production in the US. Indeed, more than 90% of grafted vegetable
seedlings are tomatoes in North America (Kubota, personal communication,
2006). Virtually all these grafted tomatoes are used in greenhouse
production.

It is not clear whether grafting is being evaluated for resistance to
Phytophthora spp. pathogens, a critical disease pest of cucurbits
currently targeted by MeBr use in the US. USG is unaware of any research
conducted on the suitability of grafting as a control option against
this pathogen.

Table XII.2: Resistance to Important Plant Pathogens and Pests in North
Carolina and the Mediterranean.  TC "Table XII.2: Resistance to
Important Plant Pathogens and Pests in North Carolina and the
Mediterranean." \f F \l "1"

Pathogen or Pest	Resistant Line Reported by North Carolina (F. Louws)
Resistant Lines Reported in Mediterranean (M. Besri)

Verticillium race 1	Yes	Yes

Verticillium race 2	No	Not listed

Ralstonia solanacearum	Yes	Yes

Fusarium solani race 1& 2	Yes	Yes

Fusarium solani race 3 	Yes	Not listed

Sclerotium rolfsii	No	Not listed

Root knot nematodes Meloidogyne spp.	Yes	Yes

Phytophthora capsici	No	Not listed

Pseudomonas corrugate	No	Yes

Pythium root rot 	No	Not listed

Source:  Louws et al 2002 and Besri, M.  2005.

Table XII.3: Resistance of Tomato Rootstocks to the Most Common Soil
Borne Pathogens  TC "Table XII.3: Resistance of Tomato Rootstocks to the
Most Common Soil Borne Pathogens" \f F \l "1"

Rootstock	Pathogens

	K	V (1)	F (1, 2)	N	Fr

L. esculentum x L. hirsutum	+	+	+	+	+

L. esculentum	+	+	+	+	+

Source:  Besri, M.  2005.

K: Pyrenochaeta lycopersici, V (1): Verticillium dahliae (race 1), F
(1,2): F. oxysporum f.sp. lycopersici (races 1 and 2), N: Meloidogyne
spp, Fr: F.oxysporum f.sp. radicis lycopersici  Resistance to
Pseudomonas (Ralstonia) solanacearum is provided by S .torvum and S.
aethiopicum.  In addition, these two rootstocks are resistant to
Meloidogyne spp.

In addition, USG is not aware of any research demonstrating that
grafting offers protection against weeds (such as nutsedge). A
significant portion of the US nomination for MeBr is for the control of
weeds (in the southeast) and nematodes (California), as well as
soilborne diseases.  In the protected environment of the greenhouse,
grafting may offer sufficient disease protection, but in the open field
situation which characterizes most of the vegetable production in the
US, grafting does not offer protection against the suite of pests faced
by growers.  Therefore, even if resistance to Phytophthora pathogens is
identified, several years’ tests of how grafting can be effectively
integrated with other pest management strategies will be necessary
before it can find commercial acceptability in open-field vegetable
production in the US. At present there are no grafted rootstocks that
can deal with the entire US pest complex.

In addition, cost remains a significant factor inhibiting adoption of
grafted plants in open-field vegetable production.  Grafting is a very
labor-intensive activity, consequently the cost of grafted plants is
highly dependent on labor costs.  In countries as geographically
separated as Morocco and Mexico, the cost of a grafted vegetable plant
is approximately $0.10 each.  In the United States, and countries with
similar labor costs, such as Canada, however, higher labor costs push
the cost of a grafted stem to more than four times the cost.

According to Dr. Chieri Kubota (personal communication), a grafting
expert with the University of Arizona, a grafted plug of two stems, that
is ready for field use, costs $0.90,  The presence of two stems means
that the plant will have twice the yield of a normal, one stemmed,
plant.  The cost increase, however is still significant.  The normal
cost of a non-grafted plug, ready for planting in the field, is
approximately $0.20.  The grafted plant, then, costs 125% more than a
conventional plant per stem.

MBTOC Question

Please refer particularly to general questions above.

US Response

Please see detailed responses in the separate section addressing the
general questions.

US TURF / SOD RECONSIDERATION  TC "US TURF / SOD RECONSIDERATION" \f C
\l "2"

MBTOC Comment

MBTOC does not recommend MB for use in USA sod production. Effective
alternatives have been found for 99% of all turf production and the
party has significantly reduced the nomination requests for this use
from 2007 t in 2005 to 78 t in 2007.  Alternatives such as dazomet
provide equal control of weedy grasses and slightly better control of
broadleaf weeds when compared to MB (Unruh et al., 2002).  1,3-D and
1,3-D + Chloropicrin can be used if nematodes are the primary pest, or
possibly in conjunction with dazomet or metam-sodium.
Metam-Sodium/Chloropicrin provided comparable control (vs. MB) of weedy
grasses and nutsedge (eg., Unruh and Brecke, 2001; Unruh et al., 2002)

US Response

The US requests that MBTOC reconsider the CUN for the nomination of the
sod production sector.  The milestones achieved in this sector include
the reduction of total tonnage requested since 2002, a significant
reduction in rates, and a vigilant ongoing research programs.  Taken
together, these milestones indicate a significant achievement in
reducing the US sod producing industry’s reliance on MeBr combined
with the strong, demonstrated commitment of those involved with this
sector to continued research onto alternatives, argues strongly that
critical use methyl bromide should be approved for this sector to allow
time for alternatives that are both technically and economically
feasible for the very small remaining specialty uses to be developed.

Since 2002 the US nomination has reduced the total amount of methyl
bromide for sod production from 352,194 kg to 52,199 kg.  This 85%
reduction in total tonnage requested for this sector came from efforts
undertaken in two areas.  First, there was an overall significant
reduction in use made by the elimination of the golf course industry
from this sector, and second, significant reductions in rate structure
were achieved which resulted in application rates being decreased from
>450 kg ha-1 to 300 kg ha-1.  Overall reductions in this sector have
been dramatic and eclipse those of many other sectors.

The US has shown in the CUN that only 1% of the turf industry is unable
to switch to the alternatives.  This one percent is primarily the
certified sod production industry.  This part of the industry grows a
sod crop that is highly specialized and is regulated to exclude the
presence of off-type turfgrasses as well as any weeds.  There is no
threshold for weeds, especially any of the nutsedge species. As is the
case in the ornamental flower industry the stands of certified sod must
be a monoculture of a particular type of turfgrass or penalties are
plausible.  As a result of these restrictions certified sod commands a
premium price

While one percent of the turfgrass industry may seem very small, in this
case, this one percent has a disproportionately large part of the
economic share of the industry.  The cost of certified sod is 75% higher
than standard sod, providing a significant source of profits for the
sector.  In addition to the monetary returns, the purchasers of
certified sod rely on this product to build brand equity with their
customers which also aids their non certified sod production.

The information presented above serves to demonstrate, on an applied
level, the importance of maintaining a monoculture in certified sod
production.  This means following best management and cultural
maintenance practices.  However, these are not enough and often the use
of MeBr fumigant is needed.  Current research projects focusing on
alternative fumigants “…confirm that no EPA-registered fumigant
alternatives to MeBr, applied alone or in combination for preplant turf
soil fumigation, exists.” (Unruh et al., 2002)  In fact, research
conducted to evaluate the soil applied herbicide dazomet, alone or in
combination, demonstrated inconsistencies in weed control at the state
level;  while “dazomet (and combination) treatments provided good
control of weedy grasses at the western Florida site, control was not
consistent at the southern Florida site.” (Unruh et al., 2001)  These
types of inconsistencies and lack of control are not acceptable for the
certified sod industry as this is a perennial crop that must begin with
a weed free soil.

There is active and wide-ranging research currently underway to find
alternatives.  At Auburn University in Alabama researchers are
evaluating dithiocarbamate, but have encountered development of
resistant weeds.  A more promising line involves sodium azide in
combination with herbicides (particularly EPTC, chemical name: S-ethyl
dipropylthiocarbamate).  However neither sodium nor potassium azides are
currently registered for pesticide use in the US.  There is an
additional problem that continued use of EPTC results in enhanced
biodegradation of this chemical and reduced efficacy.  Some work is also
ongoing using 1,3-D at rates higher than those currently on the label.
Should this research prove fruitful, it would still require a label
change in order to be used for other than research.  (personal
communication, Robert H. Walker, PhD, Auburn University).

At the University of Florida the research includes blending dazomet with
the soil of putting greens, and testing high rates of 1,3-D.  The
research team is waiting to hear on the funding of several grant
proposals including one evaluating sheet steaming, dazomet, and “hot
gas”.  (personal communication, J. Bryan Unruh, PhD, University of
Florida)

The milestones that have been achieved to date have drastically reduced
the amount of MeBr requested and used by this sector.  The importance of
MeBr to a very small part of this sector is disproportionate to the
overall economic picture.   As indicated by the current research, the
lack of efficacy for soil fumigants and fumigant combinations, along
with the inconsistent efficacy of dazomet and dazomet combinations
demonstrate that at this time there are no viable alternatives to MeBr
for certified sod production.

In 2003 the TEAP found that there were no feasible alternatives for
golfcourses.  Please see Appendix B for more detail.

POST HARVEST QUESTIONS  TC "POST HARVEST QUESTIONS" \f C \l "1"

US COUNTRY HAM  TC "US COUNTRY HAM" \f C \l "2"

MBTOC General Comment

We acknowledge that these applicants do not currently have a registered
effective alternative, but we also have concerns about the amount of MB
that will be used. Our questions concern two factors that contribute to
an appropriate minimal use of methyl bromide: dosage rate and frequency
of fumigation. Our questions may result from our inability to understand
the new BUNNI because we could not determine if USG had reduced the
amount requested by some applicants to account for a standard dosage
rate that the USG will allow. And, if so, we could not determine the
standard dosage rate that the USG intended to use.

