[Federal Register Volume 86, Number 52 (Friday, March 19, 2021)]
[Notices]
[Pages 14907-14908]
[FR Doc No: 2021-05697]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0324; FRL--10021-80-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Marine Tank Vessel Loading
Operations (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), NESHAP for Marine Tank Vessel
Loading Operations (EPA ICR Number 1679.11, OMB Control Number 2060-
0289), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through May
31, 2021. Public comments were previously requested, via the Federal
Register on May 12, 2020 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller

description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 19,
2021.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OECA-2013-0324, online using www.regulations.gov (our preferred
method<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460. EPA's policy is that all comments
received will be included in the public docket without change including
any personal information provided, unless the comment includes
profanity, threats, information claimed to be Confidential Business
Information (CBI), or other information whose disclosure is restricted
by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Marine Tank Vessel Loading Operations (40 CFR
part 63, subpart Y) establishes Maximum Achievable Control Technology
(MACT) standards for existing facilities and new facilities that load
marine tank vessels with petroleum or gasoline. These facilities have
aggregate actual hazardous air pollutants (HAP) emissions of 10 tons or
more of each individual HAP, or 25 tons or more of all HAP combined.
This NESHAP regulation also established reasonably-available control
technology (RACT) standards to such facilities with an annual
throughput of 10 million or more barrels of gasoline or 200 million or
more barrels of crude oil. This information is being collected to
assure compliance with 40 CFR part 63, subpart Y.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NESHAP.
    Form Numbers: None.
    Respondents/affected entities: Owners or operators of marine tank
vessel loading operations.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart Y).
    Estimated number of respondents: 804 (total).
    Frequency of response: Initially and semiannually.
    Total estimated burden: 10,700 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $1,260,000 (per year), which includes $0 for
annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is no change in burden from the
most-recently approved ICR as currently identified in the OMB Inventory
of Approved Burdens. This is due to two considerations: (1) the
regulations have not changed over the past three years and are not
anticipated to change over the next three years; and (2) the growth
rate for this industry is very low or non-existent, so there is no
significant change in the overall burden. Since there are no changes in
the regulatory requirements and there is no significant industry
growth, there are also no changes in the capital/startup and/or
operation and maintenance (O&M) costs.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-05697 Filed 3-18-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Proposed Rules]
[Pages 41953-41954]
[FR Doc No: 2012-17367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. FDA-2012-F-0728]

Representative Edward J. Markey; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Representative Edward J. Markey has filed a petition proposing that the
food additive regulations be amended to no longer provide for the use
of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for
infant formula because these uses have been abandoned. FDA expressly
requests comments on the petitioner's request.

DATES: Submit either electronic or written comments by September 17,
2012.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
F-0728 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-F-0728. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vanee Komolprasert, Center for Food
Safety and Applied Nutrition (HFS-275), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 348(b)(5)), notice is given that a food
additive petition (FAP 2B4791) has been filed by Representative Edward
J. Markey, House of Representatives, 2108 Rayburn House Office
Building, Washington, DC 20515-2107. The petition proposes to amend the
food additive regulations in Sec.  175.300 (21 CFR 175.300) to no
longer provide for the use of BPA-based epoxy resins as coatings in
packaging for infant formula because these uses have been intentionally
and permanently abandoned. BPA-based epoxy resins are formed by the
reaction of 4,4'-isopropylenediphenol (i.e., BPA), and epichlorohydrin.

II. Abandonment

    Under section 409(i) of the FD&C Act, FDA ``shall by regulation
prescribe the procedure by which regulations under the foregoing
provisions of this section may be amended or repealed, and such
procedure shall conform to the procedure provided in this section for
the promulgation of such regulations.'' FDA's regulations specific to
administrative actions for food additives provide as follows: ``The
Commissioner, on his own initiative or on the petition of any
interested person, pursuant to part 10 of this chapter, may propose the
issuance of a regulation amending or repealing a regulation pertaining
to a food additive or granting or repealing an exception for such
additive.'' (Sec.  171.130(a) (21 CFR 171.130(a))). These regulations
further provide: ``Any such petition shall include an assertion of
facts, supported by data, showing that new information exists with
respect to the food additive or that new uses have been developed or
old uses abandoned, that new data are available as to toxicity of the
chemical, or that experience with the existing regulation or exemption
may justify its amendment or appeal. New data shall be furnished in the
form specified in Sec. Sec.  171.1 and 171.100 for submitting
petitions.'' (Sec.  171.130(b)). Under these regulations, a petitioner
may propose that FDA amend a food additive regulation if the petitioner
can demonstrate that there are ``old uses abandoned'' for the relevant
food additive. Such abandonment must be complete for any intended uses
in the U.S. market. While section 409 of the FD&C Act and Sec.  171.130
also provide for amending or revoking a food additive regulation based
on safety, an amendment or revocation based on abandonment is not based
on safety, but is based on the fact that the regulatory authorization
is no longer necessary because the use of the food additive has been
abandoned.
    Abandonment may be based on the abandonment of certain authorized
food additive uses for a substance (e.g., if a substance is no longer
used in certain product categories), or on the abandonment of all
authorized food additive uses of a substance (e.g., if a substance is
no longer being manufactured). If a petition seeks an amendment to a
food additive regulation based on the abandonment of certain uses of
the food additive, such uses must be adequately defined so that both
the scope of the abandonment and any amendment to the food additive
regulation are clear.
    The petition submitted by Representative Markey contains public
information and information collected from a survey of the U.S.
registered manufacturers of infant formula to support the petitioner's
claim that all U.S. infant formula manufacturers have abandoned the use
of BPA-based epoxy resins as coatings in all food contact packaging for
infant formula. According to the petition, these companies accounted
for 100% of the current infant formula market in the United States.
    FDA expressly requests comments on the petitioner's request that
FDA amend the food additive regulations to no longer permit the use of
BPA-based epoxy resins as coatings in packaging for infant formula. For
the purposes of this petition, FDA considers the use of BPA-based epoxy
resins as coatings (as described in Sec.  175.300(a)) in packaging of
infant formula to mean a metal substrate (single use) or any suitable
substrate (repeated use) being coated with BPA-based epoxy resins as a
continuous film or enamel, serving as a functional barrier between the
infant formula (powder or liquid) and the substrate. As noted, the
basis for the proposed amendment is that the use of

