[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20509-20513]
[FR Doc No: 2011-8815]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1998-F-0072] (Formerly 98F-0165)

Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; denial of requests for a hearing and response to
objections.

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

SUMMARY: The Food and Drug Administration (FDA) is responding to
objections and is denying requests that it received for a hearing on
the final rule that amended the food additive regulations to provide
for the safe use of ionizing radiation for the reduction of Salmonella
in fresh shell eggs. After reviewing objections to the final rule and
requests for a hearing, the Agency has concluded that the objections do
not raise issues of material fact that justify a hearing or otherwise
provide a basis for revoking or modifying the amendment to the
regulation.

FOR FURTHER INFORMATION CONTACT: Teresa A. Croce, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of March 20, 1998 (63 FR 13675), FDA
published a notice announcing the filing of a food additive petition
(FAP), FAP 8M4584, submitted by Edward S. Josephson, University of
Rhode Island, Food Science and Nutrition Research Center, to amend the
regulations in part 179, Irradiation in the Production, Processing, and
Handling of Food (21 CFR part 179), to provide for the safe use of
ionizing radiation for the reduction of Salmonella in fresh shell eggs.
In response to the petition, FDA issued a final rule in the Federal
Register of July 21, 2000 (65 FR 45280), permitting the irradiation of
fresh shell eggs for the reduction of Salmonella at doses not to exceed
3.0 kiloGray (kGy) (hereafter referred to as the ``egg irradiation
rule''). FDA based its decision on data in the petition and in its
files. In the preamble to the final rule, FDA outlined the basis for
its decision and stated that objections to the final rule and requests
for a hearing were due within 30 days of the

publication date (i.e., by August 21, 2000).

II. Objections and Requests for a Hearing

    Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after
publication of an order relating to a food additive regulation, any
person adversely affected by such order may file objections,
``specifying with particularity the provisions of the order deemed
objectionable, stating reasonable grounds therefor, and requesting a
public hearing upon such objections.''
    Under 21 CFR 171.110 of the food additive regulations, objections
and requests for a hearing are governed by part 12 (21 CFR part 12) of
FDA's regulations. Under Sec.  12.22(a), each objection must meet the
following conditions: (1) Must be submitted on or before the 30th day
after the date of publication of the final rule; (2) must be separately
numbered; (3) must specify with particularity the provision of the
regulation or proposed order objected to; (4) must specifically state
each objection on which a hearing is requested; failure to request a
hearing on an objection constitutes a waiver of the right to a hearing
on that objection; and (5) must include a detailed description and
analysis of the factual information to be presented in support of the
objection if a hearing is requested; failure to include a description
and analysis for an objection constitutes a waiver of the right to a
hearing on that objection.
    Following publication of the final rule permitting the irradiation
of fresh shell eggs for the reduction of Salmonella, FDA received 26
submissions with objections to the rule within the 30-day objection
period. All but one of these submissions either expressed general
opposition to the final rule, or objected to the rule based on issues
that are outside the rule's scope such as the living conditions and
practices in commercial egg production. Although most of these letters
requested a hearing, no evidence was identified in support of any of
these objections that could be considered in an evidentiary hearing
(Sec.  12.22(a)(5)). Therefore, these objections do not justify a
hearing.\1\ The Agency will not discuss these submissions further. The
one submission raising specific objections was a letter from Public
Citizen (letter to Docket No. 98F-0165, August 17, 2000). The letter
from Public Citizen sought revocation of the final rule based on five
objections and requested a hearing on issues raised by each objection.
A more detailed response to Public Citizen's objections is found in
section IV of this document. In addition, FDA also received one letter
in support of the egg irradiation rule.
---------------------------------------------------------------------------

    \1\ FDA also received letters after the close of the objection
period that expressed general opposition to the egg irradiation
rule. Tardy objections fail to satisfy the requirements of 21 U.S.C.
348(f)(1) and need not be considered by the Agency (see ICMAD v.
HEW, 574 F.2d 553, 558 n.8 (D.C. Cir), cert. denied, 439 U.S. 893
(1978)).
---------------------------------------------------------------------------