US Response

The standard dosage rate intended by the USG is 18-20 kg/1000 m3 for
this sector.  The applicants requested these rates to control mites, ham
skippers and ham borers in their cured pork products.  These pests bore
deeply into the meat, so the fumigant must penetrate to reach the pests.
 Pests flare up very quickly.  The slight variation in the dosage rate
occurs because a critical concentration by time (CT) is necessary in
order to kill the pests. The CT is determined by the species of pests
present, temperature, and humidity.  Typically if there is a flare up of
pests just prior to a shipment of hams then the producer will try to
fumigate in a shorter time frame to meet his market demands, and need
the slightly higher rate.  In addition, methyl bromide needs to
penetrate the ham, a relatively dense structure, in order to kill the
pests that have penetrated the meat.  Cured meat has fat which also
adsorbs methyl bromide.

The hams in the ‘summer’ or ‘aging’ room are the ones that
typically get infested with mites, skippers, and borers.  These rooms
are necessary for the proper curing of the meat products.  These rooms
are maintained at 80-90° F and 55% relative humidity for 90 to 120
days.  These conditions are necessary for the meat to develop the full
compliment of flavors necessary.  Unfortunately, these conditions are
also ideal for the pests.

Ham processors usually apply methyl bromide to a cured meat product only
once, to control the mites, skippers and borers.  Occasionally a meat
product will be fumigated a second time, if it is aged for an extended
period of time.  However, since processing of these meat products is
year round, we don’t think that the number of fumigations will
decrease until more is known about the pests and viable alternatives are
identified.  The frequency of fumigations is also discussed in below, in
response to a MBTOC question subtitled ‘Frequency of fumigation’.

MBTOC Question

1. Also, although the executive summary indicates this application is
for 2008, Tables 6.1 -6.4 indicate the request is for 2007. Please
confirm date of this request.

US Response

The tables should be for 2008. Please see below.

Table 6.1: Methyl Bromide Consumption for the Past 5 Years and the
Amount Required in the Year(s) Nominated (American Association of Meat
Processors  TC "Table 6.1: Methyl Bromide Consumption for the Past 5
Years and the Amount Required in the Year(s) Nominated (American
Association of Meat Processors" \f F \l "1"

	Historical Use1	Requested Use

For each year specify: 	1999	2000	2001	2002	2003	2004	2008

Amount of MB (kg)	Information not provided	168,283

Volume Treated 1000 m³	Information not provided	7,004

Formulation of MB	Information not provided

	Dosage Rate (kg/1000 m³)	Information not provided	24.03

Actual (A) or Estimate (E)	Information not provided

	1 American Association of Meat Processors did not provide historical
data.

Updated Table 6.2: Methyl Bromide Consumption for the Past 5 Years and
the Amount Required in the Year(s) Nominated (National Country Ham
Association  TC "Updated Table 6.2: Methyl Bromide Consumption for the
Past 5 Years and the Amount Required in the Year(s) Nominated (National
Country Ham Association" \f F \l "1"

	Historical Use1	Requested Use

For each year specify: 	1999	2000	2001	2002	2003	2004	2008

Amount of MB (kg)	749	694	802	791	791	791	1,242

Volume Treated 1000 m³	38	33	45	43	43	43	67

Formulation of MB	Information not provided

Dosage Rate (kg/1000 m³)	19.68	21.03	18.01	18.60	18.60	18.60	18.60

Actual (A) or Estimate (E)	Information not provided

Table 6.3: Methyl Bromide Consumption for the Past 5 Years and the
Amount Required in the Year(s) Nominated (Nahunta Pork Center  TC "Table
6.3: Methyl Bromide Consumption for the Past 5 Years and the Amount
Required in the Year(s) Nominated (Nahunta Pork Center" \f F \l "1"

	Historical Use1	Requested Use

For each year specify: 	1999	2000	2001	2002	2003	2004	2008

Amount of MB (kg)	363	109	218	109	109	109	91

Volume Treated 1000 m³	16	5	9	5	5	5	4

Formulation of MB	Information not provided

Dosage Rate (kg/1000 m³)	23.3	23.3	23.3	23.3	23.3	23.3	23.3

Actual (A) or Estimate (E)	Actual

Updated Table 6.4: Methyl Bromide Consumption for the Past 5 Years and
the Amount Required in the Year(s) Nominated (Gwaltney of Smithfield  TC
"Updated Table 6.4: Methyl Bromide Consumption for the Past 5 Years and
the Amount Required in the Year(s) Nominated (Gwaltney of Smithfield" \f
F \l "1"

	Historical Use1	Requested Use

For each year specify: 	1999	2000	2001	2002	2003	2004	2008

Amount of MB (kg)	363	1,361	907	2,177	1,361	3,266	1,905

Volume Treated 1000 m³	21	21	21	177	177	177	177

Formulation of MB

	Information not provided

Dosage Rate (kg/1000 m³)	17.09	64.07	42.72	12.32	7.70	18.48	10.78

Actual (A) or Estimate (E)

	Information not provided

Dosage Rate  TC "Dosage Rate" \f C \l "3"

MBTOC Question

2. Please clarify the dosage rate that will be used for the treatment of
country ham by the four applicants. If the four applicants intend to use
different dosage rates please supply information to justify a technical
need for the higher rates.

US Response

The standard dosage rate intended by the USG is 16-24 kg/1000 m3 for
this sector, and all of the ham nominations fall within these standard
dosages.  The applicants requested these rates to control mites, ham
skippers and ham borers in their cured pork products.  The slight
variation in dosage rates is due to the location of the pest being
targeted by the fumigation.  When the pests infest the pork products
they will burrow deep into the meat.  If these pests have begun to
burrow into the meat a higher rate is required so that the fumigant can
penetrate the meat to effectively control the embedded pests.

The industry is trying to hire researchers to investigate how to detect
the key pests early (especially the mites), and to treat these pests
before they become a major problem.  However, there are few scientists
who are willing to work on the mites, as they very difficult to confine
in laboratory conditions. The control of mites is critical to get a
better handle of this problem.   Consequently, no work on mites has yet
been started, but the industry is still hopeful that studies will be
conducted soon.

MBTOC Question

3. Tables 6.1 to 6.4 and the BUNNI indicate intended dosage rates that
vary between 10.78 and 73.10 kg/1000M3. We had thought the 73.10 was a
typo except it is also repeated in the BUNNI. If it is a typo please let
us know the actual number. If it is the actual intended dosage rate,
please provide a technical justification for this use rate. Lack of
gastight fumigation chambers or inadequately controlled fumigation is
not usually considered adequate technical justification.

US Response

Please see answer to question above.  MBTOC is correct in that this is a
typo in the volume treated.  The previous volume was 17 which should
have been 67.  Therefore, the dosage rate of 73.10 should be 18.60.  The
table above has been updated to reflect these changes.

The USG is not using gastightness of the chambers as a technical
justification, but rather the susceptibility and location of the pests,
the maintenance of Concentration x Time to kill the pests, and time
frame required by the producers to get their product shipped when
necessary.

Frequency of Fumigation  TC "Frequency of Fumigation" \f C \l "3"

MBTOC Question

4. We understand that two of the four applicants (Gwaltney and Nahunta)
have improved gas tightness to reduce frequency of fumigation. These
questions pertain to the other two applicants.  Has the BUNNI reduced
applicants request to take into consideration planned improvements in
gastightness that will be achieved by 2008 so that frequency of
fumigation will be reduced to <3 per year.

US Response

The frequency of fumigation will probably never reach less than <3 per
year.  The hams in the summer or aging room are the ones that get
infested with mites, skippers, and borers.  These rooms are necessary
for the proper curing of the meat products.  These rooms are maintained
at 80-90° F and 55% relative humidity for 90 to 120 days.  These
conditions are necessary for the meat to develop the full compliment of
flavors necessary.  Unfortunately, these conditions are also ideal for
the pests.

The processors usually apply methyl bromide to a cured meat product only
once, to control the mites, skippers and borers.  Occasionally a meat
product will be fumigated a second time, if it is aged for an extended
period of time.  However, since processing of these meat products is
year round, we don’t think that the number of fumigations will
decrease until more is known about the pests and viable alternatives are
identified.

MBTOC Question

5. USG reports that gastightness is poor in some of these facilities and
this is further substantiated in the CUN when it indicates that
frequency of fumigation can vary between 2-8 times per year although
usually 3-5 time a year. For two years now MBTOC has asked that
facilities requiring methyl bromide treatment meet standards of 'good'
gastightness (as defined in the Handbook). Using MB in facilities of
poor gastightness increases MB use and is not in keeping with Decision
IX/6. The CUN reports that State university researchers will conduct a
survey of country ham producers and determine gastightness. This is
excellent, but MBTOC needs to know that country ham facilities will then
be improved to 'good' gastightness by 2008 or if other means will be
employed to reduce frequency of fumigation to <3 per year or some other
technically justified frequency.

US Response

As MBTOC notes, gastightness is one area that is being surveyed by
researchers.  The goal is to improve gastightness in all the older
facilities.  However, advances in gastightness will only help retain
gas, and may not necessarily affect pest pressure.  The researchers in
this area also want to study the biology of the pests in relation to
gastightness in order to enhance pest control as well  For instance, one
of the new, gastight, facilities was infested with mites after 9 months
of operation.  After all the hams were sold, the summer room was
scrubbed and sanitized.  Yet, within one month of moving new hams into
the room for curing, mites began infesting the meat, resulting in methyl
bromide fumigation.  While the gastightness improves the fumigation and
reduces methyl bromide emissions, until more biological information is
known about the pests, it will probably not decrease the number of times
fumigation is needed.

