proposed rule under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3520). FDA also provided the analyses for public
input (78 FR 3504 at 3616).
    We performed additional analyses to examine the impacts of the
amended and new proposed provisions described in this document under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is a significant
regulatory action as defined by Executive Order 12866. We present our
additional analyses, including the total estimated costs and benefits
of the Produce Safety proposed rule as amended (Ref. 41). We seek
comment on our additional analyses.

B. Regulatory Flexibility Analysis

    FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities consistent with statutory objectives. FDA tentatively
concludes that the proposed rule will have a significant economic
impact on a substantial number of small entities. The Small Business
Administration (SBA) defines farms involved in crop production as
``small'' if their total revenue is less than $750,000 (Ref. 42).
Approximately 95 percent of all farms that grow covered produce are
considered small by the SBA definition.
    The proposed rule reduces the burden on small entities in part
through the use of exemptions: Certain small entities are eligible for
a qualified exemption based on average monetary value of food sold and
direct sales to qualified end users (proposed Sec.  112.5). The
proposed rule additionally reduces the burden on small entities by not
covering farms with $25,000 or less of average annual monetary value of
produce sold (proposed Sec.  112.4(a)).
    The proposed rule additionally provides all farms flexibility for
alternative practices to be used for certain listed requirements with
adequate scientific support. The proposed rule also provides for States
and foreign countries to submit a request for a variance for one or
more requirements of the proposed rule. To be granted, the procedures,
processes, and practices to be followed under the variance must be
reasonably likely to ensure that the produce is not adulterated under
section 402 of the FD&C Act (21 U.S.C. 342) and to provide the same
level of public health protection as the requirements of the proposed
rule.
    Farms defined as small businesses have an additional 2 years to
comply with most provisions of the rule after the effective date of
FDA's final rule and farms defined as very small businesses have an
additional 3 years. There is also an extended 2-year compliance period
for certain proposed provisions for water quality in Sec.  112.44 and
related provisions in Sec. Sec.  112.45 and 112.50 (specifically,
Sec. Sec.  112.50(b)(5), 112.50(b)(6), and 112.50(b)(7)). The extended
compliance dates for these specific water quality standards would then
be 4 years from the effective date for small businesses and 5 years
from the effective date for very small businesses.
    For a more detailed description of the full regulatory flexibility
options offered for this proposed rule, see the Preliminary Regulatory
Impact Analysis (PRIA) (Ref. 43).

C. Unfunded Mandates

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement including an assessment of
anticipated costs and benefits before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the 2012 Implicit Price Deflator
for the Gross Domestic Product. FDA has determined that this proposed
rule is significant under the Unfunded Mandates Reform Act. FDA has
carried out the cost-benefit analysis in preceding sections. The other
requirements under the Unfunded Mandates Act of 1995 include assessing
the rule's effects on: Future costs; particular regions, communities,
or industrial sectors; national productivity; economic growth; full
employment; job creation; and exports.
    The issues listed above are covered in detail in the cost benefit
analysis of the preceding sections and in the PRIA (Ref. 43).

D. Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act of 1996
(Pub. L. 104-121) defines a major rule for the purpose of congressional
review as having caused or being likely to cause one or more of the
following: An annual effect on the economy of $100 million or more; a
major increase in costs or prices; significant adverse effects on
competition, employment, productivity,

or innovation; or significant adverse effects on the ability of U.S.-
based enterprises to compete with foreign-based enterprises in domestic
or export markets. In accordance with the Small Business Regulatory
Enforcement Fairness Act, the Office of Management and Budget (OMB) has
determined that this proposed rule is a major rule for the purpose of
congressional review.

IV. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). A description of these provisions is given in
the following paragraphs with an estimate of the annual recordkeeping
and reporting burdens. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    Title: Standards for the Growing, Harvesting, Packing and Holding
of Produce for Human Consumption.
    Description: Section 105 of the FDA Food Safety and Modernization
Act requires that ``not later than 1 year after the date of enactment,
. . . shall publish a notice of proposed rulemaking to establish
science-based minimum standards for the safe production and harvesting
of those types of fruits and vegetables, including specific mixes or
categories of fruits and vegetables, that are raw agricultural
commodities for which the Secretary has determined that such standards
minimize the risk of serious adverse health consequences or death . .
.''
    Description of Respondents: The proposed rule applies to farms that
grow produce, meaning fruits and vegetables such as berries, tree nuts,
herbs, and sprouts. There are 40,211 farms in the United States, the
District of Columbia, and the Commonwealth of Puerto Rico, excluding
sprouting operations (Ref. 44), that would be covered by the proposed
rule. We estimate that there are approximately 285 sprouting operations
covered by this proposed rule.
    The information collection estimate for the produce safety proposed
rule will change due to the number of farms that are affected by the
requirements and the revised testing requirements for agricultural
water. Table 2 provides the revised estimates of the recordkeeping
burden associated with supplemental requirements. The information
collection estimate for the produce safety proposed rule was 1,289,959
annual hours, when the number of covered farms was 40,211. Under this
supplemental codified, the number of covered farms is 35,503. After
accounting for the decreased recordkeeping burden due to the lower
number of farms, and the increased average hourly burden due to new
records that may accompany the relaxed requirement for water usage and
application intervals after, we estimate that it will take farms a
total of 1,197,369 hours to collect information under this supplemental
notice. This represents an annual hourly savings of 92,590 hours and
approximately $5.16 million. For full information on the calculation of
all recordkeeping hourly burdens please refer to the original PRA (Ref.
43). Estimates of two new information collections are presented in
Table 2: Sec. Sec.  112.50(b)(8) and 112.50(b)(9).
    Section 112.50(b)(8) of this supplemental notice requires
scientific data or information farms rely on to determine the time
interval (in days) between harvest and end of storage and/or other
activities such as commercial washing, as applicable, used to achieve
the calculated log reduction of generic E. coli, in accordance with
Sec.  112.44(c)(2). Currently, no information is available to the
Agency to estimate how many farms would choose to apply a post-harvest
time interval that would require them to keep records to comply with
Sec.  112.50(b)(8). We do not expect this number to be zero annually,
nor do we expect the number to be very large. We believe that farms are
more likely to use the pre-harvest interval option offered in proposed
Sec.  112.44(c)(1), which would not require additional recordkeeping,
where the farm applies the proposed microbial die-off rate to calculate
an appropriate time interval. Based on our current understanding of
operations in the produce industry, for the purposes of this analysis,
it is estimated that, annually, 100 farms would choose to apply a post-
harvest time interval as a result of this supplemental notice. We
estimate that these farms will spend .33 hour (20 minutes) annually to
obtain and maintain this documentation. Therefore, 100 records x .33
hour = 33 annual hours for farms to comply with this requirement. We
acknowledge the uncertainty in these estimates. We request comment on
the number of farms that would choose to apply a post-harvest time
interval and the time needed to comply with this recordkeeping
requirement.
    Section 112.50(b)(9) of this supplemental notice requires
scientific data or information you rely on to support your testing
frequency for untreated surface water used for purposes that are
subject to the requirements of Sec.  112.44(a). No information is
currently available that would allow us to estimate the number of farms
that would be subject to this requirement. However, we expect that it
would be extremely rare for a farm to use untreated surface water for
activities, such as hand washing, that would be subject to the
requirements of Sec.  112.44(a). Therefore, for the purposes of this
analysis, we estimate that one farm per year will engage in activity
related to the requirement of Sec.  112.50(b)(9) and that this farm
will spend .33 hour (20 minutes) annually to obtain and maintain this
documentation. Therefore, 1 record x .33 hour = .33 annual hours. We
acknowledge the uncertainty in these estimates. We request comment on
the number of farms that would use untreated surface water for purposes
listed in Sec.  112.44(a) (such as hand washing), and the time needed
to comply with this recordkeeping requirement.

