1 MEMORANDUM DATE: June 8, 2005 SUBJECT: Availability of Ultra Low Sulfur Diesel Fuel FROM: Melanie Taylor, Alpha Gamma Technologies, Inc.

TO: Sims Roy, EPA OAQPS ESD Combustion Group Introduction The proposed new source performance standards ( NSPS) for stationary compression ignition ( CI) internal combustion engines ( ICE) require owners and operators of stationary CI ICE that use diesel fuel to use diesel fuel with a sulfur content of 500 parts per million ( ppm) or less ( known as low sulfur diesel or LSD) beginning October 1, 2007, and 15 ppm or less ( known as ultra low sulfur diesel or ULSD) beginning October 1, 2010. Larry Sorrels of EPA's Air Quality Strategies and Standards Division, Integrated Policy and Strategies Group performed an analysis to determine whether a sufficient quantity of LSD and ULSD will be available when the fuel requirements take effect. Larry used the EPA's summary of pre compliance reports submitted by refiners presented in the " Summary and Analysis of the Highway Diesel Fuel 2004 Pre compliance Reports" ( EPA420 R 04 014, September 2004). A summary of the results is presented below.

Summary Results  ULSD Availability in 2007 and 2011 Based on 2004 Refinery Pre Compliance Reports ( as of 9/ 21/ 04) for CI NSPS Proposal  analysis performed by Larry Sorrels 2007 Results C The gallons of fuel, all of which is assumed to be LSD, needed in 2007 for new stationary CI engines ( including both prime and emergency engines) is expected to be 196 million gallons each year, or 4.7 million barrels ( bbls) per year. Both prime and emergency stationary CI engines are required to use LSD.

C Expected production of LSD in 2007 as shown in the report on 2004 refinery precompliance reports is about 2,875,000 bbls/ day or about 120.8 million gallons/ day. The 2007 LSD production figure represents the combined total of both LSD and ULSD. Note that the 2004 OTAQ report estimates that 95 percent of highway diesel fuel is expected to be ULSD nationally by June 1, 2006. 2 Translated to annual terms, the number of barrels produced will then be about 1.05 billion bbls or about 44.07 billion gallons.

C The increased demand for ULSD in 2007 based on the need for new stationary CI engines is equal to 4.7/ 1050 = 0.45 percent. It should be noted that the Energy Information Administration ( EIA) has estimated a demand for highway diesel fuel of 2,788 bbl/ day in 2007.

Conclusion for 2007 C Given this small percentage increase in demand, it is likely that there will be sufficient ULSD available for new stationary diesel engines affected by this NSPS in 2007. However, given that overall highway diesel fuel production ( including 500 ppm sulfur) should exceed diesel demand by only 3 percent according to the estimates listed above, some caution in making this conclusion is appropriate.

2011 Results C The gallons of fuel, all of which is assumed to be ULSD, needed in 2011 for new stationary CI engines is expected to be 1.04 billion gallons each year, or 25 million barrels per year.

C For 2011, expected production of ULSD is 3,022,000 bbls/ day. We take 2010 estimates as a proxy for 2011 since 2010 is the last year for which there is data in the 2004 OTAQ report. Translated to annual terms, the number of barrels produced will then be about 1.10 billion bbls or about 46.33 billion gallons.

C The increased demand for ULSD in 2011 based on the need for new stationary CI engines is equal to 25/ 1,103 = 2.3 percent. It should be noted that the EIA has estimated a demand for highway diesel fuel ( including 500 ppm sulfur content) of 3,017 bbl/ day in 2011.

Conclusion for 2011 C Given this relatively small percentage increase in demand ( just over 1 percent), it is likely that there will be sufficient ULSD available for new stationary diesel engines affected by this NSPS in 2011. However, given that overall highway diesel fuel production ( including 500 ppm sulfur) should exceed diesel demand by only 2.4 percent according to the estimates listed above, caution in making this conclusion is appropriate.

Notes about Results: Reference for estimates of U. S. domestic production of diesel fuels is " Summary and Analysis of the Highway Diesel Fuel 2004 Pre compliance Reports," September 2004. This is an OTAQ report. Results are based on precompliance reports filed by refiners in 2004 for expected annual production from 2006 to 3 2010. These reports are required under the heavy duty diesel fuel rule. Annual reports are required for 2005 as well.

The 2004 reports show a slightly smaller amount of highway diesel fuel expected to be available in 2007 and 2011 compared to the 2003 pre compliance reports.

The reference for the amount of ULSD needed for consumption by new stationary CI engines is a spreadsheet prepared by Alpha Gamma for Sims Roy that I received from Sims on June 3, 2005. This spreadsheet (" calculation of consumption of diesel fuel 2007 2012 6 3 05. xls") contains information based on data from Power Systems Research and assumes that only about 20 percent of the new CI engines are prime engines that will be affected by this NSPS. All other new engines are assumed to be emergency engines. The spreadsheet is included following this analysis.

Caveats: These reports only account for domestic production; import data is not included in the totals above. Hence the production estimates above may underestimate the available ULSD in the future years. However, the size of this underestimate is expected to be small ( less than 2 percent of total U. S. domestic production). Thus, the conclusions drawn above are relatively robust even if imported diesel fuels are accounted for. Also, the refinery pre compliance reports only cover production estimates for ULSD and 500 ppm sulfur content fuel, and do not cover 5000 ppm sulfur content fuel production. Number of gallons of diesel fuel needed for stationary CI engines in 2007  2012 6/ 8/ 05 Assumptions: 0.002544 MMBtu/ hp hr ( conversion factor) 38% engine efficiency 1000 avg hours of operation per year for prime engines 37 avg hours of operation per year for emergency engines 0.143 MMBtu/ gal ( heating value of fuel oil)

