter 5.40 of the Aircraft
Maintenance Manual (AMM).
    Additionally, the Master Minimum Equipment List (MMEL) is
temporarily modified by this AD to prohibit dispatch of the
aeroplane with some specific identified failures.
    To correct this unsafe condition and allow resumption of flights
for aeroplanes equipped with HSECU P/N 051244-02, EASA issued AD
2011-0114-E, which superseded EASA AD 2011-0102-E, to require:
    1. Accomplishing two Dassault Aviation modifications,
    2. Amending the AFM and installing a placard in the cockpit,
    3. Amending the Minimum Equipment List (MEL), and
    4. Implementing an operational test of the HSTA electric motors
reversion relays.
    For aeroplanes equipped with HSECU P/N 051244-04, the
prohibition of flights was maintained.
    Since EASA AD 2011-0114-E was issued, Dassault Aviation have
issued SB F7X-212 which gives instructions, for aeroplanes equipped
with HSECU P/N 051244-04, to remove the HSECU for verification by
Rockwell Collins and replace it with an HSECU that has passed the
verification, having a name plate with a stamped V. After

replacement of the HSECU P/N 051244-04 with a verified HSECU P/N
051244-04 ``V'', the airplane can resume flights, provided the
requirements of this AD are complied with.
    For the reasons described above, EASA AD 2011-0114R1 was issued
to allow aeroplanes equipped with HSECU P/N 051244-04 to resume
flights under the same conditions as those previously established
for aeroplanes equipped with HSECU P/N 051244-02, provided an HSECU
P/N 051244-04 with stamped ``V'' is installed.
    Since EASA AD 2011-0114R1 was issued, Dassault Aviation have
developed a modification of HSECU P/N 051244-04 which corrects the
production defect found on some of these units inspected during the
initial investigation. This modified unit has a new P/N 051244-05
and it is eligible for installation on an aeroplane.
    For the reasons described above, this revised AD is issued to
allow aeroplanes equipped with HSECU P/N 051244-05 to resume flights
under the same conditions as those previously established for
aeroplanes equipped with HSECU P/N 051244-02, or HSECU P/N 051244-04
with stamped ``V.''
    This revised AD is still considered to be an interim measure.
Pending results of the ongoing investigations, further AD action may
follow to restore a fully certified flight envelope for aeroplanes
of this type design.

Required actions include revising the AFM to limit operation with
certain inoperative MEL items, and revising the electronic checklist.
You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Dassault has issued Mandatory Service Bulletin 7X-211, Revision 2,
including New Standard Installation Checklist and Appendix A, dated
June 22, 2011, including FCS Data Loading Procedure, Issue D, dated May
28, 2010; Mandatory Service Bulletin 7X-212, Revision 2, dated July 7,
2011; Service Bulletin 7X-213, dated June 22, 2011; Falcon 7X Airplane
Flight Manual, Revision 12, dated June 16, 2011; and Dassault Aviation,
Falcon 7X Maintenance Manual, Falcon 7X--Chapter 5-40-00 after Rev 01,
dated June 10, 2011 (Commonly referred to as Dassault Change Proposal
(CP) CP009 to Chapter 5-40-00 of Dassault Falcon 7X Maintenance
Manual). The actions described in this service information are intended
to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the AD.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
the possibility of an uncontrolled pitch trim runaway during descent,
which could result in loss of control of the airplane. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2011-0631; Directorate
Identifier 2011-NM-134-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-16735 (76 FR
37251, June 27, 2011) and adding the following new AD:

2011-16-01 Dassault Aviation: Amendment 39-16759. Docket No. FAA-
2011-0631; Directorate Identifier 2011-NM-134-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective August
22, 2011.

Affected ADs

    (b) This AD supersedes AD 2011-12-51, Amendment 39-16735.

Applicability

    (c) This AD applies to all Dassault Aviation Model FALCON 7X
airplanes, certificated in any category, all serial numbers.

