Senate Committee Completes Labor-H Bill
The full Senate Appropriations Committee reported the FY2006
Labor, HHS, Education, & Related Agencies Appropriations bill to the Senate.
The committee recommends a spending package of $145.693 billion, a slight increase
over FY2005 funding level of $143.463 billion and the President’s request
of $141.919 billion.
Issues raised in the committee report include:
National Institutes of Health – The Senate
bill includes $29.415 billion, an increase of $1.050 billion over the FY2005
appropriation and $905 million
over the President’s budget request.
Centers for Disease Control & Prevention Buildings and
Facilities – The
Senate bill includes $195 million over the budget request, for a total of $225
million.
Health Information Technology – The bill provides
$95.2 million, an increase of $21 million over the FY2005 level.
Geriatric Education Centers & Training - The
Committee provided $29.5 million for the Geriatrics Education Centers & Training
programs. The FY2005 comparable level was $31.5 and the administration did
not request any funds for this program in FY2006.
Embryo Adoption – The bill provides $2 million for
an embryo adoption awareness campaign, an increase of $1 million over the FY2005
level.
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Lautenberg Introduces Toxic Substances Bill
On July 13, Sen. Frank Lautenberg (D-NJ) introduced
with six other senators, S. 1391, the Child, Worker & Consumer-Safe
Chemicals Act
of 2005 (the Kid Safe Chemicals Act). The bill would amend the Toxic
Substances Control Act (TSCA) to modify procedural requirements and
make other changes that, in the view of the sponsors, will enhance
the ability of the Environmental Protection Agency (EPA) to regulate
the contents of consumer products with regard to the inclusion of toxic
chemicals.
The bill is in partial response to a recent report
by GAO that EPA is not doing a good job in controlling the risks of
chemicals not
already on the market, assessing the risks of substances in existing
products, or informing the public of information provided by manufacturers
under TSCA. GAO recommended Congress revise EPA’s authorities
and that EPA improve its management of its chemical program.
In statements on the Senate floor, Lautenberg and
Sen. Jaim Jeffords (I-VT) emphasized the importance of ensuring
household products
are safe, especially for children. They noted that many chemicals identified
years ago as being toxic have never been removed from common consumer
products.
The bill, according to its sponsors, would apply standards
similar to those already in place under the Food Quality Protection
Act (FQPA), including
requiring manufacturers to test all products and provide data to EPA,
authorizing public disclosure of hazard and exposure information, and
requiring EPA to prioritize and evaluate the safety of 300 chemicals
in the next five years. The bill would require all chemicals in commerce
meet the new safety standards by the year 2020. TSCA currently does
not apply to chemicals in products regulated by other agencies like
FDA, and this bill would not change that.
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NIH Submits Report on Conflicts of Interest
This week, the House Energy & Commerce Committee released a report
NIH submitted July 8 on the agency’s investigation into whether
its officials and scientists violated conflict of interest requirements,
particularly in regard to work they had done for or on behalf of pharmaceutical
companies.
NIH’s report indicates that of 81 scientists
previously identified by the committee’s Oversight & Investigations
subcommittee as potentially having violated ethics rules, 44 were found
to have
broken one or more rules. These scientists failed to disclose work
they were doing, failed to take leave for private work, or failed to
seek prior approval for outside activities. Of the 44, according to
NIH, 36 may be subject to disciplinary action and nine have been referred
for investigation to the HHS Office of the Inspector General.
In the course of the oversight subcommittee’s
investigation, violations identified included scientists receiving
large payments
from pharmaceutical companies and failing to receive proper clearance
for their work. The ommittee chair and ranking Democrat, Reps.
Joe Barton (R-TX) and John Dingell (D-MI), wrote in March to NIH Director
Elias Zerhouni, M.D. to ask for an investigation and a report. They
determined this week releasing the report was in the public interest.
In commenting on the report, Barton commended Zerhouni for taking
the matter seriously and conducting a fair investigation. Zerhouni’s
revision of NIH’s conflict of interest rules was applauded by
Dingell, but has been controversial among
NIH employees.
Barton also noted Congress needs to proceed this year
to reauthorize NIH programs. In particular, he said the NIH Director
needs greater
authority and flexibility to adjust funding and move funds among NIH
components to ensure funding of the best and most promising research.