Number of new compression ignition engines per year ( prime and emergency): HP Range Avg HP 2007 2008 2009 2010 2011 2012 50 75 63 7,043 7,280 7,517 7,754 7,990 8,227 75 100 88 11,389 11,914 12,440 12,965 13,491 14,016 100 175 135 16,846 17,400 17,954 18,507 19,061 19,615 175 300 238 16,506 17,187 17,868 18,549 19,230 19,911 300 600 450 6,345 6,510 6,674 6,839 7,004 7,168 600 750 675 894 910 927 943 960 976 750 1200 975 2,078 2,140 2,202 2,264 2,326 2,388 1200 3000 2100 2,038 2,103 2,167 2,231 2,295 2,359 > 3000 5000 160 160 160 160 160 160 Total 63,298 65,603 67,907 70,212 72,516 74,820 Number of new compression ignition engines per year ( prime only, assume 20% are prime): HP Range Avg HP 2007 2008 2009 2010 2011 2012 50 75 63 1,409 1,456 1,503 1,551 1,598 1,645 75 100 88 2,278 2,383 2,488 2,593 2,698 2,803 100 175 135 3,369 3,480 3,591 3,701 3,812 3,923 175 300 238 3,301 3,437 3,574 3,710 3,846 3,982 300 600 450 1,269 1,302 1,335 1,368 1,401 1,434 600 750 675 179 182 185 189 192 195 750 1200 975 416 428 440 453 465 478 1200 3000 2100 408 421 433 446 459 472 > 3000 5000 32 32 32 32 32 32 Total 12,660 13,121 13,581 14,042 14,503 14,964 Gallons of diesel fuel needed each year for prime engines: HP Range Avg HP 2007 2008 2009 2010 2011 2012 50 75 63 4,154,590 8,448,877 12,882,860 17,456,541 22,169,918 27,022,992 75 100 88 9,383,813 19,200,629 29,450,448 40,133,271 51,249,096 62,797,925 100 175 135 21,294,241 43,288,356 65,982,345 89,376,209 113,469,947 138,263,559 175 300 238 36,782,123 75,081,871 114,899,243 156,234,239 199,086,859 243,457,105 300 600 450 26,735,609 54,164,798 82,287,567 111,103,914 140,613,842 170,817,348 600 750 675 5,647,104 11,398,492 17,254,163 23,214,117 29,278,355 35,446,876 750 1200 975 18,967,711 38,502,344 58,603,900 79,272,379 100,507,780 122,310,103 1200 3000 2100 40,080,781 81,423,918 124,029,410 167,897,258 213,027,463 259,420,023 > 3000 5000 7,490,615 14,981,229 22,471,844 29,962,459 37,453,073 44,943,688 Total 170,536,587 346,490,513 527,861,780 714,650,386 906,856,333 1,104,479,619 Gallons of diesel fuel needed each year for emergency engines: HP Range Avg HP 2007 2008 2009 2010 2011 2012 50 75 63 614,879 1,250,434 1,906,663 2,583,568 3,281,148 3,999,403 75 100 88 1,388,804 2,841,693 4,358,666 5,939,724 7,584,866 9,294,093 100 175 135 3,151,548 6,406,677 9,765,387 13,227,679 16,793,552 20,463,007 175 300 238 5,443,754 11,112,117 17,005,088 23,122,667 29,464,855 36,031,651 300 600 450 3,956,870 8,016,390 12,178,560 16,443,379 20,810,849 25,280,968 600 750 675 835,771 1,686,977 2,553,616 3,435,689 4,333,197 5,246,138 750 1200 975 2,807,221 5,698,347 8,673,377 11,732,312 14,875,151 18,101,895 1200 3000 2100 5,931,956 12,050,740 18,356,353 24,848,794 31,528,064 38,394,163 > 3000 5000 1,108,611 2,217,222 3,325,833 4,434,444 5,543,055 6,651,666 Total 25,239,415 51,280,596 78,123,543 105,768,257 134,214,737 163,462,984 Total all engines ( gallons) 195,776,002 397,771,109 605,985,323 820,418,644 1,041,071,070 1,267,942,602 ( barrels) 4,661,333 9,470,741 14,428,222 19,533,777 24,787,406 30,189,110


[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Rules and Regulations]
[Pages 21688-21694]
[FR Doc No: 2017-09364]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during January and February 2017. FDA is also
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to reflect several
changes of sponsorship of applications and to make correcting
amendments to improve the accuracy of the regulations.

DATES: This rule is effective May 10, 2017, except for amendatory
instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21
CFR 522.1002, which are effective May 22, 2017.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and an ANADA during January and February 2017, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday. Persons with access to the Internet may
obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                              Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Approval date           File No.          Sponsor            Product name             Species         Effect of the action    Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
January 13, 2017............      141-468  Phibro Animal Health  STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Corp., GlenPointe     (virginiamycin)                              for prevention of
                                            Centre East, 3d       plus BIO-COX                                 necrotic enteritis
                                            Floor, 300 Frank W.   (salinomycin)                                and coccidiosis in
                                            Burr Blvd., Suite     combination drug                             broiler chickens.
                                            21, Teaneck, NJ       Type C medicated
                                            07666.                feeds.
January 13, 2017............      141-469  Phibro Animal Health  STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Corp., GlenPointe     (virginiamycin)                              for prevention of
                                            Centre East, 3d       plus AMPROL                                  necrotic enteritis
                                            Floor, 300 Frank W.   (amprolium)                                  and coccidiosis in
                                            Burr Blvd., Suite     combination drug                             broiler chickens.
                                            21, Teaneck, NJ       Type C medicated
                                            07666.                feeds.
January 13, 2017............      141-470  Phibro Animal Health  STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Corp., GlenPointe     (virginiamycin)                              for prevention of
                                            Centre East, 3d       plus AVATEC                                  necrotic enteritis
                                            Floor, 300 Frank W.   (lasalocid)                                  and coccidiosis in
                                            Burr Blvd., Suite     combination drug                             broiler chickens.
                                            21, Teaneck, NJ       Type C medicated
                                            07666.                feeds.
January 13, 2017............      141-472  Huvepharma AD, 5th    STAFAC                Chickens.............  Original approval     FOI Summary.
                                            Floor, 3A Nikolay     (virginiamycin)                              for prevention of
                                            Haytov Str.,1113      plus CLINACOX                                necrotic enteritis
                                            Sophia, Bulgaria.     (diclazuril)                                 and coccidiosis in
                                                                  combination drug                             broiler chickens.
                                                                  Type C medicated
                                                                  feeds.
February 13, 2017...........      141-445  Intervet, Inc., 2     REVALOR-XR            Cattle...............  Original approval     FOI Summary; EA/
                                            Giralda               (trenbolone acetate                          for increased rate    FONSI.\1\
                                            Farms,Madison, NJ     and estradiol)                               of weight gain and
                                            07940.                Extended-Release                             improved feed
                                                                  Implant.                                     efficiency during
                                                                                70 to 200 days
                                                                                after implantation
                                                                                in beef steers and
                                                                                heifers fed in
                                                                                confinement for
                                                                                slaughter.
February 17, 2017...........      200-609  Anzac Animal Health,  DIROBAN (melarsomine  Dogs.................  Original approval as  FOI Summary.
                                            LLC, 218 Millwell     dihydrochloride)                             a generic copy of
                                            Dr., Suite B,         Powder for                                   NADA 141-042.
                                            Maryland Heights,     Injection.
                                            MO 63043.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

    Following the approval of ANADA 200-609, Anzac Animal Health, LLC
will now be included in the lists of sponsors of approved applications
in Sec.  510.600(c) (21 CFR 510.600(c)).

II. Changes of Sponsorship

    Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St.
Joseph, MO 64506-2002 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following
applications to Bayer HealthCare LLC, Animal Health Division, P.O. Box
390, Shawnee Mission, KS 66201:

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-099.............................  CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle.          524.1450
141-220.............................  CYDECTIN (moxidectin) Injectable Solution for Beef and            522.1450
                                       Nonlactating Dairy Cattle.
141-247.............................  CYDECTIN (moxidectin) Oral Drench for Sheep.............          520.1454
----------------------------------------------------------------------------------------------------------------

    Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 33500
Libourne, France has informed FDA that it has transferred ownership of,
and all rights and interest in, the following applications to Cross
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-420.............................  TILDREN (tiludronate disodium) Powder for Infusion......          522.2473
200-481.............................  ALTRESYN (altrenogest) Solution 0.22%...................            520.48
----------------------------------------------------------------------------------------------------------------

    Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24,
Ireland has informed FDA that it has transferred ownership of, and all
rights and interest in, the following application to Ceva Sante
Animale, 10 Avenue de la Ballasti[egrave]re, 33500 Libourne, France:

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
200-587.............................  FERROFORTE (gleptoferron) Solution, 200 mg/mL...........          522.1055
----------------------------------------------------------------------------------------------------------------

    Nexcyon Pharmaceuticals, Inc., P.O. Box 259158, Madison, WI 53725
has informed FDA that it has transferred ownership of, and all rights
and interest in, the following applications to Pegasus Laboratories,
Inc., 8809 Ely Rd., Pensacola, FL 32514:

----------------------------------------------------------------------------------------------------------------
              File No.                                      Product name                         21 CFR section
----------------------------------------------------------------------------------------------------------------
141-272.............................  RECONCILE (fluoxetine hydrochloride) Chewable Tablets...           520.980
----------------------------------------------------------------------------------------------------------------

    Accordingly, the animal drug regulations are being amended to
reflect these changes of sponsorship. Following this withdrawal of
approval, Nexcyon Pharmaceuticals, Inc. is no longer the sponsor of an
approved application. Accordingly, it will be removed from the list of
sponsors of approved applications in Sec.  510.600(c).

