[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20187-20188]
[FR Doc No: 2021-07879]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4498-DR; Docket ID FEMA-2021-0001]

Colorado; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Colorado (FEMA-4498-DR), dated March 28, 2020, and
related determinations.

DATES: This amendment was issued February 2, 2021.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, pursuant to the
President's Memorandum to Extend Federal Support to Governors' Use of
the National Guard to Respond to COVID-19 and to Increase Reimbursement
and Other Assistance Provided to States, dated January 21, 2021 and the
President's Memorandum on Maximizing Assistance from the Federal
Emergency Management Agency, dated February 2, 2021 FEMA is amending
the cost-sharing arrangements regarding Federal funds provided under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the ``Stafford Act'') for all of
the COVID-19 emergency and major disaster declarations. FEMA is
amending this declaration as follows:

    Federal funds for emergency protective measures (Category B),
including direct Federal assistance, under the Public Assistance
program (Section 403) are authorized at 100 percent of total
eligible costs for work performed from January 20, 2020 through
September 30, 2021.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030,

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

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-07879 Filed 4-15-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36928-36929]
[FR Doc No: 2011-15691]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0226]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BROVANA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BROVANA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product BROVANA
(arformoterol tartrate). BROVANA is indicated for the long term, twice
daily (morning and evening) maintenance treatment of
bronchoconstriction in patients with chronic obstructive pulmonary
disease, including chronic bronchitis and emphysema. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for BROVANA (U.S. Patent No. 6,589,508) from
Sepracor Inc. (now Sunovion Pharmaceuticals, Inc.), and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration and that FDA determine
the product's regulatory review period. In a letter dated June 1, 2011,
FDA advised the Patent and Trademark Office that this human drug
product had undergone a regulatory review period and that the approval
of BROVANA represented the first permitted commercial marketing or use
of the product.
    FDA has determined that the applicable regulatory review period for
BROVANA is 3,118 days. Of this time, 2,819 days occurred during the
testing phase of the regulatory review period, while 299 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: March 26, 1998. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on March 26, 1998.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
12, 2005. The applicant claims December 8, 2005, as the date the new
drug application (NDA) for Brovana (NDA 21-912) was initially
submitted. However, FDA records indicate that NDA 21-912 was submitted
on December 12, 2005.
    3. The date the application was approved: October 6, 2006. FDA has
verified the applicant's claim that NDA 21-912 was approved on October
6, 2006.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 745 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 22, 2011. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 20, 2011. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on

http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 2, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-15691 Filed 6-22-11; 8:45 am]
BILLING CODE 4160-01-P


METHYL BROMIDE CRITICAL USE RENOMINATION FOR POST-HARVEST -- DRY CURED
PORK PRODUCTS

Nominating Party: The United States of America

FILE NAME  USA CUN13 POST HARVEST -- Dry, Cured Pork Products

Brief descriptive Title of Nomination:

Methyl Bromide Critical Use Nomination for Post Harvest Use on Dry Cured
Pork Products (Submitted in 2011 for 2013 Use Season)

STRUCTURE, COMMODITY or OBJECT TREATED:

This sector is for the production of cured meat products, such as
country hams.  These are produced primarily in the southern U.S.  This
sector has no known viable alternative currently available.

Quantity of methyl bromide requested in each year of nomination:

Table 1: Quantity of Methyl Bromide Requested in Each Year of Nomination

Year	Nomination Amount (kilograms)

2013	3,730

(Details on this page are requested under Decision Ex. I/4(7), for
posting on the Ozone Secretariat website under Decision Ex. I/4(8).)

In assessing nominations submitted in this format, TEAP and MBTOC will
also refer to the original nomination on which the Party’s first-year
exemption was approved, as well as any supplementary information
provided by the Party in relation to that original nomination.  As this
earlier information is retained by MBTOC, a Party need not re-submit
that earlier information.

NOMINATING PARTY CONTACT DETAILS:

Contact Person:	John Thompson

Title:	Foreign Affairs Officer

Address:	Office of Environmental Policy

	U.S. Department of State

	2201 C Street, N.W. Room 2658

	Washington, D.C. 20520

	U.S.A.

