ICAO COMMITTEE ON AVIATION ENVIRONMENTAL PROTECTION

WORKING GROUP 3 – EMISSIONS TECHNICAL

London, England

April 1-3, 2009

Response to U.S. EPA Papers 14 and 16

(Presented by ICCAIA)

1.       Introduction

ICCAIA would first of all like to thank the U.S. EPA for once again
participating directly in the CAEP Working Group 3 meeting. This enables
more direct contact on issues both important to the Agency and important
to the manufacturers. This paper is written in response to several
issues with regards to the 3 working papers submitted to the 6th meeting
of CAEP Working Group 3 during the CAEP8 cycle.

2.	WP14 Production Cut-Offs for NOx Standards

At the September 2008 Steering Group Meeting in Seattle, the meeting
agreed to proceed with further studies of a production cut-off for the
CAEP/6 NOx standards in FESG and MODTF (CAEP-SG/20082_SD/4).  These
studies would focus on the analysis of costs and benefits of a CAEP/6
NOx production cut-off.

In the current EPA paper they suggest various reasons why they wish to
push for production cut-off regulations for aviation with the following
paragraph being one of the main reasons: “In domestic U.S. programs,
for mobile sources (except aircraft), manufacturers must recertify their
product lines each year, thus creating some form of a production cut-off
on the first year of a new emission standard. To accommodate reasonable
business practice, the U.S. EPA has incorporated various provisions to
ensure an orderly product phase-in and phase-out (e.g., annual %
phase-in/phase-out requirements by models or production), but in no case
are previously certified engine families grandfathered into the new
program indefinitely.  Such provisions are very workable in other
sectors, but may be less attractive in the aviation sector. As discussed
in CAEP-SG/20071-WP/26, ultimately, for the U.S. and the nations of many
participating CAEP members, the aviation sector stands as the only
source that is allowed to indefinitely produce existing engines that do
not meet the latest emission standards.”

 ICCAIA wish to state a few points with regards to this statement: -

It has been proven within CAEP that market forces mean that aircraft
engine manufacturers have voluntary complied with CAEP NOx standards
within a suitable timeframe from when the regulations were first agreed.

Aircraft engines are covered by airworthiness regulations throughout
their life and any changes to such engines have to get approval from the
airworthiness authorities. It is noted that there are virtually no
examples where an aircraft engine has been re-certificated with inferior
NOx emissions after the original certification date.

Furthermore CAEP has accepted advice on the minor affect of in-service
deterioration CAEP-WG3-CETG-WP5-6 on NOx emissions.

Finally at this meeting a paper is being presented, that has been
accepted by the EPA on applicability of emissions standards for engines
that covers the issue of post certification changes
CAEP-WG3-CTG6-WP6-Att A.

EPA makes various further claims that engine manufacturers do not
voluntary comply with CAEP NOx standards and the EPA states, “For the
same reasons, a production cut-off should be considered for the CAEP/8
NOx stringency increase.  Although CAEP-SG/20082-WP6, Production Cut-Off
for Engine NOx Standards (Presented by FESG Rapporteurs, September 4,
2008), asserts that market forces have worked in the absence of a
production cut-off, we believe there is still much to gain by
considering and possibly adopting a production cut-off provision.
Ultimately, a production cut-off may best ensure that backsliding does
not occur and that the emission reduction benefits expected from the new
standards are achieved.” In the recommendations EPA suggest production
cut-off standards “8 years” after the agreement on NOx regulations.

On the one hand this paragraph accepts the FESG assertion that market
forces are working, and yet on the other hand it still wishes to push
for production cut-off rules for CAEP8.

ICCAIA expects the continued work of the FESG will maintain that a
production cut-off provision for the CAEP6 standard is not required due
to market forces providing the incentive.

ICCAIA asks that the meeting note that ICCAIA member companies have
always voluntarily met and often bettered the “8 years” criterion
used in the EPA Working Paper in the past.

ICCAIA suggests that any discussion on CAEP8 production cut-off
regulations be referred directly to SG, but ICCAIA wish to note that
imposition of this work during this cycle is inappropriate, as FESG will
not have time to consider this in their analysis.

ICCAIA recommends that any work on CAEP8 production cut-off
considerations does not start until some time into the CAEP9 cycle, and
ICCAIA further notes that its membership does not believe there is a
necessity to complete such work as history has shown that manufacturers
voluntarily comply with CAEP NOx standards.

3.	WP16 Exemption Working Paper

ICCAIA supports the work to include suitable exemption text and guidance
in Annex 16 and the ETM. This is primarily covered in the work of the
ad-hoc group on Annex 16 and ETM referenced in CAEP-WG3-CTG6-WP5, and
ICCAIA thanks the EPA for becoming involved in this ad-hoc group. ICCAIA
does not believe that just including such provisions in the CAEP
recommendations should be some kind of green light for production
cut-off regulations for the reasons stated in section 3.

EPA makes the following very good points that ICCAIA supports: -

“The language for these allowances, which is contained in <IP_ADDRESS> of
Volume II, can be interpreted and implemented in a variety of ways.  The
U.S. has applied this allowance in its regulations (40 CFR 87.7) to
create three broad categories for potential exemptions from U.S.
emissions standards: (1) temporary exemptions, (2) very low production
exemptions, and (3) hardship exemptions.  The temporary exemptions
address situations such as aircraft manufactured in the U.S. that are
being exported.  The exemption for very low production models allows for
consideration of exemptions of a total production for U.S. civil
aviation of up to 200 units covered by the same type certificate after
January 1, 1984.  The hardship provision potentially allows exemptions
based on other factors.  The term “exemption” is not defined in U.S.
aircraft regulations, but the regulatory exemptions are drafted such
that exempted aircraft engines are exempted only from emission standards
while remaining subject to the regulations overall.”

“Reciprocity.  The language related to exemptions does not address
whether exemptions issued by one certificating authority should
necessarily be accepted by other authorities.  Whether or not such
reciprocity is assumed directly affects the need for the Annex to
include detailed provisions related to exemptions in this area.
Increased specificity of the Annex would likely increase the likelihood
that reciprocity would be seen as appropriate. Some degree of
reciprocity is already covered under existing bilateral agreements.
Greater specificity in these provisions would promote a harmonized
approach to granting exemptions and thus reinforce the utility of
current reciprocity agreements.”