Committee staff are working on what Barton hopes can be a bipartisan
NIH reauthorization bill. The first hearing on a draft proposal is
scheduled for next week and Barton has expressed hope a bill can
be moved through the committee quickly.
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Davis, Waxman, Dingell Introduce
Supplement Legislation
On
June 30, Reps. Susan Davis (D-CA), Henry Waxman (D-CA), and John Dingell
(D-MI) introduced the Dietary Supplement Access & Awareness
Act, which would amend the Food, Drug & Cosmetic (FDC) Act to increase
dietary supplement regulatory provisions. Like legislation they introduced
in the last Congress, the bill would exempt from its requirements supplements
that are vitamins or minerals, or that do not contain botanicals or
amino acids.
The legislation would require dietary supplement manufacturers
(already required to register with HHS/FDA) to report twice a year
a list of
each dietary supplement manufactured or processed for the U.S. market,
the labeling of those products, a list of ingredients in each, and
a list of any products discontinued. Supplement manufacturers also
would be required to report serious adverse events within 15 days of
receiving a notification of such an event, to investigate such events,
and to report additional information. The definition of serious adverse
experience is consistent with existing FDA rules.
FDA would be authorized to order a manufacturer to
conduct postmarket surveillance “if there is a reasonable possibility
that a use or expected use of the supplement may have serious adverse
health consequences” and
to order a manufacturer to demonstrate within 180 days that a product
is not adulterated, if there are “reasonable grounds” to
believe it is.
Regulations would be required to establish criteria for evaluating
if a supplement may pose a risk to children and to require manufacturers
to maintain records of serious adverse event reports. Failure to comply
with the new requirements would be specifically prohibited under the
FDC Act.
The bill would authorize the secretary to make a determination
of “unreasonable
risk” if it is determined the risks of a product outweigh
its benefits, based on “any science-based evidence,” regardless
of whether it is shown the product actually caused a particular
harm. This language appears to be responsive to the court’s decision
in the ephedra case that FDA had exceeded its authority by looking
at the risk-benefit relationship for ephedra products.
The bill authorizes funds requiring FDA to carry out a program to
educate health care professionals about the importance of reporting
adverse events and consumers about the need to advise their health
care providers about supplement use.
The bill has been referred to the House Energy & Commerce
subcommittee on health.
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BioShield Hearings in House
This week the House Homeland Security subcommittee
on Emergency Preparedness, Science, & Technology held a hearing
on “Project BioShield:
Linking Bioterrorism Threats and Countermeasure Procurement to Enhance
Terrorism Preparedness.” Also this week, the House Government
Reform Committee held a hearing on “One Year Later: Evaluating
the Effectiveness of Project BioShield.”
A number of industry panelists criticized DHS and
HHS for muddling the BioShield process, with members of both committees
appearing frustrated
with the DHS and HHS witnesses for not using BioShield more effectively.
Rep. Bill Pascrell (D-NJ) noted when Congress set up BioShield
it did not include specifics for how to conduct Material Threat Assessments
(MTA) because they were viewed as preliminary and quick. However, it
has become very complex and CDC now has at least 33 agents on its list
that have not been reviewed. A call for more transparency was made
from members and industry witnesses.
Rep. Michael McCaul (R-TX) asked the panel what could
be done to bring big pharmaceutical companies to the table. Witness
responded that barriers
include previous markets and indemnification. Pascrell said pharmaceutical
companies are hesitant to become involved in BioShield because of the
potential for liability. They also fear losing intellectual
property rights should Congress request mass production.
In addition to industry and academic witnesses, appearing before
both committees were Stewart Simonson, assistant secretary for Public
Health Emergency Preparedness at HHS and Dr. John Vitko, Director
of Biological Countermeasures Portfolio, Science, & Technology
Directorate at DHS. Dr. Anthony Fauci, Director of the National Institute
of Allergy and Infectious Disease at NIH appeared before the Government
Reform Committee.
According to Simonson, the R&D pipeline has few,
if any, candidates for BioShield products which is why HHS is currently
using advanced
development products. He also said the department is actively monitoring
the medical countermeasure pipeline - both within and outside the government
- by evaluating government research and development portfolios and
engaging
industry through the publication of Requests for Information (RFIs).
Only a portion of the $5.6 billion Congress allocated for Project
Bioshield to HHS has been spent. Yet Fauci said the issue is
not just whether the government has the money to buy products, but
whether they are FDA licensable.
