[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Page 26772]
[FR Doc No: 2013-10949]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-254-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on April 24, 2013, Columbia Gas Transmission, LLC
(Columbia), 5151 San Felipe, Suite 2500, Houston, Texas 77056, filed a
prior notice request pursuant to sections 157.205, 157.208, and
157.216(b) of the Commission's regulations under the Natural Gas Act
(NGA) for authorization to replace approximately 6.07 miles of bare,
coupled, 12-, 16-, and 20-inch diameter pipeline (Line PM-17) located
in Pike County, Kentucky. Columbia states that Line PM-17 will be
replaced with 10-inch diameter cathodically protected, steel pipeline.
Columbia avers that the reduction in the pipeline diameter will have no
adverse impact on Columbia's ability to meet operational needs and firm
commitments on Line PM-17. Columbia asserts that it does not propose
abandonment of any service in relation to this project. Columbia
estimates the cost of the proposed replacement to be approximately
$20.2 million, all as more fully set forth in the application, which is
on file with the Commission and open to public inspection. The filing
may also be viewed on the web at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding the application should be directed to
Fredric J. George, Senior Counsel, Columbia Gas Transmission, LLC, PO
Box 1273, Charleston, West Virginia 25325-1273, by telephone at (304)
357-2359, or by facsimile at<PHONE_NUMBER>.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1) (iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: May 2, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-10949 Filed 5-7-13; 8:45 am]
BILLING CODE 6717-01-P


Analysis, US DOC News, November 9, 2007, pages 12 and 15,
available online at
http://www.bea.gov/newsreleases/international/trade/2007/pdf/trad
0907.pdf.
List of Subjects in 21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority
delegated to the Commissioner of Food and Drugs, 21 CFR part 1 is amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
1. The authority citation for 21 CFR part 1 continues to read as follows:
Authority:  15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332,
333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216,
241, 243, 262, 264.
2. Subpart I, consisting of §§ 1.276 through 1.285, is added to part 1 to read as follows:

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Subpart I--PRIOR NOTICE OF IMPORTED FOOD
General Provisions
Sec.
1.276  What definitions apply to this subpart?
1.277  What is the scope of this subpart?
Requirements to Submit Prior Notice of Imported Food
Sec.
1.278  Who is authorized to submit prior notice?
1.279  When must prior notice be submitted to FDA?
1.280  How must you submit prior notice?
1.281  What information must be in a prior notice?
1.282  What must you do if information changes after you have received confirmation of a prior
notice from FDA?
Consequences
Sec.
1.283  What happens to food that is imported or offered for import without adequate prior
notice?
1.284  What are the other consequences of failing to submit adequate prior notice or otherwise
failing to comply with this subpart?
1.285  What happens to food that is imported or offered for import from unregistered facilities
that are required to register under 21 CFR part 1, subpart H?

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General Provisions
Sec.
§ 1.276  What definitions apply to this subpart?
(a) The act means the Federal Food, Drug, and Cosmetic Act.
(b) The definitions of terms in section 201 of the act (21 U.S.C. 321) apply when the
terms are used in this subpart, unless defined in this section.
(1) Calendar day means every day shown on the calendar.
(2) Country from which the article originates means FDA Country of Production.
(3) Country from which the article is shipped means the country in which the article of
food is loaded onto the conveyance that brings it to the United States or, in the case of food sent
by international mail, the country from which the article is mailed.
(4) FDA Country of Production means:  (i) For an article of food that is in its natural
state, the country where the article of food was grown, including harvested or collected and
readied for shipment to the United States. If an article of food is wild fish, including seafood that
was caught or harvested outside the waters of the United States by a vessel that is not registered
in the United States, the FDA Country of Production is the country in which the vessel is
registered. If an article of food that is in its natural state was grown, including harvested or
collected and readied for shipment, in a Territory, the FDA Country of Production is the United
States.
(ii) For an article of food that is no longer in its natural state, the country where the article
was made; except that, if an article of food is made from wild fish, including seafood, aboard a
vessel, the FDA Country of Production is the country in which the vessel is registered. If an

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article of food that is no longer in its natural state was made in a Territory, the FDA Country of
Production is the United States.
(5) Food has the meaning given in section 201(f) of the act, except as provided in
paragraph (b)(5)(i) of this section.
(i) For purposes of this subpart, food does not include:
(A) Food contact substances as defined in section 409(h)(6) of the act (21 U.S.C.
348(h)(6)); or
(B) Pesticides as defined in 7 U.S.C. 136(u).
(ii) Examples of food include fruits, vegetables, fish, including seafood, dairy products,
eggs, raw agricultural commodities for use as food or as components of food, animal feed
(including pet food), food and feed ingredients, food and feed additives, dietary supplements and
dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water),
live food animals, bakery goods, snack foods, candy, and canned foods.
(6) Full address means the facility’s street name and number; suite/unit number, as
appropriate; city; province or state as appropriate; mail code as appropriate; and country.
(7) Grower means a person who engages in growing and harvesting or collecting crops
(including botanicals), raising animals (including fish, which includes seafood), or both.
(8) International mail means foreign national mail services. International mail does not
include express consignment operators or carriers or other private delivery services unless such
service is operating under contract as an agent or extension of a foreign mail service.
(9) Manufacturer means the last facility, as that word is defined in § 1.227(b)(2), that
manufactured/processed the food.  A facility is considered the last facility even if the food
undergoes further manufacturing/processing that consists of adding labeling or any similar