The frequency of fumigation will probably never reach less than <3 per
year.  The hams in the summer or aging room are the ones that get
infested with mites, skippers, and borers.  These rooms are necessary
for the proper curing of the meat products.  These rooms are maintained
at 80-90° F and 55% relative humidity for 90 to 120 days.  These
conditions are necessary for the meat to develop the full compliment of
flavors necessary.  Unfortunately, these conditions are also ideal for
the pests.

The processors usually apply methyl bromide to a cured meat product only
once, to control the mites, skippers and borers.  Occasionally a meat
product will be fumigated a second time, if it is aged for an extended
period of time.  However, since processing of these meat products is
year round, USG does not think that the number of fumigations will
decrease until more is known about the pests.

Historical Use  TC "Historical Use" \f C \l "3"

MBTOC Question

6. Since use of MB in 2005 will be controlled, please report actual use
of MB by members of American Meat Producers in 2005.

US Response

The US regulatory framework for MB critical use exemptions is designed
to track the sales of critical use methyl bromide to sectors of approved
critical users.  For the 2005 control period, the dry cured pork
products sector was grouped in the larger commodities sector.  Thus,
2005 sales of critical use MB to the dry cured pork products sector
cannot be segregated from sales to other commodity sectors, such as
dried fruit, walnuts, and beans.  However, for the 2006 calendar year
the regulation was slightly changed and we expect to be able to account
for sales of critical use MB to the dry cured pork products sector
separately.  Please note that we do not track sales of critical use MB
to individual end-users through the regulatory framework for MB critical
uses.  We also do not track actual use of methyl bromide by sector or by
individual end-user.

US NPMA FOOD PROCESSING STRUCTURES  TC "US NPMA FOOD PROCESSING
STRUCTURES" \f C \l "2"

Questions Pertaining to All Sectors Included in this CUN  TC "Questions
Pertaining to All Sectors Included in this CUN" \f C \l "3"

MBTOC Question

1. Please update the registration status of sulfuryl fluoride in
California for the types of food processing facilities and commodities
included in this CUN.

US Response

The registration status of sulfuryl fluoride has not undergone any
further changes in California.

On January 23, 2004, the U. S. EPA registered sulfuryl fluoride as a
post-harvest fumigant for cereal grains, dried fruit and tree nuts.
Sulfuryl fluoride was registered for these uses in California in May,
2005.  Sulfuryl fluoride received a U. S. registration July 15th, 2005
for these food processing facilities.  All states, except California,
have also registered these use sites.

The industry will need time to incorporate this new alternative into
their management plan.  In addition, label language only allows for
“incidental fumigation” for processed foods.  Subsequently only
minimal amounts of ingredients and products should be left in a facility
during sulfuryl fluoride fumigations.  Since many of these buildings
have no way to separate products and ingredients from the equipment,
this label restriction may be problematic.

Trade Restrictions  TC "Trade Restrictions" \f C \l "3"

MBTOC Question

2. If our understanding is correct, the CUN indicates the applicant is
concerned that if their structure is fumigated with sulfuryl fluoride,
then exports of their commodities may not be accepted by an importing
country which does not have SF registered for structures. However many
countries have registered SF for structural use. Therefore MBTOC does
not understand if this problem is a major factor or not. Please submit
the list of countries that the applicants export to which would not
accept commodities coming from a structure that had been treated with
SF, and indicate the percentage of the export volume this would pertain
to. It is also possible that MBTOC has misunderstood this issue and its
impact on the use of alternatives to MB. If so, please correct our
misunderstanding.

US Response

The Codex Alimentarius Commission was created in 1963 by the Food and
Agriculture Organization (FAO) and World Health Organization (WHO) to
develop food standards, guidelines and related texts such as codes of
practice under the Joint FAO/WHO Food Standards Programme.  This
commission has encouraged food-related scientific and technological
research as well as lifting the world community’s awareness of food
safety and related. The Codex Alimentarius Commission has become the
single most important international reference point for developments
associated with food standards.  The purposes of this group are
protecting health of the consumers and ensuring fair trade practices in
the food trade, and promoting coordination of all food standards work
undertaken by international governmental and non-governmental
organizations (  HYPERLINK
"http://www.fao.org/docrep/008/y7867e/y7867e02.htm#bm02"
http://www.fao.org/docrep/008/y7867e/y7867e02.htm#bm02 ).

Sulfuryl fluoride is currently undergoing review by the Codex
Alimentarius Commission to establish maximum residue levels (MRL) from
the use of quarantine fumigations and by the Committee for the Agreement
on the Application of Sanitary and Phytosanitary Measures to set
standards for its use.  If approved by Codex MRLs would be established
for foods such as: dried fruits and tree nuts, bran, cereal grains, and
flour (e.g. maize, rye, and wheat).  However, MRLs need to be
established by Codex on all the products imported.  If residues of
fluoride should be found on products for which there is no tolerance,
the goods could be rejected, and trade disrupted. USG also notes here
that even after an MRL is established by the Codex, individual countries
may have to establish their own specific MRL (depending on their own
internal policies and laws). This means that global acceptance of
sulfuryl fluoride in terms of MRLs will take time beyond that required
for a Codex decision. This time needs to be considered for when
considering the practical availability of this methyl bromide
alternative.

Cheese Stores  TC "Cheese Stores" \f C \l "3"

MBTOC Question

3. Provide research plan for control of pests in cheese stores.

Although USG indicates transition plans for other food processing uses,
there is no transition or research plan for cheese storages. While we
acknowledge there is currently no alternative registered for this use,
there is also no research program to find alternatives or minimize use
in this sector as required in Decision IX/6.

Please describe the research plan intended to reduce the need for methyl
bromide in this sector.

US Response

Although cheese production is a major industry in the US, the fumigation
of cheese processing facilities is actually small.  A methyl bromide
fumigation is only done if USDA inspectors request it.  Consequently, it
is not always the same facility nor the same location.  While there are
usually a few fumigations done each year in cheese processing plants, it
is difficult to coordinate a research plan.

The pests in cheese (mites, skippers, and borers) are the same pests
that infest the processed meats.  So the research done on country hams
will be applicable to cheese facilities.  The primary difference between
the two production practices is that ham is cured at 80-90° F and 55%
relative humidity; whereas cheese is cured at 35° F from milk that has
been pasteurized.  The conditions under which cheese is processed reduce
the pest pressure.

MBTOC Question

4. Provide volume of cheese store to be fumiqated.

Provide volume of each cheese store to be fumigated, with a gastightness
evaluation (as described in the Handbook for Critical Use Nominations).
How will methyl bromide use be minimized through sealing and other good
fumigation practices?

US Response

As mentioned in the previous answer, there is no specific cheese
facility that is being fumigated, therefore to specify a volume is very
difficult.  The range of volumes can be from 5,000 cubic feet to 250,000
cubic feet.  However, since cheese is cured at fairly low temperatures,
to keep those temperatures, and maintain sanitation, the facilities are
very gastight.

As with any facility undergoing fumigation, the building is examined and
sealed according to the US methyl bromide label and fumigation guide.

MBTOC Question

5. Describe MB use minimizing procedures

Is the methyl bromide only used when cheese is present in the cheese
storage? When the cheese is removed from the storage room, other
sanitizing or fumigation agents can be used.

US Response

Fumigations occur when an USDA inspector deems that the product is
infested and must be fumigated. Therefore the cheese is present in the
storage and both are fumigated.  However, the cheese industry is
diligent about maintaining micro-sanitation and employs other sanitizing
methods to clean the storages when the cheese is not there.  The
facilities are often emptied and sanitized between batches.  In
addition, cheese is produced under very cool conditions which reduces
insect and mite pest pressure, but does not always eliminate pests.

Herb and Spice Facilities and Commodities  TC "Herb and Spice Facilities
and Commodities" \f C \l "3"

MBTOC Question

6. QPS Use

Page 16 of the CUN says that small amounts of herbs and spices included
in the application were for quarantine and pre-shipment uses. Products
treated as for quarantine or pre-shipment purposes are not included in
the phase out of methyl bromide and can not be included in critical use
nomination. If we have understood the CUN correctly, please indicate the
amount of methyl bromide that was intended for this purpose, recalculate
and send us the revised request for this sector, minus the QPS use.

US Response

The 2008 nomination for methyl bromide is for the domestic uses of dried
herbs and spices at blending facilities.  These facilities produce
packages (i.e. pizza mixes, chili mixes, etc.) that are then added to
pre-packaged goods.  These facilities are similar to grain mills in that
there are silos, mixing areas, packaging areas, etc.  Infestation in
herb and spice blending facilities is not localized to machinery that
can be spot heat treated.  These facilities utilize methyl bromide to
target pests present in inaccessible areas of the structure, not the
ingredients or finished products that may be stored on-site.

The information regarding the export of dried herbs and spices was only
intended for comparison information, and was not part of the methyl
bromide nominated in this CUN.  Therefore, the nominated amount of
methyl bromide for this use remains: 4,046 kg for 203,000 m3, at a rate
of 20kg/1000 m3.

MBTOC Question

7. Commodity Use

Alternatives to methyl bromide for herbs and spices are in widespread
commercial use in all regions of the United States. These include
ethylene oxide, irradiation and steam treatment. These treatments
control pests and microbial pathogens. Some spice packers have in-house
facilities to conduct these treatments and some spice packers use
contract treatment facilities. Please indicate the amount of methyl
bromide intended for herb and spice commodity included in this CUN.

