```

[Senate Report 112-131]
[From the U.S. Government Publishing Office]

112th Congress                                                   Report
                                 SENATE
 2d Session                                                     112-131
_______________________________________________________________________

                                     

                                                       Calendar No. 297

 
               COMMERCIAL SEAFOOD CONSUMER PROTECTION ACT

                               __________

                              R E P O R T

                                 OF THE

           COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

                                   on

                                 S. 50

                                     

                January 26, 2012.--Ordered to be printed
       SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
                      one hundred twelfth congress
                             second session

            JOHN D. ROCKEFELLER IV, West Virginia, Chairman

DANIEL K. INOUYE, Hawaii             KAY BAILEY HUTCHISON, Texas
JOHN F. KERRY, Massachusetts         OLYMPIA J. SNOWE, Maine
BARBARA BOXER, California            JIM DeMINT, South Carolina
BILL NELSON, Florida                 JOHN THUNE, South Dakota
MARIA CANTWELL, Washington           ROGER F. WICKER, Mississippi
FRANK R. LAUTENBERG, New Jersey      JOHNNY ISAKSON, Georgia
MARK PRYOR, Arkansas                 ROY BLUNT, Missouri
CLAIRE McCASKILL, Missouri           JOHN BOOZMAN, Arkansas
AMY KLOBUCHAR, Minnesota             PATRICK J. TOOMEY, Pennsylvania
TOM UDALL, New Mexico                MARCO RUBIO, Florida
MARK WARNER, Virginia                KELLY AYOTTE, New Hampshire
MARK BEGICH, Alaska                  DEAN HELLER, Nevada

                     Ellen Doneski, Staff Director
                   James Reid, Deputy Staff Director
                Todd Bertoson, Republican Staff Director
            Jarrod Thompson Republican Deputy Staff Director
               Rebecca Seidel, Republican General Counsel

                                                       Calendar No. 297
112th Congress                                                   Report
                                 SENATE
 2d Session                                                     112-131

======================================================================

               COMMERCIAL SEAFOOD CONSUMER PROTECTION ACT

                                _______
                                

                January 26, 2012.--Ordered to be printed

                                _______
                                

     Mr. Rockefeller, from the Committee on Commerce, Science, and 
                Transportation, submitted the following

                                 REPORT

                          [To accompany S. 50]

    The Committee on Commerce, Science, and Transportation, to 
which was referred the bill (S. 50) to strengthen Federal 
consumer product safety programs and activities with respect to 
commercially-marketed seafood, by directing the Secretary of 
Commerce to coordinate with the Federal Trade Commission (FTC) 
and other appropriate Federal agencies to strengthen and 
coordinate those programs and activities, having considered the 
same, reports favorably thereon without amendment and 
recommends that the bill do pass.

                          Purpose of the Bill

  The purpose of S. 50, the Commercial Seafood Consumer 
Protection Act, is to improve the protections afforded under 
Federal law to consumers from contaminated seafood by 
strengthening the National Marine Fisheries Service (NMFS) 
Seafood Inspection Program (SIP), within the National Oceanic 
and Atmospheric Administration (NOAA), to ensure that 
commercially distributed seafood sold in the United States is 
fit for human consumption.

                          Background and Needs

  According to NOAA in the Department of Commerce, 84 percent 
of the finfish and shellfish consumed in the United States in 
2010 was imported (compared to 55 percent in 1995), and of the 
seafood imported into the United States, approximately 50 
percent is produced by aquaculture.\1\ China and Thailand are 
the largest exporters of seafood to the United States, 
accounting for roughly 23 percent and 16 percent of U.S. 
seafood imports, respectively.\2\ In monetary terms, U.S. 
seafood imports from China were valued at $2.4 billion in 2010, 
an increase of 336 percent from $550 million in 2001.\3\
---------------------------------------------------------------------------
    \1\National Oceanic and Atmospheric Administration. National Marine 
Fisheries Service, FishWatch-U.S. Seafood Facts: Trade (Sept. 8, 2010), 
http://www.nmfs.noaa.gov/fishwatch/trade_and_aquaculture.htm.
    \2\Id.
    \3\National Marine Fisheries Service, Fisheries Statistics & Econ. 