BPA-based epoxy resins as coatings in packaging for infant formula has
been permanently and completely abandoned. Accordingly, FDA requests
comments that address whether these uses of BPA-based epoxy resins have
been completely abandoned, such as information on whether infant
formula packaging containing BPA-based epoxy resins as coatings is
currently being introduced or delivered for introduction into the U.S.
market. Further, FDA requests comments on whether the uses that are the
subject of the petition (BPA-based epoxy resins as coatings in infant
formula packaging) have been adequately defined. FDA is not aware of
information that suggests continued use of BPA-based epoxy resins as
coatings in packaging for powder or liquid infant formula. FDA is
providing the public 60 days to submit comments. FDA anticipates that
some interested persons may wish to provide FDA with certain
information that they consider to be trade secret or confidential
commercial information (CCI) that would be exempt under Exemption 4 of
the Freedom of Information Act (5 U.S.C. 552). Interested persons may
claim information that is submitted to FDA as CCI or trade secret by
clearly marking both the document and the specific information as
``confidential.'' Information so marked will not be disclosed except in
accordance with the Freedom of Information Act (5 U.S.C. 552) and FDA's
disclosure regulations (21 CFR part 20). For electronic submissions to
http://www.regulations.gov, indicate in the ``comments'' box of the
appropriate docket that your submission contains confidential
information. Interested persons must also submit a copy of the comment
that does not contain the information claimed as confidential for
inclusion in the public version of the official record. Information not
marked confidential will be included in the public version of the
official record without prior notice.
    FDA is not requesting comments on the safety of these uses of BPA-
based epoxy resins as coatings because, as discussed previously, such
information is not relevant to establishing abandonment as the basis of
the proposed action. Any comments addressing the safety of BPA-based
epoxy resins or containing safety information on these resins will not
be considered in FDA's evaluation of this petition. Separate from FDA's
consideration of this petition, FDA is actively assessing the safety of
BPA (see 75 FR 17145, April 5, 2010; see also http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm064437.htm).
    FDA has determined under 21 CFR 25.32(m) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17367 Filed 7-16-12; 8:45 am]
BILLING CODE 4160-01-P


Page 1 of 12 PLANT INCORPORATED PROTECTANTS BASED ON PLANT VIRAL COAT PROTEINS Introduction A plant incorporated protectant ( PIP) is a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof1, and the genetic material necessary for production of such a pesticidal substance. The term includes both active and inert ingredients. PIPs are regulated as pesticides by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) because they meet the FIFRA definition of a pesticide, being intended for preventing, destroying, repelling, or mitigating a pest.

PIPs may be genetically engineered into plants2. Some specific genetic sequences, when incorporated into a plant's genome, can endow the plant with the ability to resist damage from certain pests. Plant virus coat protein PIPs ( PVCP PIPs) are PIPs in which the inserted genetic material is derived from a plant virus sequence that encodes a coat protein. Plant virus coat proteins encapsidate the viral nucleic acid and are known to have a role in nearly every stage of viral infection including replication, movement throughout an infected plant, and transport from plant to plant. Incorporation of plant viral coat protein ( PVCP) gene sequences into plant genomes has been found to confer resistance to the virus from which it was derived, and often to related viruses ( OECD Environment Directorate 1996).