US Response

The 2008 nomination for methyl bromide is for the domestic uses of dried
herbs and spices at blending facilities.  These facilities produce
packages (i.e. pizza mixes, chili mixes, etc.) that are then added to
pre-packaged goods.  These facilities are similar to grain mills in that
there are silos, mixing areas, packaging areas, etc.  Infestation in
herb and spice blending facilities is not localized to machinery that
can be spot heat treated.  These facilities utilize methyl bromide to
target pests present in inaccessible areas of the structure, not the
ingredients or finished products that may be stored on-site.  The
industry does do a draw-down before fumigating; however, there will be
small amounts of dried herbs and spices within the machinery that would
be exposed.  Sulfuryl fluoride was registered for this use a year ago,
but as these are very small operations, it will take some
experimentation to determine how best to use this alternative and to
determine if it is economically feasible.

This nomination is only for a few facilities that are quite small and
target the domestic market.  Because these are very small operations,
they have little profit to invest in the capital costs required to
utilize the alternatives that the larger manufacturers have been able to
employ.  Therefore, the nominated amount of methyl bromide for this use
is:  4,046 kg for 203,000 m3, at a rate of 20kg/1000 m3.

US COMMODITIES  TC "US COMMODITIES" \f C \l "2"

MBTOC Question

1. General Questions for this CUN

Clarify the requested amount

The total amount requested for all sectors is 67,678 kg but the amount
requested in the CUN is 67,699 kg. Is the difference (21 kg) the amount
USG intends to designate for research or is there a discrepancy in the
amount of methyl bromide requested?

US Response

The nominated amount for the commodity sector is 67,679 kg, with 20 kg
for research for a total of 67,699 kg.

MBTOC Question

2. Emissions Control and Recapture

Provide information on the gas tightness of the chambers used to
fumigate commodities with methyl bromide. Have any of the fumigation
chambers been fitted with methyl bromide recapture technologies?

US Response

The USG is confident that the majority of these chambers used to
fumigate commodities are very gas-tight. These fumigations are conducted
in California, and the state has many restrictions already in place.  In
addition, the state of California has County Agriculture Commissioners
that monitor these situations.  To reduce buffer zones during
fumigations, the chambers must be very gas-tight, according to
California regulations.

The USG is aware that many of the quarantine chambers have
capture-destruction technologies.  However, it is unknown at this time
how many, if any of the commodity chambers are also fitted with these
new technologies.

MBTOC Question

3. Methyl Bromide Fumigation Outside of Autumn Harvest Time

TABLE B.2 (Page 10 CUN) (Fumigation Schedule MB) indicates year round
fumigation of commodities, although increased fumigation during autumn
months. If fast treatments are needed only for the holiday target market
window (October to January), indicate what amount of each commodity is
fumigated outside these months. Does the amount of methyl bromide
requested in the CUN include the fumigations conducted outside the
months of October -January and if so why?

US Response

The walnuts and dried fruit are fumigated August through November, the
dates are fumigated September through January, and the dried beans,
garbanzos are fumigated in June and black-eyed are fumigated July and
September through November.

Although fumigations of commodities may occur through out the year (as
indicated by the small x) most of these fumigations will be done with
phosphine.  The only methyl bromide outside of the peak harvest is for
the export market (which are not part of this CUN because it meets the
requirements of the QPS exemption), or an order that must be filled
quickly (which is part of this CUN) to meet the demands of a client.
Dates, however, must be fumigated with methyl bromide as phosphine
changes the flavor, and there are as yet, no technically feasible
alternatives.

MBTOC Question

4. Dried Fruit (Dried Plums)

Clarify the products to be treated

Although the heading for the request is dried plums, the CUN also says
this category includes raisins and figs. Are raisins and figs included
in this CUN, and if so please provide volumes of each commodity.

US Response

Yes, raisins and figs are included along with dried plums as part of
this nomination for 2008 as they were in previous years.  The California
Dried Plum Board takes the lead in submitting documentation for the
critical use exemption on behalf of the dried fruit producers in
California.  Therefore, this nomination includes raisins, figs as well
as the dried plums.

Average amount of commodity treated in 2003 through 2005 is about
101,000 tons of prunes, about 13,767 tons of figs, and about 298,233
tons of raisins.

MBTOC Question

5. Adoption of Alternatives by Dried Plums

This year the CUN requests an amount for 2008 that is only approximately
5% less methyl bromide for dried fruit than was granted by the Parties
in 2007. Yet the previous amount granted included several dried fruit
commodities. Does this mean that the amount of methyl bromide used for
dried plums has increased? Please show methyl bromide history of use for
dried plums. The bulk of dried fruits in California are now treated with
phosphine instead of methyl bromide. Please provide the technical or
economic supporting data for not using phosphine to fumigate dried
plums, when it is technically effective and economic to use by other US
dried fruit sectors.

US Response

The dried fruit nomination is for dried plums, raisins and figs.  The
amount nominated does not reflect an increase for dried plums.  The
nomination is strictly for use during the peak harvest period when the
timing of fumigation is critical.  MBTOC is correct that the bulk of
dried fruits in California are treated with phosphine.  However, the US
nomination is intended to ensure that the produce may be processed
quickly during the peak harvest, when a short fumigation is required to
handle the amount harvested. Fumigation must occur in a timely manner in
order to be technically and economically feasible.

MBTOC Question

6. Conditions of Dried Plum Fumigation

Describe the conditions and method of fumigating dried plums. Are they
fumigated in chamber, or is the dried plum storage facility fumigated as
a structural treatment? Describe gastightness of dried plum fumigation
chamber or facility.

US Response

Dried plums, as well as raisins and figs, are typically fumigated in
chambers, bins or containers.  For the purpose of this US methyl bromide
nomination, the fumigations are for the peak harvest time when timing is
critical to the production and to meet market demands.

Virtually all production of the dried fruits involved, as well as the
fumigation chambers, is located in California.  As mentioned above, the
USG is confident that the majority of these chambers used to fumigate
commodities are very gas-tight.  These fumigations are conducted in
California, and the state has many fumigation restrictions already in
place.  In addition, the state of California has County Agriculture
Commissioners that monitor these situations.  To reduce buffer zones
during fumigations, the chambers must be very gas-tight.  For more
information on California regulations in this regard, please see the
following website: (  HYPERLINK
"http://www.cdpr.ca.gov/docs/enfcmpli/manuals/mbcomfum.pdf"
http://www.cdpr.ca.gov/docs/enfcmpli/manuals/mbcomfum.pdf ).

MBTOC Question

7. Timing of Dried Plums Fumigation

When are dried plums fumigated with methyl bromide? Are they fumigated
with methyl bromide more than once a year?

US Response

The nomination for dried plums, raisins and figs is strictly for use
during the peak harvest period when the timing of fumigation is
critical.  MBTOC is correct that the bulk of dried fruits in California
are treated with phosphine.  However, the US nomination is to ensure
that the produce may be processed quickly during the peak harvest, when
a short fumigation is required to handle the amount harvested.  In
addition, this nomination includes incidental methyl bromide fumigations
to account for the need to process an order quickly. This is often
necessary because buyers (grocery supermarkets, for example) demand
shipments quickly (a 2-3 day notice and turnaround is typical).  Methyl
bromide fumigations for the export market are not included in this CUN.

MBTOC Question

8. Walnuts

The current CUN requests an amount for 2008 that is only approximately
5% less methyl bromide for walnuts than was granted by the Parties in
2007. Table 12.1 page 16 CUN indicates that 50% of shelled walnuts are
stored in facilities that can not be sealed for the 5 days required for
phosphine fumigation. The citation for this is California Walnut
Commission 2003. The current CUN requests methyl bromide for 2008. This
information seems out of step with the current situation. How do you
plan to minimize the use of MB for the critical use in the future?

US Response

The conditions that are described are still accurate, although the
reference to the California Walnut Commission is from information that
the Commission provided to EPA in 2003.  Primarily the phosphine and
Eco2fume labels have not changed in the last 3 years.

In general, phosphine alone or in combination is not suitable to replace
methyl bromide when rapid fumigations are needed to meet customer
timelines.  The delay would disrupt processing of dried fruit and nuts,
increasing production costs and interfering with access to the holiday
market.  Furthermore, phosphine is corrosive to some metals in electric
and electronic equipment in processing plants.

Phosphine fumigation takes 3-10 days, depending on temperature, compared
to 1 day for MB (phosphine labels).  An additional 2 days are needed for
outgassing phosphine.  Phosphine fumigation is least feasible during the
colder winter months when, according to label directions, the minimum
exposure periods increases to 8-10 days (plus two days for aeration)
when commodity temperature decreases to 5oC - 12 oC.  Phosphine is not
used when commodity temperature drops below 5oC (Phosphine and
Eco2fume® labels).

For walnuts sold as in-shell (approximately 25% of the California
production) phosphine fumigation takes too long during the peak
production period, when large volumes of walnuts are processed and
shipped rapidly.  In some cases, however, phosphine has already replaced
MB fumigation whenever feasible.  For walnuts sold as shelled product,
phosphine combined with carbon dioxide (Eco2fume®) is being used for
in-storage fumigation by approximately 50% of the industry since 2001.
The remaining 50% lack large storage facilities that can be sealed and
left for at least five days, the time required to fully disinfest the
commodity (California Walnut Commission & Walnut Marketing Board, 2003).

MBTOC Question

9. Dried Beans

Please provide technical or economic reason why phosphine can not be
used to fumigate dried beans. Is the entire dried bean harvest included
in the amount of product that will be treated with methyl bromide?
Please provide an economic impact evaluation for the use of phosphine
for dried beans. How do you plan to minimize the use of MB for the
critical use in the future?