Div., Trade Balance by Country: China, 2010 (April, 2011), http://
www.st.nmfs.noaa.gov/pls/webpls/
trade_balance_c.results?qyear=2010&qcountry=5700&qoutput=TABLE.
---------------------------------------------------------------------------
  While the Food and Drug Administration (FDA) is the primary 
government agency that manages food safety and food health 
issues, NOAA's NMFS provides the general public with 
information regarding seafood products that are imported into 
the United States, and also conducts a voluntary SIP. The SIP 
works with the seafood industry to improve the overall quality 
and marketability of seafood and ensure that all processing 
firms are compliant with FDA and Department of Commerce 
regulations. It operates under the authority of the 
Agricultural Marketing Act of 1946\4\ and the Fish and Wildlife 
Act of 1956\5\ and ostensibly coordinates its efforts with 
those of FDA under a long-standing memorandum of understanding 
(MOU) between NOAA and FDA.\6\ The SIP offers a variety of 
services to industry, most notably inspection and testing of 
seafood products and certifying compliance with Hazard Analysis 
Critical Control Point (HACCP) requirements. The SIP employs 
approximately 170 people and operates on a fee-for-service 
basis. Presently, it is funded entirely by the fees it collects 
for its services and uses no appropriated funds for its 
operation.
---------------------------------------------------------------------------
    \4\Agricultural Marketing Act of 1946, 7 U.S.C. 1621-1638d 
(2010).
    \5\Fish and Wildlife Act of 1956, 16 U.S.C.  742a-742j (2009).
    \6\Memorandum of Understanding Between U.S. Dept. of Commerce Nat'l 
Oceanic & Atmospheric Admin. Nat'l Marine Fisheries Service and U.S. 
Dept. of Health, Education, & Welfare Food & Drug Admin. (1974).
---------------------------------------------------------------------------
  NMFS maintains the in-house scientific capability to support 
seafood inspection and product quality testing services at its 
National Seafood Inspection Laboratory in Pascagoula, 
Mississippi. On very rare occasions, NMFS also will allow 
samples to be verified and inspected at local, certified labs. 
In addition, 40 foreign facilities on an approved list are 
certified to perform inspections, and more facilities are being 
certified by the SIP. It is important to note that meeting 
inspection standards at these overseas facilities does not 
nullify FDA standards or the mandatory HACCP requirements 
necessary for importation. All products inspected at NMFS-
certified facilities are still subject to inspection by FDA 
upon entry into the United States.
  The SIP provides services beyond HACCP certification and 
product inspection and testing, including vessel and plant 
sanitation, label review, laboratory analysis, training, and 
consultative and informational services. Those who participate 
in the SIP may use official marks on complying products, which 
indicate they were federally inspected. This is vital to U.S. 
exports to certain markets; for example, the European Union 
requires a certification label on all imported seafood 
products. The SIP provides these certification services for 
approximately 2,500 foreign and domestic firms annually. Based 
on 2008 per capita consumption data, approximately 34 percent 
of seafood consumed in the United States is certified under the 
auspices of the SIP.\7\ By all accounts, the SIP is regarded as 
an effective and successful program for assuring the quality, 
wholesomeness, safety, proper labeling, and marketability of 
fish and fishery products.
---------------------------------------------------------------------------
    \7\Nat'l Marine Fisheries Service, Fisheries of the United States 
2009, at 83 (2010).
---------------------------------------------------------------------------
  In January 2001, a report by the Government Accountability 
Office (GAO) first raised concerns about the effectiveness of 
FDA's seafood safety inspection program and the adequacy of FDA 
inspection and laboratory resources.\8\ In its recommendations, 
GAO focused on means by which FDA might better leverage its 
resources in order to provide greater assurance that seafood--
particularly imported seafood--is safe.\9\ One of the key 
reasons for the 1974 MOU between NMFS and FDA was to enhance 
FDA's efficient use of its inspection resources by minimizing 
FDA inspections of firms already inspected by NMFS.\10\ The MOU 
states, among other things, that FDA will:
---------------------------------------------------------------------------
    \8\See U.S. Gov't Accountability Office, Food Safety: Federal 
Oversight of Seafood Does Not Sufficiently Protect Consumers (2001).
    \9\Id. 58.
    \10\Memorandum of Understanding between U.S. Dep't of Commerce 
Nat'l Oceanic & Atmospheric Admin. Nat'l Marine Fisheries Service & 
U.S. Dep't of Health, Education, & Welfare Food & Drug Admin. (1974).