Background In 1994 EPA published its policy regarding regulation of PIPs ( then called plant pesticides) under FIFRA. Recognizing the breadth of the definition of a PIP and that some PIPs present a lower overall risk and thus may not require regulation, the Agency proposed several exemptions to regulation. Included were two options to exempt PVCP PIPs. A full categorical exemption from regulation under FIFRA was proposed for PVCP PIPs based on the rationale that they generally pose a low probability of risk to human health or the environment. However, recognizing that other plants could acquire the virus resistance through hybridization with a transgenic plant, an alternative to a full categorical exemption was also proposed to promote full discussion of this issue. Under this alternative exemption option, the Agency defined a set of criteria to identify those viral coat protein/ plant combinations with the lowest potential to confer selective advantage on wild or weedy plant relatives. Only those PVCP PIPs so identified would have been exempt from regulation. The 1994 policy statement described this alternative exemption as follows:

Coat proteins from plant viruses [ would be exempt] if the genetic material necessary to produce a coat protein is introduced into a plant's genome and the plant has at least one of the following characteristics:

1 The phrase " or produce thereof" is included in the definition of a PIP to make it clear that pesticidal substances active in the fruit or other plant product for pesticidal purposes are also considered to be PIPs. 2 PIPs may also be found naturally occurring in plants or may be introduced through conventional breeding. However, the focus here is on PIPs, specifically those based on viral coat proteins, that are introduced into plants through genetic engineering. Page 2 of 12 ( 1) The plant has no wild relatives in the United States with which it can successfully exchange genetic material, i. e., corn, tomato, potato, soybean, or any other plant species that EPA has determined has no sexually compatible wild relatives in the United States.

( 2) It has been demonstrated to EPA that the plant is incapable of successful genetic exchange with any existing wild relatives ( e. g., through male sterility, self pollination).

( 3) If the plant can successfully exchange genetic material with wild relatives, it has been empirically demonstrated to EPA that existing wild relatives are resistant or tolerant to the virus from which the coat protein is derived or that no selective pressure is exerted by the virus in natural populations.

Some proposals in the 1994 policy statement were finalized in 2001. However, neither the full nor alternative exemption for PVCP PIPs was finalized, in part because more recent information had questioned the idea that PVCP PIPs would generally pose a low probability of risk and would not pose unreasonable adverse effects to human health or the environment in the absence of any regulation under FIFRA. For example, the 2000 National Research Council ( NRC) report, Genetically Modified Pest Protected Plants, recommended that,

" EPA should not categorically exempt viral coat proteins from regulation under FIFRA. Rather, EPA should adopt an approach, such as the agency's alternative proposal , that allows the agency to consider the gene transfer risks associated with the introduction of viral coat proteins to plants."

In addition to the risks associated with gene transfer, the 2000 NRC report considered other concerns associated with the use of PVCP PIPs, including the potential for adverse effects following recombination, heterologous encapsidation, and synergy. Although the report concluded that, "[ m] ost virus derived resistance genes are unlikely to present unusual or unmanageable problems that differ from those associated with traditional breeding for virus resistance," neither formulation of the exemption proposed in 1994 contained provisions that would have enabled EPA to ensure that the risk management strategies suggested by the NRC would be implemented, e. g., elimination of specific sequences to limit the potential for recombination.

In 2001 the Agency reopened the comment period on the PVCP PIP exemption proposals and sought advice from the public on how best to proceed. EPA is in the process of reevaluating how PVCP PIPs will be treated by the Agency in light of comments and advice it received. The Agency is reconsidering the scientific merit and feasibility of exempting a subset of PVCP PIPs from regulation under FIFRA as one of several regulatory options. Potential conditions intended to reduce the risks associated with the use of PVCP PIPs are included in the questions to the panel to provide a structure that may facilitate discussion of environmental concerns raised with regard to commercial use of PVCP PIPs. Page 3 of 12 Charge to the SAP EPA requests that the Scientific Advisory Panel provide scientific advice to assist EPA in its evaluation of plant incorporated protectants ( PIPs) based on plant virus coat proteins ( PVCPPIPs During the public comment periods for PVCP PIPs in 1994 and again in 2001, the Agency received comments from the scientific community that covered viewpoints ranging from support for a full categorical exemption to opposition to any exemption procedure for PVCP PIPs. These comments highlighted several areas of scientific uncertainty that are addressed in our questions to the panel. The Agency asks for the panel's scientific advice in three areas: gene flow, viral interactions, and other issues. EPA seeks the assistance of the SAP in evaluating whether gene flow and viral interactions may pose environmental hazards, and if so, whether these concerns could be mitigated under certain circumstances. EPA seeks the advice of the SAP to ensure that PVCP PIPs are appropriately described and to develop a more complete technical record.

Charge   Gene Flow Gene flow from plants containing PVCP PIPs is a potential concern to the extent that new genes conferring virus resistance may be introduced into wild or weedy relatives with the potential either to release them from growth and/ or reproduction constraints imposed by naturally occurring virus( es) or conversely to decrease their fitness through changes in gene expression. These relatives of transgenic plants may then have the potential for increased weediness and/ or the ability to outcompete other species. Conversely, plants also may become less competitive.