      Recommendations

ICCAIA recommends that any analysis for the requirement for production
cut-off provisions for any future CAEP8 standard should not be
considered in advance of any CAEP8 standard setting procedure be
completed.

ICCAIA supports the work to include suitable exemption text and guidance
in Annex 16 and the ETM and recommends that CAEP WG3 support the
inclusion of this work.

WG3-Flimsy6-2

Summary

This working paper responds to the issues brought to CAEP WG3 by the
U.S. Environmental Protection Agency (EPA) in Working Papers 14 and 16.

ICCAIA is pleased that the U.S. EPA are once again directly involved in
the CAEP process and within CAEP work on analysis on whether there is a
need for production cut-offs for NOx standards. ICCAIA believes the
evidence presented within CAEP proves that market forces do indeed show
that the manufacturers voluntarily comply with new CAEP NOx standards.
For CAEP6 ICCAIA can state with confidence that it is highly likely that
all commercial engines in production by the end of 2010 will meet the
CAEP6 NOx standards. ICCAIA recommends that any analysis for the
requirement for production cut-off provisions for any future CAEP8
standard should not be considered in advance of any CAEP8 standard
setting procedure be completed.

ICCAIA supports the work to include suitable exemption text and guidance
in Annex 16 and the ETM and recommends that CAEP WG3 support the
inclusion of this work in the future work programme.


US - Electric Sector CO2 Emissions

US,Electric Sector CO2 Emissions,Reference, Dual Rate, Mass (E+N), Mass (existing), Patchwork (E+N), Patchwork (existing)

<li class="filterall filter-electric-sector-co2-emissions filter-reference-no-cpp-ee-dual-rate-ee-mass-en-ee-mass-existing-ee-electric-sector-co2-emissions filter-east eg-grant-wrapper eg-post-id-35811 tp-esg-item esg-hovered itemtoshow loadedmedia isvisiblenow" data-date="1471356192" style="opacity: 1; visibility: inherit; transform: matrix3d(1, 0, 0, 0, 0, 1, 0, 0, 0, 0, 1, 0, 0, 0, 0.1, 0.999917); height: auto; width: 287px; display: block; top: 9423px; left: 0px; transform-origin: center center 0px;">

East - Electric Sector CO2 Emissions

East,Electric Sector CO2 Emissions,Reference, No CPP (EE), Dual Rate (EE), Mass (E+N, EE), Mass (existing, EE)

<li class="filterall filter-electric-sector-co2-emissions filter-reference-no-cpp-ee-dual-rate-ee-mass-en-ee-mass-existing-ee-electric-sector-co2-emissions filter-ercot eg-grant-wrapper eg-post-id-35812 tp-esg-item esg-hovered itemtoshow loadedmedia isvisiblenow" data-date="1471356200" style="opacity: 1; visibility: inherit; transform: matrix3d(1, 0, 0, 0, 0, 1, 0, 0, 0, 0, 1, 0, 0, 0, 0.1, 0.999917); height: auto; width: 287px; display: block; top: 9423px; left: 634px; transform-origin: center center 0px;">

ERCOT - Electric Sector CO2 Emissions

ERCOT,Electric Sector CO2 Emissions,Reference, No CPP (EE), Dual Rate (EE), Mass (E+N, EE), Mass (existing, EE)

<li class="filterall filter-electric-sector-co2-emissions filter-reference-no-cpp-ee-dual-rate-ee-mass-en-ee-mass-existing-ee-electric-sector-co2-emissions filter-west eg-grant-wrapper eg-post-id-35813 tp-esg-item esg-hovered itemtoshow loadedmedia isvisiblenow" data-date="1471356209" style="opacity: 1; visibility: inherit; transform: matrix3d(1, 0, 0, 0, 0, 1, 0, 0, 0, 0, 1, 0, 0, 0, 0.1, 0.999917); height: auto; width: 287px; display: block; top: 9846px; left: 317px; transform-origin: center center 0px;">

West - Electric Sector CO2 Emissions

West,Electric Sector CO2 Emissions,Reference, No CPP (EE), Dual Rate (EE), Mass (E+N, EE), Mass (existing, EE)

<li class="filterall filter-electric-sector-co2-emissions filter-reference-no-cpp-ee-dual-rate-ee-mass-en-ee-mass-existing-ee-electric-sector-co2-emissions filter-us eg-grant-wrapper eg-post-id-35814 tp-esg-item esg-hovered itemtoshow loadedmedia isvisiblenow" data-date="1471356203" style="opacity: 1; visibility: inherit; transform: matrix3d(1, 0, 0, 0, 0, 1, 0, 0, 0, 0, 1, 0, 0, 0, 0.1, 0.999917); height: auto; width: 287px; display: block; top: 9866px; left: 0px; transform-origin: center center 0px;">

US - Electric Sector CO2 Emissions

US,Electric Sector CO2 Emissions,Reference, No CPP (EE), Dual Rate (EE), Mass (E+N, EE), Mass (existing, EE)

East - Electric Sector CO2 Emissions

East,Electric Sector CO2 Emissions,Reference, Dual Rate, Mass (E+N), Mass (existing)

ERCOT - Electric Sector CO2 Emissions

ERCOT,Electric Sector CO2 Emissions,Reference, Dual Rate, Mass (E+N), Mass (existing)

West - Electric Sector CO2 Emissions

West,Electric Sector CO2 Emissions,Reference, Dual Rate, Mass (E+N), Mass (existing)

US - Electric Sector CO2 Emissions

US,Electric Sector CO2 Emissions,Reference, Dual Rate, Mass (E+N), Mass (existing)

All - ERC/Allowance Prices

ERC/Allowance Prices,Dual Rate, Mass (E+N), Mass (E+N, banking), Mass (existing)

All - ERC/Allowance Prices

ERC/Allowance Prices,Dual Rate, Mass (E+N), Mass (E+N, banking), Mass (existing)

All - ERC/Allowance Prices

ERC/Allowance Prices,Dual Rate, Mass (E+N), Mass (E+N, banking), Mass (existing)

All - ERC/Allowance Prices

ERC/Allowance Prices,Dual Rate (EE), Mass (E+N, EE), Mass (existing, EE)

All - ERC/Allowance Prices

ERC/Allowance Prices,Dual Rate (EE), Mass (E+N, EE), Mass (existing, EE)

All - ERC/Allowance Prices

ERC/Allowance Prices,Dual Rate (EE), Mass (E+N, EE), Mass (existing, EE)