III. Withdrawals of Approval

    In addition, during January and February 2017, the following
sponsor requested that FDA withdraw approval of the NADAs listed in the
following table because the products are no longer manufactured or
marketed:

------------------------------------------------------------------------
      File No.            Sponsor        Product name    21 CFR section
------------------------------------------------------------------------
009-505.............  Sioux            F.S.H.-P                 522.1002
                       Biochemical,     (follicle
                       Inc., 204        stimulating
                       Third St. NW.,   hormone)
                       Sioux Center,    Powder for
                       IA 51250.        Injection.
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 009-505, and all supplements and amendments
thereto, is withdrawn, effective May 22, 2017. Following this
withdrawal of approval, Sioux Biochemical, Inc., is no longer the
sponsor of an approved application. As provided in the regulatory text
of this document, the animal drug regulations are amended to reflect
this voluntary withdrawal of approval.

IV. Technical Amendments

    We are also making several technical amendments in part 558, which
was amended on December 27, 2016 (81 FR 94991), and February 24, 2017
(82 FR 11510), as part of the FDA Center for Veterinary Medicine's
(CVM's) Judicious Use Initiative. These actions are being taken to
improve the accuracy of the regulations.
    This final rule is issued under Section 512(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.360b(i)), which requires Federal
Register publication of ``notice[s]. . . effective as a regulation,''
of the conditions of use of approved new animal drugs. This rule sets
forth technical amendments to the regulations to codify recent actions
on approved new animal drug applications and corrections to improve the
accuracy of the regulations, and as such does not impose any burden on
regulated entities.
    Although denominated a rule pursuant to the Federal Food, Drug, and
Cosmetic Act, this document does not meet the definition of ``rule'' in
5 U.S.C. 804(3)(A) because it is a ``rule of particular
applicability.'' Therefore, it is not subject to the congressional
review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule
subject to Executive Order 12866 which defines a rule as ``an agency
statement of general applicability and future effect, which the agency
intends to have the force and effect of law, that is designed to
implement, interpret, or prescribe law or policy or to describe the
procedure or practice requirements of an agency.'' As such, this
document is also not subject to Executive Order 12866.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Effective May 10, 2017, in Sec.  510.600, in the table in paragraph
(c)(1), alphabetically add an entry for ``Anzac Animal Health, LLC'',
and remove the entry for ``Nexcyon Pharmaceuticals, Inc.''; and in the
table in paragraph (c)(2), remove the entry for ``050929'', and
numerically add an entry for ``086073.'' The additions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B,              086073
 Maryland Heights, MO 63043.............................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
086073.......................  Anzac Animal Health, LLC, 218 Millwell
                                Dr., Suite B, Maryland Heights, MO
                                63043.

                              * * * * * * *
------------------------------------------------------------------------

Sec.  510.600  [Amended]

0
3. Effective May 22, 2017, in Sec.  510.600, in the table in paragraph
(c)(1), remove the entry for ``Sioux Biochemical, Inc.'' .''; and in
the table in paragraph (c)(2), remove the entry for ``063112''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b.

Sec.  520.48   [Amended]

0
5. In Sec.  520.48, in paragraph (b), remove ``013744'' and in its
place add ``061623''.

Sec.  520.980   [Amended]

0
6. In Sec.  520.980, in paragraph (b), remove ``050929'' and in its
place add ``055246''.

Sec.  520.1454   [Amended]

0
7. In Sec.  520.1454, in paragraph (b), remove ``000010'' and in its
place add ``000859''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for part 522 continues to read as follows:

    Authority:  21 U.S.C. 360b.

Sec.  522.90b   [Amended]

0
9. In Sec.  522.90b, in paragraph (a), remove ``50, 100, or 250'' and
in its place add ``200, 250, or 400''.

Sec.  522.1002   [Amended]

0
10. Effective May 22, 2017, in Sec.  522.1002, remove paragraph (b);
and redesignate paragraph (c) as paragraph (b).

Sec.  522.1055   [Amended]

0
11. In Sec.  522.1055, in paragraph (b), remove ``Nos. 013744 and
061623'' and in its place add ``No. 013744''.

Sec.  522.1362   [Amended]

0
12. In Sec.  522.1362, in paragraph (b), remove ``No. 050604'' and in
its place add ``Nos. 050604 and 086073''.

Sec.  522.1450   [Amended]

0
13. In Sec.  522.1450, in paragraph (b), remove ``000010'' and in its
place add ``000859''.

0
14. In Sec.  522.1662a, revise paragraph (e)(1); and in paragraph
(e)(3)(i)(c), revise the fifth sentence to read as follows:

Sec.  522.1662a   Oxytetracycline hydrochloride injection.

* * * * *
    (e) * * *
    (1) Specifications. Each milliliter of solution contains 100
milligrams of oxytetracycline hydrochloride.
* * * * *
    (3) * * *
    (i) * * *
    (c) * * * Exceeding the highest recommended dose of 5 milligrams
per pound of body weight per day, administering more than the
recommended number of treatments, and/or exceeding 10 milliliters
intramuscularly or subcutaneously per injection site in adult beef and
dairy cattle may result in antibiotic residues beyond the withdrawal
period. * * *
* * * * *

Sec.  522.2473   [Amended]

0
15. In Sec.  522.2473, in paragraph (b), remove ``013744'' and in its
place add ``061623''.

0
16. In Sec.  522.2477, revise paragraph (b)(2) and add paragraph (d)(4)
to read as follows:

Sec.  522.2477   Trenbolone acetate and estradiol.

* * * * *
    (b) * * *
    (2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A),
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A),
(d)(3)(ii), (d)(3)(iii), and (d)(4) of this section.
* * * * *
    (d) * * *
    (4) Beef steers and heifers fed in confinement for slaughter--(i)
Amount. Each extended- and delayed-release implant contains 200 mg
trenbolone acetate and 20 mg estradiol (one implant consisting of 10
pellets, each pellet containing 20 mg trenbolone acetate and 2 mg
estradiol) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and
improved feed efficiency during 70 to 200 days after implantation.
    (iii) Limitations. Implant subcutaneously in the ear only. Do not
use in lactating dairy cows or in animals intended for subsequent
breeding. Use in these cattle may cause drug residues in milk and/or in
calves born to these cows. Do not use in calves to be processed for
veal. A withdrawal period has not been established for this product in
pre-ruminating calves. Effectiveness and animal safety in veal calves
have not been established. Not approved for repeated implantation
(reimplantation) with this or any other cattle ear implant during the
production phase(s) identified on labeling (beef steers and heifers fed
in confinement for slaughter) unless otherwise indicated on labeling
because safety and effectiveness have not been evaluated.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
17. The authority citation for part 524 continues to read as follows:

    Authority:  21 U.S.C. 360b.