        Recognize that the NMFS service provided in connection 
        with the voluntary inspection of fishery processing 
        establishments contributes to the protection of 
        consumers and aids FDA in enforcement of pertinent 
        statutes. The NMFS inspection service will not diminish 
        FDA's authority to inspect but should minimize FDA 
        inspections in establishments under NMFS contract 
        inspection. In this regard, NMFS inspectors shall 
        routinely notify contract establishments of pertinent 
        FDA requirements, advise them on how to comply and 
        verify compliance. NMFS inspectors may not act as FDA 
        inspectors but their inspections and consultations with 
        FDA should reduce the necessity for FDA 
        inspections.\11\
---------------------------------------------------------------------------
    \11\Id.

  In March 2005, one of several follow-up reports by GAO 
concluded that FDA had not yet fulfilled this and other 
commitments under the 1974 MOU with NMFS and that, in some 
cases, FDA was still unnecessarily duplicating NMFS 
inspections.\12\ Roughly a year earlier, in a 2004 report 
requested by several Members of this Committee, GAO noted 
ongoing concerns expressed by FDA regarding its limited 
resources and competing priorities.\13\ GAO recommended in 
response that NMFS put SIP personnel at FDA's disposal to 
bolster FDA's provision of various services, potentially 
including inspections of foreign firms, importer inspections, 
port-of-entry examinations and sample collections, and 
laboratory analyses.\14\ FDA did not pursue this strategy with 
NMFS.
---------------------------------------------------------------------------
    \12\U.S. Gov't Accountability Office, Oversight of Food Safety 
Activities: Federal Agencies Should Pursue Opportunities to Reduce 
Overlap and Better Leverage Resources (2005).
    \13\U.S. Gov't Accountability Office, Food Safety: FDA'S Imported 
Seafood Safety Program Shows Some Progress, But Further Improvements 
Are Needed 29 (2004).
    \14\Id.
---------------------------------------------------------------------------
  In January 2007, GAO added the Federal oversight of food 
safety to its list of high-risk areas needing broad-based 
transformation, largely because of continued ineffective 
coordination and inefficient use of resources.\15\ As a part of 
that 2007 update to its high-risk list, GAO reiterated its 
recommendation that FDA consider using SIP personnel to augment 
FDA's inspection capacity.\16\ In February 2009, GAO reported 
that FDA and NMFS still had not begun to work together and 
recommended that the agencies collaborate in order to enhance 
their use of inspection resources and Federal oversight of 
seafood.\17\ The 2009 report included the following passage, 
which is instructive in understanding the nature, scope, and 
impacts of this ongoing deficiency:
---------------------------------------------------------------------------
    \15\U.S. Gov't Accountability Office, High-Risk Series: An Update 
(2007).
    \16\Id. 29.
    \17\U.S. Gov't Accountability Office, Seafood Fraud: FDA Program 
Changes and Better Collaboration Among Key Federal Agencies Could 
Improve Detection and Prevention (2009).

        Not only does the lack of collaboration create 
        inefficient information sharing between the key federal 
        agencies, it also creates overlapping agency efforts 
        and inefficient use of government resources. NMFS and 
        FDA have similar inspection programs--NMFS inspects 
        facilities, on request, for health, safety, and 
        economic integrity issues, while FDA focuses its 
        inspections on health and safety concerns. However, an 
        FDA official said that the agency is not sure whether 
        it can rely on NMFS inspections, in part due to 
        concerns about potential conflicts of interest because 
        NMFS is paid by industry to conduct its inspections. 
        FDA has identified these potential conflicts as an 
        impediment to fully using NMFS inspection efforts in 
        the past. In our 2004 report on FDA's imported seafood 
        safety program, we stated that an official raised 
        concerns about potential conflicts of interest with 
        NMFS inspections, but that other officials thought that 
        these concerns could be addressed in an agreement 
        between the two agencies. We recommended that FDA and 
        NMFS develop a MOU that, in part, would use and 
        leverage NMFS inspection services to more efficiently 
        and effectively monitor the safety of imported seafood. 