US Response

This nomination is only for the peak harvest season for garbanzo and
black-eyed beans.  All other dried beans, as well as the early and late
season garbanzo and black-eyed beans are fumigated with phosphine.
During the peak harvest so many dried beans must be processed that
phosphine takes too long resulting in a backlog of beans.  Essentially,
if the beans remain in the fumigation chambers for 3 days, then the
trucks cannot unload the beans, which then become unavailable to
transport beans from the fields, and harvesters will have to stop
harvesting, resulting in a loss of yield.

An economic analysis was not done for dried beans because there are no
technically feasible alternatives for dried beans.

The industry is hopeful that the state of California will register
sulfuryl fluoride for this use in the future.  In addition, sulfuryl
fluoride is currently undergoing review by the Codex Alimentarius
Commission to establish maximum residue levels (MRL) from the use of
quarantine fumigations and by the Committee for the Agreement on the
Application of Sanitary and Phytosanitary Measures to set standards for
its use.  If approved by Codex MRLs would be established for foods such
as: dried fruits and tree nuts, bran, cereal grains, and flour (e.g.
maize, rye, and wheat).  However, dried beans are not yet on the current
list. USG hopes that they would be added in the future.

US STRUCTURES  TC "US STRUCTURES" \f C \l "2"

MBTOC Question

1. Re-examine Table 14.1

This table may have been submitted in error because the costs indicate
no change in cost of alternatives over the past three years. Could the
Party re-examine this table and send corrections that might be available
to MBTOC?

US Response

The cost estimates are averaged over three years due to fluctuations in
revenues and costs each year.  Therefore the cost estimates appear
unchanged each year. We are investigating to determine whether this
assumption is accurate.

MBTOC Question

2. Increase in MB Requested for Rice Milling

Looking at the amount of MB granted by the Parties for rice milling for
2007, the request for 2008 represents a considerable increase. (Parties
granted 64.150 kg for 2007 but the 2008 CUN requests 81,258 kg.) Yet
alternatives such as sulfuryl fluoride will have been registered for
rice milling for a few years by 2008. The CUN includes the following
paragraph on page 13, "This year rice millers decreased their request
because the number of fumigations they typically have conducted declined
due to two good crop years, increased use of existing mill and storage
space, use of a newly registered alternative, and some mills made
capital investments on construction for better sealing and sanitation.
However, some mills had increase in use due to high humidity, high
temperatures, and excessive storms blowing in pests". Please provide a
full discussion explaining why this sector requests a large increase in
MB for 2008, when alternatives are registered and in partial use for
this sector in the US.

US Response

The 2008 CUN is nominating 81,258 kg for the US rice mills because USG
accidentally took out too much of their request believing it would
qualify for QPS in the 2007 nomination.  The increase of 17,108 kg
essentially represents the amount that was accidentally removed from
last year’s nomination.  The US Rice Federation had been requesting
USG for 200,000 kg (202,756 kg for use in 2006; 200,488 kg for use in
2007), but they requested 145,603 kg for use in 2008, because they have
been able to use alternatives, had two good years of crops, and made
some improvements in their mills.  Although, they have asked for more
than what MBTOC granted for use in 2007, USG feels that to hold the rice
millers to that amount is continuing to penalize the millers for a
mistake that was made in the previous nomination.

Post-harvest Questions from the TEAP/MBTOC Report May 2006  TC
"Post-harvest Questions from the TEAP/MBTOC Report May 2006" \f C \l "1"

US Commodities  TC "US Commodities" \f C \l "2"

MBTOC Comment

1. This CUN includes walnuts, dried fruit, beans and dates. MBTOC
recommends the 0.021 tonnes planned to support alternatives research for
these commodities. MBTOC is unable to assess the amount of methyl
bromide required by walnut sector pending the Party’s reassessment of
MB needs as circumstances are in flux.

MBTOC awaits results of trials with the newly registered alternative
propylene oxide (PPO), a potentially useful method if the sector’s
currently used vacuum chambers can be switched to PPO instead of MB.

US Response

Dr. James Leesch, research entomologist with USDA, is currently
conducting research on PPO in walnuts.  His experiments are on-going and
results are inconclusive at this time.

MBTOC Comment

2. Two EU countries have adopted maximum residue levels (MRL) for
fluoride that may facilitate the adoption of sulfuryl fluoride by this
sector.

US Response

The US exports walnuts to several nations, including Japan, Spain,
Canada, Germany, and Italy.  The US also exports a small percentage of
walnuts to South American nations.  It would be impossible to determine
at harvest what nuts are going to which country.  So at this time the US
is nominating 43,888 kg of methyl bromide to treat its walnuts at peak
harvest.

However, sulfuryl fluoride is apparently currently undergoing review by
the Codex Alimentarius Commission to establish maximum residue levels
(MRL) from the use of quarantine fumigations and by the Committee for
the Agreement on the Application of Sanitary and Phytosanitary Measures
to set standards for its use.  If approved by Codex, MRLs would be
established for foods such as: dried fruits and tree nuts, bran, cereal
grains, and flour (e.g. maize, rye, and wheat).  If this occurs, it
would remove this obstacle and allow for investigation and potentially
future transition.

MBTOC Comment

3. MBTOC also requests information on the potential for decreased MB
requirement by walnut sector if vacuum treatment time was increased by
one hour, with the resulting 20% decrease in required dosage rate.

US Response

The US nomination is for walnuts during the peak harvest when timing is
very critical to production.  Typically, three (3) truckloads of walnuts
are fumigated sequentially during a 24 hour period.  This is necessary
to eliminate the pests and to handle the load of the harvest peak.
Therefore, this nomination is for the time constraints of the industry
during peak harvest.  In addition, there are no data to support the
lower rate and increased time of exposure, but the fact is that the
delay of time would cause a backlog of nuts leaving the field and before
processing.

MBTOC Comment

4. Bean sector has investigated using cylinderized phosphine finding it
useful for product in storage but too time consuming for the immediate
post-harvest treatment before holiday marketing. The Party has indicated
it will review transition rates for this sector when more is known about
adoption of sulfuryl fluoride, which may depend on adoption of MRLs by
importers.

US Response

This is correct.  This sector will be re-evaluated as sulfuryl fluoride
continues to undergo review by the Codex Alimentarius Commission to
establish maximum residue levels (MRL) from the use of quarantine
fumigations and by the Committee for the Agreement on the Application of
Sanitary and Phytosanitary Measures to set standards for its use.
Currently it appears that if sulfuryl fluoride is approved by Codex,
MRLs would be established for foods such as: dried fruits and tree nuts,
bran, cereal grains, and flour (e.g. maize, rye, and wheat).  The
current list of foods does not yet include beans, but USG is continuing
to monitor the situation.

US Cocoa Beans  TC "US Cocoa Beans" \f C \l "2"

MBTOC Comment

5. Currently the Party indicates a need for two fumigations per year of
the cocoa beans: the first fumigation upon import and a second
fumigation immediately before shipment to the chocolate manufacturers.
However, MBTOC requests the Party to recalculate the impact on MB volume
required for this CUN if alternatives were used, especially to replace
the second fumigation before shipment to chocolate manufacturers, to the
extent that this could be achieved by 2008.

US Response

The second fumigation of cocoa beans, just prior to shipping to
manufacturers, is often in warehouses under tarpaulins.  The warehouse
would need to be evacuated for 2-8 days (this is more than is needed
under methyl bromide fumigation) depending on amount of phosphine
necessary; otherwise this would violate the US phosphine pesticide
label.  Since more than one commodity is stored at these port
facilities, this is not practical.

MBTOC Comment

6. For the first fumigation, changed logistics that may allow increased
use of phosphine including in-transit treatments conducted at time of
export from producing countries may be useful in reducing the need for
the first fumigation (Watson et al, 2000)

US Response

We are still investigating whether or not it is feasible.  According to
the US phosphine pesticide label, in-transit fumigation of transport
containers aboard ships are governed by D.O.T. RSPA 49 CFR 176.76(i) and
International Maritime Dangerous Goods Code P9025-1 Amdt. 27-94. These
standards include the gastightness of the ship, notification of crew,
among other regulations.  To have cocoa beans fumigated at the port of
origin would place these burdens, including the safety of the crew on
other nations.  The USG is still seeking information regarding this
option.

MBTOC Comment

7. For the second fumigation, the Party may wish to base its
determination on further research of techniques that allow weekend
fumigation using treatments that only target post-embryonic stages,
since egg kill should not be a requirement if the chocolate
manufacturers quickly use the cocoa beans shipped to them. Avenues of
investigation for cocoa might include furthering the applicant’s
current work with the recently registered sulfuryl fluoride.

US Response

Sulfuryl fluoride was registered for this use in May of 2005 by USEPA.
The industry is working with the registrant to determine how to
implement this new chemical into the current pest control strategies.
However, to only target post-embryonic stages would require a change in
the mind-set of industry, and this requires testing of the new chemical
in a commercial setting, and education of users (all of which, in turn,
requires time).  The feasibility of this approach requires that cocoa
beans be used in a fairly short window after fumigation or the remaining
viable eggs will result in a high and increasing level of insect
infestation.  This approach may not, therefore, be feasible

MBTOC Comment

8. Propylene oxide is also registered for use in cocoa beans, although
suitable chambers would have to be installed. IPM approach improvements
such as enhanced cocoa inspection programs and methods could be
investigated to determine if the fumigation before shipment to chocolate
manufacturers could be avoided during winter or in other circumstances.