Sec.  524.1450   [Amended]

0
18. In Sec.  524.1450, in paragraph (b)(1), remove ``000010'' and in
its place add ``000859''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
19. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Sec.  558.4   [Amended]

0
20. In Sec.  558.4, in paragraph (d), in the Category I table, remove
the row entry for ``Penicillin''; and in the Category II table, remove
the row entry for ``Sulfamethazine'' the first time it appears only
along with the subsequent entries for ``Chlortetracycline'' and
``Penicillin''.

Sec.  558.76   [Amended]

0
21. In Sec.  558.76, remove and reserve paragraph (e)(1)(vii).

0
22. In Sec.  558.115, revise paragraph (d)(4) to read as follows:

Sec.  558.115   Carbadox.

* * * * *
    (d) * * *
    (4) Carbadox may also be used in combination with oxytetracycline
as in Sec.  558.450.

0
23. Amend Sec.  558.128 as follows:
0
a. In paragraph (b)(1), remove ``50, 65, or 100'' and in its place add
``50, 90, or 100'';
0
b. In paragraphs (e)(1)(i) and (v), in the ``Limitations'' column,
remove ``Do not feed to chickens producing eggs for human
consumption.'' and in its place add ``For No. 066104: Do not feed to
chickens producing eggs for human consumption.'';
0
c. In paragraph (e)(3)(v), in the ``Sponsor'' column, add ``054771''
before ``069254'';
0
d. In paragraph (e)(4)(iii), in the ``Indications for use'' column,
remove ``anaplsmosis'' and in its place add ``anaplasmosis''; and
0
e. Redesignate paragraphs (e)(4)(xxiv) and (xxv) as paragraphs
(e)(4)(xxv) and (xxvi), respectively, and add new paragraph
(e)(4)(xxiv).
    The addition reads as follows:

Sec.  558.128   Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
    Chlortetracycline amount          grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(xxiv) 25 to 2,800 to provide    Lasalocid, 30 to    Beef cattle         Hand feed continuously           054771
 350 mg/head/day.                 181.8.              weighing under      at a rate of 350 mg
                                                      700 pounds: For     chlortetracycline and
                                                      control of active   1 mg lasalocid per 2.2
                                                      infection of        lb. body weight daily
                                                      anaplasmosis        to cattle with a
                                                      caused by           maximum of 360 mg of
                                                      Anaplasma           lasalocid per head per
                                                      marginale           day. Do not allow
                                                      susceptible to      horses or other
                                                      chlortetracycline   equines access to
                                                      ; and for the       feeds containing
                                                      control of          lasalocid. No
                                                      coccidiosis         withdrawal period is
                                                      caused by Eimeria   required. A withdrawal
                                                      bovis and E.        period has not been
                                                      zuernii.            established for this
                                                                          product in pre-
                                                                          ruminating calves. Do
                                                                          not use in calves to
                                                                          be processed for veal.
                                                                          See Sec.   558.311(d)
                                                                          of this chapter.
                                                                          Chlortetracycline and
                                                                          lasalocid as provided
                                                                          by No. 054771 in Sec.
                                                                           510.600(c) of this
                                                                          chapter.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.140   [Amended]

0
24. In Sec.  558.140, in paragraph (b)(1), remove ``(d)(1)'' and in its
place add ``(e)(1)''; and in paragraph (b)(2), remove ``(d)(2)'' and in
its place add ``(e)(2)''.

0
25. In Sec.  558.325, redesignate paragraphs (e)(2)(vii) to (xvi) as

paragraphs (e)(2)(viii) to (xvii), respectively, and add new paragraph
(e)(2)(vii) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
      Lincomycin grams/ton            grams/ton              use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(vii) 40.......................  Pyrantel, 800.....  For the treatment   Feed as a single                 066104
                                                      and/or control of   therapeutic treatment
                                                      swine dysentery;    at a rate of 1 lb of
                                                      for removal and     feed per 40 lb of body
                                                      control of large    weight for animals up
                                                      roundworm           to 200 lb and 5 lb of
                                                      (Ascaris suum)      feed per head for
                                                      and nodular worm    animals over 200 lb.
                                                      (Oesophagostomum    Not to be fed to swine
                                                      spp.) infections.   that weigh more than
                                                                          250 pounds. Withdraw
                                                                          24 hours prior to
                                                                          slaughter. See
                                                                          paragraph (d) of this
                                                                          section. Lincomycin as
                                                                          provided by No.
                                                                          054771; pyrantel as
                                                                          provided by No. 066104
                                                                          in Sec.   510.600(c)
                                                                          of this chapter.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
26. In Sec.  558.366, revise paragraph (e) to read as follows:

Sec.  558.366   Nicarbazin.

* * * * *
    (e) Nicarbazin may also be used in combination with:
    (1)-(3) [Reserved]
    (4) Lincomycin as in Sec.  558.325.

Sec.  558.485   [Amended]

0
27. In Sec.  558.485, remove paragraph (e)(1)(iv).

0
28. In Sec.  558.550, add paragraph (d)(5) to read as follows:

Sec.  558.550   Salinomycin.

* * * * *
    (d) * * *
    (5) Salinomycin may also be used in combination with:
    (i)-(ii) [Reserved]
    (iii) Chlortetracycline as in Sec.  558.128.
    (iv) Lincomycin as in Sec.  558.325.

0
29. Amend Sec.  558.625 as follows:
0
a. Revise paragraph (d)(2);
0
b. Add paragraphs (d)(4) and (5);
0
c. In paragraphs (e)(2)(iv), (v), (viii), (x), (xii), and (xiii), in
the ``Limitations'' column, add a new sentence ``See Sec.  558.355(d)
in this chapter.'' between the fourth and fifth sentences;
0
d. In paragraph (e)(2)(vi), in the ``Limitations'' column, add a new
sentence ``See Sec.  558.355(d) in this chapter.'' between the seventh
and eighth sentences; and
0
e. In paragraphs (e)(2)(vii), (ix), (xi), (xiv), and (xv), in the
``Limitations'' column, add a new sentence ``See Sec.  558.355(d) in
this chapter.'' between the fifth and sixth sentences.
    The revisions and additions read as follows:

Sec.  558.625   Tylosin.

* * * * *
    (d) * * *
    (2) The expiration date of VFDs for tylosin medicated feeds must
not exceed 6 months from the date of issuance. VFDs for tylosin shall
not be refilled.
* * * * *
    (4) Tylosin liquid Type B medicated feeds must bear an expiration
date of 31 days after the date of manufacture.
    (5) Do not use tylosin liquid Type B medicated feeds in any liquid
feed containing sodium metabisulfite or in any finished feed
(supplement, concentrate, or complete feed) containing in excess of 2
percent bentonite.
* * * * *

0
30. In Sec.  558.635, revise paragraph (e)(1) to read as follows:

Sec.  558.635   Virginiamycin.