East - Generation Mix

East,Generation Mix,Average Annual Comparison, Reference, Dual Rate, Mass (E+N), Mass (existing)

ERCOT - Generation Mix

ERCOT,Generation Mix,Average Annual Comparison, Reference, Dual Rate, Mass (E+N), Mass (existing)

West - Generation Mix

West,Generation Mix,Average Annual Comparison, Reference, Dual Rate, Mass (E+N), Mass (existing)

US - Generation Mix

US,Generation Mix,Average Annual Comparison, Reference, Dual Rate, Mass (E+N), Mass (existing)

East - Generation Mix

East,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Increased Stringency

ERCOT - Generation Mix

ERCOT,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Increased Stringency

West - Generation Mix

West,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Increased Stringency

US - Generation Mix

US,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Increased Stringency

East - Generation Mix

East,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Mass (FP OBA), Mass (100% OBA)

ERCOT - Generation Mix

ERCOT,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Mass (FP OBA), Mass (100% OBA)

West - Generation Mix

West,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Mass (FP OBA), Mass (100% OBA)

US - Generation Mix

US,Generation Mix,Average Annual Comparison, Reference, Mass (existing), Mass (FP OBA), Mass (100% OBA)

East - Generation Mix

East,Generation Mix,Average Annual Comparison, Reference, No CPP (high gas), Mass (E+N), Mass (E+N, high gas)

ERCOT - Generation Mix

ERCOT,Generation Mix,Average Annual Comparison, Reference, No CPP (high gas), Mass (E+N), Mass (E+N, high gas)

West - Generation Mix

West,Generation Mix,Average Annual Comparison, Reference, No CPP (high gas), Mass (E+N), Mass (E+N, high gas)

US - Generation Mix

US,Generation Mix,Average Annual Comparison, Reference, No CPP (high gas), Mass (E+N), Mass (E+N, high gas)

East - Generation Mix

East,Generation Mix,Average Annual Comparison, Reference, No CPP (EE), Mass (E+N, EE), Mass (existing, EE)

ERCOT - Generation Mix

ERCOT,Generation Mix,Average Annual Comparison, Reference, No CPP (EE), Mass (E+N, EE), Mass (existing, EE)

West - Generation Mix

West,Generation Mix,Average Annual Comparison, Reference, No CPP (EE), Mass (E+N, EE), Mass (existing, EE)

US - Generation Mix

US,Generation Mix,Average Annual Comparison, Reference, No CPP (EE), Mass (E+N, EE), Mass (existing, EE)

East - Generation Mix

East,Generation Mix,Mass (E+N) Generation Mix Over Time

ERCOT - Generation Mix

ERCOT,Generation Mix,Mass (E+N) Generation Mix Over Time

West - Generation Mix

West,Generation Mix,Mass (E+N) Generation Mix Over Time

US - Generation Mix

US,Generation Mix,Mass (E+N) Generation Mix Over Time

East - Generation Mix

East,Generation Mix,Reference Generation Mix Over Time

ERCOT - Generation Mix

ERCOT,Generation Mix,Reference Generation Mix Over Time

West - Generation Mix

West,Generation Mix,Reference Generation Mix Over Time

US - Generation Mix

US,Generation Mix,Reference Generation Mix Over Time

East - NGCC Capacity Factors

East,NGCC Capacity Factors,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

ERCOT - NGCC Capacity Factors

ERCOT,NGCC Capacity Factors,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

West - NGCC Capacity Factors

West,NGCC Capacity Factors,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

US - NGCC Capacity Factors

US,NGCC Capacity Factors,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

East - New NGCC Builds

East,New NGCC Builds,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

ERCOT - New NGCC Builds

ERCOT,New NGCC Builds,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

West - New NGCC Builds

West,New NGCC Builds,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

US - New NGCC Builds

US,New NGCC Builds,Reference, Mass (E+N), Mass (existing), Mass (FP OBA), Mass (100% OBA)

East - New NGCC Builds

East,New NGCC Builds,Reference, Dual Rate, Mass (E+N), Mass (existing), Patchwork (E+N), Patchwork (existing)


APR 10 2003 MEMORANDUM SUBJECT: Review of Section G Experimental Plan for Maize optimized Cry1F insect control protein as expressed in maize, a Bacillus thuringiensis var. aizawai based plant incorporated protectant.

TO: Mike Mendelsohn, Product Manager Microbial Pesticides Branch Biopesticides and Pollution Prevention Division FROM: Chris A. Wozniak, Ph. D., Biologist / s/ Microbial Pesticides Branch Biopesticides and Pollution Prevention Division THROUGH: John L. Kough, Ph. D., Biologist / s/ Senior Scientist, Microbial Pesticides Branch Biopesticides and Pollution Prevention Division ACTION REQUESTED To review the experimental design for the field testing of the product maize optimized Cry1F insect control protein from Bacillus thuringiensis var aizawai strain PS81l ( NRRL B 18484) as modified for expression in maize for an experimental use permit. This submission requests an extension of the previous EUP, which expired in March, 2003, until March 2004.

BACKGROUND Dow AgroSciences / Mycogen has submitted an application for an experimental use permit to evaluate their product as a means of European corn borer control. These products are based on the insecticidal protein of B. thuringiensis var. aizawai, Cry1F, in a truncated and synthetic ( modified) form which represents the active ingredient of this plant pesticide. The coding sequence of this insecticidal protein gene has been modified to express the same protein as the previously registered Cry1F, however, the modifications in the gene sequence will provide for greater stability ( less variation) in expression levels; there is no change in the sequence or structure of the Cry1F protein. Maize plants are also intended to express phosphinothricin acetyl transferase for tolerance to the herbicide glufosinate ammonium. 2 EVALUATION REPORT Reviewed by: Chris A. Wozniak, Ph. D., Biologist, OPP / BPPD Secondary Reviewer: John L. Kough, Ph. D., Biologist, OPP / BPPD Active Ingredients: Bacillus thuringiensis var. aizawai   endotoxin ( synthetic truncated form) as optimized for and expressed in maize Product Name: Cry1F insect control protein as expressed in maize ID No.: 068467 EUP 4 Chemical No.: 006481 Bacillus thuringiensis Cry1F protein Confidentiality: No claim of confidentiality is made for information contained in this study within the scope of FIFRA 10( d)( 1)( A), ( B) or ( C). Sponsor: Mycogen Seeds / Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268 Authors: P. Hunst Testing Facility: Various field sites and the laboratories of Pioneer Hi Bred International, Johnston, IA, and Mycogen Seeds / Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268 Study Titles: Experimental use permit extension request for Bacillus thuringiensis var. aizawai mo Cry1F insecticidal crystal protein as expressed in maize. Study Date: November 15, 2002 Introduction  A previous experimental use permit ( 68467 EUP 3) evaluated the agronomic characteristics, breeding, hybrid production, insect resistance management trials, herbicide tolerance and efficacy of a maize optimized Cry1F maize ( moCry1F) for control of the European Corn Borer ( ECB; Ostrinia nubilalis), the Fall Armyworm ( Spodoptera frugiperda) and other lepidopteran pests of corn. The subject of the present EUP request is the same modification of the gene sequence ( cry1F) designed to optimize expression in maize via codon usage without changing the amino acid sequence of the Cry1F protein. This maize optimized Cry1F ( moCry1F) corn will be grown under an experimental program to evaluate the efficacy of this plantincorporated protectant against the same lepidopteran pests as for the previously examined plant optimized poCry1F maize. Additionally, agronomic characteristics, breeding and introgression into elite corn lines, herbicide tolerance and insect resistance management concerns will also be addressed during this field study. Plasmid vector PHP12537 was used to create Events TC6228 and TC6275. These events will be the subject material for the field protocols listed below.