US Response

The Port Authorities own the ports at which cocoa beans, as well as
other commodities, arrive and the warehouses were cocoa beans are
stored.  The installation of new chambers to utilize propylene oxide
would be cost prohibitive.  The importers of cocoa beans are encouraged
to monitor and inspect the bags of cocoa beans while they are in
storage.  However, the manufacturers want clean cocoa beans delivered in
a timely fashion.

US NPMA  TC "US NPMA" \f C \l "2"

MBTOC Comment

9. Although MBTOC recommends 4.059 tonnes for herb and spice facilities,
MBTOC does not find that the use of MB for herb and spice commodity to
be consistent with Decision IX/6 since several alternatives are
available and in widespread commercial use. The Party is requested to
ensure herb and spice commodity are not included in facility fumigations
using MB.

US Response

The 2008 nomination for methyl bromide is for the domestic uses of dried
herbs and spices at blending facilities.  These facilities produce
packages (i.e. pizza mixes, chili mixes, etc.) that are then added to
pre-packaged goods.  These facilities are similar to grain mills in that
there are silos, mixing areas, packaging areas, etc.  Infestation in
herb and spice blending facilities is not localized to machinery that
can be spot heat treated.  These facilities utilize methyl bromide to
target pests present in inaccessible areas of the structure, not the
ingredients or finished products that may be stored on-site.  The
industry does do a draw-down before fumigating; however, there will be
small amounts of dried herbs and spices within the machinery that would
be exposed.  Sulfuryl fluoride was registered for this use a year ago,
but as these are very small operations, it will take some
experimentation to determine how best to use this alternative and to
determine if it is economically feasible.

This nomination is only for a few facilities that are quite small and
target the domestic market.  Because these are very small operations,
they have little profit to invest in the capital costs required to
utilize the alternatives that the larger manufacturers have been able to
employ.  Therefore, the nominated amount of methyl bromide for this use
is:  4,046 kg for 203,000 m3, at a rate of 20kg/1000 m3.

MBTOC Comment

10. Cheese stores are only treated with MB upon requirement of
inspectors from United States Department of Agriculture in response to
pest infestation. To ensure the requirements of Decision IX/6 are met,
the Party should conduct research to find alternatives and/or methods to
reduce infestation and the requirement to use MB. Further avenues of
investigation for cheese stores might include peer-industry information
exchange, reviews of pertinent literature, pest control through
temperature manipulation and improvements in IPM approach and sanitation
that will reduce infestation until the cheese can be removed from the
store. Since there may be a lengthy requirement for the use of MB in
cheese stores and since the stores are fairly gastight, the Party is
encouraged to consider the use of recapture equipment to reduce
emissions from this continued use.

US Response

Although cheese production is a major industry in the US, the fumigation
of cheese processing facilities is actually quite small.  A methyl
bromide fumigation is only done if USDA inspectors request it.
Consequently, it is not always the same facility nor the same location.
While there are usually a few fumigations done each year in cheese
processing plants, it is difficult to coordinate a research plan.
However, the cheese industry is diligent about maintaining
micro-sanitation.  The facilities are often emptied and sanitized
between batches.

The pests in cheese (mites, skippers, and borers) are the same pests
that infest the processed meats.  So the research done on country hams
will be applicable to cheese facilities.  The primary difference between
the two production practices is that ham is cured at 80-90° F and 55%
relative humidity; whereas cheese is cured at 35° F from milk that has
been pasteurized.  The conditions under which cheese are processed
reduce the pest pressure of insects and mites.  In order for these
facilities to maintain these conditions, their facilities are very
gastight.

All alternatives to methyl bromide are re-evaluated each year, including
recapture technology in the post-harvest sector.  The technical and
economic feasibilities are investigated as new information becomes
available.

MBTOC Comment

NPMA Economics:

11. CUN states that the economic impacts cannot be assessed since the
applicant is not the end-user. Economic impacts arise from three
contributing factors: direct pest control costs increase because of
increased labor time required for longer treatment time and increased
number of treatments; capital expenditures may be required to adopt
phosphine for accelerated replacement of plant and equipment due to its
corrosive nature; and additional production downtimes for the use of
alternatives are unavoidable

US Response

The USG is pointing out that it is not able to access firm-level data.
This does not differ between the NPMA sector and other post-harvest
sectors.  MBTOC is correct in its discussion of the elements of cost
change.  The USG case for NPMA is based on the lack of technical
feasibility of all other alternatives in the circumstances of the
nomination.

MBTOC Comment

12. Sulfuryl fluoride was registered last year, and adoption of heat and
phosphine treatments increased, which resulted in a decrease in MB
requested by the Party.  The Party is encouraged to conduct and
strengthen its research program and assist commercial adaptation of
alternatives to ensure the requirements of Decision IX/6 are fully met
for all sectors included in this CUN and to avoid these future
requirements for MB. The Party has indicated it will reassess the
quantity of MB to be permitted through domestic regulation if the
circumstances of the nomination change. For example, as more experience
is gained with sulfuryl fluoride and heat by 2008, it should be possible
to decrease the need for MB in flour and rice milling to allow these
sectors to more closely mirror decreases made in pet foods and bakeries.

US Response

The USG is committed to meeting the criteria under Decision IX/6.  Not
only are the milling and food processing industries committed to
continuing research into alternatives on their own, but the USG has
promoted research on new and existing pesticidal active ingredients to
determine their potential as methyl bromide alternatives.  Ongoing
research supported by the USG is being conducted by the Agricultural
Research Service (ARS) and the Cooperative State Research, Education,
and Extension Service (CSREES).  One of the programs funded by CSREES is
the IR-4 Program, which is conducting methyl bromide alternatives
research in conjunction with alternatives manufacturers.

US Ham  TC "US Ham" \f C \l "2"

MBTOC Comment

13. MBTOC recommends 18.998 tonnes for this use in 2008. Although the
Party requested an increase for 2008, it did not justify the use of an
amount greater than granted by the Parties in 2007. Although
alternatives for this use are unknown to MBTOC, the onus rests on the
Party to ensure use of methyl bromide is minimized as much as possible.

US Response

USG realized that 671 kg more than what was granted by MBTOC for 2007
was nominated; however, it was 21,185 kg less than nominated for use in
2007.  The nomination was based on information obtained from the
manufacturers of methyl bromide and the fumigators of dry cured pork
products.  The USG believes that this nomination more accurately
reflects usage in an industry that does not yet have an identified
alternative.

MBTOC Comment

14. The Party has begun a survey of facility gastightness in this
sector; low facility gastightness is a major contributing factor to MB
use by two of the applicants included in the CUN. However, two other
applicants, Nahunta Pork and Gwaltney of Smithfield have already
invested in improved facilities that reduce MB use. MBTOC expects that
facilities operated by members of American Meat Association and National
Country Ham Association will be required to improve gastightness as a
condition of MB use by 2008.  The Party is encouraged to conduct
research and reduce emissions by improving gastightness to ensure the
requirements of Decision IX/6 are fully met for this sector and to
minimize use of methyl bromide. Research on the effectiveness of
sulfuryl fluoride alone or in combination with other processes, on other
treatments such as cold, to improve IPM tools to avoid infestation, and
on changing processing logistics to allow treatment by phosphine might
be helpful in finding avenues to reduce MB use.

US Response

By conducting research on the major pests of dry cured pork products, to
improve gastightness and identify other IPM strategies, this small
industry is making progress and fulfilling its requirements of Decision
IX/6.  In addition, several producers are cooperating with the
registrant of sulfuryl fluoride to determine if this alternative will
control the primary pests, as efficacy data are unavailable at this
time.  Cold treatments could not be used in the Summer (or Aging) Room
where the temperature (80-90° F) and relative humidity (55%) must be
maintained to cure the product.  Phosphine does not control the mites,
and is illegal to use in North Carolina except for rodent control.

ECONOMIC QUESTIONS  TC "ECONOMIC QUESTIONS" \f C \l "1"

MBTOC Question

Post-harvest – Economic Assessment

1. Please elaborate on how days of lost production were estimated in the
post-harvest nominations.  In particular, how was 84 days estimated as
shown in Table E.3 for Dried Fruit.

Refer to Tables E.1 and E.2, page 20 of the Post Harvest use for
Commodities CUN.  The total commodity treated of walnuts is the same for
methyl bromide and phosphine.  However, the total commodity treated of
dried fruit is reduced from 88,235 for methyl bromide to 63,529 for
phosphine.  Please explain this apparent inconsistency and the steps
used to derive the smaller value for phosphine.

Table E.1: Annual Economic Impacts of Methyl Bromide Alternatives

Loss Measure	Methyl Bromide	Phosphine

Total Commodity Treated (kg/1000 m³)	320,455	320,455

Average Market Price (US$/kg)	$           1.08	$         0.886

Gross Revenue (US$/1000 m³)	$     346,091	$     283,795

Operating Cost (a+b) per 1000 m³	$     328,087	$     328,149

a) Cost of MB or Alternative	$            612	$            459

b) Other Operating Costs	$     327,475	$     327,690

Net Revenue (US$/ha) (net of operating costs)	$       18,005	$
(44,354)

Loss measures

Time Lost (days)	0	84

Loss per 1000 m³ (US$/1000 m³)	$                 -	$       62,358

Loss per Kilogram MB (US$/kg)	$                 -	$         1,299

Loss as a % of Gross Revenue (%)	0%	18%

Loss as a % of Net Revenue (%)	0%	346%

Time lost with phosphine is assumed to result in a lower average market
price for walnuts because less would be treated during peak prices, and
increased supply at other times would depress off-peak prices.

