US ■ 39
C&CI
risk-based approach to inspection that recog-
The removal of the
One of the chemicals that was identified in
nizes the important role played by states and the notice, styrene, filed suit and was granted March 2010
competent foreign authorities, in addition to
consumptive demand
a preliminary injunction to prevent listing of
proposals giving the FDA stronger enforce-
language would give customs
styrene as a Proposition 65 carcinogen
ment powers.
agents unilateral authority to
based on its IARC 2B listing. Coffee is an
Like its House companion passed in July, IARC 2B listed chemical as well. In awarding
S. 510 would grant the Food and Drug
prohibit entry should they
the preliminary injunction the court indicated
Administration (FDA) authority to oversee suspect forced or indentured that having ‘limited evidence’ of carcinogeni-
everything from food production and pro-
child labour was used to
ty, as is the case in styrene (and coffee),
cessing to distribution and retail, and to does not constitute ‘sufficient evidence,’ as is
ensure that imported food meets US safety
produce the coffee
required under Proposition 65 listing and
standards. One area where the bills differ is in labelling requirements. A hearing was held on
that the Senate bill does not include a yearly Each chamber will then approve the November 9th, but the date when the court
fee to help pay for the increased oversight. negotiated bill and send the legislation to will issue its final decision is uncertain.
President Obama for his signature, which he Listed products are exempt from con-
Some of the revisions made by the HELP is expected to sign. Chairman Harkin was sumer warning labels for the first 12 months
committee include the following: quoted as saying that with healthcare still after they are listed, if either the federal gov-
unresolved, it would be difficult for the full ernment governs warnings for the product in■ Traceability. The amended bill contains a
new section requiring FDA to establish a pilot Senate to complete consideration on food a pre-emptive manner (which is not the case
project for tracing processed food. In addi- safety by the end of 2009, so it looks like for coffee), or if it can be proven that expo-
tion, the bill contains new language specify- final Senate action and a conference with sure to the product poses no significant risk
ing that when establishing tracing require- the House will not likely occur until some- based on average daily consumption over a
ments for produce, the FDA may only require time in 2010. 70 year lifetime.
farms to provide distribution records that are The NCA's Scientific Advisory Group
kept in the normal course of business and
California Chamber of
(SAG) is in the process of evaluating scientific
that show the immediate subsequent recipi- research firms to see if a case can be devel-
ent, other than a consumer.
Commerce appeals
oped for an exemption to labelling based on
a lifetime exposure argument – that is, that■ Testing. Using language similar to the
Labour Code Case
House bill, the amended Senate bill would there is no evidence that the average con-
require food facilities to verify that the preven- Appeal briefs were filed by the California sumption of coffee, by a California coffee
tive controls are working, "including through Chamber of Commerce on November 25th drinker, over a 70 year lifetime, causes an
the use of environmental and product testing challenging the ability of the state's Office of increased risk of bladder cancer.
programmes and other appropriate means." Environmental Health Hazard Assessment
In addition, the bill contains new language (OEHHA) to automatically, without scientific
Acrylamide issue
allowing FDA to decide that it does not want review, move substances from a Labour
to receive certain test results directly from Code list to a Proposition 65 list, thereby The NCA continues to draft industry com-
accredited labs, if such reporting would not deeming the substances as carcinogenic ments in response to a notice in the Federal
protect the public health. pursuant to Proposition 65. Register in August, seeking data and infor-
■ Accreditation. The bill would require FDA The challenge specifically involved mation on methods for reducing acrylamide
to recognize accreditation bodies that OEHHA's use of what it describes as the levels in food as well as reductions that
accredit third-party auditors to certify facilities ‘Labour Code Mechanism’ to justify list- manufacturers have been able to achieve in
as meeting the requirements of the Act. If ings. The initial round of litigation was acrylamide levels. The FDA notice originally
FDA has not recognized an accreditation unsuccessful. had a deadline of November 24th 2009; that
body within one year of enactment, the Coffee is on the Labour Code list, and the deadline was extended to January 24th
agency would be authorized to directly NCA assisted in the funding of the initial litiga- 2010.
accredit third-party auditors. tion and is helping to fund the appeal as well. Acrylamide is generated in coffee during
■ Fees. The bill clarifies that fees assessed In addition, the NCA is an active participant in the roasting process. Current findings show
for recall-related activities only would be regular and frequent legal strategy confer- that the variation of processing conditions,
imposed against those facilities that do not ences with the Chamber's legal team to including roasting conditions, do not provide
comply with a mandatory recall order. ensure that coffee's interests are represented. opportunities to substantially reduce the level
Now that S. 510 has been approved by It is expected that the appeal will not be of acrylamide without compromising taste
the HELP Committee, it will next be consid- heard until late spring of 2010. and aroma.
ered by the full Senate. Prior to and during In related Labour Code litigation, In formulating its response to the FDA
the floor debate, the bill could be revised. The OEHHA in July published a notice of intent notice, the NCA is seeking to partner in a
expectation is that S. 510 will be passed by to list certain Labour Code chemicals. workshop with other members of the food
the Senate with some further amendments, Coffee was not on the notice of intent to industry. The objective is to get the word out
still undetermined. After Senate approval, list and was not one of the chemicals that the food industry is doing something
members from the House and Senate will identified by name when the Sierra Club about acrylamide and that guidance is a bet-
conference to work out any remaining differ- filed a motion for summary adjudication in ter risk management tool for governments
ences between the two bills. late 2008. than setting regulation standards. ■ C&CI
Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52