* * * * *
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
    Virginiamycin grams/ton           grams/ton              use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 20.........................  ..................  Broiler chickens:   Not for use in layers..          066104
                                                      For prevention of
                                                      necrotic
                                                      enteritis caused
                                                      by Clostridium
                                                      perfringens
                                                      susceptible to
                                                      virginiamycin.
(ii) 20........................  Amprolium 72.6 to   Broiler chickens:   For field conditions             066104
                                  113.5.              For prevention of   where only E. tenella
                                                      necrotic            is the major problem,
                                                      enteritis caused    feed continuously as
                                                      by Clostridium      the sole ration. Use
                                                      perfringens         as the sole source of
                                                      susceptible to      amprolium. Do not use
                                                      virginiamycin;      in feeds containing
                                                      and for the         bentonite. Not for use
                                                      prevention of       in laying chickens.
                                                      coccidiosis         Amprolium as provided
                                                      caused by Eimeria   by No. 016592 in Sec.
                                                      tenella.             510.600(c) of this
                                                                          chapter.
(iii) 20.......................  Amprolium 113.5 to  Broiler chickens:   For most field                   066104
                                  227.                For prevention of   conditions as they
                                                      necrotic            exist under modern
                                                      enteritis caused    management practices,
                                                      by Clostridium      feed 113.5 g/ton
                                                      perfringens         amprolium
                                                      susceptible to      continuously. Where
                                                      virginiamycin;      severe coccidiosis
                                                      and for the         conditions exist, feed
                                                      prevention of       227 g/ton. Use as the
                                                      coccidiosis where   sole source of
                                                      immunity to         amprolium. Do not use
                                                      coccidiosis is      in feeds containing
                                                      not desired.        bentonite. Not for use
                                                                          in laying chickens.
                                                                          Amprolium as provided
                                                                          by No. 016592 in Sec.
                                                                           510.600(c) of this
                                                                          chapter.

(iv) 20........................  Diclazuril 0.91...  Broiler chickens:   Feed continuously as             016592
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not use in hens
                                                      enteritis caused    producing eggs for
                                                      by Clostridium      human food. Diclazuril
                                                      perfringens         as provided by No.
                                                      susceptible to      016592 in Sec.
                                                      virginiamycin;      510.600(c) of this
                                                      and for the         chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      tenella, E.
                                                      necatrix, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      mitis (mivati),
                                                      and E. maxima.
                                                      Because
                                                      diclazuril is
                                                      effective against
                                                      E. maxima late in
                                                      its life cycle,
                                                      subclinical
                                                      intestinal
                                                      lesions may be
                                                      present for a
                                                      short time after
                                                      infection.
                                                      Diclazuril was
                                                      shown in studies
                                                      to reduce lesions
                                                      scores and
                                                      improve
                                                      performance and
                                                      health of birds
                                                      challenged with
                                                      E. maxima.
(v) 20.........................  Lasalocid 68 to     Broiler chickens:   Feed continuously as             066104
                                  113.                For prevention of   the sole ration. Do
                                                      necrotic            not feed to laying
                                                      enteritis caused    chickens. For broiler
                                                      by Clostridium      or fryer chickens
                                                      perfringens         only. Lasalocid as
                                                      susceptible to      provided by No. 054771
                                                      virginiamycin;      in Sec.   510.600(c)
                                                      and for the         of this chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      tenella, E.
                                                      necatrix, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      mivati, and E.
                                                      maxima.
(vi) 20........................  Monensin 90 to 110  Broiler chickens:   Feed continuously as             066104
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not feed to laying
                                                      enteritis caused    chickens. See Sec.
                                                      by Clostridium      558.355(d) in this
                                                      perfringens         chapter. Monensin as
                                                      susceptible to      provided by No. 058198
                                                      virginiamycin;      in Sec.   510.600(c)
                                                      and as an aid in    of this chapter.
                                                      the prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      necatrix, E.
                                                      tenella, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      maxima, and E.
                                                      mivati.
(vii) 20.......................  Salinomycin 40 to   Broiler chickens:   Feed continuously as     ..............
                                  60.                 For prevention of   the sole ration. Do
                                                      necrotic            not feed to chickens
                                                      enteritis caused    over 16 weeks of age.
                                                      by Clostridium      Do not feed to laying
                                                      perfringens         chickens. Not approved
                                                      susceptible to      for use with pellet
                                                      virginiamycin;      binders. May be fatal
                                                      and for the         if accidentally fed to
                                                      prevention of       adult turkeys or
                                                      coccidiosis         horses. Salinomycin as
                                                      caused by Eimeria   provided by No. 016592
                                                      tenella, E.         in Sec.   510.600(c)
                                                      necatrix, E.        of this chapter.
                                                      acervulina, E.
                                                      maxima, E.
                                                      brunetti, and E.
                                                      mivati.
(viii) 20......................  Semduramicin 22.7.  Broiler chickens:   Feed continuously as             066104
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not feed to laying
                                                      enteritis caused    hens. Semduramicin as
                                                      by Clostridium      provided by No. 066104
                                                      perfringens         in Sec.   510.600(c)
                                                      susceptible to      of this chapter.
                                                      virginiamycin;
                                                      and for the
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      acervulina, E.
                                                      brunetti, E.
                                                      maxima, E mivati/
                                                      mitis, E.
                                                      necatrix, and E.
                                                      tenella.
(ix) 20........................  Semduramicin        Broiler chickens:   Feed continuously as             066104
                                  (biomass) 22.7.     For prevention of   the sole ration.
                                                      necrotic            Withdraw 1 day before
                                                      enteritis caused    slaughter. Do not feed
                                                      by Clostridium      to laying hens.
                                                      perfringens         Semduramicin as
                                                      susceptible to      provided by No. 066104
                                                      virginiamycin;      in Sec.   510.600(c)
                                                      and for the         of this chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      acervulina, E.
                                                      brunetti, E.
                                                      maxima, E mivati/
                                                      mitis, E.
                                                      necatrix, and E.
                                                      tenella.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
31. In Sec.  558.680, remove paragraph (e) and add paragraph (d)(3) to
read as follows:

Sec.  558.680  Zoalene.

* * * * *
    (d) * * *
    (3) Zoalene may also be used in combination with:
    (i)-(ii) [Reserved]
    (iii) Lincomycin as in Sec.  558.325.

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09364 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 99 (Tuesday, May 22, 2012)]
[Rules and Regulations]
[Pages 30208-30212]
[FR Doc No: 2012-12230]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0819; FRL-9674-5]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Baltimore Nonattainment Area Determinations of Attainment of
the 1997 Annual Fine Particulate Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is taking action to finalize two separate and independent
determinations regarding the fine particulate matter (PM2.5)
nonattainment area of Baltimore (hereafter referred to as the
``Baltimore Area'' or ``Area''). First, EPA is determining that the
Baltimore Area has attained the 1997 annual PM2.5 National
Ambient Air Quality Standard (NAAQS) under the Clean Air Act (CAA).
This determination is based upon complete, quality-assured, and
certified ambient air monitoring data for the 2008-2010 monitoring
period showing that the Area has monitored attainment of the 1997
annual PM2.5 NAAQS, and data available to date for 2011 in
EPA's Air Quality System (AQS) database showing that the Area continues
to attain. Under EPA's PM2.5 implementation regulations,
this final determination suspends obligation of the Area to submit an
attainment demonstration and associated reasonably available control
measures and reasonably available control technologies (RACM/RACT), a
reasonable further progress (RFP) plan, contingency measures, and other
planning State Implementation Plan (SIP) revisions related to the
attainment of the standard for so long as the Area continues to attain
the 1997 annual PM2.5 NAAQS. EPA is also determining, based
on complete quality-assured and certified monitoring data for the 2007-
2009 monitoring period, that the Area attained the 1997 annual
PM2.5 NAAQS by its applicable attainment date of April 5,
2010. In addition, EPA is withdrawing its July 31, 2009 (74 FR 38161)
proposed determination of attainment for the Baltimore Area, because
more recent monitoring data has become available. EPA is finalizing a
determination of attainment for the Baltimore Area, in accordance with
the requirements of the (CAA).