Since there are no feral or indigenous relatives of maize ( Zea mays) in the U. S., its territories or possessions, and there is an established food tolerance exemption in place for the Cry1F protein, there is no requirement for an isolation distance from other crops during this EUP. 3 Experimental Design  The following protocols will be evaluated under this EUP:

EUP Protocol Acres Lbs of Seed B. t. mo Cry1F Maize breeding and observation nursery 44.0 733 B. t. mo Cry1F Maize agronomic observation trial 172.0 2872 B. t. mo Cry1F Maize demonstration trial 10.5 175 Liberty ® herbicide tolerance study 7.0 117 B. t. mo Cry1F Maize efficacy trial 53.0 885 B. t. mo Cry1F Maize insect resistance management trial 4.0 67 TOTALS 290.5 4849 The experimental program is reasonable for the purpose of the permit and the requested acreage is justified.. The experimental use permit will be used to conduct field testing in 26 states and Puerto Rico.

B. t. mo Cry1F Maize breeding and observation nursery  Standard breeding practices, as appropriate for maize are to be employed to achieve the production of moCry1F corn lines suitable for further study and incorporation into hybrid seed production programs. Maize plants are to be crossed with genetically engineered and non engineered plants, or selfed, as necessary for production of breeding lines and hybrids of moCry1F. Treatment with Liberty ® herbicide, insect bioassays and laboratory analyses will be performed in conjunction with this protocol to assess phenotype and gene segregation.

Plots will be located at 12 different locations with a total acreage of up to 44.0 acres. Planting dates are to run from 04/ 01/ 03 until 03/ 30/ 04 and harvest from 06/ 01/ 03 to 07/ 30/ 04. Since the previously issued food tolerance for Cry1F is valid for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( from the insert of plasmid PHP12537) in corn, no requirement of isolation distance is mandated. As with any crop, suitable plot design and timing should be used to prevent cross pollination into lines which are not intended to contain the genetic material carried by these inbreds and hybrids used in the breeding nursery.

Plots are to be marked appropriately to indicate the field boundaries after harvest and provide for an effective control of subsequent volunteer plants. This may be accomplished with stakes or other physical identifiers and volunteers eradicated with herbicides or cultivation. 4 Samples of plant material and seeds produced in the plots may be used for research purposes and saved for subsequent planting as needed. Remaining plant material must be tilled into the plot or properly composted. Composting site( s) must be monitored for volunteer plants that may arise. Any volunteer plants must be destroyed.

B. t. mo Cry1F Maize agronomic observation trial  Plants will be assessed for agronomic characteristics and phenotypic effects of transgene expression. Treatment with Liberty ® herbicide, insect bioassays, and other laboratory analyses will be performed in conjunction with this protocol to assess phenotype and gene segregation.

Plots will be located at 49 different locations with a total acreage of up to 172.0 acres. Planting dates are to run from 04/ 01/ 03 until 03/ 30/ 04 and harvest from 06/ 01/ 03 to 07/ 30/ 04. Since the previously issued food tolerance for Cry1F is valid for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( from the insert of plasmid PHP12537) in corn, no requirement of isolation distance is mandated. As with any crop, suitable plot design and timing should be used to prevent cross pollination into lines which are not intended to contain the genetic material carried by these inbreds and hybrids used in the breeding nursery.

Plots are to be marked appropriately to indicate the field boundaries after harvest and provide for an effective control of subsequent volunteer plants. This may be accomplished with stakes or other physical identifiers and volunteers eradicated with herbicides or cultivation.

Samples of plant material and seeds produced in the plots may be used for research purposes and saved for subsequent planting as needed. Remaining plant material must be tilled into the plot or properly composted. Composting site( s) must be monitored for volunteer plants that may arise. Any volunteer plants must be destroyed.

B. t. mo Cry1F Maize demonstration trial  Maize plants are to be crossed with genetically engineered and non engineered plants, or selfed.

Treatment with Liberty ® herbicide, insect bioassays and laboratory analyses will be performed in conjunction with this protocol to assess product efficacy against the European Corn Borer and other lepidopteran pests.

Plots will be located at 10 different locations with a total acreage of up to 10.5 acres. Planting dates are to run from 04/ 01/ 03 until 03/ 30/ 04 and harvest from 06/ 01/ 03 to 07/ 30/ 04. Since the previously issued food tolerance for Cry1F is valid for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( from the insert of plasmid PHP12537) in corn, no requirement of isolation distance is mandated. As with any crop, suitable plot design and timing should be used to prevent cross pollination into lines which are not intended to contain the 5 genetic material carried by these inbreds and hybrids used in the breeding nursery.

Transformation events TC6228 and TC6275 will be planted in 5 row plots 30 feet long. Each line may be represented by a segregant without the cry1F gene and one segregant with the cry1F gene. Rows will represent experimental units and may contain up to 300 plants.

Plots are to be marked appropriately to indicate the field boundaries after harvest and provide for an effective control of subsequent volunteer plants. This may be accomplished with stakes or other physical identifiers and volunteers eradicated with herbicides or cultivation. Samples of plant material and seeds produced in the plots may be used for research purposes and saved for subsequent planting as needed. Remaining plant material must be tilled into the plot or properly composted. Composting site( s) must be monitored for volunteer plants that may arise. Any volunteer plants must be destroyed.