394
activity of a de minimis nature.  If the food undergoes further manufacturing/processing that
exceeds an activity of a de minimis nature, then the subsequent facility that performed the
additional manufacturing/processing is considered the manufacturer.
(10) No longer in its natural state means that an article of food has been made from one
or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of
activities that render food no longer in its natural state are cutting, peeling, trimming, washing,
waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing,
mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or
packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to
harvest or collection or treated against pests, or polished are still in their natural state for
purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in
their natural state for purposes of this subpart.
(11) Port of arrival means the water, air, or land port at which the article of food is
imported or offered for import into the United States. For an article of food arriving by water or
air, this is the port of unloading.  For an article of food arriving by land, this is the port where the
article of food first crosses the border into the United States.  The port of arrival may be different
than the port where consumption or warehouse entry or foreign trade zone admission
documentation is presented to the U.S. Customs and Border Protection (CBP).
(12) Port of entry, in section 801(m) and (l) of the act (21 U.S.C. 381(m) and (l)), means
the port of entry as defined in 19 CFR 101.1.
(13) Registration number means the registration number assigned to a facility by FDA
under section 415 of the act (21 U.S.C. 350d) and 21 CFR part 1, subpart H.

395
(14) Shipper means the owner or exporter of the article of food who consigns and ships
the article from a foreign country or the person who sends an article of food by international mail
or express consignment operators or carriers or other private delivery service to the United
States.
(15) United States means the Customs territory of the United States (i.e., the 50 States,
the District of Columbia, and the Commonwealth of Puerto Rico), but not the Territories.
(16) You means the person submitting the prior notice, i.e., the submitter or the
transmitter, if any.
§ 1.277  What is the scope of this subpart?
(a) This subpart applies to all food for humans and other animals that is imported or
offered for import into the United States for use, storage, or distribution in the United States,
including food for gifts and trade and quality assurance/quality control samples, food for
transshipment through the United States to another country, food for future export, and food for
use in a U.S. Foreign Trade Zone.
(b) Notwithstanding paragraph (a) of this section, this subpart does not apply to:
(1) Food for an individual's personal use when it is carried by or otherwise accompanies
the individual when arriving in the United States;
(2) Food that was made by an individual in his/her personal residence and sent by that
individual as a personal gift (i.e., for non-business reasons) to an individual in the United States;
(3) Food that is imported then exported without leaving the port of arrival until export;
(4) Meat food products that at the time of importation are subject to the exclusive
jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.);

396
(5) Poultry products that at the time of importation are subject to the exclusive
jurisdiction of USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.);
(6) Egg products that at the time of importation are subject to the exclusive jurisdiction of
USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.); and
(7) Articles of food subject to Article 27(3) of The Vienna Convention on Diplomatic
Relations (1961), i.e., shipped as baggage or cargo constituting the diplomatic bag.
Requirements To Submit Prior Notice of Imported Food
§ 1.278  Who is authorized to submit prior notice?
A prior notice for an article of food may be submitted by any person with knowledge of
the required information. This person is the submitter. The submitter also may use another
person to transmit the required information on his/her behalf. The person who transmits the
information is the transmitter. The submitter and transmitter may be the same person.
§ 1.279  When must prior notice be submitted to FDA?
(a) Except as provided in paragraph (c) of this section, you must submit the prior notice
to FDA and the prior notice submission must be confirmed by FDA for review as follows:
(1) If the article of food is arriving by land by road, no less than 2 hours before arriving at
the port of arrival;
(2) If the article of food is arriving by land by rail, no less than 4 hours before arriving at
the port of arrival;
(3) If the article of food is arriving by air, no less than 4 hours before arriving at the port
of arrival; or
(4) If the article of food is arriving by water, no less than 8 hours before arriving at the
port of arrival.

397
(b) Except in the case of an article of food imported or offered for import by international
mail:
(1) If prior notice is submitted via Automated Broker Interface/Automated Commercial
System (ABI/ACS), you may not submit prior notice more than 30-calendar days before the
anticipated date of arrival.
(2) If prior notice is submitted via the Prior Notice System Interface (PNSI), you may not
submit prior notice more than 15-calendar days before the anticipated date of arrival.
(c) Notwithstanding paragraphs (a) and (b) of this section, if the article of food is arriving
by international mail, you must submit the prior notice before the article of food is sent to the
United States.
(d) FDA will notify you that your prior notice has been confirmed for review with a reply
message that contains a Prior Notice (PN) Confirmation Number. Your prior notice will be
considered submitted and the prior notice time will start when FDA has confirmed your prior
notice for review.
(e) The PN Confirmation Number must accompany any article of food arriving by
international mail. The PN Confirmation Number must appear on the Customs Declaration (e.g.,
CN22 or CN23 or U.S. equivalent) that accompanies the package.
(f) A copy of the confirmation, including the PN Confirmation Number, must accompany
any article of food that is subject to this subpart when it is carried by or otherwise accompanies
an individual when arriving in the United States. The copy of the confirmation must be provided
to CBP or FDA upon arrival.