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

E-mail:	 HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

■  Yes	            ( No

Signature				Name					Date

Title:

CONTACT OR EXPERT(S) FOR FURTHER TECHNICAL DETAILS:

Contact/Expert Person:	Jack Housenger

Title:	Division Director

Address:	Biological and Economic Analysis Division

	Office of Pesticide Programs

	U.S. Environmental Protection Agency

	1200 Pennsylvania Avenue, N.W. Mailcode 7503P

	Washington, D.C. 20460

	U.S.A.

Telephone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

E-mail<EMAIL_ADDRESS>

LIST OF DOCUMENTS SENT TO THE OZONE SECRETARIAT IN OFFICIAL NOMINATION
PACKAGE:

1.  PAPER DOCUMENTS:

Title of paper documents and appendices	No. of pages	Date sent to Ozone
Secretariat

2.  ELECTRONIC COPIES OF ALL PAPER DOCUMENTS:

*Title of each electronic file (for naming convention see notes above)
No. of kilobytes 	Date sent to Ozone Secretariat

USA CUN13 Post Harvest Ham

* Identical to paper documents

METHYL BROMIDE CRITICAL USE RENOMINATION FOR POST-HARVEST -- DRY CURED
PORK PRODUCTS

1.  SUMMARY OF NEED FOR METHYL BROMIDE AS A CRITICAL USE

Currently there are no viable alternatives to methyl bromide for the
dried meat industry:  heat would alter the product, and phosphine may
not control mites, a major pest.  Sulfuryl fluoride received federal
registration and has been tested for efficacy against the mites and
other pests of cured meat products.  Although mortality of the
red-legged ham beetle occurred at levels below maximum rates of sulfuryl
fluoride, the same cannot be said for the ham mites (Phillips, et al.,
2008).  Control of the ham mites took three times the legal limits of
sulfuryl fluoride (Phillips, et al., 2008).  At the time of this
nomination there are no known registered alternatives for use on hams in
the U.S. that provide the same level of pest control as methyl bromide.

This industry is cooperating with university researchers to find
technically and economically feasible alternatives to methyl bromide.
In the meantime, this industry is using IPM techniques to manage their
pest populations.  All use sanitation to keep their curing facilities
clean.  Several companies have modified their buildings to make them
more gas-tight.  Some companies are eliminating grass, trees, and shrubs
from their buildings and replacing it with gravel, as suggested by
researchers in 2008.  Many use pheromone traps; however, these traps
only used for monitoring purposes at this time (Arthur and Phillips,
2003).

This industry currently has no viable chemical alternative available.
Although its IPM measures may have reduced the number of times
fumigation is needed in some facilities, it has not eliminated the need
for fumigation.  Therefore, methyl bromide remains critical to this
industry.

Table 2.  Nomination Amount

2.  SUMMARIZE WHY ALTERNATIVES ARE NOT FEASIBLE

This industry currently has no known viable chemical alternative
available.  Although its IPM measures may have reduced the number of
times fumigation is needed, it has not eliminated the need for
fumigation.  Therefore, methyl bromide remains critical to this
industry.

3.  RESEARCH RESULTS SHOWING EFFICACY OF ALTERNATIVES

Researchers are currently investigating the control of arthropod pests
that infest dry cured pork products during the aging process.  In the
spring of 2007, a proposal was submitted to the USDA CSREES Integrated
Research, Education, and Extension Competitive Grants Program- Methyl
Bromide Transitions by several meat scientists and an entomologist.
This proposal was funded from 2007 to 2010.  A no-cost extension was
granted for 2010-2011, and additional funding has been provided through
the Southern Regions Integrated Pest Management Center to continue
research efforts for 2010 and 2011.  In addition, a grant will be
submitted to the USDA in 2011 to seek funds to continue research with
respect to potential alternatives to methyl bromide for use in the dry
cured pork industry.  All of the research projects listed above and
below are being conducted in conjunction with the National Country Ham
Association, The American Association of Meat Processors, individual ham
producers, and fumigant companies.

There were several objectives to the research project that was funded by
the USDA MBT program from 2007-2010.  The first objective was to
determine the effectiveness of chemical controls (sulfuryl fluoride,
phosphine, and methyl bromide) against all life stages of both mold
mites (Tyrophagus putrescentiae) and red legged ham beetles (Necrobia
rufipes).  The second objective was to determine the effectiveness of
carbon dioxide and ozone against all life stages of both mold mites and
red legged ham beetles.  The third objective was to test the effects of
sulfuryl fluoride, phosphine and methyl bromide on the quality and
safety of the dry cured hams.  The fourth objective was to conduct an
economic analysis of the alternatives demonstrated to be technically
viable alternatives for methyl bromide in this industry.