Return to top FDA Announces Meeting on Gluten Labeling
FDA has announced a public meeting on August 19, to
discuss the development of a paradigm for voluntary labeling of food
products as “gluten-free.” The
meeting is part of FDA’s implementation of requirements in the
Food Allergen Labeling & Consumer Protection Act of 2004, which required
the agency to issue a proposed rule in two years to define and allow
use of the term “gluten-free.”
In describing the discussion points for the upcoming
meeting, FDA notes accurately defining “gluten-free” will
help individuals who have celiac disease to make better informed food
choices.
FDA asks for participation at the meeting of food industry representatives,
particularly to discuss the mechanisms and costs associated with manufacturing
gluten-free food products and any research on consumer purchasing practices,
to help determine how the public is likely to respond to new labeling.
Other matters, such as the tolerance levels for gluten and the medical
implications of celiac disease, are being discussed by FDA’s
Food Advisory Committee this week.
FDA proposes, in the Federal Register, a number of questions it asks
meeting participants to consider, including how gluten-free foods are
produced, the technical difficulties in avoiding cross-contamination,
analytical methods to determine the presence or absence of gluten and
what consumers believe “gluten-free” means.
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Appeals
Court Overturns Canadian Cattle Ban; USDA Moves to Open Border Immediately
The temporary federal court injunction banning U.S. imports of live
Canadian cattle less than 30 months of age was overturned July 14 in
a unanimous decision by the 9th U.S. Circuit Court of Appeals. USDA
said it will implement its minimal risk rule on imports immediately.
The decision was a blow to the Ranchers-Cattlemen
Legal Action Fund (R-CALF) which won the temporary ban through a federal
district court
in Montana March 2004, alleging live cattle imports from Canada
would endanger human health and the U.S. cattle herd. The appeals court
ruling,
expected to be formally released today, will also effectively bar the
Montana federal judge from imposing another injunction.
The three-judge appeals court panel suggested during the 40-minute
hearing that federal Judge Richard F. Cebull, who issued the original
injunction, should have given USDA’s decision on designating
certain countries as BSE minimal risk nations more weight in his ruling.
Judge A. Wallace Tashima said federal law “invests the secretary
of agriculture with a certain amount of discretion,” with his
colleague Judge Connie Callahan saying USDA is “entitled to some
deference. It’s their (sic) whole job to keep up with the science
to make those decisions.”
The Justice Department argued the USDA department
rulemaking to allow live cattle imports from Canada was based upon “good
science,” and would not result in BSE introduction to the U.S.
Secretary of Agriculture Mike Johanns said in a prepared statement, “Because
the ruling is effective immediately we are immediately taking steps
to resume the importation of cattle less than 30 months of age from
Canada.”
USDA said APHIS, upon hearing of the appeals court
decision, immediately contacted the Canadian Food Inspection Agency
to prepare to certify
cattle for shipment. U.S. meat processors said they could resume imports
immediately given much preliminary work is already complete.
R-CALF said the court decision places U.S. beef at risk. The American
Meat Institute said the R-CALF-inspired border closure cost more than
8,000 U.S. meat processing jobs, and contributed to driving ground
beef prices from $1.85 per pound before the border closed to $2.55
per pound today.
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Japan Reportedly Nervous Over US Testing System Missing Texas Cow
Media reports out of Tokyo this week indicate the Japanese government’s
food safety regulators are questioning U.S. beef safety after a Ministry
of Agriculture study showed U.S. cattle testing methods would have
missed nine out of the 20 cases of BSE confirmed in Japan. Scientists
asked for more details on the second case of BSE found in the U.S. – and
this nation’s first native-born case – out of concern BSE
animals may have reached market because they appeared healthy. Officials
further acknowledged their request for additional information will
likely delay any decision to reopen beef trade with the U.S.
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Bovine TB Found in Minnesota
A northern Minnesota cattle herd tested positive for bovine tuberculosis,
the first discovery in Minnesota since 1971, after USDA slaughter inspectors
identified a suspect animal and subsequent testing confirmed the disease.
This week USDA officially declared the herd infected and began the
process of destroying up to 900 animals. USDA paid the owner for the
cattle. Federal officials will begin tracing any animals which left
the farm over the last seven years, but Minnesota will not lose its
TB-free status unless another infected animal is found and that animal
is not related to the current investigation, officials said.