        In response, FDA stated that there were already three 
        MOUs between FDA and NMFS that dealt with seafood 
        safety and inspection operations, but that it would 
        explore additional opportunities to better leverage 
        NMFS inspection resources and more efficiently and 
        effectively protect the public health. Among the three 
        MOUs, the 1974 MOU between FDA and NMFS stated, in 
        part, that NMFS would provide FDA with information on 
        establishments under contract with it, and that such 
        inspections and consultations with FDA should diminish 
        the need for FDA inspections. Despite FDA's statements 
        and the provisions in its 1974 MOU, FDA still does not 
        take into account whether NMFS has already inspected a 
        facility when FDA determines which facilities it will 
        inspect. For example, from 2005 through 2008, NMFS 
        inspected one facility we visited at least four times a 
        year, yet FDA also inspected it in 2005, 2006, and 
        2008. Furthermore, neither agency found any significant 
        issues during their inspections of this facility. 
        Overall, in fiscal year 2007, FDA inspected 120 
        facilities that were also inspected by NMFS, while FDA 
        had not inspected 1,464 other facilities since before 
        fiscal year 2003. Also during fiscal year 2007, NMFS 
        inspected 88 facilities that FDA either had not 
        inspected within the same fiscal year or had not 
        inspected at all. In its technical comments to our 
        draft report, FDA stated that it is currently 
        negotiating an MOU with NMFS that is intended to 
        address its concerns about potential conflicts of 
        interest.\18\
---------------------------------------------------------------------------
    \18\Id. 28-29.

  On October 26, 2009, NOAA and FDA did, in fact, enter into a 
revised MOU, the stated purpose of which is, ``Cooperation and 
information sharing in the inspection of fish and fishery 
products and establishments.''\19\ The revised MOU reflects a 
mutual agreement that ``[e]ach agency will take advantage of 
the inspectional capabilities of the other to achieve the 
maximum utilization of resources, when appropriate and as 
resources permit.''\20\ In support of this mutual commitment, 
the revised MOU also states that NMFS will ``[p]rovide 
information to FDA concerning specific establishments or 
products that have been inspected by NMFS relevant to 
compliance with FDA requirements, when requested by FDA,'' and 
will ``[p]erform sample analysis and/or conduct inspections of 
fish and fishery product processors, as appropriate, on FDA's 
request and upon mutual agreement.''\21\
---------------------------------------------------------------------------
    \19\Memorandum of Understanding between U.S. Department of Commerce 
National Oceanic and Atmospheric Admin. and U.S. Department of Health 
and Human Services Food and Drug Admin., 74 Fed. Reg. 58027 (Nov. 10, 
2009).
    \20\Id. 58032.
    \21\Id. 58030.
---------------------------------------------------------------------------
  In another development intended to improve seafood safety, on 
January 4, 2011, the President signed into law the FDA Food 
Safety Modernization Act (FSMA).\22\ FSMA was intended as a 
comprehensive modernization of FDA in order to enhance food 
safety, and included two provisions specific to seafood safety 
and oversight. First, it amended the Federal Food, Drug, and 
Cosmetic Act\23\ (FFDCA) to provide permissive authority for 
the Secretary of Health and Human Services (HHS), the Secretary 
of Commerce, the Secretary of Homeland Security, the Chairman 
of the FTC, and the heads of other appropriate agencies to 
enter into such agreements as may be necessary or appropriate 
to improve seafood safety.\24\ Second, it provided permissive 
authority for the Secretary of Commerce, in coordination with 
the Secretary of HHS, to send one or more inspectors to a 
country or facility of an exporter from which seafood is 
imported into the United States to assess practices and 
processes used in connection with the farming, cultivating, 
harvesting, preparation, and transportation of seafood.\25\ In 
addition to these two seafood-specific provisions, FSMA amended 
the FFDCA to require the Secretary of HHS to establish a 
program for the testing of food by accredited laboratories, and 
to establish a publicly available registry of HHS-recognized 
accreditation bodies and the laboratories accredited by those 
bodies to perform food testing and import sampling.\26\
---------------------------------------------------------------------------
    \22\FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 
Stat. 3885 (2010).
    \23\Federal Food, Drug, and Cosmetic Act, 21 U.S.C.  301-399a 
(2009).
    \24\FDA Food Safety Modernization Act  201(a).
    \25\FDA Food Safety Modernization Act  306(b).
    \26\FDA Food Safety Modernization Act  202(a).