                                                        Table 2--New Recordkeeping Hourly Burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------
                          Documentation of Scientific Data to Support Time Interval Between Last Irrigation and End of Storage
--------------------------------------------------------------------------------------------------------------------------------------------------------
112.50(b)(8)............................................             100               1             100             .33              33              $0
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Documentation of Scientific Data to Support Testing Frequency for Untreated Surface Water Used for Purposes Subject to Sec.   112.44(a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
112.50(b)(9)............................................               1               1               1             .33             .33              $0
--------------------------------------------------------------------------------------------------------------------------------------------------------

V. Analysis of Environmental Impact

    In publishing the Produce Safety proposed rule, we relied on a
categorical exclusion from the need to prepare an EA or EIS under 21
CFR 25.30(j) (78 FR 3504 at 3616). However, as explained in the NOI,
based on currently available information, including comments received,
and upon further analysis, FDA has determined that the proposed action
may significantly affect the quality of the human environment (21 CFR
25.22(b)), and therefore, an EIS is necessary for the final rule (78 FR
50358, August 19, 2013). Accordingly, FDA is in the process of
preparing an EIS and, under that process, expects to provide a draft
EIS for public comment prior to preparing a final EIS document and
issuing the Record of Decision.

VI. Comments

    Interested persons may submit either electronic comments regarding
the specific issues identified for public comment in this document to
http://www.regulations.gov or written comments to the Division of
Dockets Management (see ADDRESSES). It is only necessary to send one
set of comments. Identify comments with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

VII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
These references are also available electronically at http://www.regulations.gov. (We have verified the Web site addresses, but we
are not responsible for any subsequent changes to Web sites after this
document publishes in the Federal Register.)

1. Taylor, M., ``Your Input Is Bringing Change to Food Safety
Rules,'' (http://blogs.fda.gov/fdavoice/index.php/tag/produce-safety-rule/), December 19, 2013. Accessed and printed on March 14,
2014.
2. Taylor, M., ``Getting Importers' Pulse About Food Safety Plans,''
(http://blogs.fda.gov/fdavoice/index.php/tag/fda-food-safety-modernization-act-of-2011-fsma/), November 4, 2013. Accessed and
printed on March 14, 2014.
3. Taylor, M., ``We're Partnering With Mexico to Keep Foods Safe,''
(http://blogs.fda.gov/fdavoice/index.php/2013/11/were-partnering-with-mexico-to-keep-foods-safe/), November 14, 2013. Accessed and
printed on March 14, 2014.
4. Taylor, M., ``Statement From FDA Deputy Commissioner for Foods
and Veterinary Medicine, Michael Taylor, on Key Provisions of the
Proposed FSMA Rules Affecting Farmers,'' (http://www.fda.gov/Food/
GuidanceRegulation/FSMA/
ucm379397.htm?source=govdelivery&utmmedium=email&utm
source=govdelivery), December 19, 2013. Accessed and printed on
March 14, 2014.
5. FDA, ``Title 21 of the Code of Federal Regulations, Proposed Part
112--Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption, Tracked Changes Compared to Proposed
Part 112 issued on January 16, 2013,'' September 2014.
6. Cooley, M., D. Carychao, L. Crawford-Miksza, et al., ``Incidence
and Tracking of Escherichia Coli O157:H7 in a Major Produce
Production Region in California,'' PLoS One, 2:e1159, 2007.
7. Gemmell, M. E. and S. Schmidt, ``Is the Microbiological Quality
of the Msunduzi River (KwaZulu-Natal, South Africa) Suitable for
Domestic, Recreational, and Agricultural Purposes?,'' Environmental
Science and Pollution Research, 20:6551-6562, 2013.
8. Holvoet, K., I. Sampers, M. Seynnaeve, and M. Uyttendaele,
``Relationships Among Hygiene Indicators and Enteric Pathogens in
Irrigation Water, Soil and Lettuce and the Impact of Climatic
Conditions on Contamination in the Lettuce Primary Production,''
International Journal of Food Microbiology, 171:21-31, 2014.
9. EPA, ``Ambient Water Quality Criteria for Bacteria--1986,'' 1986.
10. FDA and Interstate Shellfish Sanitation Conference, ``National
Shellfish Sanitation Program: Guide for the Control of Molluscan
Shellfish--2009 Revision,'' 2011.
11a. WHO, ``WHO Guidelines for the Safe Use of Wastewater, Excreta
and Greywater,'' 2006.
11b. WHO, ``Guidelines for Drinking-Water Quality--Second Edition,''
1997.
12. National Resource Management Ministerial Council, Environment
Protection and Heritage Council, and Australian Health Ministers'
Conference, ``National Water Quality Management Strategy: Australian
Guidelines for Water Recycling: Managing Health and Environmental
Risks (Phase 1),'' 2006.
13. Ravaliya, K., Marianne, F., and Snellman, E., ``Memorandum to
the File--Review of Water Quality Standards in Development of
Proposed Microbial Standard in Sec.  112.44(c) of the Proposed
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption,'' September 2014.
14. EPA, ``Recreational Water Quality Criteria,'' 2012.
15. Beuchat, L. R., ``Ecological Factors Influencing Survival and
Growth of Human Pathogens on Raw Fruits and Vegetables,'' Microbes
and Infection, 4:413-423, 2002.
16. Islam, M., M. P. Doyle, S. C. Phatak, et al., ``Persistence of
Enterohemorrhagic Escherichia Coli O157:H7 in Soil and on Leaf
Lettuce and Parsley Grown in Fields Treated With Contaminated Manure
Composts or Irrigation Water,'' Journal of Food Protection, 67:1365-
1370, 2004.
17. Snellman, E., Marianne, F., Ravaliya, K., and Assar, S.,
``Memorandum to the File--Review of Microbial Decay Constants
Reported in Field Trials of Contaminated Produce,'' September 2014.
18. WHO, Monitoring Bathing Waters--A Practical Guide to the Design
and Implementation of Assessments and Monitoring Programmes, edited
by J. Bartram and G. Rees, London, E & FN Spon, 2000.
19. Kay, D., J. Bartram, A. Pruss, et al., ``Derivation of Numerical
Values for the World Health Organization Guidelines for Recreational
Waters,'' Water Research, 38:1296-1304, 2004.
20. Wyer, M. D., D. Kay, J. M. Fleisher, et al., ``An Experimental
Health-Related Classification for Marine Waters,'' Water Research,
33:715-722, 1999.
21. Bowers, J., ``Memorandum to the File--Minimum Sample Size for
Surveys of Water Quality of Surface Water Sources to be Used for
Agricultural Water,'' September 2014.
22. Ingham, S. C., M. A. Fanslau, R. A. Engel, et al., ``Evaluation
of Fertilization-to-Planting and Fertilization-to-Harvest Intervals
for Safe Use of Noncomposted Bovine Manure in Wisconsin Vegetable
Production,'' Journal of Food Protection, 68:1134-1142, 2005.
23. Hutchison, M. L., L. D. Walters, T. Moore, et al., ``Fate of
Pathogens Present in