DATES: This final rule is effective on June 21, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2011-0819. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT: Emlyn V[eacute]lez-Rosa, (215) 814-
2038, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. Background
II. What is EPA's analysis of the relevant air quality data?
III. Summary of Public Comment and EPA Response
IV. Final Action

I. Background

    On July 18, 1997 (62 FR 36852), EPA established a health-based
PM2.5 NAAQS at 15.0 micrograms per cubic meter ([micro]g/
m\3\) based on a 3-year average of annual mean PM2.5
concentrations (hereafter referred to as ``the annual PM2.5
NAAQS'' or ``the annual standard''). At that time, EPA also established
a 24-hour standard of 65 [micro]g/m\3\ (the ``1997 24-hour standard'').
See 40 CFR 50.7. On January 5, 2005 (70 FR 944), EPA published its air
quality designations and classifications for the 1997 PM2.5
NAAQS based upon air quality monitoring data from those monitors for
calendar years 2001-2003. These designations became effective on April
5, 2005. The Baltimore Area was designated nonattainment for the 1997
PM2.5 NAAQS during this designations process. See 40 CFR
81.321 (Maryland).
    On October 17, 2006 (71 FR 61144), EPA retained the 1997 annual
PM2.5 NAAQS at 15.0 [micro]g/m\3\ based on a 3-year average
of annual mean PM2.5 concentrations, and promulgated a 24-
hour standard of 35 [micro]g/m\3\ based on a 3-year average of the 98th
percentile of 24-hour concentrations (the ``2006 24-hour standard'').
On November 13, 2009, EPA designated the Baltimore

Area as attainment for the 2006 24-hour standard. In that action, EPA
also clarified the designations for the PM2.5 NAAQS
promulgated in 1997, stating that the Baltimore Area was attainment for
the 1997 24-hour standard (74 FR 58688). Today's action, however, does
not address either the 1997 or the 2006 24-hour standard.
    In response to legal challenges of the annual standard promulgated
in 2006, the U.S. Court of Appeals for the District of Columbia Circuit
(DC Circuit) remanded this standard to EPA for further consideration.
See American Farm Bureau Federation and National Pork Producers
Council, et al. v. EPA, 559 F.3d 512 (DC Cir. 2009). However, given
that the 1997 and 2006 annual standards are essentially identical,
attainment of the 1997 annual standard would also indicate attainment
of the remanded 2006 annual standard.
    On April 25, 2007 (72 FR 20664), EPA promulgated its
PM2.5 implementation rule, codified at 40 CFR part 51,
subpart Z, in which EPA provided guidance for state and tribal plans to
implement the 1997 PM2.5 standard. This rule, at 40 CFR
51.1004(c), specifies some of the regulatory consequences of attaining
the standard, as discussed later.
    Under CAA section 179(c), EPA is required to make a determination
that a PM2.5 nonattainment area has attained by its
applicable attainment date, and publish that determination in the
Federal Register. On November 23, 2011 (76 FR 72374), EPA published a
notice of proposed rulemaking (NPR) for the State of Maryland,
proposing to determine that the Baltimore Area has attained the 1997
annual PM2.5 NAAQS, based on the most recent three years of
complete, quality-assured and certified data and data available to date
for 2011. EPA also proposed, based on complete, quality-assured and
certified data for 2007-2009 that the Area attained the 1997 annual
PM2.5 NAAQS by its applicable attainment date of April 5,
2010. EPA's determinations are in accordance with the CAA, EPA's
PM2.5 Implementation Rule of April 25, 2007 (72 FR 20664),
and other applicable regulations. During the comment period on its
proposed determinations, EPA received a comment letter from
Earthjustice on December 23, 2011. A summary of the comments submitted
by Earthjustice and EPA's responses are provided in section III of this
document.

II. What is EPA's analysis of the relevant air quality data?

    EPA has reviewed the ambient air monitoring data for
PM2.5, consistent with the requirements contained in 40 CFR
part 50 and based on data from the EPA AQS database for the Baltimore
Area, for the monitoring periods of 2007-2009, 2008-2010, and for data
available to date for 2011. Based upon the most recent three years of
complete, quality-assured, quality-controlled, and certified ambient
air monitoring data as well as the data available to date for 2011, EPA
determines that the Baltimore Area has monitored attainment of the 1997
annual PM2.5 standard. EPA also determines, based on
complete, quality-assured and certified 2007-2009 monitoring data, that
the Area attained the 1997 annual PM2.5 NAAQS by its
applicable attainment date of April 5, 2010.
    Under EPA regulations at 40 CFR 50.7(b), the annual primary and
secondary PM2.5 standards are met when the annual arithmetic
mean concentration, as determined in accordance with 40 CFR part 50,
appendix N, is less than or equal to 15.0 [mu]g/m\3\. The values
calculated in accordance with 40 CFR part 50, appendix N, are referred
to as design values, and these values are used to determine if an area
is attaining the PM2.5 NAAQS.
    The air quality monitoring network design criteria, established in
40 CFR part 58 appendix D, describe the specific requirements for the
number and location of Federal Reference Method (FRM), Federal
Equivalent Method (FEM), and Approved Regional Method (ARM) monitoring
sites for specific pollutants. The network criteria apply to the
Baltimore-Towson, Maryland Metropolitan Statistical Area (hereby ``the
Baltimore MSA''), which consists of Baltimore City and the counties of
Anne Arundel, Baltimore, Carroll, Harford, Howard, and Queen Anne's.
Metropolitan areas are determined using the statistical-based
definitions provided by the Office of Management and Budget and the
Census Bureau. Section 4.7.1 of appendix D requires the Baltimore MSA
network to operate at a minimum two PM2.5 monitoring sites.
Currently, the Baltimore MSA network consists of eight PM2.5
FRM monitors and one PM2.5 FEM monitor. Thus, EPA has
determined that the PM2.5 monitoring network in the
Baltimore MSA is adequate, in accordance with 40 CFR part 58, appendix
D.
    Additionally, EPA has determined that the PM2.5
Baltimore MSA monitoring network meets all relevant criteria specified
in 40 CFR part 58 and is in accordance with the monitoring network
plans that have been reviewed and approved by EPA on an annual basis.
Additional information about the monitoring network and air quality
data was included in the Technical Support Document (TSD) for this
action which is available online at www.regulations.gov, Docket number
EPA-R03-OAR-2011-0819.