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request
for a hearing are set out in Sec.  12.24(b). Under that regulation, a
hearing will be granted if the material submitted by the requester
shows, among other things, the following: (1) There is a genuine and
substantial factual issue for resolution at a hearing; a hearing will
not be granted on issues of policy or law; (2) the factual issue can be
resolved by available and specifically identified reliable evidence; a
hearing will not be granted on the basis of mere allegations or denials
or general descriptions of positions and contentions; (3) the data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
requestor; a hearing will be denied if the data and information
submitted are insufficient to justify the factual determination urged,
even if accurate; and (4) resolution of the factual issue in the way
sought by the person is adequate to justify the action requested; a
hearing will not be granted on factual issues that are not
determinative with respect to the action requested (e.g., if the action
would be the same even if the factual issue were resolved in the way
sought).
    A party seeking a hearing is required to meet a ``threshold burden
of tendering evidence suggesting the need for a hearing'' (Costle v.
Pac. Legal Found., 445 U.S. 198, 214 (1980), reh. denied, 446 U.S. 947
(1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S.
609, 620-21 (1973)). An allegation that a hearing is necessary to
``sharpen the issues'' or to ``fully develop the facts'' does not meet
this test (Georgia-Pacific Corp. v. U.S. EPA, 671 F.2d 1235, 1241 (9th
Cir. 1982)). If a hearing request fails to identify any factual
evidence that would be the subject of a hearing, there is no point in
holding one. In judicial proceedings, a court is authorized to issue
summary judgment without an evidentiary hearing whenever it finds that
there are no genuine issues of material fact in dispute and a party is
entitled to judgment as a matter of law (see Fed. R. Civ. P. 56). The
same principle applies in administrative proceedings (see Sec.  12.24).
    A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact ``concerning which a meaningful
hearing might be held'' (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083,
1085 (9th Cir. 1982)). Where the issues raised in the objection are,
even if true, legally insufficient to alter the decision, the Agency
need not grant a hearing (see Dyestuffs and Chemicals, Inc. v.
Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911
(1960)). A hearing is justified only if the objections are made in good
faith and if they ``draw in question in a material way the
underpinnings of the regulation at issue'' (Pactra Industries v. CPSC,
555 F.2d 677, 684 (9th Cir. 1977)). A hearing need not be held to
resolve questions of law or policy (see Citizens for Allegan County,
Inc. v. FPC, 414 F.2d 1125, 1128 (D.C. Cir. 1969); Sun Oil Co. v. FPC,
256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S. 872 (1958)).
    Even if the objections raise material issues of fact, FDA need not
grant a hearing if those same issues were adequately raised and
considered in an earlier proceeding. Once an issue has been so raised
and considered, a party is estopped from raising that same issue in a
later proceeding without new evidence. The various judicial doctrines
dealing with finality, such as collateral estoppel, can be validly
applied to the administrative process (see Pac. Seafarers, Inc. v. Pac.
Far East Line, Inc., 404 F.2d 804, 809 (D.C. Cir. 1968), cert. denied,
393 U.S. 1093 (1969)). In explaining why these principles ought to
apply to an agency proceeding, the U.S. Court of Appeals for the
District of Columbia Circuit wrote: ``The underlying concept is as
simple as this: Justice requires that a party have a fair chance to
present his position. But overall interests of administration do not
require or generally contemplate that he will be given more than a fair
opportunity.'' Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316,
322 (D.C. Cir. 1972); see also Costle v. Pac. Legal Found., 445 U.S. at
215-17).

IV. Analysis of Objections and Response to Hearing Requests

    The letter from Public Citizen contains five numbered objections
and requests a hearing on each of them. FDA addresses each of the
objections in this document, as well as the evidence and information
filed in support of each, comparing each objection and the information
submitted in support of it to

the standards for granting a hearing in Sec.  12.24(b).