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House Passes Four OSHA Bills
The full House this week approved four bills aimed at reducing small
business burdens resulting from OSHA compliance requirements. Major
Democrats immediately attacked the bills for jeopardizing workers.
Despite impassioned floor statements that passing
the bills would undermine OSHA’s authority to protect workers,
the GOP-controlled House nonetheless made good on its commitment to
curb what proponents
describe as “overzealous” rulemaking. The House passed
similar bills in the last session which were blocked in the Senate.
Bill champions said the bills merely give small business more options
in OSHA compliance. One bill provides exemptions from the 15-day deadline
for challenging OSHA citations, based on small business limits on getting
expert assistance to file appropriate paperwork. The second bill reduces
the Occupation Safety & Health Commission from five to three members.
The third bill addresses a 1991 Supreme Court decision by restoring
a small business’ right to appeal cases to an independent court.
The fourth bill requires OSHA to pay court and attorney fees if a business
can show charges brought by OSHA to be frivolous.
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White House Pushing for Late July CAFTA Vote
Hoping to capitalize on its win in the Senate, the
White House is rallying CAFTA supporters and pushing House leadership
for a late July
vote. Meanwhile, opponents of the Central American trade pact are trying
to politicize the vote by letting supporters know that a “yes” vote
on CAFTA means they’ll face a 2006 election issue.
The vote, according to House leadership, would likely be one of the
last cast before Congress recesses for August. The fate of the 2006
election political strategy, first put forward by Democrat leadership,
hinges on several undecided House Democrats who are not in line with
general party opposition over insufficient labor protections. Some
Republicans who would likely vote against CAFTA have been riled over
the Democratic election strategy and may vote for the trade pact out
of party loyalty.
At issue are labor, sugar and textile issues that put members from
these states in a precarious political position. GOP and Democrat members
from these states are getting serious pressure from both sides of the
CAFTA issue. Right now, five Democrats are publicly supporting CAFTA,
with estimates of how many will vote “yes” ranging from
10 to 20 members.
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House Names Energy Conferees; MTBE, RFS Among Hurdles Under White House and Congressional leadership pressure
to finish conference committee action on the comprehensive energy package
before
the August recess,
the House named its conferees this week. This action set up a race
to finish the conference, pass the bill through both chambers and get
it to the President’s desk in three weeks.
House and Senate conferees held their first meeting
late in the week, but no substantive issues were discussed, “just
a willingness to work in a bipartisan fashion and meet the President’s
goal of a bill before the August recess,” said one staffer.
Major hurdles in the conference include liability protections for
makers of MTBE, a gasoline additive, included in the House bill but
not in the Senate version. A Democrat move this week in the House to
instruct conferees to reject the MTBE language failed. Rep. Joe Barton
(R-TX), chair of the House Energy & Commerce Committee, has a compromise
on MTBE he’ll present to the Senate conferees soon, he reported
this week.
Other sticking points include the level of alternative fuels diesel
refiners must blend in their diesel and gasoline under the Renewable
Fuels Standard (RFS). The House bill mandates five billion gallons
by 2012; the Senate bill calls for eight billion gallons. The House
bill would allow oil and gas exploration in the Arctic National Wildlife
Refuge, language the Senate rejected twice in last session’s
energy effort and not included in this version of the bill. The Senate
bill mandates electric utilities to generate 10% of their electricity
from renewable sources by 2020, a provision opposed by House leadership.
Another hurdle to overcome is the cost of tax incentives. The Senate
approved $18 billion over 10 years, with $4 billion in identified offsets.
The House approved $8 billion in tax breaks, and the White House wants
both chambers to hold the line at less than $7 billion.
Return to top Highway Conference Set to Wrap Up Next Week
House and Senate highway program reauthorization conferees
hope to wrap up work by the end of next week as staff meets through
the weekend
to meet a July 18 deadline for presenting a conference report to members
for a July 19 signoff. The vote on the highway package could come as
early as the afternoon of July 19.
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New Bills
A number of new bills have been introduced. Click
here to send a request for a copy of the text or more information about
the bill.
S.1373
Sen. Sam Brownback (R-KS) introduced a bill that would prohibit human
chimeras.
H.CON.RES.204
Rep. Robert Andrews (D-NJ) offered a resolution on obesity in the United
States.
H.R.3250
A bill proposed by Rep. Bart Gordon (D-TN) would authorize appropriation
for the National Aeronautics & Space Administration.
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