Liberty ® herbicide tolerance study  B. t. mo Cry1F plants will be tested for resistance to the herbicide Liberty ® and may also be evaluated for yield, herbicide effects on plant development and other agronomic traits.

Plots will be located at 8 different locations with a total acreage of up to 7.0 acres. Planting dates are to run from 04/ 01/ 03 until 03/ 30/ 04 and harvest from 06/ 01/ 03 to 07/ 30/ 04. Since the previously issued food tolerance for Cry1F is valid for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( from the insert of plasmid PHP12537) in corn, no requirement of isolation distance is mandated. As with any crop, suitable plot design and timing should be used to prevent cross pollination into lines which are not intended to contain the genetic material carried by these inbreds and hybrids used in the breeding nursery. Plants may be naturally or artificially infested with lepidopteran pests, such as the ECB.

Plots are to be marked appropriately to indicate the field boundaries after harvest and provide for an effective control of subsequent volunteer plants. This may be accomplished with stakes or other physical identifiers and volunteers eradicated with herbicides or cultivation. Samples of plant material and seeds produced in the plots may be used for research purposes and saved for subsequent planting as needed. Remaining plant material must be tilled into the plot or properly composted. Composting site( s) must be monitored for volunteer plants that may arise. Any volunteer plants must be destroyed.

B. t. mo Cry1F Maize efficacy trial  The ability of mo Cry1F maize plants to resist attack from the European Corn Borer ( ECB) and other lepidopteran insects will be evaluated in this protocol. Genetically modified and non modified lines will be sued to evaluate the effect of the insecticidal transgene on insect feeding and damage. 6 Plots will be located at 58 different locations with a total acreage of up to 53.0 acres. Planting dates are to run from 04/ 01/ 03 until 03/ 30/ 04 and harvest from 06/ 01/ 03 to 7/ 30/ 04. Since the previously issued food tolerance for Cry1F is valid for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( from the insert of plasmid PHP12537) in corn, no requirement of isolation distance is mandated. As with any crop, suitable plot design and timing should be used to prevent cross pollination into lines which are not intended to contain the genetic material carried by these inbreds and hybrids used in the breeding nursery.

Plots are to be marked appropriately to indicate the field boundaries after harvest and provide for an effective control of subsequent volunteer plants. This may be accomplished with stakes or other physical identifiers and volunteers eradicated with herbicides or cultivation. Samples of plant material and seeds produced in the plots may be used for research purposes and saved for subsequent planting as needed. Remaining plant material must be tilled into the plot or properly composted. Composting site( s) must be monitored for volunteer plants that may arise. Any volunteer plants must be destroyed.

B. t. mo Cry1F Maize insect resistance management trial  Maize plants expressing the Cry1F transgene and those segregants not expressing Cry1F will be tested for comparison with respect to infestation and damage from ECB and other lepidopterans, and focus on determining if moCry1F expresses a high dose against the ECB.

Plots will be located at 4 different locations with a total acreage of up to 4.0 acres. Planting dates are to run from 04/ 01/ 03 until 03/ 30/ 04 and harvest from 06/ 01/ 03 to 07/ 30/ 04. Since the previously issued food tolerance for Cry1F is valid for Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( from the insert of plasmid PHP12537) in corn, no requirement of isolation distance is mandated. As with any crop, suitable plot design and timing should be used to prevent cross pollination into lines which are not intended to contain the genetic material carried by these inbreds and hybrids used in the breeding nursery.

Plots are to be marked appropriately to indicate the field boundaries after harvest and provide for an effective control of subsequent volunteer plants. This may be accomplished with stakes or other physical identifiers and volunteers eradicated with herbicides or cultivation. Samples of plant material and seeds produced in the plots may be used for research purposes and saved for subsequent planting as needed. Remaining plant material must be tilled into the plot or properly composted. Composting site( s) must be monitored for volunteer plants that may arise. Any volunteer plants must be destroyed.

BPPD Comment: The applicant must report to the Agency the total number of acres of maize receiving the cry1F gene through pollen transfer in its annual report regarding the EUP progress.


Page 1 of 12 Response to Comments Document for Pesticide Registration Notice 2003 1 Labeling of Pesticide Products under the National Organic Program This document contains a summary of comments received and the Agency response to these comments. The Agency recorded 12 comments as received. A review found 1 comment for another docket and one duplicate comment. This means a total of 10 different sets of comments were received. Comments and EPA response follows:

Comment # 3 3 01: EPA failed to consider " all data submitted"

Response: The commenter has not specified what data/ information EPA has failed to consider and therefore EPA cannot respond specifically to the commenter. EPA believes, however, that it has considered all submissions.

3 02: Suggest EPA should not handle requests in a transparent manner.

Response: We believe this individual misunderstands what we mean by transparent. We operate in a transparent manner so an individual can understand why we take an action. This also enables an adversely impacted individual to comment on the proposed action so we can take the impact into account. EPA has considered the needs of farmers in developing its PR Notice.

Comment# 4 4 01: Supports action generally but are concerned with 25( b) products. EPA is relying upon the companies to ensure 25( b) products contain only ingredients permitted under the NOP and that 25( b) products conform in all respects with the criteria of the National List. It is nearly impossible for state regulatory agencies or Cooperative Extension Service to identify the active ingredients and label directions for 25( b) products. These two items will make it extremely difficult to educate and regulate the uses of 25( b) products for organic use.

Response: EPA can only review labeling submissions for pesticide products that are registered or proposed to be registered. EPA does not, however, review product labels of minimal risk pesticides exempt under 25( b) and, therefore, EPA cannot approve the use of NOP language on 25( b) product labels. Products exempted under FIFRA section 25( b) are not precluded from identifying whether they meet the requirements of the National Organic Program. However, manufacturers of minimal risk products exempted under 25( b) are required to list all ingredients in the product which makes it relatively easy for an organic farmer and certifier to verify that the Page 2 of 12 product meets the requirements of the NOP.

We are requiring a registrant to demonstrate a registered pesticide product meets the requirements of the NOP and suggest States regulating Federally exempted products do the same. One needs to remember, that the manufacturer of an exempted product could lawfully add a statement indicating compliance with the NOP ( assuming such a statement is accurate) without this PR Notice or any policy by EPA allowing NOP statements on registered pesticide products.