A. Findings of Study Co-Authored by Donald Thayer

    The first objection raised by Public Citizen in response to this
rule contends that the Agency misrepresented the findings of the 1990
study co-authored by Donald Thayer (Ref. 1). Specifically, the rule (65
FR 45280 at 45281) states, ``* * * S. enteritidis was found to have
similar sensitivities to ionizing radiation as five other strains of
Salmonella'' (S. is referring to Salmonella) when, in the original
study, Thayer et al. state, ``S. enteritidis was significantly more
resistant to ionizing radiation than the other five strains of
Salmonella tested * * *.'' Public Citizen asserts that by stating the
findings in this manner FDA gives ``* * * the false impression that the
same level of radiation can be used to eliminate S. enteritidis as
other strains of Salmonella.''
    The full sentence in the final rule states that ``Salmonella
strains, in addition to S. enteritidis, in fresh shell eggs should also
be reduced by irradiation since S. enteritidis was found to have
similar sensitivities to ionizing radiation as five other strains of
Salmonella * * *.'' (65 FR 45280 at 45281). The reasoning supporting
the statement's conclusion is that because irradiation reduces S.
enteritidis it would be expected to reduce other strains of Salmonella.
To the extent that S. enteritidis is more resistant to ionizing
radiation than the other strains, the conclusion is strengthened.
Further, FDA made clear in the final rule that irradiation of fresh
shell eggs at the doses requested in the petition will reduce, but not
entirely eliminate, microorganisms in eggs (65 FR 45280 at 45281).
    FDA evaluated data provided by the petitioner on the absorbed
radiation required to achieve inactivation of S. enteritidis in shell
eggs. The data showed that irradiation at a dose as low as 1 kGy
reduces the viability of S. enteritidis by 3-log10 (99.9
percent reduction) (Ref. 2). These data are comparable to the results
seen by Thayer, et al., in a similar medium inoculated with S.
enteritidis, which showed a 3- to 4-log10 reduction of this
pathogen at a dose of 1 kGy (Ref. 1). Furthermore, the standards for
microbiological safety of fresh shell eggs are independent of the final
rule permitting the irradiation of fresh shell eggs. Irradiation is a
potential control point in the mitigation of S. enteritidis and other
food-borne pathogens. The rule is not predicated on the approved
treatment, by itself, resulting in fresh shell eggs that are pathogen-
free. FDA is denying the request for a hearing on this point because
the action would be the same even if the factual issue were resolved in
the manner sought (Sec.  12.24(b)(4)).

B. Vitamin A Loss

    In the egg irradiation final rule, FDA states that the vitamin A
retention resulting from the irradiation of shell eggs at a maximum
absorbed dose of 1.0 kGy (65 FR 45280 at 45281) yields a relative
retention rate of 76 percent following a 24-day storage period. Public
Citizen asserts that the final rule misrepresents the vitamin A loss
from fresh shell eggs following irradiation at 3.0 kGy because FDA
based these conclusions on vitamin A loss from the results of a study
that used a maximum dose of 1.0 kGy compared to the maximum petitioned
dose of 3.0 kGy, whereas another study in the petition showed that
vitamin A retention by the eggs irradiated at 3.1 kGy and stored for 2,
15, and 33 days was 41.8 percent, 35.5 percent, and 20.1 percent,
respectively (Refs. 3 and 4).
    The studies that Public Citizen refers to were included in the
petition and were analyzed and considered when making the safety
assessment. FDA acknowledges that stating a vitamin A retention in the
range of 20.1 to 35.5 percent is more appropriate in light of the
maximum petitioned dose. Importantly, in its review of the petition,
FDA considered the health implications from vitamin A loss in eggs at
the maximum petitioned dose and concluded that the effect on health
from this vitamin loss is not significant because a variety of foods
provide vitamin A and the intake of other foods can compensate for any
loss (Refs. 5 and 6).
    The issue raised by Public Citizen must be a material issue
concerning which a meaningful hearing might be held (Pineapple Growers
Ass'n v. FDA, 673 F.2d at 1085). The Agency recognizes that irradiation
can produce nutrient losses under some conditions and has concluded
that such effects are not a safety concern under the conditions of this
regulation. To justify a hearing on the vitamin A issue, Public Citizen
must provide evidence that the nutritional loss in a food irradiated
under the conditions of this regulation raises a safety concern because
of its cumulative effect on the human diet (see 21 U.S.C.
348(c)(5)(B)). While FDA has the ultimate burden of proof when it
approves the use of a food additive, once the Agency makes a finding of
safety in a listing document, the burden shifts to an objector to come
forward with evidence that raises a material issue of fact with regard
to FDA's conclusion (American Cyanamid Co. v. FDA, 606 F.2d 1307, 1314
(DC Cir. 1979)). Public Citizen has submitted no information to support
that vitamin A loss in fresh shell eggs irradiated under the conditions
of the regulation is a safety concern. Therefore, this objection does
not raise a genuine and substantial issue of fact for resolution at a
hearing. FDA is denying the request for a hearing on this point because
a hearing will not be granted if there is no genuine and substantial
factual issue to be resolved (Sec.  12.24(b)(1)).