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(g) The PN Confirmation Number must accompany any article of food for which the
prior notice was submitted through the FDA Prior Notice System Interface (FDA PNSI) when
the article arrives in the United States and must be provided to CBP or FDA upon arrival.
§ 1.280  How must you submit prior notice?
(a) You must submit the prior notice electronically to FDA. You must submit all prior
notice information in the English language, except that an individual's name, the name of a
company, and the name of a street may be submitted in a foreign language. All information,
including the items listed in the previous sentence, must be submitted using the Latin (Roman)
alphabet. Unless paragraph (c) of this section applies, you must submit prior notice through:
(1) The CBP Automated Broker Interface of the Automated Commercial System
(ABI/ACS); or
(2) The FDA PNSI at http://www.access.fda.gov. You must submit prior notice through
the FDA PNSI for articles of food imported or offered for import by international mail, and other
transaction types that cannot be made through ABI/ACS.  Prior notice for articles that have been
refused under section 801(m)(1) of the act and this subpart must be submitted through the FDA
PNSI until such time as FDA and CBP issue a determination that ACS or its successor system
can accommodate such transactions.
(b) If a customhouse broker's or self-filer's system is not working or if the ABI/ACS
interface is not working, prior notice must be submitted through the FDA PNSI.
(c) If FDA determines that FDA PNSI or the Operational and Administration System for
Import Support (OASIS) is not working, FDA will post prominent notification and instructions at
http://www.fda.gov.  FDA will accept prior notice submissions in the format it deems
appropriate during the system(s) outage.

399
§ 1.281  What information must be in a prior notice?
(a) General. For each article of food that is imported or offered for import into the United
States, except by international mail, you must submit the information for the article that is
required in this paragraph.
(1) The name of the individual submitting the prior notice and his/her business address,
phone number,  and e-mail address, and the name and address of the submitting firm, if
applicable. If the business address of the individual submitting the prior notice is a registered
facility, then the facility's registration number, city, and country may be provided instead of the
facility's full address;
(2) If different from the submitter, the name of the individual and firm, if applicable,
transmitting the prior notice on behalf of the submitter and his/her business address, phone
number, and e-mail address. If the business address of the individual transmitting the prior notice
is a registered facility, then the facility's registration number, city, and country may be provided
instead of the facility's full address;
(3) The entry type;
(4) The CBP entry identifier (e.g., CBP entry number or in-bond number), if available;
(5) The identity of the article of food being imported or offered for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described from largest container
to smallest package size; and

400
(iv) The lot or code numbers or other identifier of the food if required by the act or FDA
regulations, e.g., low acid canned foods, by 21 CFR 113.60(c); acidified foods, by 21 CFR
114.80(b); and infant formula, by 21 CFR 106.90;
(6) For an article of food that is no longer in its natural state, the identity of the
manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the manufacturer or both the full
address of the manufacturer and the reason the registration number is not provided;
(7) For an article of food that is in its natural state, the name and growing location
address of the grower, if known. If the submitter does not know the identity of the grower or, if
the article has been consolidated and the submitter does not know the identity of any of the
growers, you may provide the name and address of the firm that has consolidated the articles of
food from different growers or different growing locations;
(8) The FDA Country of Production;
(9) If the shipper is different from the manufacturer, the identity of the shipper, as
follows:
(i) The name of the shipper; and
(ii) The full address of the shipper.  If the address of the shipper is a registered facility,
you also may submit the registration number of the shipper’s registered facility;
(10) The country from which the article is shipped;
(11) Anticipated arrival information about the article of food being imported or offered
for import, as follows:
(i) The anticipated port of arrival;

401
(ii) The anticipated date on which the article of food will arrive at the anticipated port of
arrival;
(iii) The anticipated time of that arrival; and
(iv) Notwithstanding paragraphs (a)(11)(i) through (a)(11)(iii) of this section, if the
article of food is arriving by express consignment operator or carrier, and neither the submitter
nor transmitter is the express consignment operator or carrier, and prior notice is submitted via
the FDA PNSI, the express consignment operator or carrier tracking number may be submitted in
lieu of the information required in paragraphs (a)(11)(i) through (a)(11)(iii) of this section.  Until
such time as FDA and CBP issue a determination that ACS or its successor system can
accommodate such transactions, the tracking number may not be submitted in lieu of information
required in paragraphs (a)(11)(i) through (a)(11)(iii) of this section, if the prior notice is
submitted via ABI/ACS.
(12) The name and full address of the importer. If the business address of the importer is
a registered facility, you also may submit the registration number of the importer’s registered
facility.  The identity of the importer is not required for an article of food that is imported or
offered for import for transshipment through the United States under a Transportation and
Exportation entry;
(13) The name and full address of the owner if different from the importer or ultimate
consignee.  If the business address of the owner is a registered facility, you also may submit the
registration number of the owner’s registered facility.  The identity of the owner is not required
for an article of food that is imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;

402
(14) The name and full address of the ultimate consignee. If the business address of the
ultimate consignee is a registered facility, you also may submit the registration number of the
ultimate consignee’s registered facility. The identity of the ultimate consignee is not required for
an article of food that is imported or offered for import for transshipment through the United
States under a Transportation and Exportation entry;
(15) The mode of transportation;
(16) The Standard Carrier Abbreviation Code (SCAC) or International Air Transportation
Association (IATA) code of the carrier which is, or will be, carrying the article of food from the
country from which the article is shipped to the United States to the port of arrival, or if this code
is not applicable, then the name of the carrier.  If the carrier is a privately owned vehicle, the
license plate number of the vehicle and the state or province that issued the license plate number;
(17) Planned shipment information, as applicable to the mode of transportation and when
it exists:
(i) The Airway Bill number(s) or Bill of Lading number(s), as applicable. This
information is not required for an article of food when carried by or otherwise accompanying an
individual when entering the United States.  If the article of food is arriving by express
consignment operator or carrier, and neither the submitter nor transmitter is the express
consignment operator or carrier, and the prior notice is submitted via the FDA PNSI, the express
consignment operator or carrier tracking number may be submitted in lieu of the Airway Bill
number(s) or Bill of Lading number(s), as applicable.  Until such time as FDA and CBP issue a
determination that ACS or its successor system can accommodate such transactions, the tracking
number may not be submitted in lieu of the Airway Bill number(s) or Bill of Lading number(s),
if the prior notice is submitted via ABI/ACS;