III. Summary of Public Comment and EPA Response

    The commenter, Earthjustice, objected generally to EPA's proposed
attainment determination for the 1997 annual PM2.5 NAAQS for
the Baltimore nonattainment area, on the basis that such determination
relies on deficient monitoring data. The commenter asserts that there
are various deficiencies with the monitoring network and data.
    Comment: The commenter contended that there were specific
deficiencies with the monitoring network, citing Maryland's 5-Year
Network Assessment. The commenter asserts that Maryland has not assured
that adequate mandatory continuous monitors for PM2.5 are in
place in the Baltimore MSA as required by 40 CFR part 58 appendix D,
section 4.7.2. The commenter asserts that Maryland Department of
Environment (MDE) explains in its assessment that failure to meet these
requirements is caused by a ``technicality'' while testing a continuous
monitor, AQS ID: 24-510-0040 (Oldtown), in the Baltimore MSA. The
commenter indicates it is unclear whether the affected monitor was
collecting adequate continuous PM2.5 data during this
testing period and whether this data was used in the clean data
finding.
    Response: The network design criteria, in 40 CFR part 58, appendix
D, section 4.7.2, requires that the State must operate in the
PM2.5 network continuous monitors that are at least one-half
of the minimum number of the required sites, of which at least one must
be collocated with a required FRM monitor. According to Table D-5 of
appendix D, the Baltimore MSA is required to have a minimum of two
PM2.5 monitoring sites, and thus is required to have one
continuous monitor in the network. To meet this requirement, one
PM2.5 Beta Attenuation Mass (BAM) FEM monitor is operated in
the Baltimore MSA monitoring network which is collocated with an FRM
monitor at the monitoring site AQS ID: 24-510-0040 (Oldtown).
    During July 2008 thru July 2010, the continuous BAM FEM monitor was
tested to ensure that it was operating properly. Thus, during this time
the continuous monitor was designated as a Special Purpose Monitor
(SPM). The test consisted of a correlation study to compare the data
from the FRM monitor with the continuous BAM FEM data.

The study showed that the data being collected by the continuous BAM
FEM monitor correlated sufficiently well, and therefore, continuous
PM2.5 data from the Oldtown site was shown to be adequate.
As a result, as of July 2010, the continuous monitor was no longer
designated as an SPM, and is now considered a collocated monitor. The
continuous BAM FEM monitor is currently collocated with an FRM monitor
at the Oldtown site and data from these monitors during 2008-2010 is
presented in Table 1.
    Because Oldtown is a middle scale station which has not been
determined to be a population-oriented site representative of many such
locations throughout the Baltimore MSA, the data from that site is not
used for comparison to the annual PM2.5 NAAQS. See 40 CFR
58.30. Although the Oldtown monitoring site was not considered for the
attainment determination, the monitoring data from Oldtown recorded
PM2.5 levels below the level of the annual PM2.5
NAAQS during the time period of 2008-2010. Similarly, the 2011
preliminary data from both the FRM and BAM FEM in Oldtown showed levels
below the annual PM2.5 NAAQS. See the publicly available
FRM/FEM data comparison tool provided by EPA at http://www.epa.gov/airquality/airdata/ad_rep_frmvfem.html. This tool shows that the FRM
and continuous BAM FEM at the Oldtown site have good comparability. For
additional information about testing continuous monitors, see the
Technical Memorandum, ``Implementing Continuous PM2.5
Federal Equivalent Methods (FEMs) and Approved Regional Methods (ARMs)
in State or Local Air Monitoring Station (SLAMS) Networks,'' in http://www.epa.gov/ttn/airs/airsaqs/memos/Use%20of%20PM2.5%20FEMS%20and%20ARMs%20in%20SLAMS%20Network.pdf.

      Table 1--Monitoring Site Id. No. 24-510-0040 (Oldtown) 2008-2010 PM[bdi2].[bdi5] Data (in [mu]g/m\3\)
----------------------------------------------------------------------------------------------------------------
                                                              2008       2009       2010       2010       2011
             Site name                     Site ID           Annual     Annual     Annual     Design     Annual
                                                              mean       mean       mean      value     mean **
----------------------------------------------------------------------------------------------------------------
Maryland Oldtown..................  24-510-0040 POC 1....       12.8       11.2       11.2       11.7       11.7
Maryland Oldtown continuous.......  24-510-0040 POC 3....      13.7*       12.1       12.7       12.8       13.1
----------------------------------------------------------------------------------------------------------------
* Incomplete data for 2008.
** Based on preliminary data for 2011.

    Comment: The commenter raises, with regard to the monitoring
network adequacy of the Baltimore MSA, that, as of September 2010,
Maryland had not satisfied the requirement to designate a monitoring
station in the Baltimore MSA as a maximum PM2.5
concentration site. Id. 40 CFR part 58, appendix D, section
4.7.1(b)(1). MDE's 5-year network assessment states that it planned to
classify the monitoring site Id. No. 24-510-0040 (Oldtown) as the
highest concentration PM2.5 site for the Baltimore MSA. See
Maryland 5-Year Network Assessment.
    Response: Maryland satisfies the maximum PM2.5
concentration site requirements, set forth in 40 CFR part 58, appendix
D, section 4.7.1(b)(1) for the Baltimore MSA which requires at least
one monitoring station at a population-oriented area of maximum
concentration. The Maryland 5-Year Network assessment identifies two
possible locations in the Baltimore MSA as highest concentration: the
Oldtown monitoring station and the Fire Station 20 monitoring station,
AQS ID 245100008 (see Maryland 5-Year Network Assessment, page 53).
Data from the Fire Station 20, which is a neighborhood scale site
representing community wide air quality, was used in the determination
of attainment. However, because Oldtown does not meet the siting
requirements for comparing the data to the annual PM2.5
NAAQS, the monitoring data from that site was not used in the
determination of attainment. Even if the data from the Oldtown
monitoring was eligible for comparison to the annual PM2.5
NAAQS, it shows that the site is attaining the annual PM2.5
NAAQS. See Table 1.
    Comment: The commenter asserts that by not using the monitoring
data from site Id. No. 24-510-0040 (Oldtown), EPA's attainment
determination is inconsistent with the 1992 EPA Guidance regarding
NAAQS attainment determinations. See Memorandum of September 4, 1992
from John Calcagni, Director, Air Quality Management Division, to EPA
Air Division Directors, ``Procedures for Processing Requests to
Redesignate Areas to Attainment.'' This memorandum explicitly states
that data used to demonstrate attainment ``should be the product of
ambient monitoring that is representative of the area of highest
concentration.''
    Response: EPA did use monitoring data from a population oriented
monitoring site of expected maximum concentration, i.e., the Fire
Station 20 monitoring site (AQS ID: 24-510-0008). As part of this
assessment, data for 2008-2010 from Fire Station 20 site show
concentration levels that are below the level of the annual
PM2.5 NAAQS at this maximum concentration site. Because the
monitoring site Id. No. 24-510-0040 (Oldtown) is not a population
oriented monitor representative of community wide air quality, the data
from that site is not eligible for comparison to the annual
PM2.5 NAAQS. Moreover, monitoring data from site Id. No. 24-
510-0040 (Oldtown) is currently used in determining Baltimore Area's
compliance with the PM2.5 24-hour NAAQS. Additionally, even
if EPA had reviewed data from the Oldtown location for comparison to
the annual PM2.5 NAAQS, the data for 2008-2010 reflects that
the concentration levels at the site are below the level of the annual
PM2.5 NAAQS at this location. Thus, this would not have
changed EPA's action to find that the Baltimore nonattainment area
currently is attaining the NAAQS. The Oldtown data is provided in Table
1, but was not used in determining attainment of the Baltimore Area for
the annual PM2.5 NAAQS.
    Comment: The commenter asserts that MDE did not provide reasoned
justification that the existing monitoring network was sufficient to
capture representative PM2.5 concentrations and populations
exposures for Baltimore City, after removing the monitor ID 24-510-0035
(FMC-Fairfield), which was originally classified as a neighborhood
monitor.
    Response: The Baltimore MSA has an adequate PM2.5
monitoring network. 40 CFR part 58, appendix D requires two monitors in
the Baltimore MSA, which currently has eight monitors in place.
Further, the monitoring network meets all relevant criteria specified
in part 58 and is in accordance with the monitoring network plans that
have