C. Analysis of Effects of Irradiation on Egg Yolk Carotenoids

    Public Citizen asserts that FDA's analysis regarding the effects of
irradiation on egg yolk carotenoids is flawed because the information
used to analyze the nutritional information of egg yolk carotenoids is
based on doses of 0.5 kGy and 1.0 kGy, not the petitioned maximum of
3.0 kGy.
    FDA acknowledges that Agency's analysis of the effects of
irradiation on egg yolk carotenoids was based on studies performed at
lower doses than the petitioned maximum dose of 3.0 kGy; however,
because there are a number of commonly consumed foods that are
substantial sources of carotenoids in the diet, including yellow corn,
carrots, and squash (Ref. 7), FDA has no health concerns about the loss
of carotenoids in the diet from the irradiation of eggs. Public
Citizen's request for hearing suggests that there is potential for harm
from the loss of carotenoids resulting from the irradiation of shell
eggs, without providing any evidence to support this suggestion. An
objector must make an adequate proffer of evidence to support its
allegations and to show that they provide a basis on which to call into
question the Agency's conclusions. A hearing will be denied if the
Commissioner of Food and Drugs (the Commissioner) concludes that the
data and information submitted are insufficient to justify the factual
determination urged, even if accurate (Sec.  12.24(b)(3)). FDA
concludes that the data and information are insufficient; therefore,
FDA is denying the request for a hearing based on this objection.

D. Request for Updated Analysis for Irradiation of Fresh Shell Eggs Not
To Exceed 3.0 kGy

    Public Citizen objects to the egg irradiation final rule on the
grounds that the Agency did not adequately update ``[n]umerous issues
raised in the two initial analysis [sic]'' after the petition

was amended to allow for doses up to 3.0 kGy from 1.7 kGy.
    When the petition (FAP 8M4584) was originally submitted, the
maximum petitioned dose was 1.7 kGy. The petition was subsequently
amended to increase the maximum dose to 3.0 kGy and additional
chemistry and toxicology reviews were performed by FDA following this
amendment. Based on these reviews, FDA concluded that the 3.0 kGy dose
for shell eggs did not change the general conclusions from the original
reviews (Refs. 3 and 6). Public Citizen neither specifies the
``[n]umerous issues'' nor does it provide any information that would
cause the Agency to change its conclusion that the consumption of
irradiated shell eggs is safe.
    A hearing will be denied if the Commissioner concludes that the
data and information submitted are insufficient to justify the factual
determination urged, even if accurate (Sec.  12.24(b)(3)). FDA
concludes that the data and information are insufficient; therefore,
FDA is denying the request for a hearing based on this objection.

E. Bureau of Foods Irradiated Food Committee Report of 1980

    Public Citizen alleges that FDA failed to follow all of the
recommendations put forth in 1980 by the Bureau of Foods Irradiated
Food Committee (BFIFC) regarding the evaluation of irradiated foods.
Specifically, Public Citizen quotes the following from a BFIFC report:
``Foods irradiated at doses above 100 Krad [1 kGy] and comprising more
that 0.01% of the diet are estimated to contain URPs [Unique Radiolytic
Products] in sufficient quantity to warrant toxicological evaluation. *
* * [T]ests must be performed on extracts in which the concentration of
radiolytic products is maximized'' (Ref. 8).
    Public Citizen then states that there is no indication in the egg
irradiation rule or its references that such tests were conducted or
reviewed by the FDA before the petition was approved.
    The assertion that FDA failed to comply with recommendations set
forth by the BFIFC committee has been raised previously by Public
Citizen and others and has been responded to by the Agency in the
molluscan shellfish final rule (70 FR 48057 at 48069, August 16, 2005)
and in other previous rulemakings regarding the irradiation of food
(see, e.g., 53 FR 53176 at 53179, December 30, 1988, and 62 FR 64102 at
64105, December 3, 1997).
    As discussed previously, the BFIFC report was an internal document
prepared by FDA scientists that provided recommendations for evaluating
the safety of irradiated foods based on the known effects of food
irradiation and on the capabilities of toxicological testing. The
report was made available to the public for comment in the Federal
Register of March 27, 1981 (46 FR 18992). While the report and the
comments received on it have aided FDA's thinking regarding the safety
testing of irradiated foods, the report established no requirements.
Furthermore, FDA has not adopted regulations that require toxicological
testing of a food additive if that additive constitutes a certain
portion of the diet, and Public Citizen has not cited any regulation
that imposes such a requirement.
    In addition, the understanding of radiolytic products produced by
the irradiation of foods has evolved since 1980. As noted in the egg
irradiation final rule, ``[m]ost of the radiolysis products [of shell
egg irradiation up to 3kGy] are either the same as, or structurally
similar to, compounds found in foods that have not been irradiated, and
are formed in very small amounts.'' (65 FR 45280). Similarly, in the
Federal Register of December 3, 1997, for the Agency rulemaking on
irradiation of refrigerated or frozen uncooked meat, meat byproducts,
and certain meat food products to control food-borne pathogens and
extend product shelf-life, FDA concluded that, ``[i]n irradiated flesh
foods, most of the radiolytic products derived from proteins have the
same chemical composition but are altered in their secondary and
tertiary structures. These changes are similar to those that occur as a
result of heating, but in the case of irradiation, such changes are far
less pronounced and the amounts of reaction products generated are far
lower.'' (62 FR 64107 at 64110, December 3, 1997).
    Consistent with section 409 of the FD&C Act, the Agency's decision
on the safety of the irradiation of fresh shell eggs was based on the
entire record. FDA reviewed and evaluated studies submitted in the
petition as well as additional toxicology studies of irradiated foods,
including red meat, chicken, fish and eggs, which are available in
Agency files. Included in the data considered by the FDA in review of
the petition were at least three studies conducted specifically on
irradiated eggs.
    Once the Agency makes a finding of safety in an approval document,
the burden shifts to an objector to come forward with evidence that
calls into question FDA's conclusion (see Sec.  12.24(b)(2)). Although
Public Citizen alleged that the rule did not comply with the
recommendations in the BFIFC report, Public Citizen did not present any
evidence that these alleged inconsistencies, even if true, would have
led to a different conclusion concerning the safety of irradiation of
fresh shell eggs. Therefore, FDA is denying this objection and request
for a hearing because it raises no factual issue that, even if resolved
in the way sought by the objection, would justify the action requested
(Sec.  12.24(b)(4)).