    Note 1:  This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (n)(1) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
controls.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:

    Recently, a Dassault Aviation Falcon 7X aeroplane experienced an
uncontrolled pitch trim runaway during descent. The crew succeeded
in recovering a stable situation and performed an uneventful
landing.
    This condition, if occurring again, could lead to a loss of
control of the aeroplane.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Modification

    (g) Before further flight, do the applicable actions specified
in paragraphs (g)(1), (g)(2), and (g)(3) of this AD.
    (1) For airplanes on which Dassault Mandatory Service Bulletin
7X-211, Revision 1, dated June 14, 2011, has not been done as of the
effective date of this AD: Modify the airplane by adding an
automatic reversion logic and a means for the pilot to override
pitch trim control normal modes, and install placards in the cockpit
in full view of the pilots, in accordance with paragraph 2.,
``Accomplishment Instructions for Aircraft which have not Already
Implemented the Revision 1 of the Service Bulletin,'' of Dassault
Mandatory Service Bulletin 7X-211, Revision 2, including New
Standard Installation Checklist and Appendix A, dated June 22, 2011,
including FCS Data Loading Procedure, Issue D, dated May 28, 2010.
    (2) For airplanes on which Dassault Mandatory Service Bulletin
7X-211, Revision 1, dated June 14, 2011, has been done as of the
effective date of this AD:
    Replace the frame of the emergency switch box, in accordance
with paragraph 3., ``Accomplishment Instructions for Aircraft which
have Already Implemented Revision 1 of this Service Bulletin,'' of
Dassault Mandatory Service Bulletin 7X-211, Revision 2, including
New Standard Installation Checklist and Appendix A, dated June 22,
2011, including FCS Data Loading Procedure, Issue D, dated May 28,
2010.
    (3) For airplanes equipped with any horizontal stabilizer
electronic control unit (HSECU) P/N 051244-04, replace the HSECU
with any HSECU identified in paragraph (g)(3)(i), (g)(3)(ii), or
(g)(3)(iii) of this AD, in accordance with the Accomplishment
Instructions of Dassault Mandatory Service Bulletin 7X-212, Revision
2, dated July 7, 2011.
    (i) HSECU P/N 051244-02
    (ii) Verified HSECU P/N 051244-04 having a stamped ``V''
    (iii) HSECU P/N 051244-05

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (h) An HSECU replacement done before the effective date of this
AD in accordance with Dassault Mandatory Service Bulletin 7X-212,
Revision 1, dated June 23, 2011, is acceptable for compliance with
the requirements of either paragraph (g)(3)(i) or (g)(3)(ii) of this
AD.

Revision of Airplane Flight Manual (AFM)

    (i) As of the effective date of this AD, operate the airplane
according to the limitations and procedures in the Dassault Falcon
7X AFM, Revision 12, dated June 16, 2011. Revision 12 introduces
revised operational speed limitations and revised procedures
accounting for the new TRIM EMERG button.

Electronic Checklist Database Installation

    (j) Before further flight, install the electronic checklist
V0007 database, in accordance with the Accomplishment Instructions
of Dassault Service Bulletin 7X-213, dated June 22, 2011.

Operating Restrictions

    (k) Before further flight, revise the Limitations section of the
Dassault Falcon 7X AFM to include the following information. This
may be accomplished by inserting a copy of this AD into the AFM.

    ``Dispatch with any inoperative equipment identified below is
prohibited. This prohibition takes precedence over the FAA master
minimum equipment list (MMEL) or any operator's MEL.
    Air data systems (identified as MEL item 34-9)
    Multi functional probe (MFP) heating system (identified as MMEL
item 30-1)
    ACMU3 and ACMU4 (identified as MMEL item 27-3)
    LH REAR POWER 3 (identified as MMEL item 27-5-(-6)
    Back-up mode (identified as MMEL item 27-8)''

Maintenance Program Revision

    (l) Within 30 days after the effective date of this AD, revise
the maintenance program to incorporate MPD task 27-40-00-710-801, as
specified in Dassault Aviation, Falcon 7X Maintenance Manual, Falcon
7X--Chapter 5-40-00 after Rev 01, dated June 10, 2011 (Commonly
referred to as Dassault Change Proposal (CP) CP009 to Chapter 5-40-
00 of Dassault Falcon 7X Maintenance Manual). The initial compliance
time for doing the operational test of the HSTA electric motors
reversion relays is 1,850 flight hours after accomplishment of the
applicable actions required by paragraph (g) of this AD.

    Note 2:  The MM revision required by paragraph (l) of this AD
may be done by inserting a copy of Dassault CP CP009, dated June 10,
2011, to Chapter 5-40-00 of Dassault Falcon 7X MM into the MM. When
Dassault CP CP009 has been included in general revisions of the MM,
the general revisions may be inserted into the MM, provided the
relevant information in the general revision is identical to that in
Dassault CP CP009, and Dassault CP CP009 may be removed.