Livestock Wastes Spread Onto Fescue Plots,'' Applied and
Environmental Microbiology, 71:691-696, 2005.
24. Rosen, C. J. and P. M. Bierman, ``Nutrient Management for Fruit
& Vegetable Crop Production: Using Manure and Compost As Nutrient
Sources for Vegetable Crops,'' 2005.
25. Goss, M. J., A. Tubeileh, and D. Goorahoo, A Review of the Use
of Organic Amendments and the Risk to Human Health, 2013.
26. Ketterings, Q. M., G. Albrecht, K. Czymmek, and S. Bossard,
``Agronomy Fact Sheet Series: Nitrogen Credits From Manure,'' 2005.
27. Hue, N. V. and J. A. Silva, ``Organic Soil Amendments for
Sustainable Agriculture: Organic Sources of Nitrogen, Phosphorus and
Potassium,'' in Plant Nutrient Management in Hawaii's Soils,
Approaches for Tropical and Subtropical Agriculture, Manoa, Chapter
15, pp. 133-144, University of Hawaii, 2000.
28. Spargo, J. T., M. A. Cavigelli, S. B. Mirsky, et al.,
``Mineralizable Soil Nitrogen and Labile Soil Organic Matter in
Diverse Long-Term Cropping Systems,'' Nutrient Cycling in
Agroecosystems, 90:253-266, 2011.
29. Russo, V. M. and M. Taylor, ``Frequency of Manure Application in
Organic Versus Annual Application of Synthetic Fertilizer in
Conventional Vegetable Production'' Hortscience, 45:1673-1680, 2010.
30. Miller, J. J., E. C. S. Olson, D. S. Chanasyk, et al.,
``Phosphorus and Nitrogen in Rainfall Simulation Runoff After Fresh
and Composted Beef Cattle Manure Application,'' Journal of
Environmental Quality, 35:1279-1290, 2006.
31. Rynk, R., M. van de Kamp, G. B. Wilson, et al., On-Farm
Composting Handbook, edited by R. Rynk, USDA Northeast Regional
Agricultural Engineering Service Cooperative Extension, 1992.
32. Bonanomi, G., V. Antignani, C. Pane, and E. Scala, ``Suppression
of Soilborne Fungal Diseases With Organic Amendments,'' Journal of
Plant Pathology, 89:311-324, 2007.
33. Mohler, C. L. and S. E. Johnson, Crop Rotation on Organic Farms:
A Planning Manual, NRAES 177, edited by C. L. Mohler and S. E.
Johnson, Ithaca, Natural Resource, Agriculture and Engineering,
2009.
34. EPA, ``Composting: Environmental Benefits,'' (http://www.epa.gov/composting/benefits.htm), May 13, 2013. Accessed and
printed on March 14, 2014.
35. Coleman, P., ``USDA Organic: Guide for Organic Crop Producers,''
(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5101542),
November, 2012. Accessed and printed on March 14, 2014.
36. NRCS, Part 637 Environmental Engineering National Engineering
Handbook: Chapter 2 Composting, USDA, 2000.
37. USDA and NRCS, ``Nutrient Management Technical Note No. 7:
Reducing Risk of E. Coli O157:H7 Contamination,'' 2007.
38. EPA, ``Resource Conservation: Composting for Facilities
Basics,'' (http://www.epa.gov/epawaste/conserve/composting/basic.htm), May 16, 2013. Accessed and printed on March 14, 2014.
39. Organic Trade Association, ``Manure Facts,'' (http://www.ota.com/organic/foodsafety/manure.html), June 7, 2011. Accessed
and printed on March 14, 2014.
40. Resource Conservation District of Monterey County, Handbook of
Agricultural Conservation Practices, Photos and Descriptions with
Food Safety Considerations, edited by S. Ruffoni and N. Strong-
Cvetich, 3rd ed., 2012.
41. FDA, ``Supplemental Notice of Proposed Rulemaking: Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption, Economic Impact Analysis,'' September 2014.
42. ``Small Business Administration Gopher Server,'' (http://www.sba.gov/content/small-business-size-standards), 2014. Accessed
and printed on September 4, 2014.
43. FDA, ``Analysis of Economic Impacts: Standards for the Growing,
Harvesting, Packing and Holding of Produce for Human Consumption,''
(http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM334116.pdf), 2013. Accessed and printed on September 4, 2014.
44. USDA, ``Census of Agriculture, 2007,'' (http://
www.agcensus.usda.gov/Publications/2007/GettingStarted/
GuidetoCensusProducts/), 2011. Accessed
and printed on September 3, 2014.

List of Subjects in 21 CFR Part 112

    Foods, Fruits and vegetables, Packaging and containers,
Recordkeeping requirements, Safety.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR Chapter I, as proposed to be added on January 16,
2013 (78 FR 3504), be further amended as follows:

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 112 continues to read as
follows

    Authority:  21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.

Subpart A--[Amended]

0
2. In Sec.  112.3, revise paragraphs (b)(1) and (b)(2) and in paragraph
(c), revise the definitions for ``Covered activity,'' ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing'' to read as follows:

Sec.  112.3  What definitions apply to this part?