V. Summary and Conclusion

    Section 409 of the FD&C Act requires that a food additive be shown
to be safe prior to marketing. Under 21 CFR 170.3(i), a food additive
is ``safe'' if ``there is a reasonable certainty in the minds of
competent scientists that the substance is not harmful under the
intended conditions of use.'' In the Agency's July 21, 2000, final rule
approving the use of irradiation of fresh shell eggs, FDA concluded,
based on its evaluation of the data submitted in the petition and other
relevant material, that this use of irradiation is safe for its
intended use for the reduction of Salmonella in fresh shell eggs.
    The petitioner has the burden to demonstrate the safety of the
additive to gain FDA approval. However, once FDA makes a finding of
safety in an approval document, the burden shifts to an objector, who
must come forward with evidence that calls into question FDA's
conclusion (see section 409(f)(1) of the FD&C Act).
    Despite its allegations, Public Citizen has not established that
FDA overlooked significant information in the record while reaching its
conclusion that the use of irradiation for reduction of Salmonella in
fresh shell eggs is safe. Therefore, the Agency has determined that the
objections requesting a hearing do not raise any genuine and
substantial issue of fact that would justify an evidentiary hearing
(Sec.  12.24(b)). Accordingly, FDA is not making any changes in
response to the objections and is denying the requests for a hearing.

VI. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20857, under Docket No. FDA-1998-F-0072
(formerly 98F-0165) and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site
address, but FDA is not responsible for any subsequent changes to the
Web site after this document publishes in the Federal Register.)

1. Thayer, D. W., G. Boyd, W.S. Muller, et al. ``Radiation
resistance of Salmonella,'' Journal of Industrial Microbiology, 5:
383-390, 1990.
2. Memorandum for FAP 8M4584 from V. K. Bunning, FDA, to W. Trotter,
FDA, April 4, 2000.
3. Memorandum for FAP 8M4584 from K. Morehouse, FDA, to W. Trotter,
FDA, April 11, 2000.
4. Memorandum for FAP 8M4584 from K. Morehouse, FDA, to W. Trotter,
FDA, May 14, 1999.
5. Memorandum for FAP 8M4584 from I. Chen, FDA, to W. Trotter, FDA,
December 11, 1998.
6. Memorandum for FAP 8M4584 from I. Chen, FDA, to W. Trotter, FDA,
March 31, 2000.
7. U.S. Department of Agriculture, Agricultural Research Service,
USDA National Nutrient Database for Standard Reference, Release 23,
Nutrient Data Laboratory Home Page (http://www.ars.usda.gov/ba/bhnrc/ndl), 2010.
8. Bureau of Foods Irradiated Foods Committee, Recommendations for
Evaluating the Safety of Irradiated Food, Prepared for the Director,
Bureau of Foods, FDA, July 1980.

    Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8815 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 177 (Tuesday, September 13, 2011)]
[Notices]
[Page 56463]
[FR Doc No: 2011-23331]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4019-DR; Docket ID FEMA-2011-0001]

North Carolina; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Carolina (FEMA-4019-DR), dated August 31, 2011,
and related determinations.

DATES: Effective Date: September 4, 2011.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Carolina is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of August 31, 2011.