Table E.3: Annual Economic Impacts of Methyl Bromide Alternatives

Loss Measure	Methyl Bromide	Phosphine

Total Commodity Treated (kg/1000 m³)	88,235	63,529

Average Market Price (US$/kg)	$           0.75	$           0.75

Gross Revenue (US$/1000 m³)	$       66,176	$       47,647

Operating Cost (a+b) per 1000 m³	$       61,741	$       57,889

	a) Cost of MB or Alternative	$            413	$            310

	b) Other Operating Costs	$       61,328	$       57,579

Net Revenue (US$/ha) (net of operating costs)	$         4,435	 $
(10,242)

Loss measures

Time Lost (days)	0	84

Loss per 1000 m³ (US$/1000 m³)	$                 -	$       14,677

Loss per Kilogram MB (US$/kg)	$                 -	$            612

Loss as a % of Gross Revenue (%)	0%	22%

Loss as a % of Net Revenue (%)	0%	331%

Time lost with phosphine is assumed to reduce the total commodity that
could be treated.

US Response

The calculation and assumptions regarding the 84 days of downtime using
phosphine are as follows:

For the four commodities, walnuts, pistachios, dried fruit, and dates, a
major impediment to phosphine adoption is the several-fold increase in
fumigation time during the period when the commodities must be processed
quickly.  Two other major limitations to the further adoption of
phosphine are its corrosiveness to electronic sorting and processing
control equipment and its loss of effectiveness as temperature
decreases.

Considering the following:

*  The walnut co-op represents about 50% of the walnut industry.

*  The walnut co-op processes 3 million lb (1,500 tons)/day during the
peak season (several weeks).  700 tons (1.4 million lb) are processed in
the walnut facilities each day.  The remaining 800 tons per day are
processed in offsite facilities.

*  The walnut co-op has 8 vacuum fumigation chambers.  Each chamber has
a 2,500 cubic feet capacity and holds 25 tons (1 truckload) of walnuts.

*  1 ton of walnuts in shell occupies a volume of 100 cubic feet.

*  About 3.5 truckloads (175,000 lb or 87.5 tons) are put through each
fumigation chamber per day.  During peak periods, plants operate 24
hours per day.

* Conventional MeBr fumigation takes 24 hr + 4 hr for aeration.

* MeBr vacuum fumigation takes about 7 hr.  Plants operating 24 hr/day
complete 3.5 fumigations/day.

* Phosphine fumigation takes 3-4 days + 2 days for aeration, for a total
of 5-6 days.

*  Since 2001, Ecofume has replaced MeBr in the walnut co-op’s 21
storage buildings, where the walnuts that are not shipped immediately
are stored.

Even if we allow the minimum of 5 days for phosphine fumigation and one
full day for MeBr fumigation under vacuum, even though it actually takes
about 7 hours, the difference would be 4 days per fumigation.  If we
assume a peak production/processing season of only two weeks, the
downtime would be 4 x 14 = 56 days.  However, the peak season is
actually 3-4 weeks, which would translate to a downtime of 84-112 days.
We would have to multiply these figures by 3.4 to compare to the actual
fumigation rate, but that would be overkill.

Even when MeBr fumigation is not done under vacuum, such as seems to be
the case for dates, the difference is still about 4 days.

In the case of the walnut industry, we assume that because of time lost,
the average market price is reduced because not enough walnuts can be
treated during peak market pricing season using phosphine.  We also
assumed that lost days can be made up, but at a lower market price.

In the case of the dried fruit industry, we assume that because of time
lost, the industry cannot treat the same volume of commodity using
phosphine which leads to production loss.  Therefore the lost days
cannot be made up (loss in downtime) and is reflected in a reduction in
gross revenue.

MBTOC Question

2.

Michigan Pepper- Table E.3: Economic Impacts of Methyl Bromide
Alternatives

michigan pepper	Methyl Bromide	1, 3-D + Chloropicrin

Yield Loss (%) 	0%	6%

   Yield per Hectare 	4,530	4,258

* Price per Unit (us$)	$5	$5

= Gross Revenue per Hectare (us$)	$24,056	$20,916

- Operating Costs per Hectare (us$)	$23,938	$25,607

= Net Revenue per Hectare (us$)	$118	$(4,690)

Five Loss Measures *

1. Loss per Hectare (us$)	$0	$4,808

2. Loss per Kilogram of Methyl Bromide (us$)	$0	$40

3. Loss as a Percentage of Gross Revenue (%)	0%	20%

4. Loss as a Percentage of Net Revenue (%)	0%	100%

5. Profit Margin (%)	0%	-22%

In the above example, could you please report the price to two decimals
so that the impact of the missed market window is more visible?

US Response

The table below has been updated with the price per unit reported to two
decimal places.

Updated Michigan Pepper- Table E.3: Economic Impacts of Methyl Bromide
Alternatives  TC " Updated Michigan Pepper- Table E.3: Economic Impacts
of Methyl Bromide Alternatives" \f F \l "1"

michigan pepper	Methyl Bromide	1, 3-D + Chloropicrin

Yield Loss (%) 	0%	6%

   Yield per Hectare 	4,530	4,258

* Price per Unit (us$)	$5.31	$4.91

= Gross Revenue per Hectare (us$)	$24,056	$20,916

- Operating Costs per Hectare (us$)	$23,938	$25,607

= Net Revenue per Hectare (us$)	$118	$(4,690)

Five Loss Measures *

1. Loss per Hectare (us$)	$0	$4,808

2. Loss per Kilogram of Methyl Bromide (us$)	$0	$40

3. Loss as a Percentage of Gross Revenue (%)	0%	20%

4. Loss as a Percentage of Net Revenue (%)	0%	100%

5. Profit Margin (%)	0%	-22%

MBTOC Question.

Region	Alternative	Yield*	Cost in year 1 (US$/ha)	Cost in year 2
(US$/ha)	Cost in year 3 (US$/ha)

Michigan	Methyl Bromide	100	$    30,559	$    30,559	$    30,559

	1,3–D + Chloropicrin	78	 $    29,555 	$    29,555 	$    29,555

	Metam Sodium	78	 $    29,739 	$    29,739	$    29,739

	Chloropicrin	78	$    29,555	$    29,555	$    29,555

Southeastern US	Methyl Bromide	100	$     26,380	$     26,380	$
26,380

	1,3–D + Chloropicrin	83	$    24,946	$    24,946	$    24,946

* As percentage of typical or 3-year average yield, compared to methyl
bromide e.g. 10% more yield, write 110.

Year 1

Region	Alternatives

(as shown in question 21)	Gross revenue for last reported year (US$/ha)
Net Revenue for last reported year  (US$/ha)

Michigan	Methyl Bromide	$    39,996	$      9,438

	1,3–D + Chloropicrin	 $    32,880 	 $      3,325

	Metam Sodium	 $    34,931 	 $      5,192

	Chloropicrin	$    32,880	 $      3,325

Southeastern US	Methyl Bromide	$     40,914	$     14,533

	1,3–D + Chloropicrin 	$    33,772	$      8,825

Michigan - Table E.1: Economic Impacts of Methyl Bromide Alternatives

Michigan	Methyl Bromide	1,3-D + Pic	Metam Sodium	Chloropicrin

Production Loss (%) 	0%	6%	13%	6%

   Production per Hectare 	4,414	         4,132 	3,845 	4,132

* Price per Unit (us$)	$            9.44	 $           9.44 	 $
9.44 	 $            9.448

= Gross Revenue per Hectare (us$)	$    41,652	 $    38986 	 $    36,279
 $      38986

- Operating Costs per Hectare (us$)**	$    37,055	 $    32453 	 $
31,170 	 $      32,453

= Net Revenue per Hectare (us$)	$      4596	 $      6,533 	 $      5,109
	 $        6,533

Five Loss Measures *

1. Loss per Hectare (us$)	$           -	$      1,937	$      512	$
1,937

2. Loss per Kilogram of Methyl Bromide (us$)	$           -	$         16
$          4	$           16

3. Loss as a Percentage of Gross Revenue (%)	0%	5%	1%	5%

4. Loss as a Percentage of Net Operating Revenue (%)	0%	42%	11%	42%

5. Operating Profit Margin (%)	11%	17%	14%	17%

**Note that the measures in the tables below must be interpreted
carefully.  Operating costs do not include fixed costs and net revenue
equals gross revenue minus operating costs.

3. Explain the inconsistency in Yields and gross and net revenue between
the Tables.

US Response

The tables below are updated with the corrected yields and gross and net
revenues.

Updated Table 21.1: Costs of Alternatives Compared to Methyl Bromide
Over 3-Year Period  TC "Updated Table 21.1: Costs of Alternatives
Compared to Methyl Bromide Over 3-Year Period" \f F \l "1"

Region	Alternative	Yield*	Cost in year 1 (US$/ha)	Cost in year 2
(US$/ha)	Cost in year 3 (US$/ha)

Michigan	Methyl Bromide	100	$    37,056	$    37,056	$    37,056

	1,3–D + Chloropicrin	94	 $    32,453 	 $    32,453 	 $    32,453

	Metam Sodium	87	 $    31,170 	 $    31,170 	 $    31,170

	Chloropicrin	94	$    32,453	$    32,453	$    32,453

Southeastern US	Methyl Bromide	100	$     26,380	$     26,380	$
26,380

	1,3–D + Chloropicrin	83	$    24,946	$    24,946	$    24,946

* As percentage of typical or 3-year average yield, compared to methyl
bromide e.g. 10% more yield, write 110.