---------------------------------------------------------------------------
  Despite the potential of the revised MOU and FSMA to increase 
interagency coordination, GAO concluded in April 2011, in yet 
another follow-up report to Members of this Committee, that FDA 
and NMFS still have made only limited progress in implementing 
their revised 2009 MOU, and FDA still has yet to take advantage 
of NMFS inspection resources.\27\ Specifically, GAO reported 
that FDA has yet to fully meet its responsibility under the 
revised MOU to utilize NMFS foreign and domestic inspection 
resources in a systematic manner.\28\ By effectively utilizing 
NMFS inspection resources to help minimize its own inspection 
responsibilities, GAO observed, FDA could inspect other 
facilities that have not yet been inspected.\29\ GAO noted that 
FSMA ``provides FDA with new authorities that may enable it to 
more comprehensively review a foreign county's seafood safety 
system and implement the practices that other entities employ 
to ensure the safety of imported seafood products.''\30\ 
However, GAO went on to observe that:
---------------------------------------------------------------------------
    \27\Gov't Accountability Office, Seafood Safety: FDA Needs to 
Improve Oversight of Imported Seafood and Better Leverage Limited 
Resources 23 (2011).
    \28\Id.
    \29\Id.
    \30\Id. 27 (emphasis added).

        To facilitate consideration and implementation of a 
        different oversight approach to ensure the safety of 
        imported seafood, FDA must utilize its current 
        resources in the most efficient manner. However, FDA is 
        not efficiently using its resources when it does not 
        effectively implement the 2009 MOU with NMFS and fully 
        utilize the resources of NMFS' Seafood Inspection 
        Program, an agency dedicated specifically and solely to 
        ensuring the quality and safety of seafood.\31\
---------------------------------------------------------------------------
    \31\Id. 27-28.

  In light of these most recent findings by GAO, it is worth 
noting that, although FSMA represents a sweeping and sorely 
needed overhaul of the Nation's food safety system, there are 
certain things FSMA does not do.
  FSMA does not require, but instead merely permits, HHS, the 
Department of Commerce, and other appropriate departments and 
agencies to enter into interagency agreements in order to 
improve seafood safety. It also does not include within the 
scope of that permissive authority the ability to: strengthen 
cooperation on seafood labeling or seafood fraud; coordinate 
the collection and analysis of, or share, information on the 
movement of seafood in commerce in order to detect and 
investigate violations of Federal law; or engage in outreach to 
private testing laboratories, the seafood industry, and the 
public to enhance seafood safety and prevent fraud and 
mislabeling.
  Furthermore, while FSMA includes authority for FDA to 
recognize accredited food testing laboratories and to increase 
the number of laboratories qualified to perform food testing 
generally, FSMA does not seek to take advantage of the 
expertise and ability of the SIP (working in consultation with 
FDA) to increase the number of laboratories specializing in 
seafood testing that are certified to FDA standards, or to 
expand testing activities at its National Seafood Inspection 
Laboratory. In all likelihood this is because the subject 
matter is beyond the scope of modernizing FDA's food safety 
authorities.
  Finally, FSMA does not (nor was it intended to) include any 
significant measures to address the growing problem of 
mislabeling and substitution of seafood products in the stream 
of commerce, such as through the establishment of a list of 
standardized seafood names to facilitate seafood 
identification.

                         Summary of Provisions

  S. 50 would, if enacted into law, strengthen and expand 
interagency coordination with respect to seafood safety and 
inspection and consumer fraud. Importantly, it is intended to 
complement the FFDCA as amended by FSMA, not compete with or 
undermine it. It would require the Department of Commerce, the 
FTC, and other appropriate Federal agencies to strengthen 
consumer protection activities for ensuring the safety and 
quality of commercially distributed seafood in the United 
States. It would address the almost 40 years of poor 
coordination and cooperation between agencies charged with 
ensuring seafood quality and safety (which according to GAO, 
still exists to the present day) by mandating that the 
Secretary of Commerce and other Federal agencies execute 
memoranda of understanding for, among other things, cooperative 
examination and testing of seafood that leverage agencies' 
resources, capabilities, and authorities.
  S. 50 would take advantage of the seafood testing expertise 
of the SIP and its National Seafood Inspection Laboratory by 
authorizing the Secretary of Commerce, in consultation with the 
Secretary of HHS, to engage in a targeted effort to increase 
the number of U.S. and foreign laboratories certified to FDA 
standards (similar to the manner in which the SIP already 
certifies compliant U.S. and foreign seafood facilities). The 
bill also would authorize the Secretary of Commerce to increase 
the number and capacity of laboratories operated by the SIP, to 
the extent the Secretary determines such increases are 
necessary and funding is appropriated to do so.