A broad review of hybridization between plants and their wild relatives, including the potential for and possible implications of the movement of transgenes, was recently published ( Ellstrand 2003), and the issue of introgression from genetically modified crops to their wild relatives was considered in a recent review ( Stewart et al. 2003). In addition, several scientific review panels have recently analyzed the general issue of gene flow with particular attention to the regulatory issues facing both U. S. and foreign government agencies ( National Research Council 2000; GM Science Review Panel 2003) 3. The potential effects of gene flow to wild relatives specifically from plants containing PVCP PIPs has been addressed in a few experimental studies ( Bartsch et al. 1996; Bartsch et al. 2001; Spencer & Snow 2001; Ilardi & Barba 2001; Fuchs et al. 2004a; Fuchs et al. 2004b). This issue is considered in greater depth in several reviews ( Bartsch 1997; Power 2002; Tepfer 2002). The theoretical possibility that gene flow from plants containing PVCP PIPs to wild or weedy relatives could, in some instances, lead to environmental impacts is widely accepted. However, empirical or observational data on the likelihood or magnitude of such impacts are lacking. Consequently EPA is seeking the assistance of the SAP to attempt to reach a better understanding of the circumstances in which the flow of PVCP PIPs from transgenic plants to wild or weedy relatives could occur and the potential for adverse impacts from such gene flow.

3 The UK Government, the Scottish Executive, the National Assembly for Wales and the administration in Northern Ireland have been promoting a national dialogue on genetic modification ( GM) issues. One part of this was a review of the science of GM, led by Sir David King ( the Government's Chief Scientific Adviser) working with Professor Howard Dalton ( the Chief Scientific Adviser to the Secretary of State for the Environment, Food and Rural Affairs), with independent advice from the Food Standards Agency. Page 4 of 12 Questions   gene flow Concerns about the transfer of virus resistance to wild or weedy relatives include the assumption that such resistance might confer a selective advantage to a wild or weedy relative that could increase its competitive ability and potential to become weedy or invasive. The Agency would like the panel to consider the evidence supporting this assumption.

1. What scientific evidence supports or refutes the idea that plant viruses have significant effects on reproduction, survival, and growth of plant populations in natural settings? Is there scientific evidence that plant populations freed from viral pressure could have increased competitive ability leading to changes in plant population dynamics?

In the 1994 proposal, EPA identified tomato, potato, soybean, and corn as having no wild relatives in the United States with which they can successfully exchange genetic material, although the 2002 NRC report , Environmental Effects of Transgenic Plants, suggests that corn and its wild relative Eastern gamagrass ( Tripsacum dactyloides) might produce hybrids with some fertility at a very low frequency in the United States.

2. Please comment on the validity of the Agency list of crops that have no wild or weedy relatives in the United States with which they can produce viable hybrids in nature ( i. e., tomato, potato, soybean, and corn).

3. Please identify other crops that have no wild or weedy relatives in the United States with which they can produce viable hybrids in nature, e. g., papaya, peanut, and/ or chickpea.

The Agency anticipates the need to evaluate data addressing whether transgenic plant species are capable of genetic exchange with wild or weedy plant relatives. In general, EPA is focused on the potential for genetic exchange that can occur in the field. However, evaluations of the potential for genetic exchange are likely to include laboratory studies that are not necessarily an accurate indicator of plants' ability to exchange genetic material outside the lab.

4. What laboratory techniques used to achieve genetic exchange between species ( e. g., embryo rescue, use of intermediate bridging crosses, protoplast fusion) are not indicative of possible genetic exchange between these species in the field? Conversely, what techniques, if any, used in laboratory or greenhouse experiments provide the most reliable indication of ability to hybridize in the field?

EPA recognizes that it may be possible to genetically engineer a plant such that concerns about gene flow to wild or weedy relatives are significantly reduced. However, according to the 2004 NRC report, Biological Confinement of Genetically Engineered Organisms, current techniques for bioconfinement ( e. g., sterile triploids, male sterility) are imperfect and are not guaranteed to eliminate entirely gene flow to existing wild relatives. Recent modeling studies suggest Page 5 of 12 imperfections in bioconfinement could result in significant levels of gene introgression in compatible plant relatives over a period of decades ( Haygood et al. 2004).

5. Given that current bioconfinement techniques are not 100% effective, what would the environmental implications be of extremely low transfer rates of virus resistance genes over time?

EPA recognizes that concerns about gene flow to wild or weedy relatives may be ameliorated if the introduced virus resistance trait would give little or no selective advantage to the recipient plant, as would occur if the plant were already tolerant or resistant4 to the virus to which resistance is conferred. It is obvious that such resistance does exist in some populations because traditional breeding for resistance relies on finding a source of resistance within related cultivated species, old varieties, or wild species ( Khetarpal et al. 1998).

6. Please comment on the prevalence of tolerance and/ or resistance to viruses in wild relatives of crops.

7. Please specify techniques that do or do not provide measures of tolerance and/ or resistance that are relevant to field conditions.