403
(ii) For food arriving by ocean vessel, the vessel name and voyage number;
(iii) For food arriving by air carrier, the flight number.  If the article of food is arriving by
express consignment operator or carrier, and neither the submitter nor transmitter is the express
consignment operator or carrier, and the prior notice is submitted via the FDA PNSI, the express
consignment operator or carrier tracking number may be submitted in lieu of the flight number.
Until such time as FDA and CBP issue a determination that ACS or its successor system can
accommodate such transactions, the tracking number may not be submitted in lieu of the flight
number, if the prior notice is submitted via ABI/ACS;
(iv) For food arriving by truck, bus, or rail, the trip number;
(v) For food arriving as containerized cargo by water, air, or land, the container
number(s). This information is not required for an article of food when carried by or otherwise
accompanying an individual when entering the United States; and
(vi) For food arriving by rail, the car number. This information is not required for an
article of food when carried by or otherwise accompanying an individual.
(b) Articles arriving by international mail. For each article of food that is imported or
offered for import into the United States by international mail, you must submit the information
for the article that is required in this paragraph.
(1) The name of the individual submitting the prior notice and his/her business address,
phone number, and e-mail address, and the name and address of the submitting firm, if
applicable. If the business address of the individual submitting the prior notice is a registered
facility, then the facility's registration number, city, and country may be provided instead of the
facility's full address;

404
(2) If different from the submitter, the name of the individual and firm, if applicable,
transmitting the prior notice on behalf of the submitter and his/her business address, phone
number, and e-mail address. If the business address of the individual transmitting the prior notice
is a registered facility, then the facility's registration number, city, and country may be provided
instead of the facility's full address;
(3) The entry type (which will be a mail entry);
(4) The identity of the article of food being imported or offered for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The estimated quantity of food that will be shipped, described from largest container
to smallest package size; and
(iv) The lot or code numbers or other identifier of the food if required by the act or FDA
regulations, e.g., low acid canned foods, by 21 CFR 113.60(c); acidified foods, by 21 CFR
114.80(b); and infant formula, 21 CFR 106.90;
(5) For an article of food that is no longer in its natural state, the identity of the
manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the manufacturer or both the full
address of the manufacturer and the reason the registration number is not provided;
(6) For an article of food that is in its natural state, the name and growing location
address of the grower, if known. If the submitter does not know the identity of the grower or, if
the article has been consolidated and the submitter does not know the identity of any of the

405
growers, you may provide the name and address of the firm that has consolidated the articles of
food from different growers or different growing locations;
(7) The FDA Country of Production;
(8) If the shipper is different from the manufacturer, the identity of the shipper, as
follows:
(i) The name of the shipper; and
(ii) The full address of the shipper.  If the address of the shipper is a registered facility,
you also may submit the registration number of the shipper’s registered facility;
(9) The country from which the article is shipped (i.e., mailed);
(10) The anticipated date of mailing; and
(11) The name and address of the U.S. recipient.
(c) Refused articles. If the article of food has been refused under section 801(m)(1) of the
act and this subpart, you must submit the information for the article that is required in this
paragraph. However, if the refusal is based on § 1.283(a)(1)(iii) (Untimely Prior Notice), you do
not have to re-submit any information previously submitted unless it has changed or the article
has been exported and the original prior notice was submitted through ABI/ACS. If the refusal is
based on § 1.283(a)(1)(ii), you should cancel the previous submission per § 1.282(b) and (c).
(1) The name of the individual submitting the prior notice and his/her business address,
phone number, and e-mail address, and the name and address of the submitting firm, if
applicable. If the business address of the individual submitting the prior notice is a registered
facility, then the facility's registration number, city, and country may be provided instead of the
facility's full address;

406
(2) If different from the submitter, the name of the individual and firm, if applicable,
transmitting the prior notice on behalf of the submitter and his/her business address, phone
number, and e-mail address. If the business address of the individual transmitting the prior notice
is a registered facility, then the facility's registration number, city, and country may be provided
instead of the facility's full address;
(3) The entry type;
(4) The CBP entry identifier (e.g., CBP entry number or in-bond number), if available;
(5) The identity of the article of food being imported or offered for import, as follows:
(i) The complete FDA product code;
(ii) The common or usual name or market name;
(iii) The quantity of food that was shipped, described from largest container to smallest
package size; and
(iv) The lot or code numbers or other identifier of the food if required by the act or FDA
regulations, e.g., low acid canned foods, by 21 CFR 113.60(c); acidified foods, by 21 CFR
114.80(b); and infant formula, by 21 CFR 106.90;
(6) For an article of food that is no longer in its natural state, the identity of the
manufacturer, as follows:
(i) The name of the manufacturer; and
(ii) Either the registration number, city, and country of the manufacturer or both the full
address of the manufacturer and the reason the registration number is not provided;
(7) For an article of food that is in its natural state, the name and growing location
address of the grower, if known. If the submitter does not know the identity of the grower or, if
the article has been consolidated and the submitter does not know any of the growers, you may