Updated Table 22.1: Year 1 Gross and Net Revenue  TC "Updated Table
22.1: Year 1 Gross and Net Revenue" \f F \l "1"

Year 1

Region	Alternatives

(as shown in question 21)	Gross revenue for last reported year (US$/ha)
Net Revenue for last reported year  (US$/ha)

Michigan	Methyl Bromide	$    41,652	$      4,597

	1,3–D + Chloropicrin	 $    38,987 	 $      6,534

	Metam Sodium	 $    36,279 	 $      5,109

	Chloropicrin	$    38,987	 $      6,534

Southeastern US	Methyl Bromide	$     40,914	$     14,533

	1,3–D + Chloropicrin 	$    33,772	$      8,825

Updated Michigan - Table E.1: Economic Impacts of Methyl Bromide
Alternatives  TC "Updated Michigan - Table E.1: Economic Impacts of
Methyl Bromide Alternatives" \f F \l "1"

Michigan	Methyl Bromide	1,3-D + Pic	Metam Sodium	Chloropicrin

Production Loss (%) 	0%	6%	13%	6%

   Production per Hectare 	4,414	         4,132 	3,845 	4,132

* Price per Unit (us$)	$            9.44	$           9.44	$
9.44	$            9.44

= Gross Revenue per Hectare (us$)	$    41,652	 $    38,987 	 $    36,279
	 $      38,987

- Operating Costs per Hectare (us$)**	$    37,056	 $    32,453 	 $
31,170 	 $      32,453

= Net Revenue per Hectare (us$)	$      4,597	 $      6,534 	 $
5,109 	 $        6,534

Five Loss Measures *

1. Loss per Hectare (us$)	$           -	$      1,937	$      512	$
1,937

2. Loss per Kilogram of Methyl Bromide (us$)	$           -	$         16
$          4	$           16

3. Loss as a Percentage of Gross Revenue (%)	0%	5%	1%	5%

4. Loss as a Percentage of Net Operating Revenue (%)	0%	42%	11%	42%

5. Operating Profit Margin (%)	11%	17%	14%	17%

**Note that the measures in the tables below must be interpreted
carefully.  Operating costs do not include fixed costs and net revenue
equals gross revenue minus operating costs.

MBTOC Question

4. Explain why the net revenue per hectare is higher for 1,3-D + Pic
(and the 2nd and 3rd best alternative) than for MB.

US Response

The net revenue appears higher because the assumption is that harvesting
costs are calculated based on yield.  Harvesting costs were estimated to
be about $6.50 per 25 pound box and are a large proportion of operating
costs (ranging from 70% to 75%).  We are investigating to determine
whether this assumption is accurate.

MBTOC Question

Michigan Zucchini - Table E.4: Economic Impacts of Methyl Bromide
Alternatives

Michigan Zucchini	Methyl Bromide	1,3-D + Chloropicrin

Yield Loss (%) 	0%	6%

   Yield per Hectare 	2,368	2,226

* Price per Unit (us$)	$6	$5

= Gross Revenue per Hectare (us$)	$13,484	$12,041

- Operating Costs per Hectare (us$)	$16,522	$15,464

= Net Revenue per Hectare (us$)	$(3,038)	$(3,423)

Five Loss Measures *

1. Loss per Hectare (us$)	$0	$385

2. Loss per Kilogram of Methyl Bromide (us$)	$0	$3

3. Loss as a Percentage of Gross Revenue (%)	0%	3%

4. Loss as a Percentage of Net Revenue (%)	0%	-13%

5. Operating Profit Margin (%)	-23%	-28%

5. What is the significance of the negative net revenue using MB?

US Response

These calculations are based on the information provided by the
applicant based on a single crop system.  We are investigating to
determine whether this assumption is accurate.

REFERENCES  TC "REFERENCES" \f C \l "1"

Besri. M.  2005.  Current situation of tomato grafting as alternative to
methyl bromide for tomato production in the Mediterranean region.
Available online at MBAO 2005,   HYPERLINK
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http://www.mbao.org/2005/05Proceedings/047BesriM%20SD%20Nov05.pdf

Brecke, B. J., J. B. Unruh, and D. O. Stephenson IV**.  2005.  Dazomet
blended with rootzone mix for fumigation.  Int Turfgrass Res. J.
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CDFA (California Department of Food and Agriculture). 2003a. Approved
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Core, J. 2005. Grafting watermelon onto squash or gourd rootstock makes
firmer, healthier fruit. Agricultural Research 53(7). Available online
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http://www.ars.usda.gov/is/AR/archive/jul05/

Evans, M.R., B.K. Harbaugh, and G.J. Wilfret, 1993, Caladiums as Potted
and Landscape Plants, Circular 1060, FL Cooperative Extension Service,
IFAS, University of Florida, Web address:    HYPERLINK
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Gilreath, J.P., B.M. Santos, J.D. Busacca, J.E. Eger, J.M. Mirusso, and
P.R. Gilreath. 2006. Validating broadcast application of Telone C-35
complemented with chloropicrin and herbicides in commercial tomato
farms. Crop Protection 25: 79-82.

Kubota, C. Associate Professor, Department of Plant Sciences, University
of Arizona, Tucson, AZ. Personal communication via e-mail to USEPA.

Louws, Frank J., Lisa M. Ferguson  Nathan P. Lynch, and Paul B.
Shoemaker  2002.  Methyl bromide alternatives in tomato production
systems in North Carolina.  Available online at   HYPERLINK
"http://mbao.org/2002proc/101LouwsF%20AMB%20REPORT%20MB%20Conference%20r
evised%2011-02.pdf"
http://mbao.org/2002proc/101LouwsF%20AMB%20REPORT%20MB%20Conference%20re
vised%2011-02.pdf

McKenry, M. V. 1999.  The Replant Problem and Its Management.  Catalina
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http://www.uckac.edu/nematode/PDF/Replant-Sec1.pdf

Noling, J. W. 2002, revised 2005.  Reducing methyl bromide field
application rates with plastic mulch technology.  University of Florida
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"http://edis.ifas.ufl.edu/pdffiles/IN/IN40300.pdf"
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Richardson, R., B. Zandstra, and T. Dudek.  Evaluation of Herbicidal
Controls for Inula brittannica. ee CUE-0066 request Michigan Field Grown
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Santos, B.M., J.P. Gilreath, T.N. Motis, J.W. Noling, J.P. Jones, and
J.A. Norton. 2006. Comparing methyl bromide alternatives for soilborne
disease, nematode and weed management in fresh market tomatoes. Crop
Protection 25: 690-695

Schneider, S., Trout, T., and Ajwa, H. 2005.  2005 Annual International
Research Conference on Methyl Bromide Alternatives and Emissions
Reductions. Available online at   HYPERLINK
"http://www.mbao.org/2005/05Proceedings/045SchneiderS%20Replant%20paper%
20MBAO%202005.pdf"
http://www.mbao.org/2005/05Proceedings/045SchneiderS%20Replant%20paper%2
0MBAO%202005.pdf

Society of American Florists, California Cut Flower Commission, and
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Flowers, Cut Foliage and Propagative Material, September 2005.

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.2005 Annual International Research Conference on Methyl Bromide
Alternatives and Emissions Reductions. Available online at   HYPERLINK
"http://www.mbao.org/2005/05Proceedings/012TroutT%20mb-fumuse-05.pdf"
http://www.mbao.org/2005/05Proceedings/012TroutT%20mb-fumuse-05.pdf

Trout, T., Schneider, S., Ajwa, H., and Gartung, J. 2003. 2003 Annual
International Research Conference on Methyl Bromide Alternatives and
Emissions Reductions. Available online at   HYPERLINK
"http://www.mbao.org/2003/055%20TroutTmbp-conf03-peach.pdf"
http://www.mbao.org/2003/055%20TroutTmbp-conf03-peach.pdf

USDA. 2002. Crop Profile for Squash in Florida. Available online at
HYPERLINK "http://www.ipmcenters.org"  www.ipmcenters.org

 In growing areas of the United States where the weather does not put an
end to a crop, as it does in the Northeast and Midwest, the need to
prepare the ground for the next crop dictates when the current plants
must be pulled from the ground.

 The technique is referred to a “Delphi” in tribute to the oracle at
Delphi where the future was foretold.

 Changing the label to increase the amount that can be applied would
require bith Federal and State approval.  Before Federal approval could
be granted the human health and environmental risk potential would have
to be analyzed and found acceptable.  State approval would also be
contingent on whether the new rates met State regulations regarding
protecting human health and the environment.  This is a lengthly (and
uncertain) process.

US Response to MBTOC Questions of June 2006 for 2008 Nomination

 PAGE

 PAGE   27

Page

US Response to MBTOC Questions of June 2006 for 2008 Nomination


[Federal Register Volume 77, Number 120 (Thursday, June 21, 2012)]
[Notices]
[Page 37414]
[FR Doc No: 2012-15131]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Gastrointestinal Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.

DATES:  Date and Time: The meeting will be held on August 28, 2012,
from 8 a.m. to 5 p.m.
    Location: DoubleTree by Hilton Hotel Washington, DC/Silver Spring,
The Ballrooms, 8727 Colesville Road, Silver Spring, MD. The hotel phone
number is<PHONE_NUMBER>.
    Contact Person: Cindy Hong, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: (301) 847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On August 28, 2012, the committee will discuss the results
from clinical trials of supplemental biologics license application
(sBLA) 125057/232, for Humira (adalimumab), by Abbott Laboratories, for
the proposed indication (use) for reducing signs and symptoms, and
achieving clinical remission in adult patients with moderately to
severely active ulcerative colitis who have had an inadequate response
to conventional therapy.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 14, 2012. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before August 6, 2012. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by August 7, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Cindy Hong at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15131 Filed 6-20-12; 8:45 am]
BILLING CODE 4160-01-P