    Gates, Hertford, Johnston, Northampton, and Vance Counties for
Individual Assistance.
    Bertie, Brunswick, Camden, Chowan, Duplin, Edgecombe, Martin,
New Hanover, Pasquotank, and Perquimans Counties for Individual
Assistance (already designated for Public Assistance).

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-23331 Filed 9-12-11; 8:45 am]
BILLING CODE 9111-23-P


? Need to return call by / at/ between and . Signature: Project No.: 0172.01.005 DISTRIBUTION Page __ 1_ of _ 1_

Project Name: 2004/ 2005 304( m) Plan TELEPHONE CALL RECORD Outgoing Call Date: 01/ 16/ 04 Time: 12: 30 PM Company Name: Mississippi Phosphate Corp, Pascagoula, MS Contact Name: Jim Smith Phone No.: ( 228) 712 3347 Name: Arash Hooshangi Eastern Research Group, Inc.

GENERAL SUBJECT : Clarification of Manufacturing Processes and Pollutant Discharges TOPICS DISCUSSED AND ACTION TAKEN I called the Mississippi Phosphate Corporation, in Pascagoula, MS and spoke with Jim Smith on Friday, Jan. 16, 2004. I had two main questions: 1) Under which part of 40 CFR is this facility regulated? and 2) What affects the mass of pollutant discharges from year to year?

Mr Smith was quite familiar with the 40 CFR regulations and noted that this facility is regulated under 40 CFR 418 ( Fertilizer Manufacturing). He also mentioned that their SIC code is 2784. Mr. Smith stated that there are three manufacturing plants at this location: a sulfuric acid plant, a phosphoric acid plant, and a diammonia phosphate plant. He also mentioned that they produce no surperphosphates and no mixed blends. We discussed each of the subcategories for both 40 CFR 418 and 40 CFR 422 ( Phosphate Manufacturing) and confirmed that this facility is regulated under subcategory A of 40 CFR 418. Mr. Smith assured me that they currently produce no other products that fall under other categories. In the past, this facility used to produce mixed blends and was regulated under both subcategory A and subcategory G of 40 CFR 418. However, the mixed blend operations ceased before 2000.

I also asked Mr. Smith about their reported pollutant discharges and why they fluctuate from year to year. Mr. Smith explained that the facility operates a 1.5 MGD treatment system, primarily for the control of fluoride. However, the facility is located on the gulf and periodically receives significant rainfall. The normal annual precipitation for their area is around 65 inches but some years it exceeds 100 inches. The wastewater treatment system is unable to handle the increased flow during these periods of heavy rainfall. The facility's NPDES permit includes a provision that allows emergency discharges of partially treated wastewater, which explains periods of higher mass pollutant discharge.

Mr. Smith also noted that their NPDES permits includes limitations on ammonia ( imposed by the state) and fluoride and total suspended solids ( federal regulations).


 From:       Richard Krock<EMAIL_ADDRESS>

  To:         Jodi Howard/RTP/USEPA/US@EPA

  Date:       11/02/2009 09:50 AM

  Subject:    VI Letter Re: Resin Testing for PVC MACT

Dear Ms. Howard,

The attached letter was prepared on behalf of The Vinyl Institute
members to bring to the Agency’s attention certain challenges related to
testing PVC resin in response to the PVC MACT Section 114 Request.
Please do not hesitate to contact me with any questions.  Thank you.

*Please note our new contact information*

Richard Krock
Technical Director

The Vinyl Institute
1737 King Street Suite 390
Alexandria, VA 22314
Direct:<PHONE_NUMBER>
Mobile:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
Email<EMAIL_ADDRESS>http://www.vinylinfo.org
http://www.vinylindesign.com

(See attached file: VI Letter to EPA PVC MACT Resin Testing VI Work
Group Discussion 11-2-09 PDF.pdf)(Embedded image moved to file:
pic13490.jpg)VI Logo


previous rulemakings, FMCSA identified for-hire carriers with fewer
than 145 power units (i.e., trucks or tractors) as small. Thus, all of
the for-hire carriers in Brackets 1 through 4 would be considered
small, as would many of those in Bracket 5.
    Carriers are not required to report revenue to the Agency, but are
required to provide the Agency with the number of power units they
operate when they apply for operating authority and to update this
figure biennially. Because FMCSA does not have direct revenue figures,
power units serve as a proxy to determine the carrier size that would
qualify as a small business given the SBA's revenue threshold. In order
to produce this estimate, it is necessary to determine the average
revenue generated by a power unit. With regards to truck power units,
the Agency determined in the 2003 Hours of Service Rulemaking RIA \12\
that a power unit produces about $172,000 in revenue

annually (adjusted for inflation).\13\ According to the SBA, motor
carriers with annual revenue of $25.5 million are considered a small
business.\14\ This equates to 148 power units (25,500,000/172,000).
Thus, FMCSA considers motor carriers with 148 power units or less to be
a small business for SBA purposes.
---------------------------------------------------------------------------