The results of sulfuryl fluoride efficacy investigations on Tyrophagous
putrescentiae, ham mite, and Necrobia rufipes, red-legged ham beetle,
were presented at the 2008 MBAO Conference, in Orlando, FL.  The studies
included eggs and a mixture of adults and large nymphs of mites and the
eggs, large larvae, pupae and adults of beetles.  The experiments were
conducted for 48 hours at 23° C at various concentrations of sulfuryl
fluoride.  The investigators achieved 100% mortality of red-legged ham
beetle adults and pupae at about 4.0 g/m3, and 100% mortality of larvae
at 5.7 g/m3.  Eggs of red-legged ham beetles died at 24.0 g/m3 of
sulfuryl fluoride, well below the maximum label rate (Phillips et al.,
2008).  Mortality of ham mites required much higher concentrations of
sulfuryl fluoride.  A concentration of about 100.3 g/m3 was necessary to
obtain 100% mortality of adults and nymphs under the test conditions.
However, this concentration obtained only a 95% mortality of mite eggs.
This is about three times the legal label rate of sulfuryl fluoride
(Phillips et al., 2008) and thus indicates that sulfuryl fluoride is not
a viable alternative to methyl bromide for controlling ham mites.  In
addition, results also indicated that levels of residual fluoride and
sulfuryl fluoride in the hams were linearly related to fumigant
concentration and that use of high concentrations of sulfuryl fluoride
(72 g/m3 or greater) and multiple fumigations could potentially lead to
high concentrations of sulfuryl fluoride and fluoride in the ham (Sekhon
et al., 2010a).

The results of carbon dioxide, phosphine, methyl bromide and ozone
efficacy investigations on Tyrophagous putrescentiae, ham mite, and
Necrobia rufipes, red-legged ham beetle, were presented at the 2009 MBAO
Conference, in San Diego, CA (Sekhon et al., 2009a, b; Phillips, 2009,
Sehkon et al., 2010b, 2010c).  The studies included eggs and a mixture
of adults and nymphs of mites and eggs, large larvae, pupae and adults
of beetles.  The experiments were conducted for variable times at 23° C
at various concentrations of carbon dioxide, phosphine, methyl bromide
and ozone.  The investigators achieved mortality of all life stages of
mites with a concentration of 60 % carbon dioxide with 144 hr of
exposure (Sekhon et al., 2009a; Phillips, 2009; Sehkon et al., 2010b).
However, fumigation with carbon dioxide would likely not be applicable
since ham structures are not air-tight and 144 hr is too long of a time
to fumigate the hams.  In addition, a carbon dioxide concentration (> 80
%) with an exposure time of 144 hrs was necessary to cause 100 %
mortality for all life stages of red legged ham beetles (Sekhon, et al.
2009a; Phillips, 2009; Sehkon et al, 2010b).  In addition, there may be
higher numbers of ham mites that can hide in the crevices of the ham
that may be able to survive during CO2 fumigation.

Investigators achieved 100 % mortality of all life stages of red legged
ham beetles and ham mites with 48 hours exposure of 400 and 1000 ppm of
phosphine, respectively (Sekhon, et al. 2009b; Phillips, 2009; Sekhon et
al., 2010c).  In addition, residual phosphine concentrations in dry
cured hams that were fumigated for 48 hrs at 1000 ppm were below 0.01
ppm, the legal residual limit in stored food products (Sekhon, et al.
2009b; Sekhon et al., 2010c), and consumer panelists could not detect
differences between control and phosphine fumigated samples at 1000 ppm
(Sekhon et al. 2009b; Sekhon et al., 2010c).  Therefore, phosphine can
now be considered a potential alternative to methyl bromide for
controlling arthropod pests of southern dry cured hams.  Further testing
with a greater number of mites has indicated that a greater
concentration of phosphine (>1000 ppm) is likely necessary to kill
substantial mite infestations.  In addition, commercial applications of
phosphine are planned for 2010-2011 to determine the efficacy of using
phosphine at the plant level. The effectiveness of phosphine will be
evaluated through the use of both bioassays (with ham present) and on
hanging hams in a simulated dry cured ham aging room.