8. How do environmental or other factors ( e. g., temporal variations) affect tolerance and/ or resistance? Given the expected variability, what measures of tolerance and/ or resistance would be reliable?

9. What would be the ecological significance if a plant population acquired a small increase in viral tolerance and/ or resistance above a naturally occurring level?

Based on the hypothesis that concerns about the consequences of gene flow to a wild or weedy relative in the United States may be negligible in certain cases, the Agency is considering whether there are mechanisms to adequately address concerns associated with gene flow so that certain types of VCPs would be of such low risk that they would not need to be regulated by EPA. Below are examples of three conditions ( modified from those proposed in 1994) that are intended to significantly reduce any potential adverse effects of gene flow with plants containing a PVCP PIP.

( 1) The plant into which the PVCP PIP has been inserted has no wild or weedy relatives in the United States with which it can produce viable hybrids in nature, e. g., corn, tomato, potato, or soybean; or ( 2) Genetic exchange between the plant into which the PVCP PIP has been inserted and any existing wild or weedy relatives is substantially reduced by modifying the plant with a scientifically documented method ( e. g., through male sterility); or ( 3) It has been empirically demonstrated that all existing wild or weedy relatives in the United States with which the plant can produce a viable hybrid are tolerant or resistant to the virus from which the coat protein is derived.

4 See Appendix for definitions. Page 6 of 12 10. Please comment on how necessary and/ or sufficient these conditions are to minimize the potential for the PVCP PIP to harm the environment through gene flow from the plant containing the PVCP PIP to wild or weedy relatives. Would any other conditions work as well or better?

Charge   Viral Interactions Interactions between introduced plant virus sequences and other invading viruses in transgenic plants ( e. g., during recombination or heterologous encapsidation) may be a concern to the extent that such events may increase in frequency or be unlike those expected to occur in nature. It has been hypothesized that such events could lead to the creation of viruses with new disease states or transmission properties. The Agency is evaluating the circumstances that might increase the potential for such events to occur and the potential environmental consequences of novel viral interactions5 in light of the 2000 NRC report which stated that, "[ m] ost virus derived resistance genes are unlikely to present unusual or unmanageable problems that differ from those associated with traditional breeding for virus resistance." The report went on to suggest that risks might be managed by particular ways of engineering transgenes6. However, under either of the 1994 proposed exemptions, the Agency would be unable to ensure that such strategies were implemented. The Agency's literature review, " Viral interactions in viral coat protein transgenic plants," discusses possible ways of managing these potential risks in detail.

Questions   viral interactions Viral interactions may occur in natural, mixed infections which are common in plants. Hypothetical concerns related to potential adverse effects resulting from viral interactions between infecting viruses and PVCP PIPs in transgenic plants may be attributed to opportunities for interactions not expected to occur in nature. EPA is interested in evaluating the significance of novel viral interactions involving a viral transgene7.

11. To what extent are novel viral interactions ( e. g., recombination, heterologous encapsidation) involving a viral transgene an environmental concern?

Mixed viral infections can be extremely common in crops and other plants. However, scientific uncertainty exists as to whether recombination and heterologous encapsidation would occur more or less frequently in the case of a viral transgene and an infecting virus interaction as 5 See Appendix for definition of novel viral interactions. 6 The report says, "[ c] an transgenes be engineered to reduce or eliminate the risk that recombination will spawn new pathogens? Evidence suggests that elimination of genome replication control sequences from transgenes can limit recombination and therefore risk... Furthermore, strategies to produce resistance mediating transgenes that encode nonfunction proteins or no protein can be used effectively against viruses. For example, resistant plants that express nontranslatable RNA can confer immunity through induction of post transcriptional gene silencing " ( National Research Council 2000; pg. 94) 7 See EPA literature review " Viral Interactions in Viral Coat Protein Transgenic Plants" pp. 15 16. Page 7 of 12 compared to such interactions in mixed infections of a transgenic plant's non bioengineered counterpart8.

12. What conclusions can be drawn as to whether the likelihood of recombination and/ or heterologous encapsidation would be increased or decreased in a transgenic plant compared to its non bioengineered counterpart?

A number of methods for reducing the frequency of recombination and heterologous encapsidation have been identified. While the effectiveness of these techniques has been verified for particular cases, their applicability to all PVCP PIPs is unclear. Recognizing that it would be difficult for a product developer to measure rates of recombination, heterologous encapsidation, or vector transmission under field conditions, EPA is considering whether it would be necessary to verify that such methods worked in any particular instance by measuring rates in modified versus unmodified plants.

13. How effective is deleting the 3' untranslated region of the PVCP gene as a method for reducing the frequency of recombination in the region of the PVCP gene? Is this method universally applicable to all potential PVCP PIP constructs? Would any other methods work as well or better? Which methods are sufficiently effective and reproducible such that actual measurement of rates to verify rate reduction would be unnecessary?

14. Are any methods for inhibiting heterologous encapsidation or transmission by insect vectors universally applicable to all PVCP PIPs? Which methods are sufficiently effective and reproducible such that actual measurement of rates to verify rate reduction would be unnecessary?