* * * * *
    (b) * * *
    (1) Very small business. For the purpose of this part, your farm is
a very small business if it is subject to this part and, on a rolling
basis, the average annual monetary value of produce (as defined in
paragraph (c) of this section) you sold during the previous 3-year
period is no more than $250,000.
    (2) Small business. For the purpose of this part, your farm is a
small business if it is subject to this part and, on a rolling basis,
the average annual monetary value of produce (as defined in paragraph
(c) of this section) you sold during the previous 3-year period is no
more than $500,000; and your farm is not a very small business as
provided in paragraph (b)(1) of this section.
    (c) * * *
* * * * *
    Covered activity means growing, harvesting, packing, or holding
covered produce on a farm. Covered activity includes manufacturing/
processing of covered produce on a farm, but only to the extent that
such activities are performed on raw agricultural commodities and only
to the extent that such activities are within the meaning of ``farm''
as defined in this chapter. This part does not apply to activities of a
facility that are subject to part 110 of this chapter.
* * * * *
    Farm means an establishment under one ownership in one general
physical location devoted to the growing and harvesting of crops, the
raising of animals (including seafood), or both. The term ``farm''
includes establishments that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same ownership, or is processed food identified in paragraph
(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or
another farm under the same ownership; or
    (B) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same ownership consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a

distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing; and
    (2) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing.
* * * * *
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities on a
farm. Harvesting does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Gathering,
washing, trimming of outer leaves of, removing stems and husks from,
sifting, filtering, threshing, shelling, and cooling raw agricultural
commodities grown on a farm are examples of harvesting.
* * * * *
    Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food and activities performed
as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down
pallets)), but does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
* * * * *
    Packing means placing food into a container other than packaging
the food and also includes activities performed incidental to packing a
food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling and grading)), but does not include
activities that transform a raw agricultural commodity, as defined in
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a
processed food as defined in section 201(gg) of the Federal Food, Drug,
and Cosmetic Act.
* * * * *
0
3. In Sec.  112.4, revise the first sentence of paragraph (a) to read
as follows:

Sec.  112.4  Who is subject to the requirements of this part?

    (a) Except as provided in paragraph (b) of this section, if you are
a farm or farm mixed-type facility with an average annual monetary
value of produce (as ``produce'' is defined in Sec.  112.3(c)) sold
during the previous 3-year period of more than $25,000 (on a rolling
basis), you are a ``covered farm'' subject to this part.* * *
* * * * *

Subpart B--[Amended]

0
4. Section 112.12, is amended by adding the phrase ``as provided in
Sec.  112.44(d) and'' at the end of paragraph (a)(1); by removing ``;''
and adding it its place ``.'' at the end of paragraph (a)(2); and by
removing paragraphs (a)(3) and (a)(4).

Subpart E--[Amended]

0
5. Section 112.44, is amended by revising paragraphs (c) and (d) to
read as follows:

Sec.  112.44  What testing is required for agricultural water, and what
must I do based on the test results?

* * * * *
    (c) When agricultural water is used during growing activities for
covered produce (other than sprouts) using a direct water application
method you must test the quality of water in accordance with one of the
appropriate analytical methods in subpart N to develop and verify the
water quality profile of the water source as described in Sec.
112.45(b)(1). Using your water quality profile as described in Sec.
112.45(b)(1), if you find that (when applicable) the estimate of the
statistical threshold value (STV) of samples exceeds 410 colony forming
units (CFU) of generic E. coli per 100 mL of water, or if you find that
the geometric mean (GM) of samples exceeds 126 CFU of generic E. coli
per 100 mL of water (or an alternative microbial standard consistent
with paragraph (d)(1) of this section), you must either:
    (1) Apply a time interval (in days) between last irrigation and
harvest using a microbial die-off rate of 0.5 log per day (or an
alternative microbial die-off rate consistent with paragraph (d)(2) of
this section) to achieve a (calculated) log reduction of your geometric
mean of generic E. coli level to 126 CFU or less per 100 mL and (when
applicable) of your STV to 410 CFU or less per 100 mL, or an
alternative microbial standard consistent with paragraph (d)(1) of this
section;
    (2) Apply a time interval (in days) between harvest and end of
storage using an appropriate microbial die-off rate between harvest and
end of storage and/or appropriate microbial removal rates during
activities such as commercial washing to achieve a (calculated) log
reduction of your geometric mean of generic E. coli level to 126 CFU or
less per 100 mL and (when applicable) of your STV to 410 CFU or less
per 100 mL (or an alternative microbial standard consistent with
paragraph (d)(1) of this section), provided you have adequate
supporting scientific data and information. You may apply this time
interval in addition to the time interval in accordance with paragraph
(c)(1) of this section; or
    (3) If options (c)(1) or (c)(2) are not selected, immediately
discontinue use of that source of agricultural water and/or its
distribution system for the uses described in this paragraph. Before
you may use the water source and/or distribution system again for the
uses described in this paragraph, you must either reinspect the entire
agricultural water system under your control, identify any conditions
that are reasonably likely to introduce known or reasonably foreseeable
hazards into or onto covered produce or food-contact surfaces, make
necessary changes, and retest the water to determine if your changes
were effective; or treat the water in accordance with the requirements
of Sec.  112.43.
    (d) You may establish and use alternatives to the following
requirements provided you satisfy the requirements of Sec.  112.12:
    (1) Microbial quality standard established in paragraph (c) of this
section; and
    (2) Microbial die-off rate established in paragraph (c)(1) of this
section that is used to determine the time interval between last
irrigation and harvest.
0
6. Section 112.45, is revised to read as follows:

Sec.  112.45  How often must I test agricultural water that is subject
to the requirements of Sec.  112.44?

    (a) There is no requirement to test any agricultural water that is
subject to the requirements of Sec.  112.44 when:
    (1) You receive water from a public water system, as defined under
the Safe Drinking Water Act (SDWA) regulations, 40 CFR part 141, that
furnishes water that meets the microbial requirements under those
regulations or under the regulations of a State approved to administer
the SDWA public water