407
provide the name and address of the firm that has consolidated the articles of food from different
growers or different growing locations;
(8) The FDA Country of Production;
(9) If the shipper is different from the manufacturer, the identity of the shipper, as
follows:
(i) The name of the shipper; and
(ii) The full address of the shipper.  If the address of the shipper is a registered facility,
you also may submit the registration number of the shipper’s registered facility;
(10) The country from which the article is shipped;
(11) Arrival information about the article of food being imported or offered for import, as
follows:
(i) The port of arrival; and
(ii) The date on which the article of food arrived at the port of arrival.
(iii) Notwithstanding paragraph (c)(11) of this section if the article of food arrived by
express consignment operator or carrier, and neither the submitter nor transmitter is the express
consignment operator or carrier, and the prior notice is submitted via the FDA PNSI, the express
consignment operator or carrier tracking number may be submitted in lieu of the information
required in paragraph (c)(11) of this section.  Until such time as FDA and CBP issue a
determination that ACS or its successor system can accommodate such transactions, the tracking
number may not be submitted in lieu of information required in paragraph (c)(11) of this section,
if the prior notice is submitted via ABI/ACS;
(12) The name and full address of the importer. If the business address of the importer is
a registered facility, you also may submit the registration number of the importer’s registered


{ D0000414. DOC / 1} July 18, 2005 Stephen Johnson, Administrator USEPA Headquarters Ariel Rios Building 1200 Pennsylvania Avenue, N. W. Mail Code: 1101A Washington, DC 20460 Re: Standards of Performance for New and Existing Stationary Sources: Electric Utility Steam Generating Units/ OAR 2002 0056  Request for Clarification and/ or Reconsideration of the Jamestown Board of Public Utilities______________________

Dear Administrator Johnson:

The Jamestown Board of Public Utilities ( JBPU) hereby requests clarification and/ or reconsideration from the Administrator of the United States Environmental Protection Agency ( EPA) regarding the applicability definitions of the rule captioned above and published at 70 Fed. Reg. 28,606 ( May 18, 2005)( hereinafter Final Utility Rule). The Final Utility Rule inappropriately extends the definition of covered units under 40 C. F. R. § 60.4101 ( 2005) to " unit[ s] serving at any time, since the start up of a unit's combustion chamber, a generator with nameplate capacity of more than 25 MWe producing electricity for sale." 70 Fed. Reg. at 28,612. The applicability definition is inconsistent with the applicability definition of Section 112( n)( 1)( A) of the Clean Air Act ( CAA), the applicability definitions used throughout the information gathering stage of { D0000414. DOC / 1} 2 the Utility rulemaking, the Section 112( n)( 1)( A) Report to Congress and the first phase of the Utility rulemaking. Further, in violation of EPA precedent and EPA's statements in this rulemaking, EPA's expanded definition of covered units subjects certain small municipal generators, such as the JBPU, to both the Industrial, Commercial and Institutional Boiler MACT ( Boiler MACT) and the Final Utility Rule.

EPA's extension of the Final Rule to cover small municipal boilers that are already covered by the Boiler MACT in the last stages of the Utility rulemaking also violates the Unfunded Mandates Reform Act ( UMRA). Throughout the Utility Report to Congress and rulemaking process, utility boilers equal to or less than 25 MWE ( such as the JBPU's units) were not within the definition of a covered unit and instead were covered by the Boiler MACT. These units were not involved in the public outreach or the regulatory impact analysis for the Utility rulemaking. Further, at the supplemental proposed rule stage of the Utility rulemaking, when it first appeared that a small number of municipal units already subject to Boiler MACT could also be subject to the Final Utility Rule, the American Public Power Association1 requested additional outreach to these small municipal entities. Despite this, the JPBU is unaware of any EPA response to APPA's request. Instead, EPA, in violation of Section 112( n)( 1)( A) of the Clean Air Act and its own precedent and statements, has subjected the JBPU to not only the Final Utility Rule ( with very limited notice and virtually none of the outreach required by UMRA), but also to the Boiler MACT.

1 The American Public Power Association ( APPA) is the service organization for the nation's more than 2,000 community owned electric utilities that serve more than 43 million Americans. The JBPU is a member of the APPA. { D0000414. DOC / 1} 3 The JBPU requests clarification that it should be subject to only one rule and that the appropriate rule, consistent with the requirements of CAA Sections 112 and 112( n)( 1)( A), and EPA's longstanding position in the Utility rulemaking and the Boiler MACT rulemaking, is the Boiler MACT Rule. To the extent necessary, the JBPU requests reconsideration pursuant to Section 307( d)( 7)( B) of the Clean Air Act, 42 U. S. C.

§ 7607( d)( 7)( B) of the Final Utility Rule captioned above and published at 70 Fed. Reg.

28,606. ( May 18, 2005). As discussed below, the issues presented are important to the rulemaking and to EPA's stated policy that units only be subject to either the Final Utility Rule or Boiler MACT, and so legally deficient that EPA has an obligation to re examine these issues as part of its affirmative " burden of promulgating and explaining a nonarbitrary non capricious rule," Small Refiner Lead Phase Down Task Force v. EPA, 705 F. 2d 506, 534 35 ( D. C. Cir. 1983) ( quoting National Lime Ass'n v. EPA, 627 F. 2d 416,

433 ( D. C. Cir. 1980), and therefore EPA must grant reconsideration on these grounds.