15. How technically feasible would it be to measure rates of recombination, heterologous encapsidation, and vector transmission in PVCP PIP transgenic plants in order to show that rates are reduced?

EPA recognizes that scientific disagreement exists as to the likelihood of environmental impacts due to novel viral interactions in transgenic plants modified with PVCP PIPs. The Agency is considering whether there are available mechanisms to adequately address concerns associated with novel viral interactions so that certain types of PVCP PIPs would be of such low risk that they would not need to be regulated by EPA. Below are examples of conditions that might significantly reduce either the novelty [( 1) and ( 2)] or frequency [( 3) and ( 4)] of viral interactions in PVCP PIP transgenic plants.

( 1) The genetic material of the PVCP PIP is translated and/ or transcribed in the same cells, tissues, and developmental stages naturally infected9 by every virus from which any segment of a coat protein gene used in the PVCP PIP was derived.

8 See EPA literature review " Viral Interactions in Viral Coat Protein Transgenic Plants" pp. 14 15. 9 See Appendix for definition of naturally infects. Page 8 of 12 ( 2) The genetic material of the PVCP PIP contains coat protein genes or segments of coat protein genes from viruses established throughout the regions where the crop is planted in the United States and that naturally infect the crop into which the genes have been inserted.

( 3) The PVCP PIP has been modified by a method scientifically documented to minimize recombination, ( e. g., deletion of the 3' untranslated region of the coat protein gene).

( 4) The PVCP PIP has been modified by a method scientifically documented to minimize heterologous encapsidation or vector transmission, or there is minimal potential for heterologous encapsidation because no protein from the introduced PVCP PIP is produced in the transgenic plant or this virus does not participate in heterologous encapsidation in nature.

16. Please comment on how necessary and/ or sufficient each of these conditions is to minimize the potential for novel viral interactions. Please address specifically what combination would be most effective or what conditions could be modified, added, or deleted to ensure that potential consequences of novel viral interactions in PVCP PIP transgenic plants are minimized.

Other questions In 1994 EPA proposed exempting plant viral coat proteins from the requirement of a food tolerance under the Federal Food, Drug, and Cosmetic Act10 based on rationale that ( 1) virus infected plants have always been a part of the human and domestic animal food supply and ( 2) plant viruses have never been shown to be infectious to humans or mammals. The safety of consuming plant virus genes has been supported by experimental work ( Chen et al. 2003; Rogan et al. 2000; Shinmoto et al. 1995) and expert consultations including the 2000 NRC report which concluded that, " viral coat proteins in transgenic pest protected plants are not expected to jeopardize human health because consumers already ingest these compounds in nontransgenic food." However, EPA recognizes that PVCP PIP developers may wish to modify the PVCP PIP construct and that some methods of mitigating potential risks associated with recombination and heterologous encapsidation might actually require them to do so. Such modifications might result in changes to the protein( s) produced thus creating potential food safety concerns, e. g., inadvertent production of new toxins or allergens ( Day 1996). Modifications of the construct and alteration of the proteins produced creates the potential for health impacts on non target species as well as humans.

17. To what degree and in what ways might a PVCP gene be modified ( e. g., through truncations, deletions, insertions, or point mutations) while still retaining scientific support for the idea that humans have consumed the products of such genes for generations and that such products therefore present no new dietary exposures?

18. What are the potential adverse effects, if any, of such modifications on nontarget species ( e. g., wildlife and insects that consume the PVCP PIP)?

10 EPA determines whether limits ( tolerances) should be set on the amount of residues of PVCP PIPs in food derived from the improved plant. When there is substantial information indicating safety and history of safe use, the developer may request an exemption from the requirement of a tolerance. Although a general tolerance exemption for all PVCP PIPs has not been finalized, tolerance exemptions for specific PVCP PIPs have been . They can be found in 40 CFR Part 180.1182 ( potato), 180.1184 ( watermelon), 180.1185 ( papaya), and 180.1186 ( cucumber). Page 9 of 12 Modifications of the construct may also potentially create the opportunity for novel viral interactions because the inserted virus sequences could be unlike any that occur naturally.

19. To what degree and in what ways might a PVCP gene be modified ( e. g., through truncations, deletions, insertions, or point mutations) before it would be a concern that novel viral interactions due to the modifications could occur because the PVCP gene would be significantly different from any existing in nature?

The potential risk issues identified in this paper are specific to virus resistant transgenic plants. However, the Agency recognizes that it may be necessary to evaluate other information related to the PVCP PIP.

20. Would any additional requirements related to PVCP PIP identity and composition ( e. g., demonstration that the transgene has been stably inserted) be needed for significant reduction of risks associated with PVCP PIPs?