supply program, and you have public water system results or
certificates of compliance that demonstrate that the water meets that
requirement;
    (2) You receive water from a public water supply that furnishes
water that meets the microbial requirement described in Sec.
112.44(a), and you have public water system results or certificates of
compliance that demonstrate that the water meets that requirement; or
    (3) You treat water in accordance with the requirements of Sec.
112.43.
    (b) If you use untreated surface water for purposes that are
subject to the requirements of Sec.  112.44(c), you must take the
following steps for each source of the untreated surface water:
    (1) Conduct a baseline survey to develop a water quality profile of
the agricultural water source.
    (i) You must conduct a baseline survey in order to initially
develop the water quality profile of your water source. You must
determine the appropriate way(s) in which the water may be used based
on your water quality profile in accordance with Sec.  112.44(c)(1)
through (3).
    (ii) The baseline survey must be conducted over a minimum period of
2 years by calculating the geometric mean (GM) and the statistical
threshold value (STV) of generic Escherichia coli (E. coli) (colony
forming units (CFU) per 100 mL) using a minimum total of 20 samples,
consisting of samples of agricultural water as it is used during
growing activities using a direct water application method, collected
during a time period(s) as close as practical to harvest. The water
quality profile initially consists of the GM and STV of generic E. coli
calculated using this data set.
    (iii) You must develop a new water quality profile:
    (A) At least once every 10 years by recalculating the GM and STV
values using a minimum total of 20 samples collected during your most
recent annual surveys (which are required under paragraph (b)(2) of
this section); and
    (B) When required under paragraphs (b)(2) and (b)(3) of this
section.
    (2) Conduct an annual survey to verify the water quality profile of
your agricultural water.
    (i) After the baseline survey described in paragraphs (b)(1)(i) and
(b)(1)(ii) of this section, you must test the water annually to verify
your existing water quality profile to confirm that the way(s) in which
the water is used continues to be appropriate. You must analyze a
minimum number of five samples per year, consisting of samples of
agricultural water as it is used during growing activities using a
direct water application method, collected during a time period(s) as
close as practical to harvest.
    (ii) If the GM and/or STV values of the annual survey samples do
not support your water quality profile and therefore your existing
water use as specified in Sec.  112.44(c), you must develop a new water
quality profile and, as appropriate, modify your water use based on the
new water quality profile in accordance with Sec.  112.44(c)(1) through
(3) as soon as practical and no later than the following year. To
develop a new water quality profile, you must calculate new GM and STV
values using either:
    (A) Your current annual survey data, combined with your most recent
baseline or annual survey data from prior years, to make up a data set
of at least 20 samples; or
    (B) Your current annual survey data, combined with new data, to
make up a dataset of at least 20 samples; and
    (3) If you know or have reason to believe that your water quality
profile no longer represents the quality of your water for reasons
other than those in paragraph (b)(2) of this section (for example, if
there are significant changes in adjacent land use, erosion, or other
impacts to water outside your control that are reasonably likely to
adversely affect the quality of your water source), you must develop a
new water quality profile. To develop a new water quality profile, you
must calculate new GM and STV values using your current annual survey
data, combined with new data, to make up a data set of at least 20
samples. Then, as required by Sec.  112.44(c)(1) through (3), you must
modify your water use based on the new water quality profile as soon as
practical and no later than the following year.
    (c) If you use untreated ground water for purposes that are subject
to the requirements of Sec.  112.44, you must test the quality of each
source of the water at least four times during the growing season or
over a period of 1 year, using a minimum total of four samples
collected during a time period(s) as close as practical to harvest. If
the samples tested meet the applicable microbial standard of Sec.
112.44 (i.e., no detectable generic E. coli per 100 mL under 112.44(a)
or a geometric mean of generic E. coli of 126 CFU or less per 100 mL
under 112.44(c), as applicable), you may test once annually thereafter,
using a minimum of one sample collected during a time period as close
as practical to harvest. You must resume testing at least four times
per growing season or year if any annual test fails to meet the
applicable microbial standard in Sec.  112.44.
    (d) If you use untreated surface water for purposes that are
subject to the requirements of Sec.  112.44(a), you must test the
quality of each source of the water with an adequate frequency to
provide reasonable assurances that the water meets the required
microbial standard. You must have adequate scientific data or
information to support your testing frequency.
    (e) You may meet the requirements related to agricultural water
testing required under paragraphs (b), (c), and (d) of this section
using:
    (1) Test results from your agricultural water source(s) performed
by you, or by a person or entity acting on your behalf; or
    (2) Data collected by a third party or parties, provided the water
source(s) sampled by the third party or parties adequately represent
your agricultural water source(s) and all other applicable requirements
of this part are met.
0
7. Section 112.50, is amended by adding new paragraphs (b)(8) and
(b)(9) to read as follows:

Sec.  112.50  Under this subpart, what requirements apply regarding
records?

* * * * *
    (b) * * *
    (8) Scientific data or information you rely on to support the
microbial die-off or removal rate(s) that is used to determine the time
interval (in days) between harvest and end of storage and/or other
activities such as commercial washing, as applicable, used to achieve
the calculated log reduction of generic E.coli in accordance with the
provision in Sec.  112.44(c)(2); and
    (9) Scientific data or information you rely on to support your
testing frequency for untreated surface water used for purposes that
are subject to the requirements of Sec.  112.44(a).

Subpart F--[Amended]

0
8. Section 112.56 is amended by removing from paragraph (a)(1)(i) the
phrase ``9 months'' and adding in its place the phrase ``Reserved'';
removing from paragraph (a)(4)(i) the phrase ``45 days'' and adding in
its place the phrase ``0 days''; and removing and reserving paragraph
(b).
0
9. Section 112.60 is amended by removing paragraphs (b)(1) and (b)(5)
and redesignating paragraphs (b)(2), (b)(3), and (b)(4) as paragraphs
(b)(1), (b)(2), and (b)(3), respectively.

Subpart I--[Amended]

0
10. Add Sec.  112.84 to read as follows:

Sec.  112.84  Does this regulation require covered farms to take
actions that would constitute a ``taking'' of threatened or endangered
species; to take measures to exclude animals from outdoor growing
areas; or to destroy animal habitat or otherwise clear farm borders
around outdoor growing areas or drainages?

    No. Nothing in this regulation authorizes the ``taking'' of
threatened or endangered species as that term is defined by the
Endangered Species Act (16 U.S.C. 1531-1544) (i.e., to harass, harm,
pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to
attempt to engage in any such conduct), in violation of the Endangered
Species Act. This regulation does not require covered farms to take
measures to exclude animals from outdoor growing areas, or to destroy
animal habitat or otherwise clear farm borders around outdoor growing
areas or drainages.

Subpart P--[Amended]

0
11. Section 112.182, is amended by removing ``;'' and adding in its
place ``.'' at the end of paragraph (c) and removing paragraphs (d) and
(e).

Subpart R--[Amended]

0
12. Section Sec.  112.201, is revised to read as follows:

Sec.  112.201  Under what circumstances can FDA withdraw a qualified
exemption in accordance with the requirements of Sec.  112.5?

    (a) We may withdraw your qualified exemption under Sec.  112.5:
    (1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to your farm; or
    (2) If we determine that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with your farm that are material to
the safety of the food that would otherwise be covered produce grown,
harvested, packed or held at your farm.
    (b) Before FDA issues an order to withdraw your qualified
exemption, FDA:
    (1) May consider one or more other actions to protect the public
health and prevent or mitigate a foodborne illness outbreak, including
a warning letter, recall, administrative detention, refusal of food
offered for import, seizure, and injunction;
    (2) Must notify the owner, operator, or agent in charge of the
farm, in writing, of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the owner, operator, or agent
in charge of the farm to respond in writing, within 10 calendar days of
the date of the notification, to FDA's notification; and
    (3) Must consider the actions taken by the farm to address the
circumstances that may lead FDA to withdraw the exemption.
0
13. Section 112.202 is revised to read as follows:

Sec.  112.202  What procedure will FDA use to withdraw an exemption?

    (a) An FDA District Director in whose district the farm is located
(or, in the case of a foreign farm, the Director of the Office of
Compliance in the Center for Food Safety and Applied Nutrition), or an
FDA official senior to such Director, must approve an order to withdraw
the exemption before the order is issued.
    (b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
    (c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the farm.
    (d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.
0
14. Add Sec.  112.213 to read as follows:

Sec.  112.213  If my qualified exemption is withdrawn, under what
circumstances would FDA reinstate my qualified exemption?