  To further enhance the Nation's ability to protect consumers 
from contaminated seafood imports, the bill would prescribe a 
strict process for the Secretary of Commerce to follow upon a 
determination by the Secretary of HHS that a shipment of 
seafood is contaminated upon entry into the United States. It 
also would authorize the Secretary of Commerce to increase the 
number of inspectors sent abroad to a country or exporter of 
seafood products to the United States to ensure the seafood 
products are in compliance with Federal law.
  Finally, S. 50 would help detect and combat seafood 
mislabeling and fraud by requiring the development and 
publication, by joint rulemaking proceeding by the Secretary of 
Commerce and the Secretary of HHS, of a standardized list of 
names for seafood to aid distributors, retailers, and consumers 
in identifying seafood products.

                          Legislative History

  S. 50 was introduced by Senator Inouye on January 25, 2011, 
and is cosponsored by Senators Snowe, Vitter, and Begich. On 
June 8, 2011, the Committee met in open Executive Session and 
by voice vote ordered that the bill be reported favorably 
without amendment. A previous version of this legislation, S. 
2688, was introduced and ordered to be reported favorably in 
the 110th Congress.

                            Estimated Costs

  In accordance with paragraph 11(a) of rule XXVI of the 
Standing Rules of the Senate and section 403 of the 
Congressional Budget Act of 1974, the Committee provides the 
following cost estimate, prepared by the Congressional Budget 
Office:

S. 50--Commercial Seafood Consumer Protection Act

    Summary: S. 50 would require the Secretary of Commerce to 
coordinate and administer certain activities to enhance the 
safety of seafood products sold in the United States. The bill 
also would modify existing provisions that authorize the 
Secretary of Health and Human Services (HHS) to refuse entry of 
seafood imports. Finally, S. 50 would direct the Secretary of 
HHS to enter into memoranda of understanding and other 
agreements to strengthen interagency cooperation on seafood 
safety.
    Based on historical information, expert opinion, and 
information provided by the affected agencies, CBO estimates 
that implementing S. 50 would cost $80 million over the 2012-
2016 period, assuming appropriation of the necessary amounts. 
Pay-as-you-go procedures do not apply to this legislation 
because it would not affect direct spending or revenues.
    S. 50 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
    Estimated Cost to the Federal Government: The estimated 
budgetary impact of S. 50 is shown in the following table. The 
costs of this legislation fall within budget functions 300 
(natural resources and environment) and 550 (health).

----------------------------------------------------------------------------------------------------------------
                                                                      By fiscal year, in millions of dollars--
                                                                  ----------------------------------------------
                                                                    2012   2013   2014   2015   2016   2012-2016
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated Authorization Level....................................     20     20     15     15     15          85
Estimated Outlays................................................     15     19     16     15     15          80
----------------------------------------------------------------------------------------------------------------

    Basis of Estimate: For this estimate, CBO assumes that S. 
50 will be enacted near the beginning of fiscal year 2012 and 
that the necessary amounts will be appropriated for each year. 
Estimated outlays are based on historical spending patterns for 
similar programs.

Department of Health and Human Services Activities

    S. 50 would modify existing provisions that authorize the 
Secretary of HHS to refuse entry of seafood imports. Under 
current law, importers are required to prove that all shipments 
meet import requirements, and the Food and Drug Administration 
(FDA) can refuse entry of shipments that fail to appear to meet 
those requirements. This bill would increase the burden of 
proof on FDA for such refusals by requiring the agency to prove 
that a seafood shipment does not meet the import requirements. 
CBO assumes that such a change would require FDA to conduct 
additional sampling, testing, and holding of shipments that 
otherwise would have been refused entry based on appearance.
    S. 50 also would permit FDA to allow import shipments to 
enter the country if FDA finds that the shipment or conditions 
of manufacturing meet the import requirements. CBO assumes that 
provision would result in additional inspections of foreign 
facilities to ensure shipments meet the conditions of the 
manufacturing requirements.