No Alternative Procedures or Intervals

    (m) After the maintenance program has been revised as required
by paragraph (l) of this AD, no alternative procedure or interval
for the operational test may be used unless the procedure and/or
interval is approved as an AMOC in accordance with the procedures
specified in paragraph (n) of this AD.

FAA AD Differences

    Note 3:  This AD differs from the MCAI and/or service
information as follows:
    (1) EASA AD 2011-0114R2 requires repetitive operational tests of
the HSTA electric motors reversion relays, and specifies that the
aircraft maintenance program may be revised in lieu of those
repetitive tests. This FAA AD merely mandates revising the
maintenance program.
    (2) EASA AD 2011-0114R2 does not include any requirement to
revise the electronic checklist. Paragraph (j) of this FAA AD
requires this action.
    (3) EASA AD 2011-0114R2 mandates amending the minimum equipment
list (MEL) by removing certain items. This FAA AD instead requires
revising the AFM to prohibit dispatch with those items inoperative.
The operational effect, however, is the same.

Other FAA AD Provisions

    (n) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, Transport Airplane Directorate, ANM-116, FAA,
has the authority to approve AMOCs for this AD, if requested using
the

procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically refer to this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to ensure the product
is airworthy before it is returned to service.
    (3) Special Flight Permits: Special flight permits, as described
in Section 21.197 and Section 21.199 of the Federal Aviation
Regulations (14 CFR 21.197 and 21.199), are allowed, if conducted in
accordance with a method approved by the Manager, ANM-116,
International Branch, Transport Airplane Directorate, FAA.

Related Information

    (o) For related information, refer to MCAI EASA Airworthiness
Directive 2011-0114R2, dated July 7, 2011, and the service
information identified in table 1 of this AD.

                                          Table 1--Related Information
----------------------------------------------------------------------------------------------------------------
                         Document                            Revision                     Date
----------------------------------------------------------------------------------------------------------------
Dassault Mandatory Service Bulletin 7X-211, including FCS            2  June 22, 2011.
 Data Loading Procedure, Issue D, dated May 28, 2010, New
 Standard Installation Checklist, and Appendix A.
Dassault Mandatory Service Bulletin 7X-212...............            2  July 7, 2011.
Dassault Falcon 7X Airplane Flight Manual................           12  June 16, 2011.
Dassault Service Bulletin 7X-213.........................  ...........  June 22, 2011.
Dassault Aviation, Falcon 7x Maintenance Manual, Falcon    ...........  June 10, 2011.
 7X--Chapter 5-40-00 after Rev 01 (Commonly referred to
 as Dassault Change Proposal (CP) CP009 to Chapter 5-40-
 00 of Dassault Falcon 7X Maintenance Manual).
----------------------------------------------------------------------------------------------------------------

Material Incorporated by Reference

    (p) You must use the service information contained in table 2 of
this AD to do the actions required by this AD, unless the AD
specifies otherwise. Appendix A and New Standard Installation
Checklist of the Dassault Mandatory Service Bulletin 7X-211 are not
dated or identified with a document number. The document date can
only be found in the List of Revisions section of the Dassault
Falcon 7X Airplane Flight Manual.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Dassault Falcon Jet, P.O. Box 2000, South Hackensack, New Jersey
07606; telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

                                   Table 2--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
                         Document                            Revision                     Date
----------------------------------------------------------------------------------------------------------------
Dassault Mandatory Service Bulletin 7X-211, including FCS            2  June 22, 2011.
 Data Loading Procedure, Issue D, dated May 28, 2010, New
 Standard Installation Checklist, and Appendix A.
Dassault Mandatory Service Bulletin 7X-212...............            2  July 7, 2011.
Dassault Falcon 7X Airplane Flight Manual................           12  June 16, 2011.
Dassault Service Bulletin 7X-213.........................  ...........  June 22, 2011.
Dassault Aviation, Falcon 7x Maintenance Manual, Falcon    ...........  June 10, 2011.
 7X--Chapter 5-40-00 after Rev 01 (Commonly referred to
 as Dassault Change Proposal (CP) CP009 to Chapter 5-40-
 00 of Dassault Falcon 7X Maintenance Manual).
----------------------------------------------------------------------------------------------------------------

    Issued in Renton, Washington, on July 15, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-19866 Filed 8-4-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 26 (Wednesday, February 10, 2021)]
[Notices]
[Pages 8984-8985]
[FR Doc No: 2021-02769]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Actions on Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of actions on special permit applications.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein.

DATES: Comments must be received on or before March 12, 2021.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington, DC.