    (a) If the FDA District Director in whose district your farm is
located (or, in the case of a foreign farm, the Director of the Office
of Compliance in the Center for Food Safety and Applied Nutrition
(CFSAN)) determines that the farm has adequately resolved problems with
the conduct and conditions that are material to the safety of the food
produced or harvested at such farm, and that continued withdrawal of
the exemption is not necessary to protect the public health or prevent
or mitigate a foodborne illness outbreak, the FDA District Director in
whose district your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in CFSAN) shall, on his own
initiative or at the request of a farm, reinstate the qualified
exemption.
    (b) You may ask FDA to reinstate a qualified exemption that has
been withdrawn under the procedures of this subpart as follows:
    (1) Submit a request, in writing, to the FDA District Director in
whose district your farm is located (or, in the case of a foreign farm,
the Director of the Office of Compliance in CFSAN); and
    (2) Present, in writing, data and information to demonstrate that
you have adequately resolved the problems with the conduct or
conditions that are material to the safety of the food produced and
harvested at your farm, such that continued withdrawal of the exemption
is not necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak.
    (c) If your qualified exemption was withdrawn under Sec.
112.201(a)(1) and FDA later determines, after finishing the active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to your farm, FDA will reinstate your qualified
exemption under Sec.  112.5, and FDA will notify you in writing that
your exempt status has been reinstated.
    (d) If your qualified exemption was withdrawn under Sec.
112.201(a)(1) and (a)(2) and FDA later determines, after finishing the
active investigation of a foodborne illness outbreak, that the outbreak
is not directly linked to your farm, FDA will inform you of this
finding, and you may ask FDA to reinstate your qualified exemption
under Sec.  112.5, in accordance with the requirements of paragraph (b)
of this section.

    Dated: September 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-22447 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P


From:	"Stephen Mandel"<EMAIL_ADDRESS>
To:	John Schakenbach/DC/USEPA/US@EPA

Cc:	Joe Elkins/RTP/USEPA/US@EPA

Date:	04/10/2008 02:57 PM

Subject:	PGVP

John,

It was interesting to see the comments.

First off, Spectra Gases Inc is very supportive of the EPA’s efforts
to assure the quality of gases being sold as EPA Protocol. Spectra
would, of course, prefer that the program be funded totally by EPA but
we understand the constraints and are prepared to pay our fair share.

The comments about ISO 17025 are noted, but if EPA was to require ISO
17025 certification of an EPA Protocol Gas manufacturer it would force
the small companies out of the market. In checking with our quality
people the cost to hire an outside consultant (if you are a small
company you wouldn’t have the internal staff) to prepare the
documentation necessary would probably be in the $40,000 to $50,000
range. This is, of course, a one time fee but these documents do require
updating on a continual basis. Next the company has to hire the
certification agency (A2LA). This may cost $15-20,000. This is for the
initial period and then again every three years. There would then be
periodic audits that will cost in the neighborhood of $5,000/year.

As to the proposed cost ($6,000 to $7,000/ year), any company that is
producing Protocols has to have an investment that is in excess of
$500,000 in equipment for blending and analysis, in standards, and in
cylinders and valves. So an increase of 1.5% is nothing (other than a
smokescreen). However, if as has been suggested there are some companies
manufacturing Protocols that do not utilize SRMS or NTRMs then indeed
the minimal cost of the PGVP program may indeed be a big cost to them.

John, the importance of US EPA Protocol Gases being of known quality is
most important. The utility industry bases many of their decisions on
what these gases are telling them. Federal and State Agencies use EPA
Protocol Gases to evaluate the quality of the air that we all breathe.
Do we want this data to be suspect because we don’t know with any
certainty the quality of the standards that are being used?

 Stephen B. Mandel, QEP

Spectra Gases Inc

908-252-9300  ext 6218


[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Page 13173]
[FR Doc No: 2018-06120]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-135, OMB Control No. 3235-0176]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rules 8b-1 to 8b-33

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for extension of the
previously approved collection of information discussed below.
    Rules 8b-1 to 8b-33 (17 CFR 270.8b-1 to 8b-33) under the Investment
Company Act of 1940 (15 U.S.C. 80a-1 et seq.) (``Investment Company
Act'') set forth the procedures for preparing and filing a registration
statement under the Investment Company Act. These procedures are
intended to facilitate the registration process. These rules generally
do not require respondents to report information.\1\
---------------------------------------------------------------------------

    \1\ Although the rules under Section 8(b) of the Investment
Company Act are generally procedural in nature, two of the rules
require respondents to disclose some limited information. Rule 8b-3
(17 CFR 270.8b-3) provides that whenever a registration form
requires the title of securities to be stated, the registrant must
indicate the type and general character of the securities to be
issued. Rule 8b-22 (17 CFR 270.8b-22) provides that if the existence
of control is open to reasonable doubt, the registrant may disclaim
the existence of control, but it must state the material facts
pertinent to the possible existence of control. The information
required by both of these rules is necessary to insure that
investors have clear and complete information upon which to base an
investment decision.
---------------------------------------------------------------------------

    The Commission believes that it is appropriate to estimate the
total respondent burden associated with preparing each registration
statement form rather than attempt to isolate the impact of the
procedural instructions under Section 8(b) of the Investment Company
Act, which impose burdens only in the context of the preparation of the
various registration statement forms. Accordingly, the Commission is
not submitting a separate burden estimate for rules 8b-1 through 8b-33,
but instead will include the burden for these rules in its estimates of
burden for each of the registration forms under the Investment Company
Act. The Commission is, however, submitting an hourly burden estimate
of one hour for administrative purposes.
    The collection of information under rules 8b-1 to 8b-33 is
mandatory. The information provided under rules 8b-1 to 8b-33 is not
kept confidential. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
    The public may view the background documentation for this
information collection at the following website, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
[email protected]; and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE, Washington, DC 20549 or send an email
to: [email protected]. Comments must be submitted to OMB within 30
days of this notice.