4 02: The commenter has an ongoing concern with EPA's approach of handling 25( b) products, including labeling issues for workers, endangered species and groundwater.

Response: These general 25( b) issues raised by the commenter are beyond the scope of this PR Notice.

Comment # 5 Does not address this PR Notice.

Comment # 06 6 01: Suggests organic producer rely on National List rather than label language.

EPA Response: EPA's PR Notice allowing voluntary labeling does not preclude organic producers from relying on the National List and their certifier. EPA notes however, that the National List does not include a list of all products acceptable for organic production. Rather it represents a statement of what particular types of and under what conditions materials are allowable for use in organic production. EPA is working with USDA to obtain USDA's conclusions about which specific active ingredients meet these criteria. At the present, the National List only specifies by name certain synthetic active ingredients. EPA intends to rely on the expertise of USDA in all determinations regarding whether an active ingredient qualifies under the approach set forth in the National List. Therefore, until USDA identifies to EPA that specific active ingredients meet the conditions of the List, EPA may not be able to approve NOP labeling for products containing such ingredients. A list of allowable non synthetic materials will not be complete. Innovative individuals will continue to research pesticidal properties in plants and microbes and develop ways within the constraints of the National Organic Program to utilize them as pesticides.

A user must evaluate particular products to determine if they are among those types which are allowable under the NOP. Furthermore, many pesticide products do not specifically list all ingredients in the product ( inerts or other ingredients may not be listed). Thus, without label language indicating that the product can be used for organic production, organic producers may have difficulty identifying products they may use for organic production. The organic farmer must rely on their organic certifier who has the authority to certify that the farmer's practices Page 3 of 12 meet the requirements of the NOP. The suggested label language will be an additional aid where the certifier and the grower can utilize the list of products with the suggested label language to help in finding products which are allowable for organic production.

6 02: If products are labeled with NOP type statements a producer may apply a product which has been removed from the National List and be in violation of the NOP rule.

Response: The Agency understands this concern. However, USDA is required to make changes to the National List by rule making which is an involved process. Registrants will have time to request label changes to remove wording from product labels. If a registrant does not request a label change, this Agency likely will have time to take action. The question of Delisting is covered in greater detail in section XI of the PR Notice on organic labeling.

6 04: Will 40CFR list NOP claims as acceptable?

Response: EPA is not currently amending Title 40 of the Code of Federal Regulations. The Agency has worded the suggested allowed label claims to be consistent with current labeling regulations and has recommended labeling language " for organic production" for this very reason. Alternative wording submitted by registrants would have to be reviewed by the Agency for acceptability.

6 05: The list of inert ingredients is supposedly being revised. Hopefully, it will be finalized before a National List is made available.

Response: EPA expects that its on going review of inerts will lead to the continuing addition of inerts to list 4. In fact, a number of such additions has occurred recently. If, at any time, EPA determines that an inert ingredient does not meet the criteria for list 4, it will be removed from that list.

6 06: Concerned with inerts not on the label and therefore, if a chemical is removed from List 4, the organic producer will not be able to tell the product can no longer be used in organic agriculture.

Response: This presents a problem which exists without this PR Notice. This Agency is planning to set up a program which will track changes in allowed ingredients so, when necessary, the Agency can take action to assure that any product with NOP labeling continues to meet the conditions set forth in the PR Notice.

6 07: Questioned multiple use products where some meet the requirements of the NOP. The commenter is concerned with two separate products which might be confusing to the grower and registrant as well as more costly.

Response: EPA has recommended this approach because the Agency believes the simplest and Page 4 of 12 least confusing solution to address this issue is to have a separate product which meets the requirements of the NOP. This will involve additional costs for these registrants. However, an organic producer has the option of utilizing any pesticide product which her/ his certifier approves as part of the crop production plan as long as the use is permitted on the product label. EPA regulations were not designed with a program like the NOP in mind. The Agency has developed this labeling program in an attempt to make it easier for organic producers and their certifiers to recognize pesticide products which are compatible with organic production. The Agency has also been cooperating with the Organic Materials Review Institute ( OMRI) with their organic listing program.

6 08: Raises concern with products sold as 25( b) exempted products ( but not qualifying for the exemption).

Response: EPA is aware of problems States have had with 25( b) products. As EPA has already exempted these products from FIFRA, EPA cannot regulate the use of NOP type language on the exempted products except as described in Unit V of the PR Notice except under conditions where the product does not meet the requirements of the exemption.

6 09: Concern with distributor labels which are not reviewed by EPA and the time allowed for a registrant to change all labels.

Response: Distributor products are covered in 40 CFR part 152.132. Supplemental distribution ( distributor products) is permitted upon notification to the Agency only if certain conditions are met. Permitted label changes for distributor products allow for a different product name, inclusion of the distributor name and address rather than the registrant, the registration number of the registered product is followed by a dash followed by the distributor's company number, the establishment number must be that of the final establishment at which the product was produced, and specific claims may be deleted provide no other changes are necessary. Therefore, any change to add other wording ( such as NOP label language) would represent an unauthorized label change and be subject to an enforcement action. Agency regulations normally provide for 18 months to change labeling unless the Agency orders a different schedule under FIFRA sec. 6 or 13. The Agency intends to require such labeling changes correspond with schedules of USDA. The Agency believes registrants will make such changes quickly to avoid causing difficulties for their customers. The Agency has rewritten the PR Notice to make it clear that the registrant must keep abreast of delistings. Further the Agency has indicated in the PR Notice that EPA will permit registrants to remove NOP statements from product labels by notification. If a registrant does not request action in a timely manner, the Agency expects to take action.

6 10: Concern with old delisted products remaining on shelves for years.

Response: There may be products in channels of trade and in the hands of users which may not accurately reflect NOP status if an ingredient is delisted. However, organic certifiers normally provide for a period of time where producers can use up existing stocks of a delisted material. Page 5 of 12 Organic producers are required to have a plan, updated annually, which is approved by their certifier which details use of crop inputs. The certifier is required to have an on site inspection annually as required in 7CFR sec 205.400.

6 12: Given the problems listed above, the Agency should stay out of this matter. The function is for USDA or the NOSB to maintain both hard and Internet accessible copies which can be changed rapidly without going through the long process of EPA regulatory actions.