Other portions of this research include the economical analysis of using
phosphine in comparison to methyl bromide, if it is effective at
eradicating mites.  Commercial applicators and agricultural economists
are working with us on this portion of the research.  Additional items
that will be researched in the future (if funding is obtained) include
the effect of multiple fumigations on the sensory quality and residual
concentration of phosphine in ham, and the effectiveness of using
phosphine in dry cured ham facilities.  Many processors have indicated
that they would be willing to help evaluate the efficacy of phosphine
(at controlling ham mite infestations) in their plant as part of a
research project, which truly demonstrates the willingness of the
industry to do everything that they can to help determine if potential
alternatives to methyl bromide exist. In addition, we have commitments
from Universities and a commercial applicator to help implement
phosphine fumigation in dry cured ham facilities for this research to
take place.

Ozone concentrations of greater than 150 ppm for 48 hrs were able to
achieve 100 % mortality of ham beetles and mites at the bench top level
(Sekhon et al., 2009b; Phillips, 2009; Sekhon et al., 2010b).  Consumers
also could not determine sensory differences between control hams and
those that were fumigated with ozone at 175 ppm for 48 hrs (Sekhon et
al., 2010b)).  However, ozone is not able to penetrate surfaces well and
therefore may not work well in real world applications since ham mites
could potentially penetrate into crevices in the meat and ham beetles
bore through the meat tissue. Research that was conducted by one dry
cured ham processor indicated that the use of ozone in a commercial
setting was not effective at eradicating ham mite infestations, which
was likely due to the inability of the ozone to penetrate the surface of
the ham and the ability of mites to find places to hide where the ozone
did not reach.  However, ozone may play a role in integrated pest
management to help minimize infestations and enhance sanitation since it
would sanitize areas in the plant as well as equipment that could
potentially harbor bugs and pathogens.

Further research has recently been conducted on the effects of low
pressure and low oxygen concentration on the mortality of Tyrophagous
putrescentiae (mold mites).  Exposure of mites to low oxygen with
pressure (25 mmHg; approx. 3.0% O2) at 23°C for 144 hrs or greater was
effective at eradicating more than 95 % of each mite life stage (Hasan
et al., 2010).  However, testing with a larger number of mites and under
commercial conditions would need to be conducted to determine if this
technology could be considered a potential alternative to methyl
bromide.  Its limitations include length of application, ability of
mites to hide within meat crevices, and difficulty in implementing at
the plant level.

There is still no definitive alternative for methyl bromide for the dry
cured ham industry at this point in time.  Research is still ongoing
with phosphine, and controlled atmosphere, but more research and
commercial applications need to be conducted before any of these
treatments/fumigants can be considered alternatives to methyl bromide
for treatment of ham (mold) mites.

4.  REGISTRATION UPDATE

No new chemicals have been registered nor de-registered since the last
nomination.

5.  ECONOMIC INFEASIBILITY OF ALTERNATIVES

An economic analysis was not conducted because this sector has no
technically feasible alternatives at this time.

CITATIONS

Arthur, F. and T. W. Phillips.  2003.  Stored-product insect pest
management and control, In:  Food Plant Sanitation eds: Y. H. Hui, B. L.
Bruinsma, J. R. Gorham, W. Nip, P. S. Tong, and P. Ventresca.  Marcel
Dekker, Inc., New York, pp. 341-358.

Hasan, M.M., Phillips, T.W., Aikins, J.M., Schilling, M.W. 2010.
Controlled atmosphere treatments to control arthropod pests of American
dry cured hams. Annual International Research Conference on Methyl
Bromide Alternatives and Emission Reduction, Orlando, FL, November
1st-5th

Phillips, T.W. Hasan, M.M., Aikens, M.J., Schilling, M.W. 2008. Efficacy
of sulfuryl fluoride to control ham mites and red-legged ham beetles.
Annual International Research Conference on Methyl Bromide Alternatives
and Emission Reduction, Orlando, FL, November 11th-14th

Phillips, T.W. 2009. Personal Communication.