    Dated: March 22, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-06120 Filed 3-26-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Page 70968]
[FR Doc No: 2019-27755]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2006-0369; FRL-10003-41-OW]

Proposed Information Collection Request; Comment Request;
National Estuary Program (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``National Estuary Program
(Renewal)'' (EPA ICR No. 1500.10, OMB Control No. 2040-0138) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the ICR, which is currently approved through September 30, 2020. An
Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before February 24, 2020.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2006-0369, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Vince Bacalan, Oceans, Wetlands, and
Communities Division; Office of Wetlands, Oceans, and Watersheds, (Mail
Code 4504T), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
202-566-1336; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (1) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (2) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) enhance the quality, utility, and clarity of the information
to be collected; and (4) minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses. EPA will consider the
comments received and amend the ICR as appropriate. The final ICR
package will then be submitted to OMB for review and approval. At that
time, EPA will issue another Federal Register notice to announce the
submission of the ICR to OMB and the opportunity to submit additional
comments to OMB.
    Abstract: The National Estuary Program (NEP) involves collecting
information from the state or local agency or nongovernmental
organizations that receive funds under Sec. 320 of the Clean Water Act
(CWA). The regulation requiring this information is found at 40 CFR
part 35.
    Prospective grant recipients seek funding to develop or oversee and
coordinate implementation of Comprehensive Conservation Management
Plans (CCMPs) for estuaries of national significance. In order to
receive funds, grantees must submit an annual workplan to EPA which are
used to track performance of each of the 28 estuary programs currently
in the NEP. EPA provides funding to NEPs to support long-term
implementation of CCMPs if such programs pass a program evaluation
process. The primary purpose of the program evaluation process is to
help EPA determine whether the 28 programs included in the National
Estuary Program (NEP) are making adequate progress implementing their
CCMPs and therefore merit continued funding under Sec. 320 of the Clean
Water Act. EPA also requests that each of the 28 NEPs receiving Sec.
320 funds report information that can be used in the GPRA reporting
process. This reporting is done on an annual basis and is used to show
environmental results that are being achieved within the overall
National Estuary Program. This information is ultimately submitted to
Congress along with GPRA information from other EPA programs.
    Form numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are those state or local agencies or nongovernmental
organizations in the National Estuary Program (NEP) who receive grants
under Section 320 of the Clean Water Act.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (Section 320 of the Clean Water Act).
    Estimated number of respondents: 28 (total).
    Frequency of response: Annual.
    Total estimated burden: 5,600 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $314,138 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: There is likely a decrease in the total
estimated respondent burden compared with the ICR currently approved by
OMB. This decrease is due to program evaluations taking place for only
two years, compared to three years in the currently approved ICR. Note
that these estimates will be updated in the final FR Notice.

    Dated: December 18, 2019.
Brian Frazer,
Director, Oceans, Wetlands, and Communities Division, Office of Water,
Environmental Protection Agency.
[FR Doc. 2019-27755 Filed 12-23-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Page 15985]
[FR Doc No: 2022-05872]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9639-01-OA]

Notification of a Public Meeting of the Clean Air Scientific
Advisory Committee (CASAC) Lead Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces a
public meeting of the Clean Air Scientific Advisory Committee (CASAC)
Lead Review Panel to provide a consultation on Volume 2 of the Agency's
Integrated Review Plan for the Lead National Ambient Air Quality
Standards (IRP).

DATES: The public meeting will be held on April 8, 2022, from 11:00
a.m. to 3:00 p.m. Eastern Time.

ADDRESSES: The meeting will be conducted virtually. Please refer to the
CASAC website at https://casac.epa.gov for details on how to access the
meeting.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this notice may contact Mr. Aaron Yeow,
Designated Federal Officer (DFO), SAB Staff Office, by telephone at
(202) 564-2050 or via email at [email protected]. General information
concerning the CASAC, as well as any updates concerning the meeting
announced in this notice can be found on the CASAC website: https://casac.epa.gov.

SUPPLEMENTARY INFORMATION:
    Background: The CASAC was established pursuant to the Clean Air Act
(CAA) Amendments of 1977, codified at 42 U.S.C. 7409(d)(2), to review
air quality criteria and national ambient air quality standards (NAAQS)
and recommend to the EPA Administrator any new NAAQS and revisions of
existing criteria and NAAQS as may be appropriate. The CASAC shall
also: Advise the EPA Administrator of areas in which additional
knowledge is required to appraise the adequacy and basis of existing,
new, or revised NAAQS; describe the research efforts necessary to
provide the required information; advise the EPA Administrator on the
relative contribution to air pollution concentrations of natural as
well as anthropogenic activity; and advise the EPA Administrator of any
adverse public health, welfare, social, economic, or energy effects
which may result from various strategies for attainment and maintenance
of such NAAQS. As amended, 5 U.S.C., App. Section 109(d)(1) of the CAA
requires that EPA carry out a periodic review and revision, as
appropriate, of the air quality criteria and the NAAQS for the six
``criteria'' air pollutants, including lead (Pb).
    The CASAC is a Federal Advisory Committee chartered under the
Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2, and conducts
business in accordance with FACA and related regulations. The CASAC and
the CASAC Lead Review Panel will comply with the provisions of FACA and
all appropriate SAB Staff Office procedural policies. Pursuant to FACA
and EPA policy, notice is hereby given that CASAC Lead Review Panel
will hold a public meeting to provide a consultation on Volume 2 of the
Agency's Integrated Review Plan for the Lead National Ambient Air
Quality Standards (IRP). This document identifies policy-relevant
issues in the review and serves as the planning document for the
Integrated Science Assessment (ISA) for lead, describing key
considerations and the process for its development. Volume 1 of the IRP
contains contextual background material and the anticipated schedule
for the current review of the air quality criteria and NAAQS for Pb.
    Technical Contacts: Any technical questions concerning EPA's IRP
for lead should be directed to Dr. Deirdre Murphy
([email protected]).
    Availability of Meeting Materials: Prior to the meeting, the review
documents, agenda and other materials will be accessible on the CASAC
website: https://casac.epa.gov.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office. Federal advisory committees and panels, including
scientific advisory committees, provide independent advice to EPA.
Members of the public can submit relevant comments on the topic of this
advisory activity, including the charge to the CASAC and the EPA review
documents, and/or the group conducting the activity, for the CASAC to
consider as it develops advice for EPA. Input from the public to the
CASAC will have the most impact if it provides specific scientific or
technical information or analysis for CASAC to consider or if it
relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should follow the
instructions below to submit comments.
    Oral Statements: Individuals or groups requesting an oral
presentation during the public meeting will be limited to three
minutes. Each person making an oral statement should consider providing
written comments as well as their oral statement so that the points
presented orally can be expanded upon in writing. Interested parties
should contact Mr. Aaron Yeow, DFO, in writing (preferably via email)
at the contact information noted above by April 1, 2022, to be placed
on the list of public speakers.
    Written Statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by CASAC
members, statements should be supplied to the DFO (preferably via
email) at the contact information noted above by April 1, 2022. It is
the SAB Staff Office general policy to post written comments on the web
page for the advisory meeting or teleconference. Submitters are
requested to provide an unsigned version of each document because the
SAB Staff Office does not publish documents with signatures on its
websites. Members of the public should be aware that their personal
contact information, if included in any written comments, may be posted
to the CASAC website. Copyrighted material will not be posted without
explicit permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Mr. Aaron Yeow at (202)
564-2050 or [email protected]. To request accommodation of a
disability, please contact the DFO, at the contact information noted
above, preferably at least ten days prior to each meeting, to give EPA
as much time as possible to process your request.