See also Appalachian Power Co. v. EPA, 135 F. 3d 791, 818 ( D. C. Cir. 1998). The Administrator must therefore either provide clarification or " convene a proceeding for reconsideration of the rule and provide the same procedural rights as would have been afforded had the information been available at the time the rule was proposed." 42 U. S. C.

§ 7607( d)( 7)( B) ( 2000).

Jamestown Board of Public Utilities The JBPU is a small municipally owned generating utility in western New York.

The JBPU owns a single generating facility, the Samuel Carlson Generating Station. The Carlson Generating Station consists of four coal fired boilers, which provide power to a { D0000414. DOC / 1} 4 variety of industries, commercial enterprises and residences in the Jamestown area. 2 Each of Jamestown's coal fired boilers individually generates less than 25 MWe. All of the boilers feed into a common steam header which feeds generators that are below 25 MWe.

In the past, however, the JBPU's boilers have fed generators that were at, or just barely above, 25 MWe. In the past, one generator was rated at 25 MWe, and the other was rated at 28.75 MWe.

Thus, the JBPU's boilers are not currently and have never been rated at or above 25 MWe. The JBPU's generators are also currently not rated at or above 25MWe.

However, in the past the JBPU's boilers have served generators at, or just above, 25 MWe ( 25 MWe and 28.5 MWe).

Background History of the Mercury Rulemaking EPA's authority in Utility rulemaking originates from CAA Section 112( n)( 1)( A),

which requires EPA to study and determine whether MACT regulation is appropriate for " electric utility steam generating units."

CAA Section 112( a)( 8) defines an electric utility steam generating unit as " any fossil fuel fired combustion unit of more than 25 megawatts that serves a generator that produces electricity for sale." 42 U. S. C. § 7412( a)( 8) ( 2000). Because the JBPU's 2 The JBPU also owns a single gas turbine. { D0000414. DOC / 1} 5 boilers are not more 25 MWe, the JBPU was not included in the definition of covered units for the CAA § 112( n)( 1)( A) Report to Congress and the rulemaking process under Section 112( n)( 1)( A). The Report to Congress required by Section 112( n)( 1)( a)

addressed only " fossil fuel fired combustion unit[ s] of more than 25 megawatts electric ( MWe) that serves a generator that produce[] electricity for sale." Final Report to Congress, Executive Summary at ES 1. Similarly, in the 1998 informational survey that formed the basis for the rulemaking, only units covered by Section 112( n)( 1)( A) were included. Jamestown was not involved in the survey.

When the Proposed Utility Rule was issued, it covered only CAA Section 112( n)( 1)( A) units. 69 Fed. Reg. 4652 ( Jan. 30, 2004). The JBPU was not covered by the Proposed Rule. The UMRA and Regulatory Flexibility Analysis ( RFA) associated with the Proposed Rule similarly did not include the JBPU. Regulatory Flexibility Analysis, Section 7.16.1 ( p. 7 30), Table 7 35.

In the Supplemental Proposed Utility Rule, EPA, for the first time, expanded the definition of covered units to include a " coal fired combustion unit that serves a generator of more than 25 MW that produces electricity for sale." Proposed Rule, 69 Fed. Reg. 12,397, 12,441 ( Mar. 16, 2004). EPA stated that the change would be applicable only to units regulated under Section 112( n)( 1)( A), despite the fact that Section 112( n)( 1)( A) addressed only boilers above 25 MWe, not generators above 25 MWe. Although the JBPU's generators are not rated at more that 25 MWe, EPA nonetheless appeared to include the JBPU at this stage of the rulemaking. The JBPU assumes that it was included because the JBPU had, in the past, run generators at, or { D0000414. DOC / 1} 6 slightly above, 25 MWe. The JBPU, however, was unable to find any explicit statements in the Supplemental Proposed Rule that the 25MWe cutoff was based on an historic rating number.

In the Final Utility Rule, EPA further expanded the reach of the rule to include " unit[ s] serving at any time, since the start up of the unit's combustion chamber, a generator with nameplate capacity of more than 25 MWe producing electricity for sale."

70 Fed. Reg. at 28,612 ( to be codified at 40 C. F. R. § 60.4101). Thus, the Final Utility Rule included not only units that served generators which, at the time of the rulemaking were more than 25 MWe ( which did not include the JBPU), but also units that had at any time served a generator more than 25 MWe. The applicability provision was extended under both CAA Sections 112 and 111. Because the JBPU's boilers in the past served generators that were at, or slightly above, 25 MWe, the JBPU is subject to the Final Utility Rule.

Boiler MACT Consistent with CAA Sections 112 and 112( n)( 1)( A), the Boiler MACT covers industrial, commercial and institutional boilers and process heaters that are not covered by CAA Section 112( n)( 1)( A). Specifically, Boiler MACT covers industrial, commercial and institutional boilers and process heaters at major facilities except for, inter alia:

An electric utility steam generating unit that is a fossil fuel fired combustion unit of more than 25 megawatts that serves a generator that produces electricity for sale. A fossil fuel fired unit that cogenerates steam and electricity, and supplies more than one { D0000414. DOC / 1} 7 third of its potential electric output capacity, and more than 25 megawatts electrical output to any utility power distribution system for sale is considered an electric utility steam generating unit.

40 C. F. R. § 63.7491( c) ( 2005). Because the JBPU's boilers are not greater than 25Mwe,

it is not subject to the above exemption. Consequently, the JBPU is covered by the Boiler MACT in addition to the Final Utility Rule.