    \12\ Regulatory Analysis for: Hours of Service of Drivers;
Driver Rest and Sleep for Safe Operations, Final Rule--Federal Motor
Carrier Safety Administration. 68 FR 22456--Published 4/23/2003.
    \13\ The 2000 TTS Blue Book of Trucking Companies, number
adjusted to 2008 dollars for inflation.
    \14\ U.S. Small Business Administration Table of Small Business
Size Standards matched to North American Industry Classification
(NAIC) System codes, effective August 22, 2008. See NAIC subsector
484, Truck Transportation.
---------------------------------------------------------------------------

    With regards to bus power units, the Agency conducted a preliminary
analysis to estimate the average number of power units (PUs) for a
small entity earning $7 million annually, based on an assumption that a
passenger carrying CMV generates annual revenues of $150,000. This
estimate compares reasonably to the estimated average annual revenue
per power unit for the trucking industry ($172,000). A lower estimate
was used because buses generally do not accumulate as many vehicle
miles traveled (VMT) per power units as trucks,\15\ and it is assumed
therefore that they would generate less revenue on average. The
analysis concluded that passenger carriers with 47 PUs or fewer
($7,000,000 divided by $150,000/PU = 46.7 PU) would be considered small
entities. The Agency then looked at the number and percentage of
passenger carriers registered with FMCSA that would fall under that
definition (of having 47 PUs or less). The results show that 28,838
\16\ (or 99%) of all active registered passenger carriers have 47 PUs
or less. Therefore, the overwhelming majority of passenger carriers
would be considered small entities.
---------------------------------------------------------------------------

    \15\ FMCSA Large Truck and Bus Crash Facts 2008, Tables 1 and
20; http://fmcsa.dot.gov/facts-research/LTBCF2008/Index-2008Large_
TruckandBusCrashFacts.aspx.
    \16\ FMCSA MCMIS snapshot on 2/19/2010.
---------------------------------------------------------------------------

    After careful consideration, however, FMCSA has determined that the
recommended UCR fee will, in every case involving a viable small
entity, be well below the threshold level of one percent of revenues
used for determining significant impacts. This conclusion is based the
observation that the maximum fee per vehicle is $76, which is less than
one percent of the $14,500 annual salary of even a single employee
working 40 hours per week for 50 weeks per year and earning the current
Federal minimum wage of $7.25.\17\ Because an entity without sufficient
revenues to pay even one employee per vehicle would not be viable, it
is clear that the recommended UCR fees will not reach the threshold of
one percent of revenues. Thus, FMCSA certifies that the rule will not
have a significant economic impact on a substantial number of small
entities.
---------------------------------------------------------------------------

    \17\ The Fair Labor Standards Act (FLSA) establishes minimum
wage, overtime pay, recordkeeping, and youth employment standards
affecting employees in the private sector and in Federal, State, and
local governments. Covered nonexempt workers are entitled to a
minimum wage of not less than $7.25 per hour effective July 24,
2009. http://www.dol.gov/esa/whd/flsa/.
---------------------------------------------------------------------------

    Several commenters addressed the impact of the change in the fees
on small entities. A carrier with 11 tractors noted that its costs are
spread over fewer assets than those of larger companies. The carrier
also said that any further cost increases will drive smaller companies
out of business. The American Bus Association said that the average bus
operator has eight motorcoaches, and described the operator as a small
business that would be impacted by the fees. FMCSA cannot validate this
and therefore did not include this in the analysis. In contrast,
another carrier approved of the proposed fee structure because it would
benefit owner-operators and small trucking companies.
    Based on this analysis as well as the rule's regulatory evaluation,
FMCSA certifies that the rule will not have a significant economic
impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4; 2 U.S.C.
1532) requires each agency to assess the effects of its regulatory
actions on State, local, and tribal governments and the private sector.
Any agency promulgating a final rule likely to result in a Federal
mandate requiring expenditures by a State, local, or tribal government,
or by the private sector of $136.1 million or more in any one year,
must prepare a written statement incorporating various assessments,
estimates, and descriptions that are delineated in the Act. FMCSA has
determined that this rule will not have an impact of $136.1 million or
more in any one year.

Executive Order 12988 (Civil Justice Reform)

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Executive Order 13045 (Protection of Children)

    FMCSA has analyzed this rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. FMCSA has determined that this rulemaking would not create an
environmental risk to health or safety that would disproportionately
affect children.