21. Are there any considerations beyond gene flow, recombination, and heterologous encapsidation as posed in the preceding questions that the Agency should consider in evaluating the risk potential of PVCP PIPs ( e. g., synergy)? Page 10 of 12 References Bartsch, D. 1997. Ecological impact of transgenic virus resistance in crop, weed, and wild plant populations ( due to potential alterations of plant invasiveness). In Tepfer, M. and Balázs, E., eds. Virus resistant Transgenic Plants: Potential Ecological Impact. Springer, Berlin, pp 107 113. Bartsch, D., Brand, U., Morak, C., Pohl Orf, M., Schuphan, I., and Ellstrand, N. 2001. Biosafety of hybrids between transgenic virus resistant sugar beet and swiss chard. Ecol. Appl. 11: 142 147. Bartsch, D., Schmidt, M., Pohl Orf, M., Haag, C., and Schuphan, I. 1996. Competitiveness of transgenic sugar beet resistant to beet necrotic yellow vein virus and potential impact on wild beet populations. Mol. Ecol. 5: 199. Chen, Z. L., Gu, H., Li, Y., Su, Y., Wu, P., Jiang, Z., Ming, X., Tian, J., Pan, N., and Qu, L. J. 2003. Safety assessment for genetically modified sweet pepper and tomato. Toxicology 188: 297 307. Day, P. R. 1996. Genetic modification of plants: significant issues and hurdles to success. American Journal of Clinical Nutrition 63: 651S 656S. Ellstrand, N. 2003. Dangerous Liaisons. Johns Hopkins University Press, Baltimore. Fuchs, M., Chirco, E. M., and Gonsalves, D. 2004a. Movement of coat protein genes from a commercial virus resistant transgenic squash into a wild relative. Environ. Biosafety Res. 3: 5 16. Fuchs, M., Chirco, E. M., McFerson, J. R., and Gonsalves, D. 2004b. Comparative fitness of a wild squash species and three generations of hybrids between wild × virus resistant transgenic squash. Environ. Biosafety Res. 3: 17 28. GM Science Review Panel . GM Science Review First Report. http:// www. gmsciencedebate. org. uk/ report/ pdf/ gmsci report1 full. pdf . 2003. 5 12 0004. Haygood, R., Ives, A. R., and Andow, D. A. 2004. Population genetics of transgene containment. Ecology Letters 7: 213 220. Ilardi, V. and Barba, M. 2001. Assessment of functional transgene flow in tomato fields. Molecular Breeding 8: 311 315. Khetarpal, R. K., Maisonneuve, B., Maury, Y., Chalhoub, B., Dinant, S., Lecoq, H., and Varma, A. 1998. Breeding for resistance to plant viruses. In Hadidi, A., Khetarpal, R. K., and Koganezawa, H., eds. Plant Virus Disease Control. APS Press, St. Paul, pp 14 32. National Research Council 2000. Genetically Modified Pest Protected Plants: Science and Regulation. National Academy Press, Washington, DC. National Research Council 2002. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation. National Academy Press, Washington, D. C. National Research Council 2004. Biological Confinement of Genetically Engineered Organisms. National Academies Press, Washington, DC. OECD Environment Directorate . Consensus document on general information concerning the biosafety of crop plants made virus resistant through coat protein gene mediated protection. http:// www. olis. oecd. org/ olis/ 1996doc. nsf/ 62f30f71be4ed8a24125669e003b5f73/ ce3a104b8ada9e8ac1256 3e2003183bb/$ FILE/ 11E63213. ENG . 1996. Power, A. G. 2002. Ecological risks of transgenic virus resistant crops. In Letourneau, D. K. and Burrows, B. E., eds. Genetically Engineered Organisms: Assessing Environmental and Human Health Effects. CRC Press, Boca Raton, pp 125 142. Rogan, G. J., Bookout, J. T., Duncan, D. R., Fuchs, R. L., Lavrik, P. B., Love, S. L., Mueth, M., Olson, T., Owens, E. D., Raymond, P. J., and Zalewski, J. 2000. Compositional analysis of tubers from insect and virus resistant potato plants. J. Agric. Food Chem. 48: 5936 5945. Shinmoto, H., Tomizawa, A., Kobori, M., Tsushida, T., and Shinohara, K. 1995. Assessment of the mutagenicity of extracts of TMV coat protein gene induced transgenic tomato by the umu test. Biosci. Biotechnol. Biochem. 59: 2151 2152. Spencer, L. J. and Snow, A. A. 2001. Fecundity of transgenic wild crop hybrids of Cucurbita pepo ( Cucurbitaceae): implications for crop to wild gene flow. Heredity 86: 694 702. Stewart, C. N. Jr., Halfhill, M. D., and Warwick, S. I. 2003. Transgene introgression from genetically modified crops to their wild relatives. Nat. Rev. Genet. 4: 806 817. Tepfer, M. 2002. Risk assessment of virus resistant transgenic plants. Annu. Rev. Phytopathol. 40: 467 491. Page 11 of 12 U. S. Environmental Protection Agency 2004. Viral Interactions in Viral Coat Protein Transgenic Plants: A Literature Review. Office of Science Coordination and Policy, Office for Prevention, Pesticides and Toxic Substances, U. S. Environmental Protection Agency, Washington, DC. Page 12 of 12 Appendix: Definitions Resistant, when referring to PVCP PIPs only, means the plant is not infected by or is a non host of the virus concerned.