Argument Inclusion of the JBPU in the Boiler MACT and the Final Utility Rule Violates EPA Precedent and EPA's Statements in the Utility and Boiler MACT Rulemakings that Electric Utility Steam Generating Units under CAA § 112( n)( 1)( A) Would Not Be Subject to Both the Final Utility Rule and Boiler MACT.

EPA's inclusion of small municipal boilers, such as the JBPU, in both the Final Utility Rule and the Boiler MACT violates EPA precedent and EPA's statements in this rulemaking that units would not be subject to both the Final Rule and the Boiler MACT.

EPA has consistently stated that units should not be subject to two MACT rules.

In the Boiler MACT, EPA reiterated that units would not be subject to both the Boiler MACT and the utility rulemaking. In the Boiler MACT, EPA stated that:

The final rule regulates source categories covering industrial boilers, institutional and commercial boilers, and process heaters. These source categories potentially include combustion units that are already regulated by other MACT standards. Therefore, we are excluding from the final rule any combustion units that are already or will be subject to regulation under another MACT standard . . . Electric utility steam generating units are not subject to the final rule. { D0000414. DOC / 1} 8 69 Fed. Reg. 55,218, 55,220 ( Sept. 13, 2004) ( emphasis supplied) . Throughout the Utility rulemaking, EPA has stated that units would not be subject to both the Final Rule and the Boiler MACT. Proposed Rule, 69 Fed. Reg. 4652, 4657 ( Jan. 30, 2004) ( The Boiler MACT regulations do not apply to Utility units, which are regulated " under CAA Section 112( n)( 1)( A) . . . because Section 112( n)( 1)( A) is uniquely applicable to Utility Units as defined in the CAA.")

In the Final Rule, EPA reiterated that it thought it had resolved the issue of units potentially covered by both Boiler MACT and the Final Utility Rule. The Final Utility Rule states that:

Because of the similarities in the design and operational characteristics of the units that would be regulated by the different combustion rules, there are situations where coal fired units potentially could be subject to multiple rules. An example of this situation would be cogeneration units that are covered under the proposed IB [ Boiler] rule, potentially meeting the definition of a Utility Unit, and vice versa. This might occur where a decision is made to increase/ decrease the proportion of production output being supplied to the electric utility grid, thus causing the unit to exceed the IB/ electric utility cogeneration criteria ( i. e. greater than one third of its potential output capacity and greater than 25 MWe). As discussed below, EPA has clarified the definitions and applicability provisions to lessen any confusion as to which rule a unit may be subject to.

Final Utility Rule, 70 Fed. Reg. at 28,609 ( emphasis supplied). EPA went on to explain that:

EPA received comment requesting clarification of the applicability definition relating to whether a unit would be classified as a Utility Unit or an IB. For the purposes of 40 CFR part 60, subpart Da, EPA believes that the definition being finalized today in 40 CFR part 60, subpart Da clearly defines two categories of new sources  Utility Units and non Utility Units ( which could include IB units, etc.). { D0000414. DOC / 1} 9 Final Utility Rule, 70 Fed. Reg. at 28,611 ( emphasis supplied).

Despite EPA's efforts to clarify the scope of the Boiler MACT and Final Utility Rule so that units would be subject to only one of the two rulemakings, a very limited number of units, including the JBPU, continue to be subject to both rules. The JBPU is subject to both rules because its boilers have never been rated over 25 MWe ( and thus it is covered by the Boiler MACT and not subject to the exemption from Boiler MACT for Utility units) but its generators have, in the past, served generators equal to or over 25 MWe, thus making it subject to the Final Utility Rule. The JBPU requests clarification and/ or reconsideration that it is only subject to either the Boiler MACT or the Final Utility Rules and not both rules. As discussed in more detail below, consistent with EPA's statements in the Boiler MACT and throughout the Utility MACT rulemaking until the final phase, the JPBU should be subject only to the Boiler MACT.

EPA's Failure To Provide Adequate Notice and Outreach to the Municipal Utilities Subject to Both the Final Utility Rule and Boiler MACT Violates the Unfunded Mandates Reform Act EPA's actions in this proceeding further violate the UMRA, which requires that agencies provide active outreach to municipal entities, and particularly small municipal entities potentially subject to rules, early in the rulemaking process. UMRA also requires that EPA to minimize the record keeping and regulatory impacts of its rules on small government entities. UMRA states that for actions that have significant or unique impacts on small government entities, EPA must: "( 1) provide notice of the requirements { D0000414. DOC / 1} 10 to potentially affected small governments . . . ; ( 2) enable officials of affected small governments to provide meaningful and timely input in the development of regulatory proposals containing significant Federal intergovernmental mandates; and ( 3) inform,

educate, and advise small governments on compliance with the requirements." 2 U. S. C.

§ 1533 ( 2000). EPA states in the Final Utility Rule that it has complied with UMRA's requirements. 70 Fed. Reg. at 28,645.3 Contrary to EPA's statements, for the small municipal utilities that are subject to both the Final Utility Rule and Boiler MACT, EPA has failed to provide outreach adequate to comply with UMRA. EPA was clear in the Boiler MACT rulemaking and the early stages of the Utility rulemaking that units such as the JBPU would be addressed in the Boiler MACT. Further, CAA Section 112( n)( 1)( A) made clear that these units could only be included in the Boiler MACT and not in the Final Utility Rule.

Consequently, the JBPU participated in the Boiler MACT rulemaking and not the Utility MACT rulemaking.