been reviewed and approved by EPA on an annual basis.
    The FMC-Fairfield monitor was shut down due to the demolition of
the FMC-Fairfield Agricultural Plant. At the time of the FMC-Fairfield
closure in 2008, the FMC-Fairfield monitor was showing annual means
that attained the annual PM2.5 standard. Because the
Baltimore MSA already had sufficient number of PM2.5
monitors in its network, MDE did not need to relocate the FMC-Fairfield
monitor to another site. Also, contrary to commenter's assertion, EPA's
supporting documents include sufficient justification for removing the
monitor from this location. See TSD attachments, ``MDE's Analysis
regarding Closure of the FMC PM2.5 Monitor'' and
``Notification by Maryland Department of the Environment (MDE)
regarding the closure of the FMC PM2.5 Monitor.'' MDE
explained that the FMC-Fairfield monitoring site was no longer meeting
the population-oriented siting requirements that reflect community wide
air quality. When originally located, the FMC-Fairfield monitor met
these siting requirements. However, conditions around the monitor
location changed over time and the 2000 census data shows that the
population density around the FMC-Fairfield monitor has declined. FMC-
Fairfield, thus, no longer met its intended purpose of providing data
for neighborhood scale/population exposure. Data from the monitoring
site ID 24-510-0035 (FMC-Fairfield) was comparable to the monitoring
site Id. No. 24-510-0008 (Fire Station 20). Since 2008, Fire Station 20
has shown annual PM2.5 means below the annual NAAQS.
    Comment: The commenter asserts that the monitoring site Id. No. 24-
510-0008 (Fire Station 20), which they believe is representative of the
communities surrounding the FMC-Fairfield monitoring site, did not
satisfy the completeness criteria for the 2010 period.
    Response: The commenter's statement that the data at monitor
location Id. No. 24-510-0008 (Fire Station 20) does not satisfy the
completeness criteria for 2010 is incorrect. As explained in the TSD,
the missing data from the primary monitor at this location for the
first quarter of 2010 was replaced with data from a collocated monitor
at the same site location to meet the completeness monitoring data
requirement of 40 CFR part 50, appendix N. Missing data from a primary
monitor at a site does not necessarily mean that the data at the
monitoring site is incomplete. When data from a collocated monitor is
used to substitute for missing data at a primary monitor, the data at
the monitor location is considered to be complete if EPA regulations
and guidance are followed for performing the necessary data
substitution. Specifically, section 3.0 of 40 CFR part 50, appendix N
specifies that if a valid 24-hour measurement is not produced from the
primary monitor for a particular day, but a valid sample is generated
by a collocated monitor, then that collocated value shall be considered
part of the site data. In order to replace the missing data, the
collocated substitution was followed, in accordance with the procedures
explained in ``Guideline on Data Handling Conventions for the PM
NAAQS,'' EPA-454/R-99-008 (April 1999). The substitution requires
replacing the missing data from the primary monitor with collocated
data for the same year and quarter, provided that the site has valid
data for at least 50 percent of the scheduled number of samples for
each quarter for all three years, and that the emissions and
meteorology for the quarters to be substituted are comparable to the
emissions and meteorology for the quarters in question. Air quality
data from Fire Station 20 monitoring site met these criteria and thus
the collocated data sampled at the site was used to complete the
missing data from the primary monitor. Therefore, monitoring site Id.
No. 24-510-0008 (Fire Station 20) has complete data for the year 2010.

IV. Final Action

    First, EPA determines that Baltimore Area has attained the 1997
annual PM2.5 NAAQS, based on the complete, quality assured
and certified data from 2008-2010, and data available to date in AQS
for 2011. Pursuant to 40 CFR 51.1004(c), this determination of
attainment will suspend the requirements for Maryland to submit for the
Baltimore Area an attainment demonstration and associated RACM/RACT,
RFP plan, contingency measures, and other planning SIP revisions
related to the attainment of the standard for so long as the Area
continues to attain the 1997 annual PM2.5 NAAQS. In
addition, EPA is finalizing a separate and independent determination
that the Baltimore Area attained the 1997 annual PM2.5
standard by the applicable attainment date of April 5, 2010, thereby
satisfying EPA's obligation pursuant to section 179(c)(1) of the CAA to
make a determination of whether the Area attained the standard by the
applicable attainment date.
    Finalizing this action does not constitute a redesignation of the
Baltimore Area to attainment for the 1997 annual PM2.5 NAAQS
under CAA section 107(d)(3). Further, finalizing this action does not
involve approving a maintenance plan for the Baltimore Area, nor does
it involve a determination that the Area has met all the requirements
for redesignation under the CAA. Therefore, the designation status of
the Baltimore PM2.5 nonattainment area will remain
nonattainment for the 1997 annual PM2.5 NAAQS until such
time as EPA takes final rulemaking action to determine that such
portions meet the CAA requirements for redesignation to attainment.

V. Statutory and Executive Order Reviews

A. General Requirements

    This action finalizes attainment determinations based on air
quality data and does not impose any additional requirements. For that
reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249,

November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 23, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This determination that the Baltimore Area has attained the
1997 p.m.2.5 NAAQS may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: May 8, 2012.
W.C. Early,
Acting, Regional Administrator, Region III.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart V--Maryland

0
2. Section 52.1081 is amended by adding paragraph (c) to read as
follows:

Sec.  52.1081  Control strategy: Particulate matter.

* * * * *
    (c) Determination of Attainment. EPA has determined, as of May 22,
2012, based on ambient air quality data of 2008 to 2010 and the
preliminary data of 2011, that the PM2.5 nonattainment area
of Baltimore, Maryland has attained the 1997 annual PM2.5
NAAQS. This determination, in accordance with 40 CFR 51.1004(c),
suspends the requirements for this area to submit an attainment
demonstration, associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and other
planning SIPs related to attainment of the standard for as long as this
area continues to meet the 1997 annual PM2.5 NAAQS.

0
3. Section 52.1082 is amended by adding paragraph (e) to read as
follows:

Sec.  52.1082  Determinations of attainment.

* * * * *
    (e) Based upon EPA's review of the air quality data for the 3-year
period 2007 to 2009, EPA determined that the PM2.5
nonattainment area of Baltimore, Maryland attained the 1997 annual
PM2.5 NAAQS by the applicable attainment date of April 5,
2010. Therefore, EPA has met the requirement pursuant to CAA section
179(c) to determine, based on the area's air quality as of the
attainment date, whether the area attained the NAAQS. EPA has also
determined that the PM2.5 nonattainment area of Baltimore,
Maryland is not subject to the consequences of failing to attain
pursuant to section 179(d).

[FR Doc. 2012-12230 Filed 5-21-12; 8:45 am]
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