    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on February 4, 2021.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special
          Application No.                   Applicant        Regulation(s) affected        permits thereof
----------------------------------------------------------------------------------------------------------------
                                                     Granted
----------------------------------------------------------------------------------------------------------------
14636-M............................  Department of Defense   172.301(c), 180.209...  To modify the special
                                      (Military Surface                               permit to streamline the
                                      Deployment &                                    identification of tubes
                                      Distribution Command).                          being requalified and to
                                                                                authorize additional
                                                                                OCONUS locations.
15691-M............................  Department of Defense   172.301(c), 180.209...  To streamline the listing
                                      (Military Surface                               of authorized cylinders,
                                      Deployment &                                    update the locations where
                                      Distribution Command).                          the permitted cylinders
                                                                                are authorized and remove
                                                                                the one-time extension and
                                                                                restate the five year
                                                                                requalification
                                                                                requirements.
16118-M............................  Toyota Motor Sales USA  173.301(a)(1).........  To modify the special
                                      Inc.                                            permit to more closely
                                                                                align it with relevant
                                                                                sections for compressed
                                                                                hydrogen in the UN Model
                                                                                Regulation 21st Revision,
                                                                                Special Provision 392.
16308-M............................  Vero Biotech LLC......  173.175...............  To modify the special
                                                                                permit to authorize a new
                                                                                absorbent filler
                                                                                surrounding the ampules
                                                                                being transported.
21018-M............................  Packaging and Crating   172.200, 172.300,       To modify the special
                                      Technologies, LLC.      172.400, 172.600,       permit to authorize
                                                              172.700(a),             batteries up to 1200Wh to
                                                              173.185(b),             be transported in Thermo
                                                              173.185(c),             Shield pleatwrap.
                                                              173.185(f).
21135-N............................  JohnDow Industries,     178.503(a)............  To authorize the marking of
                                      Inc.                                            specification packagings
                                                                                that were mismarked with
                                                                                an incorrect
                                                                                specification.
21142-N............................  Atlas Air, Inc........  172.101(j),             To authorize the
                                                              172.204(c)(3),          transportation in commerce
                                                              173.27(b)(2),           of explosives forbidden
                                                              173.27(b)(3).           aboard cargo-only aircraft
                                                                                by cargo-only aircraft.
21166-M............................  Federal Cartridge       173.56(b).............  To modify the special
                                      Company.                                        permit to authorize
                                                                                private carriage of the
                                                                                authorized hazmat.
21173-N............................  Lynden Air Cargo, LLC.  172.101 Column (9B)...  To authorize the
                                                                                transportation in commerce
                                                                                of certain explosives
                                                                                which are forbidden for
                                                                                transport by cargo-only
                                                                                aircraft.
21175-N............................  I-K-I Manufacturing     173.306(a)(5).........  To authorize the
                                      Co., Inc.                                       transportation in commerce
                                                                                of plastic aerosols
                                                                                classed as Division 2.1
                                                                                for the purposes of
                                                                                testing and disposal.
21176-N............................  Solvay Fluorides, LLC.  173.227...............  To authorize the
                                                                                transportation in commerce
                                                                                of 3 cargo containers
                                                                                containing a 6.1 hazmat
                                                                                that has been packaged and
                                                                                packed in accordance with
                                                                                IMDG regulations but not
                                                                                the HMR.
----------------------------------------------------------------------------------------------------------------
                                                     Denied
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                    Withdrawn
----------------------------------------------------------------------------------------------------------------
21108-N............................  Aerospacelab..........  173.185(a)(1).........  To authorize the
                                                                                transportation in commerce
                                                                                of low production lithium
                                                                                batteries contained in
                                                                                equipment by motor vehicle
                                                                                and cargo-only aircraft.
21113-N............................  Spaceflight, Inc......  173.185(a)(1).........  To authorize the
                                                                                transportation in commerce
                                                                                of low production lithium
                                                                                batteries contained in
                                                                                spacecraft by cargo-only
                                                                                aircraft.
21164-N............................  The Boeing Company....  172.102, 172.200,       To authorize the
                                                              172.560, 172.301,       transportation in commerce
                                                              172.700(a), 172.447,    of a temperature-
                                                              173.27, 173.185,        controlled Active Unit
                                                              178.600.                Load Device (containing
                                                                                compressed gas and lithium
                                                                                battery) via aircraft.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-02769 Filed 2-9-21; 8:45 am]
BILLING CODE 4909-60-P