Response: USDA and the NOSB do not have access to pesticide product ingredients to enable them to develop such a list for specific registered products. This Agency has the ability to compare ingredients on a submission requesting such labeling against records for that product. If our records do not agree with the submission, the request for NOP labeling would be denied. Furthermore, EPA is not requiring a registrant to place such wording on a label.

6 13: Registrants will use the NOP statements as a marketing tool. In addition, consumers will see the word organic as a safety claim.

Response: Some registrants will use this as a marketing tool. However, providing their marketing is not false and misleading, it should be allowed. The Agency has made it clear in this PR Notice that use of the word organic is appropriate only for the narrow purpose of identifying the conformity of the product with the National Organic Program. It is to be viewed as a statement of fact that the product is allowed under the National Organic Program. If a registrant makes any claim that states or implies any false or misleading safety aspect, the Agency will have authority to consider the product misbranded under 40 CFR Part 156.10( a)( 5). The Agency has considered possible consumer reactions and does not believe consumer reactions will result in unreasonable adverse effects.

Commenter # 7 Comment: Supports EPA actions allowing but not requiring NOP logos No Response needed.

Commenter 08 08 01: Generally supports concept of PR Notice. Also requests OMRI approved label in addition to EPA NOP type language.

Response: The Agency has been accepting labeling of pesticide products which contain the OMRI designation . Before approving such labeling, EPA independently evaluates the accuracy of such labeling. Page 6 of 12 08 02: EPA needs a thorough, open, and deliberative process for this label program that consults with all stakeholders, gathers data, and identifies both the needs and challenges that the organic sector faces.

Response: EPA believes it has involved stakeholders by requesting comment and responding to comments and the changes made to the PR Notice in response to the comments. EPA also wants to expand this relationship by continuing to support USDA's NOP staff, the NOSB and nongovernmental organic organizations through providing current lists of pesticide products determined to meet the requirements of the NOP and updates inert pesticide ingredients on List 4. EPA is not in a position to make policy decisions on whether pesticide products are allowable under the National Organic Program. It is in a position to provide lists of allowable pesticide products under this program ( those products where registrants have demonstrated to the Agency that the products are allowable for each labeled use site under the NOP) and status of inert pesticide ingredients on List 4.

08 03: PR Notice should be revised to recognize that the certification agent ascertains that a pesticide product meets the requirements of the NOP.

Response: EPA agrees and revised the PR Notice to make it clear the certification agent determines that the organic farmer's practices meet the requirements of the NOP.

08 04: Agency needs to clarify that 25b products do not require registration to be used by organic producers.

Response: EPA agrees and has clarified the text in the PR Notice.

08 05: It is important to clarify whether or not exempt product producers may register their products with EPA and obtain the NOP approved label.

Response: EPA has clarified that a 25b exempt product producer has the option to register their products under FIFRA.

08 06: Requests that the guidelines recognize that third party professional scientific bodies who independently verify labels for compliance with the organic regulations ( NOP) be allowed to place a seal of said organization for both EPA registered and EPA exempted products.

Response: The Agency has rewritten the text to recognize independent verification of products.

08 07: NOP needs to provide EPA periodic updates on allowed materials including timely notification of any materials that have been de listed Response: This is critical to EPA. However, EPA needs to be notified when a de listing is proposed. The USDA/ NOP has to amend the National List by rule making, so it will not be a Page 7 of 12 difficult task to inform EPA when a de listing is proposed.

08 08: Supports EPA plan to limit label directions to those uses allowed by the NOP via the National List.

Response: None necessary 08 09: EPA should work with the NOSB to clarify outstanding issues.

Response: The Agency is working with the NOSB and USDA's NOP staff to clarify and resolve outstanding issues.

08 10: EPA labeling program should not be fully implemented until a number of issues are resolved.

Response: EPA has addressed a number of issues believe there are no issues to be resolved prior to implementing this program.

08 11: Suggests EPA consult with NOSB about any unclear restrictions and provide guidance as to the scope of restrictions that are enforceable for a pesticide label.

Response: The EPA is setting up a procedure for consultations with the NOP staff and the NOSB.

08 12: EPA should provide the NOP and make available to OMRI and any other interested member of the public a regular ( no less than annual) report of all approved active ingredients, products and label restrictions. .

Response: The EPA Office of Pesticide Programs currently lists all inert ingredients used in pesticide formulations on its WEB site. The EPA has roughly 800 active ingredients which are in registered pesticide products. Providing a list of these active ingredients represents a fairly simple task. EPA intends to establish a listing of registered pesticide products which have label identification indicating they are allowable for use in organic production on its web page.

08 13: EPA should also provide NOP with information about products that have identical formulations, but may have more than one label required in order to meet the organic labeling requirements. Producers may not always have access to organic labeled products, or they may not be made available in commercial quantities. In other cases, a transitioning farmer may have an inventory of a formulation that meets the requirements of the NOP Final Rule standards even if it is not labeled as such.

Response: We understand the concerns expressed. However, we are not allowed to release formulations without the registrant's approval. We have been encouraging registrants to list all of their ingredients on pesticide labels for a number of years. None of these actions will resolve the Page 8 of 12 concerns expressed. This PR Notice informs registrants of procedures to make information available to organic producers. The organic farmer is expected to work with her/ his certifier to determine if a product is allowed under the NOP. In some cases, the farmer and certifier may not be able to determine that a product is allowable under the NOP.

08 14: EPA needs to incorporate a delisting procedure.

Response: EPA has added procedures for delisting in the PR Notice.

08 15: OMRI suggests EPA consult with the NOSB about any restrictions that are not clear and produce guidance as to the scope of restrictions that are enforceable for a pesticide label under FIFRA requirements.

Response: EPA plans to have more interaction with the NOSB members to enable the board to recommend clarification of National List annotations which are not enforceable under FIFRA.

08 16: Several comments not related to this PR Notice.

Response: We are addressing these comments through our interactions with the USDA NOP Staff.

Commenter # 9 09 01: Concerned that 25b products may utilize NOP label while not fully complying.

Response: 25b products must list all ingredients so it would be fairly easy for individuals associated with organic production to verify whether or not a 25b product meets the requirements of the NOP.

09 02: Concerned that 25b product producers often do not follow rules and market products without listing ingredients.

Response: The NOP requires organic farmers to rely on their certifiers to determine if a product meets the requirements of the NOP. The certifier and organic farmer should know that such a product would not have adequate information on the label to allow the use in organic production since the required ingredients are not on the label.