Thomas H. Brennan,
Director, Science Advisory Board Staff Office.
[FR Doc. 2022-05872 Filed 3-18-22; 8:45 am]
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[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15018-15019]
[FR Doc No: 2023-04927]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-060]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed February 27, 2023 10 a.m. EST Through March 7, 2023 10 a.m. EST
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxapps.epa.gov/cdx-enepa-II/public/action/eis/search.

EIS No. 20230039, Draft Supplement, USFS, ID, Hungry Ridge Restoration
Project, Comment Period Ends: 04/24/2023, Contact: Jennie Fischer 208-
983-4048.

Amended Notice

EIS No. 20230006, Draft, BLM, ID, Lava Ridge Wind Project, Comment
Period Ends: 04/20/2023, Contact: Kasey Prestwich<PHONE_NUMBER>.

    Revision to FR Notice Published 01/20/2023; Extending the Comment
Period from 03/21/2023 to 04/20/2023.

    Dated: March 7, 2023.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2023-04927 Filed 3-9-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 147 (Friday, July 31, 2015)]
[Proposed Rules]
[Pages 45627-45629]
[FR Doc No: 2015-18844]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0604]
RIN 1625-AA00

Safety Zone; Intermedix IRONMAN 70.3 Event, Savannah River;
Augusta, GA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
on the waters of the Savannah River during the Intermedix IRONMAN 70.3
event on September 27, 2015. This regulation is necessary to protect
the lives of the participants on the navigable waters of the Savannah
River due to hazards associated with 3,600 IRONMAN athletes swimming in
the Savannah River. Entry into this zone is prohibited unless
specifically authorized by the Captain of the Port (COTP) Savannah or a
designated representative.

DATES: Comments and related material must be received by August 15,
2015. Requests for public meetings must be received by the Coast Guard
by August 7, 2015.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Christopher McElvaine, Marine Safety Unit
Savannah Prevention Department, Coast Guard; telephone<PHONE_NUMBER>
ext.221, email<EMAIL_ADDRESS>If you have questions
on viewing or submitting material to the docket, call Cheryl Collins,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number USCG-2015-0604 in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number USCG-2015-0604 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request

for one, using one of the methods specified under ADDRESSES. Please
explain why you believe a public meeting would be beneficial. If we
determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Basis and Purpose

    The legal basis for this rulemaking is the Coast Guard's authority
to establish regulated navigation areas and other limited access areas:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, and 160.5;
Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to ensure the safety of life and vessels
on a navigable waterway of the United States during the Intermedix
IRONMAN 70.3 event.

C. Discussion of Proposed Rule

    The Coast Guard proposes to establish this safety zone to protect
the lives of those near the Savannah River during the Intermedix
Ironman 70.3 event. Approximately 3,600 participants will be swimming
one mile on the Savannah River from the 5th Street Marina, river mile
197, to the Boathouse at river mile 198.
    The safety zone will cover all waters from river mile 197 to river
mile 198. During the swim portion of the event, no vessel may enter,
transit through, anchor in, or remain within the safety zone unless
authorized by the COTP Savannah or a designated representative. This
proposed rule would be effective on September 27, 2015 from 7:30 a.m.
until 11 a.m., or until all swimmers are out of the water.
    Persons or vessels desiring to enter, transit through, anchor in,
or remain within the safety zone may contact the Captain of the Port
Savannah by telephone at<PHONE_NUMBER>, or a designated representative
via VHF radio on channel 16, to request authorization. If authorization
to enter, transit through, anchor in, or remain within the safety zone
is granted by the Captain of the Port Savannah or a designated
representative, all persons and vessels receiving such authorization
must comply with the instructions of the Captain of the Port Savannah
or a designated representative. The Coast Guard will provide notice of
the safety zones by Broadcast Notice to Mariners, and on-scene
designated representatives.
    The COTP Savannah or a designated representative will inform the
public through broadcast notice to mariners of the enforcement periods
for this safety zone.

D. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on these statutes and executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The economic impact of this rule is not significant for the
following reasons: (1) The safety zone will only be effective for three
and one-half hours and it will only be enforced during the Intermedix
IRONMAN 70.3 event; (2) although non-participant persons and vessels
will not be able to enter, transit through, anchor in, or remain within
the event area without authorization from the Captain of the Port
Savannah or a designated representative, they may operate in the
surrounding area during the enforcement period; (3) non-participant
persons and vessels may still enter, transit through, anchor in, or
remain within the event area during the enforcement period if
authorized by the Captain of the Port Savannah or a designated
representative; and (4) the Coast Guard will provide advance
notification of the safety zone to the local maritime community by
Local Notice to Mariners and Broadcast Notice to Mariners.
    Notifications of the enforcement periods of this safety zone will
be made to the marine community through broadcast notice to mariners.
Representatives of the COTP will be on-scene to coordinate the
movements of vessels seeking to enter the safety zone. These
representatives will authorize vessel transits into the zone to the
maximum safely allowable during the Intermedix IRONMAN 70.3.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule will not have a significant economic impact on a substantial
number of small entities for the following reasons: (1) The COTP
Savannah may consider granting vessels permission to enter into the
safety zone if conditions allow for such transit to be conducted
safely, and (2) the safety zone will only be enforced during the event.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

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

9. Civil Justice Reform

    This proposed 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.

10. Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This proposed rule is not an economically significant rule and
does not create an environmental risk to health or risk to safety that
may disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the creation of a temporary safety
zone. This rule is categorically excluded, under figure 2-1, paragraph
(34)(g) and paragraph (35)(a), of the Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add a temporary Sec.  165.T07-0604 to read as follows:

Sec.  165.T07-0604  Safety Zone; Intermedix IRONMAN 70.3, Savannah
River, Augusta, GA.

    (a) Regulated Area. The following areas are safety zones:
    (1) Fixed Safety Zone. All waters of the Savannah River from the
5th Street Marina, river mile 197, to the Boathouse at river mile 198
in Augusta, Georgia.
    (2) Reserved.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Savannah in the enforcement of the regulated area.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
proposed safety zones unless authorized by the Captain of the Port
Savannah or a designated representative.
    (2) Persons or vessels desiring to enter, transit through, anchor
in, or remain within the safety zones may contact the Captain of the
Port Savannah by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
the safety zone is granted by the Captain of the Port Savannah or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Savannah or a designated representatives.
    (3) The Coast Guard will provide notice of the regulated areas by
Broadcast Notice to Mariners and on-scene designated representatives.
    (d) Effective period. This rule is effective September 27, 2015
from 7:30 a.m. until 11 p.m. or until all swimmers are out of the
water.

    Dated: July 17, 2015.
A.M. Beach,
Commander, U.S. Coast Guard, Captain of the Port Savannah.
[FR Doc. 2015-18844 Filed 7-30-15; 8:45 am]
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