When there were first indications that EPA would be expanding the Final Utility Rule beyond the CAA Section 112( n)( 1)( A) definition, APPA4 specifically requested in its comments that EPA meet with the small number of units that this changed affected and obtain their input. APPA stated:

3 EPA states that it does not believe that it is subject to the Small Government outreach requirements because the rule will be implemented by the states. Nonetheless, by making small government entities subject to both Boiler MACT and the Final Utility Rule, and requiring states to impose requirements at least as stringent as the federal rules, the EPA has effectively subjected the JBPU to two duplicative and inconsistent rules.

4 JBPU participated in and supported APPA's Comments on this issue. { D0000414. DOC / 1} 11 APPA also requests that EPA confer with APPA and its members regarding the appropriate rule for the small number of governmentowned units that appear to be subject to both rules. . . . APPA requests that EPA consider the appropriate rulemaking in light of . . . the limited number of utilities potentially subject to both the Boiler MACT and the Utility rulemaking . . . APPA requests further discussions with EPA on this issue.

APPA Comments on the Supplemental Proposed Rule. Despite this request, to the best of JBPU's knowledge, EPA did not follow up with the municipals that are subject to both the Boiler MACT and the Final Utility Rule, or sought their input on these requirements.

EPA's actions in this rulemaking violate the letter and spirit of UMRA. While UMRA requires early and effective outreach by EPA to local governmental entities affected by a rulemaking, in this case EPA failed to provide early outreach to the municipals it is now subjecting to duplicative regulation. Further, when the municipalities covered by both the Boiler MACT and the Final Utility Rule raised their concerns and requested a meeting, EPA failed to meet with them and finalized the Utility Rule without addressing their concerns. The JBPU requests that EPA, through clarification or reconsideration address this problem by determining that municipals subject to duplicative regulation, such as the JPBU, are subject only to the Boiler MACT.

The JBPU Should, Consistent with CAA § 112( n)( 1)( A) and EPA's Statements in this Rulemaking, Be Subject Only to Boiler MACT Consistent with CAA Section 112 and 112( n)( 1)( A), as well as EPA's statements in the Boiler MACT and throughout the Utility MACT rulemaking until the final phase,

the JPBU should be subject to the Boiler MACT rather than the Final Utility Rule. { D0000414. DOC / 1} 12 The JBPU requests that in addition to clarifying that the JBPU is only subject to either the Final Utility Rule or the Boiler MACT ( not both), that EPA also determine that JBPU is subject to Boiler MACT. CAA Section 112 requires that the JBPU's units be regulated under a MACT standard. While CAA Section 112( n)( 1)( A) gives EPA the authority to exempt electric utility steam generating units ( defined as boilers over 25 MWe), it does not give EPA the authority to exempt units with boilers equal to or less than 25 MWe from MACT regulation. The JBPU's boilers are less than 25 MWe and therefore should be subject to MACT regulation. As a result, these boilers cannot be included in the Final Utility Rule.

Consistent with CAA Section 112( n)( 1)( A), EPA in the Boiler MACT and early Utility rulemakings has included units with boilers less than 25 MWe but generators greater than 25 MWe in the Boiler MACT. The Boiler MACT rulemaking,

the CAA § 112( n)( 1)( A) Report to Congress for Utilities, the information gathering efforts in the Utility rulemaking, and the early phase of the proposed Utility rule included these units in Boiler MACT. These units should continue to be subject to the requirements of Boiler MACT.

The clarification necessary to make these units subject to only Boiler MACT can be implemented in a variety of ways, including cross referencing the Boiler MACT in the Final Utility Rule to explain that units covered in the Boiler MACT are not subject to the Final Utility Rule. The JBPU recommends that EPA amend Section 60.4101( a) to add an { D0000414. DOC / 1} 13 additional exclusion in subsection ( c). Specifically, the JBPU recommends the following underlined language be added to Section 60.4101:

The following units in a State shall be Hg Budget units, and any source that includes one or more such units shall be a Hg Budget source, subject to the requirements of this subpart: ( a) Except as provided in paragraphs ( b) and ( c) of this section, a unit serving at any time, since the start up of the unit's combustion chamber, a generator with nameplate capacity of more than 25 MWe producing electricity for sale.

( b) For a unit that qualifies as a cogeneration unit during the 12 month period starting on the date the unit first produces electricity and continues to qualify as a cogeneration unit, a cogeneration unit serving at any time a generator with nameplate capacity of more than 25 MWe and supplying in any calendar year more than onethird of the unit's potential electric output capacity or 219,000 MWh, whichever is greater, to any utility power distribution system for sale. If a unit qualifies as a cogeneration unit during the 12 month period starting on the date the unit first produces electricity but subsequently no longer qualifies as a cogeneration unit, the unit shall be subject to paragraph ( a) of this section starting on the day on which the unit first no longer qualifies as a cogeneration unit. ( c) Units regulated under 40 C. F. R. Part 63, Subpart DDDDD.

In the alternative, the JBPU requests that EPA provide clarification or an applicability determination for the limited number of units, including the JBPU, that are subject to regulation under both rules. JBPU request that EPA determine in any such clarification or applicability determination that the JBPU is subject to only to the Boiler MACT.

Dated: July 18, 2005 Respectfully submitted,

_____________________________ Tanja Shonkwiler Duncan, Weinberg, Genzer & { D0000414. DOC / 1} 14 Pembroke, P. C. 1615 M Street, N. W. Suite 800 Washington, D. C. 20036 ( 202) 467 6370 tms@ dwgp. com Attorney for the Jamestown Board Of Public Utilities