    Based on historical information and expert opinion, CBO 
estimates that implementing S. 50 would cost $80 million over 
the 2012-2016 period assuming appropriation of the necessary 
amounts. While this estimate reflects CBO's best judgment on 
the basis of available information, that projected cost is an 
expected value of outcomes for future seafood import problems 
and is subject to a great deal of uncertainty. The costs of 
testing are likely to vary depending on the product, the length 
of time to complete testing, and whether or not foreign 
manufacturing facilities will need to be inspected.
    S. 50 also would direct the Secretary of HHS to enter into 
memoranda of understanding and other agreements to strengthen 
interagency cooperation on seafood safety. Under current law, 
the FDA is already engaging in such interagency activities. 
Thus, CBO anticipates that those provisions would have no 
significant budgetary impact.

Department of Commerce Activities

    S. 50 would require the Secretary of Commerce to coordinate 
and administer certain multi-agency activities to enhance the 
safety of seafood products. Because the bill contains several 
provisions that require the Secretary to carry out activities 
that are required under current law, CBO estimates that 
implementing those provisions would not affect the federal 
budget. The bill also would require the Secretary to prepare 
several reports related to the execution of certain multi-
agency agreements and measures taken to enhance consumer 
protection and enforcement activities related to seafood 
safety. Based on information regarding the cost of producing 
similar reports, CBO estimates that the costs of carrying out 
those activities would not be significant.
    Pay-as-you-go considerations: None.
    Intergovernmental and private-sector impact: S. 50 contains 
no intergovernmental or private-sector mandates as defined in 
UMRA. Because the bill would codify existing policy for 
identifying seafood, it would not impose a new enforceability 
duty on tribal or private seafood manufacturers.
    Estimate prepared by: Federal Costs: Ellen Werble and Jeff 
LaFave; Impact on State, Local, and Tribal Governments: Lisa 
Ramirez-Branum; Impact on the Private Sector: Mann Randall.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                      Regulatory Impact Statement

  In accordance with paragraph 11(b) of rule XXVI of the 
Standing Rules of the Senate, the Committee provides the 
following evaluation of the regulatory impact of the 
legislation, as reported:

                       NUMBER OF PERSONS COVERED

  S. 50, as reported, would refine and improve current 
statutory authorities for an existing NOAA program which 
operates on a voluntary, fee-for-service basis. The bill would 
have little, if any, regulatory impact.

                            ECONOMIC IMPACT

  S. 50, as reported, would improve seafood safety and, in so 
doing, would reduce consumption of contaminated seafood. S. 50 
also would reduce fraud, deception, and unfair business 
practices that currently impact U.S. businesses and consumers. 
The legislation is therefore not expected to have a negative 
impact on the Nation's economy.

                                PRIVACY

  The reported bill would have little, if any, impact on the 
personal privacy of U.S. citizens.

                               PAPERWORK

  The reported bill would not increase paperwork requirements 
for the private sector. NOAA and FDA paperwork requirements 
would likely increase slightly as a result of the enhanced 
authorities and rulemaking and reporting requirements provided 
in the bill.

                   Congressionally Directed Spending

  In compliance with paragraph 4(b) of rule XLIV of the 
Standing Rules of the Senate, the Committee provides that no 
provisions contained in the bill, as reported, meet the 
definition of congressionally directed spending items under the 
rule.

                      Section-by-Section Analysis

Section 1. Short title

  This section would provide that this Act may be cited as the 
``Commercial Seafood Consumer Protection Act.''

Section 2. Commercially marketed seafood consumer protection safety net

  This section would require the Secretary of Commerce, in 
coordination with the FTC and other appropriate Federal 
agencies and consistent with U.S. international obligations, to 
strengthen Federal consumer protection activities for ensuring 
that commercially distributed seafood meets applicable Federal 
food quality and safety requirements. It would require the 
Secretary of Commerce and other appropriate Federal agencies to 
enter into memoranda of understanding to strengthen interagency 
cooperation on seafood safety, seafood labeling, and seafood 
fraud. These memoranda would be required to include provisions, 
as appropriate, for:

           Examination and testing of imported seafood;

           Inspection of foreign facilities;

           Standardizing data on seafood names, 
        inspection records, and laboratory testing;

           Coordinating and sharing information in 
        order to detect and investigate violations under 
        applicable Federal laws;

           Developing a process for expediting imports 
        of seafood into the United States from foreign 
        countries and exporters that consistently adhere to the 
        highest standards for ensuring seafood safety;

           Coordinating the tracking of shipments of 
        seafood in the distribution chain within the United 
        States;

           Enhancing labeling requirements and methods 
        of assuring compliance with such requirements to 
        clearly identify species and prevent fraudulent 
        practices;

           Commissioning of NOAA officers and employees 
        to examine seafood on behalf of other agencies;

           Sharing of information concerning non-
        compliance and new regulation;

           Joint training on subjects related to 
        seafood inspection; and

           Outreach to private testing laboratories, 
        industry, and the public on Federal efforts to enhance 
        seafood safety and compliance with labeling 
        requirements.