Sekhon, R.K., Schilling, M.W., Phillips, Hasan, M.M., Aikens, M.J,
Mikel, W.B. 2009. Chemical Composition of Dry Cured Hams Fumigated with
Carbon Dioxide. Annual International Research Conference on Methyl
Bromide Alternatives and Emission Reduction, San Diego, CA, November
10th-13th

Sekhon, R.K., Schilling, M.W., Phillips, Hasan, M.M., Aikens, M.J,
Mikel, W.B. 2009. Chemical composition of dry cured hams fumigated with
phosphine. Annual International Research Conference on Methyl Bromide
Alternatives and Emission Reduction, San Diego, CA, November 10th-13th

Sekhon, R.K., Schilling, M.W., Phillips, T.W., Hasan, M.M., Aikens, M.J.
Mikel, W.B. 2010a. Sulfuryl fluoride fumigation effects on the safety,
volatile composition, and sensory quality of dry cured ham. Meat
Science. 84(3):505-511.

Sekhon, R.K., Schilling, M.W., Phillips, T.W., Hasan, M.M., Aikens,
M.J., Nannapaneni, R., Mikel, W.B. 2010. Effects of carbon dioxide and
ozone treatments on the volatile composition and sensory quality of dry
cured ham. J. Food Science. 75(5):452-458.

Sekhon, R.K., Schilling, M.W., Phillips, T.W., Hasan, M.M., Aikens,
M.J., Corzo, A. Mikel, W.B. 2010. Effects of phosphine and methyl
bromide fumigation on the volatile flavor profile and sensory quality of
dry cured ham. Meat Science. 86(2):411-417.

 PAGE   50

USA CUN13 POST HARVEST -- Dry, Cured Pork Products 		Page   PAGE  7


Meeting With U. S. EPA April 29, 2005 Southern Pressure Treaters Association and Creosote Council III Martin Rollins, P. E.

H. M. Rollins Company, Inc.

Gulfport, Mississippi, Purpose of Meeting ° Discuss PAC and Creosote Releases from Creosote Wood Preserving Industry ° Present Data on Industry Storm Water Analyses ° Discuss Development of Factors to Estimate PAC Releases Historic Industry Data ° PAC and Creosote Releases Based on Surrogate Analyses ° Can't Analyze for " Creosote"

° Facilities Don't Analyze Storm Water for PACs ° Surrogate Analyte Normally Oil and Grease ° PACs Considered 9.5217% of O& G ° O& G Considered 100% Creosote ° Oil and Grease Can Include Non Creosote Compounds ° Industry Undertook Study to Measure Actual PAC Releases in Storm Water Industry Study ° Sample Storm Water Throughout Rainfall Event ° Analyze for PACs and Potential Surrogates ° Use Methods with Low PAC Detection Limits ° Develop Basis for Comparison to Earlier Data ° Ten Facilities Provided Data ° Most Large Facilities ° Most Facilities with High Reported PAC Releases Results ° 74 Storm Water Samples Taken ° 37 Samples Had Positive Result for One or More PACs ° Fluoranthene Only Compound Found in All 37 Samples ° Fluoranthene 78% of PAC Mass ° 37 Samples ND for PACs ° Oil and Grease and TOC Possible Suitable Surrogates Results  Continued ° No Clear Declining Trend with Rainfall Duration ° Highest Total PAC Concentration 156.6 ppb ° O& G Results  High 19ppm 53 NDs ° TOC Ranged from 3.6 to 166 ppm ° Ratio of PACs to O& G and TOC Based on Positive PACs, < 1.23% and 0.13%

Respectively Results  Continued ° Ratio of PACs to O& G and TOC Based on ND for PACs, < 0.21% and< 0.47%

Respectively ° Average for Two Indicates PACs Are < 0.72%

of O& G Result and < 0.30% of TOC Result Summary and Conclusions ° Historic Reported Releases of PACs Are Grossly Overestimated ° Overstated By at Least One Order of Magnitude ° Based on These Actual Analyses for PACs,

Historic Creosote Reported Releases Are Also Overestimated Future Actions ° Guidance Will Be Provided to Industry to Estimate PAC Releases as 0.72% of Annual Average O& G Result or 0.3% of Annual Average TOC Result ° If All Surrogate Analytical Results are ND at Appropriate Method Detection Limits for a Reporting Year Then Facility Will Report Zero for Estimated PAC Releases ° Industry May Amend Prior Year TRI Reports Discussion and Identification of Remaining Issues Thank You for the Opportunity to Provide This Input!