Executive Order 12630 (Taking of Private Property)

    This rule would not affect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Executive Order 13132 (Federalism)

    This rule has been analyzed in accordance with the principles and
criteria contained in Executive Order 13132. FMCSA has determined that
this rulemaking would not have a substantial direct effect on States,
nor would it limit the policy-making discretion of the States. Nothing
in this proposal would preempt any State law or regulation. As detailed
above, the UCR Board of Directors includes substantial State
representation. The States have already had notice of this action and
opportunity for input through their representatives and through
comments submitted on the NPRM. FMCSA received comments from the States
that failure to promulgate this rule would have a substantial direct
effect on the States as outlined in Executive Order 13132.

Executive Order 12372 (Intergovernmental Review)

    The regulations implementing Executive Order 12372 regarding
intergovernmental consultation on Federal programs and activities do
not apply to this program.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that FMCSA consider the impact of paperwork and other information
collection burdens imposed on the public. FMCSA has determined that
there are no current or new information collection requirements by
FMCSA associated with this rule.

National Environmental Policy Act

    The Agency analyzed this final rule for the purpose of the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) and
determined under our environmental procedures Order 5610.1, issued
March 1, 2004 (69 FR 9680), that this action is categorically excluded
(CE) under Appendix 2, paragraph 6.h of the Order from further
environmental

documentation. The CE under Appendix 2, paragraph 6.h relates to
establishing regulations and actions taken pursuant to the regulations
implementing procedures to collect fees that will be charged for motor
carrier registrations and insurance.
    FMCSA has also analyzed this rule under the Clean Air Act, as
amended (CAA), section 176(c) (42 U.S.C. 7401 et seq.), and
implementing regulations promulgated by the Environmental Protection
Agency. Approval of this action is exempt from the CAA's General
Conformity requirement since it involves policy development.

Executive Order 13211 (Energy Effects)

    FMCSA has analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. FMCSA has determined that it would not be a
``significant energy action'' under that Executive Order because it
would not be likely to have a significant adverse effect on the supply,
distribution, or use of energy.

List of Subjects in 49 CFR Part 367

    Commercial motor vehicle, Financial responsibility, Motor carriers,
Motor vehicle safety, Registration, Reporting and recordkeeping
requirements.

0
For the reasons discussed in the preamble, the Federal Motor Carrier
Safety Administration is amending title 49 CFR Chapter III, subchapter
B, part 367 as follows:

PART 367--STANDARDS FOR REGISTRATION WITH STATES

0
1. Revise the authority citation for part 367 to read as follows:

    Authority: 49 U.S.C. 13301, 14504a; and 49 CFR 1.73.

Subpart A--[Removed and Reserved]

0
2. Remove and reserve subpart A, consisting of Sec. Sec.  367.1 through
367.7 and Appendix A to subpart A.

Subpart B--Fees Under the Unified Carrier Registration Plan and
Agreement

0
3. Amend subpart B by revising the heading of Sec.  367.20 to read as
follows:

Sec.  367.20  Fees Under the Unified Carrier Registration Plan and
Agreement for Each Registration Year Until Any Subsequent Adjustment in
the Fees Becomes Effective.

* * * * *

0
4. Add Sec.  367.30 to subpart B to read as follows:

Sec.  367.30  Fees Under the Unified Carrier Registration Plan and
Agreement for Registration Years Beginning in 2010.

            Fees Under the Unified Carrier Registration Plan and Agreement for Each Registration Year
----------------------------------------------------------------------------------------------------------------
                                                                               Fee per entity
                                                Number of commercial motor      for exempt or
                                               vehicles owned or operated by  non-exempt motor   Fee per entity
                   Bracket                      exempt or non-exempt motor     carrier, motor     for broker or
                                                  carrier, motor private      private carrier,   leasing company
                                               carrier, or freight forwarder     or freight
                                                                                forwarder
----------------------------------------------------------------------------------------------------------------
B1..........................................  0-2...........................               $76               $76
B2..........................................  3-5...........................               227  ................
B3..........................................  6-20..........................               452  ................
B4..........................................  21-100........................             1,576  ................
B5..........................................  101-1,000.....................             7,511  ................
B6..........................................  1,001 and above...............            73,346  ................
----------------------------------------------------------------------------------------------------------------

    Issued on: April 21, 2010.
Alais L.M. Griffin,
Chief Counsel.
[FR Doc. 2010-9674 Filed 4-26-10; 8:45 am]
BILLING CODE 4910-EX-P