  The Secretary of Commerce, the Chairman of the FTC, and the 
heads of other appropriate Federal agencies would be required 
to report annually to Congress on specific efforts undertaken 
pursuant to these agreements, as well as the budget, personnel, 
and any additional authorities needed to improve seafood safety 
and labeling and prevent seafood fraud. Separately, the 
Secretary of Commerce and the Chairman of the FTC would be 
required to submit a joint report to Congress within one year 
after the date of enactment of this Act on consumer protection 
and enforcement efforts with respect to seafood marketing and 
labeling in the United States.

Section 3. Certified laboratories

  This section would require the Secretary of Commerce, in 
consultation with the Secretary of HHS, to increase the number 
of laboratories certified to the standards of FDA to analyze 
seafood both in the United States and in foreign nations that 
export seafood to the United States.

Section 4. NOAA laboratories

  This section would authorize the Secretary of Commerce to 
increase the number and capacity of NOAA laboratories that are 
involved with the NMFS SIP.

Section 5. Contaminated seafood

  This section would establish a strict procedure for dealing 
with cases where contaminated shipments of seafood are found 
entering the United States or there is reliable evidence 
suggesting that seafood from a given country is not likely to 
meet Federal standards. It would allow the Secretary of HHS to 
refuse imported contaminated seafood and to request increased 
testing of seafood originating from countries where there is 
reasonable evidence of contamination. It would allow individual 
shipments to be admitted into the United States if there is 
laboratory evidence that a shipment meets the requirements of 
Federal law. The Committee notes that section 801(a) of the 
FFDCA has long provided the Secretary of HHS with the authority 
to refuse admission into the United States of food or other 
articles if it appears that they are, inter alia, manufactured, 
processed, or packed under unsanitary conditions, adulterated, 
or misbranded.\32\ Section 5(a) of S. 50 would permit the 
Secretary of HHS to refuse admission of shipments of seafood if 
the Secretary determines that they do not meet the requirements 
of Federal law. It is not the intent of the Committee that a 
violation of Federal law be proven or otherwise formally 
determined to have occurred in order for the Secretary of HHS 
to exercise the authority granted under section 5(a). Rather, 
it is the intent of the Committee that section 5(a) be read and 
interpreted in conformity with the longstanding appearance 
standard established by section 801(a) of the FFDCA. Under 
section 5(a), the Secretary of HHS would be authorized to issue 
an order refusing admission into the United States of imports 
of seafood or seafood products if it appears to the Secretary 
that shipments of such seafood or seafood products do not meet 
the requirements established under applicable Federal law.
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    \32\Federal Food, Drug, and Cosmetic Act 801(a), 21 U.S.C. 381 
(2009).
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Section 6. Inspection teams

  This section would authorize the Secretary of Commerce, in 
cooperation with the Secretary of HHS, to send inspectors 
overseas to assess the methods used by seafood exporters to 
ensure they are compatible with Federal law and report on their 
findings.

Section 7. Seafood identification

  This section would direct the Secretary of Commerce and the 
Secretary of HHS to initiate a joint rulemaking proceeding to 
develop and make public a list of standardized names for 
seafood identification purposes at distribution, marketing, and 
consumer retail stages.

Section 8. Definitions

  This section would define the terms, ``applicable Federal 
laws,'' ``appropriate Federal agencies,'' and ``Secretary'' for 
purposes of the Act.

                        Changes in Existing Law

  In compliance with paragraph 12 of rule XXVI of the Standing 
Rules of the Senate, the Committee states that the bill as 
reported would make no change to existing law.

                                  
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