Naturally infects means a naturally occurring virus is transmitted to a plant by direct plant toplant contact, inanimate objects, or vectors such as pollen, arthropods, nematodes, or fungi; and the virus replicates and moves within the recipient plant. It does not include human intervention, e. g., manual inoculation.

Novel viral interaction means interaction between portions of two or more different viruses ( e. g., through recombination or heterologous encapsidation) not expected to occur in a mixed viral infection found in nature.

PVCP PIP means a plant incorporated protectant created from the gene, or a segment of the gene, that codes for a coat protein of a virus that naturally infects crop plants.

Tolerant, when referring to PVCP PIPs only, means the plant is able to sustain the effects of a virus infection with negligible or mild symptom expression and negligible or mild effects on fitness or growth despite the presence of the virus within the host.


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on September 14, 2005

   NOTICE OF ACTION TAKEN -- DOCKET OST-2005-21724

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Joint Application of   Shuttle America Corporation (Shuttle America) and
Delta Air Lines, Inc. (Delta)

filed   6/27/05 for:

XX  Exemption for Shuttle America for two years under 49 U.S.C. 40109 to
provide the following service:

Scheduled foreign air transportation of persons, property, and mail
between the terminal point Salt Lake City, Utah, and the terminal point
Mazatlan, Mexico, and to combine such exemption authority with existing
certificate and exemption authority held by Shuttle America,  consistent
with applicable international agreements.

XX  Exemption for Delta for two years under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of persons, property, and mail
between the terminal point Salt Lake City, Utah, and the terminal point
Mazatlan, Mexico, and to combine such exemption authority with existing
certificate and exemption authority held by Delta, consistent with
applicable international agreements.

Joint Applicant rep: Robert E. Cohn<PHONE_NUMBER>   DOT Analyst: Linda
Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action granting exemption authority to Shuttle America was
effective when taken:  September 14, 2005, through September 14, 2007.

The above action granting exemption authority to Delta was effective
when taken:  September 14, 2005,

through September 14, 2007.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX Holder’s certificates of public convenience and necessity

XX Standard exemption conditions (attached)

Conditions:  The U.S.-Mexico exemption authority granted is subject to
the dormancy notice requirements set forth in condition 7 of Appendix A
of Order 88-10-2.  Consistent with our standard policy, the dormancy
notice period will begin March 1, 2006, the carriers’ startup date for
the proposed service.   The exemption authority granted to Delta is
limited to services provided on a code-share basis only.  The exemption
authority granted to Shuttle America for direct-carrier (own-aircraft)
service is awarded subject to the terms of the correspondence dated
April 6, 2005, referenced in note 1.

The code-share operations conducted under this authorization are subject
to the following conditions:

The code-sharing operations conducted under this authority must comply
with 14 CFR 257 and with any amendment to the Department’s regulations
concerning code-share arrangements that may be adopted.  Notwithstanding
any provisions in the contract between the carriers, our approval here
is expressly conditioned upon the requirements that the subject foreign
air transportation be sold in the name of the carrier holding out such
service in computer reservation systems and elsewhere; that the carrier
selling such transportation (i.e., the carrier shown on the ticket)
accept responsibility for the entirety of the code-share journey for all
obligations established in its contract of carriage with the passenger;
and that the passenger liability of the operating carrier be unaffected;
and

The authority granted here is specifically conditioned so that neither
Shuttle America nor Delta shall give any force or effect to any
contractual provisions between themselves that are contrary to these
conditions.

________________________________________________________________________
___

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicants qualified to provide
the exemption services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

   Shuttle America is a commuter carrier certificated to provide
scheduled interstate air transportation using aircraft with fewer than
60 seats (Order 98-11-15).  By letter dated April 6, 2005, to Mr. Robert
Cohn (Counsel for Shuttle America) from Mr. William Bertram (Chief, Air
Carrier Fitness Division, Office of Aviation Analysis), the Department
authorized Shuttle America to engage in interstate scheduled
transportation using large aircraft, subject to the restriction that
Shuttle America’s operations are performed under a fee-for-service
agreement with a major U.S carrier.  In the instant application, Shuttle
America states that it plans to introduce daily nonstop service on the
Salt Lake City-Mazatlan route, using 70-seat Embraer 170 aircraft, and
that the proposed services will be offered under a code-share
fee-for-service agreement with Delta, whereby Shuttle America will
operate flights under Delta’s “DL*” code as a “Delta
Connection” carrier.

  By letter dated September 1, 2005, Counsel for Shuttle America advised
the Department that it plans to begin the subject services on March 1,
2006, instead of its originally proposed startup of December 1, 2005,
and requested that any dormancy condition relating to the authority
requested run from March 1, 2006.

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