09 03: Suggests we allow use of USDA Organic seal.

Response: USDA intends for this seal to be used on food products which meet the Organic requirements. It could be confusing and possibly dangerous to place the USDA organic seal intended for food products on pesticide products. Page 9 of 12 09 04: Concern with our wording of the draft PR Notice regarding appearance on the National List.

Response: The National List consists of 5 parts. We have revised the PR Notice to convey that only materials that are on the National List as allowed substances comply with the NOP.

Commenter # 10 10 01: EPA must continue to prohibit additional label claims implying product safety.

Response: EPA carefully developed wording for this labeling to minimize the probability of the wording being misleading and we intend to continue evaluating potentially false and misleading label wording.

10 02: Agrees that EPA should only review labeling submissions for pesticide products that are registered or proposed to be registered.

Response: EPA cannot approve the use of the suggested label language on any products exempted from regulation under 25( b) of FIFRA. However, manufacturers of exempted products can use the suggested wording providing their products are allowable under the NOP for labeled uses or they could get their product registered under FIFRA Section 3.

Commenter # 11 11 01: Disagrees that EPA cannot approve use of NOP on exempted pesticides.

Response: If a product meets all of the requirements under 25( b) of FIFRA and meets the requirements of the NOP, while we are not reviewing and accepting the use of the suggested label wording on exempted product labels, the inclusion of this wording would not necessarily be false and misleading. Therefore, the Agency would not have grounds to take action against such a product.

Commenter # 12 & 13 12 01: For this program to be effective the EPA must work hand in hand with the National Organic Program to come up with a complete list of approved active and inert ingredients.

Response: We are and expect to continue to work with the NOSB and the NOP staff to develop a list of active ingredients as the list is expected to change over time. List 4 inert ingredients are available on our WEB site and we intend to keep the NOSB informed of changes in List 4.

12 02: EPA does not wish to exclude natural materials not specifically included on the National List although the wording of the EPA draft PR Notice document does. Page 10 of 12 Response: The EPA has reworded the PR Notice to explicitly recognize this issue.

12 03: There are gray areas such as methods of extraction and handling of adjuvants.

Response: We rely on the NOP/ NOSB to deal with methods of extraction since the organic program is not an EPA program. Adjuvants are not pesticide products unless packaged with the pesticide product. Adjuvants are considered inerts if specified on a pesticide label. Therefore, some adjuvants would be on our inerts lists and those on list 4 would be allowed as would any other adjuvant which meets the requirements of the NOP. We have no authority on wording on adjuvant packaging unless it is packaged with a registered pesticide product. Therefore, the NOSB/ NOP is faced with the task of allowing/ prohibiting adjuvants which are not pesticide inerts.

12 04: There must be a clearly defined process for listing and delisting products as standards continue to change according to work done by the NOSB and NOP. Growers must be given time to use up what they have on hand when a material gets delisted.

Response: Listing and delisting are the responsibility of the NOSB/ NOP. EPA is setting up a process where the registrant is advised to promptly request modification of label language if a product no longer is allowed. If the registrant fails to take this action, the Agency has the authority to take action to bring products into compliance. Organic certifiers typically allow time for growers to use up existing stocks. The EPA generally considers existing stocks and makes appropriate provisions for their use or disposal when EPA initiates an action to remove a pesticide product from the marketplace.

12 05: There is much work to be done to move suitable inert ingredients to list 4. There should be a formal link between EPA and NOP to notify when items get moved from List 3 to List 4 ( besides publication in the Federal Register), as there may be items the NOSB would like to prohibit.

Response: The EPA is working to move ingredients to List 4 if the Agency has sufficient information to justify such an action. EPA will also move inerts from List 4 if information becomes available to justify removal. The changes to List 4 are being made in a transparent manner and the Agency intends to notify the USDA NOP staff when they occur.

12 06: We would like to see all inert ingredients on pesticide labels so the grower can make an intelligent choice about whether or not a product meets the organic standards.

Response: The EPA is encouraging registrants to list all ingredients on pesticide labels. However, a pesticide registrant has the legal right not to list inert ingredients unless they are list 1 inerts.

12 07: There is also the issue of genetically modified crops that may be used in making pesticides since the NOP requires all items to be free from genetic modification techniques. Page 11 of 12 Response: EPA is relying on the NOSB and the NOP staff to determine which materials are allowable. We cannot determine whether an ingredient is allowable under the NOP.

12 08: As a certifier, we know that our inspectors will be the primary agents insuring compliance with organic standards.

Response: We have modified the PR Notice to make it clear the responsibility is with the certifier.

12 09: We are concerned with the use of split labels.

Response: We have modified our guidance for what products we will allow suggested wording, limiting it to only those products which fully meet the requirements of the NOP. No other uses nor formulations will be allowed for these products.

12 10: Would like to see a national posting of approved materials on a web site.

Response: We already have posted inert materials on our web site with the list for each cleared inert noted. EPA will rely on USDA to provide the list of acceptable active ingredients for the NOP. EPA will list on its WEB site all of the products which we review and approve for a label statement regarding the NOP.

12 11: Concern expressed about EPA allowed materials not being posted on the OMRI listing and causing grower confusion.

Response: EPA plans to post products as OMRI does. If OMRI wished to list materials for which EPA has accepted organic label language, EPA would try to work out a procedure with OMRI to expedite such posting. Currently, such materials would be public information and OMRI could include them on its list.

12 12: Concern that 25b exempted products would not be included in this program and would like to see all products used by organic growers included in this program.

Response: We have not excluded 25b exempted products from use of suggested label language. However, it is the responsibility of the manufacturer of the exempted product to verify that the product meets the requirements of the NOP. The fact that EPA has List 4 inerts on our web site and those active ingredients with registered products and exempted from regulation which are allowed under the NOP should make it fairly easy for a manufacturer of an exempted product to determine if her/ his exempted product meets the requirements. Because EPA does not review exempt pesticide products, we are not including these on our WEB site.

12 13: Would like to see rapid deployment of this program once problems are resolved.

Response: EPA will be implementing this program once the PR Notice is final and available to the Page 12 of 12 public.

Commenter # 14 14 01: Generally supportive Response: None Needed 14 02: Suggested changes in Logo Response: We have examined changes in the acceptable labeling and could not adopt using the USDA logo modified to include organic wording. The use of the USDA logo could be confusing with the USDA logo for organic foods. We have adopted changes in the logo which address concerns with the originally proposed logo.